Patent Application
20100310682
The present invention relates to a pharmaceutical composition or a healthcare food manufactured from the raw materials including ginsenoside Rg1 and Rb1, glycyrrhizic acid and jujuba cyclic adenosine monophosphate (jujuba cAMP) for treating anxiety disorder. In particular, the present invention relates to the pharmaceutical composition or the healthcare food for treating anxiety disorder; it has definite functions and components, obvious curative effect, fewer side effects and high safety for long-term usage.
Psychological disorders are caused by brain dysfunction and afflicted individuals show abnormalities in awareness, thought, emotion, behavior, will and intelligence, etc. Psychological disorders occupy four in ten diseases, causing the most serious load in society. People are now paying more and more attention to psychological dysfunction in the course of social development. The medical community and the society as a whole are urgently seeking psychological medicine to combat psychological disorders. Anxiety disorder is one common psychological dysfunction, with anti-anxiety pharmaceuticals being the main method of treatment.
Anxiety disorder is a psychological disease manifest mainly as anxious emotion. The main characteristics are breakout or continuous anxious emotions such as anxiety, catatonia and fear, etc., in combination with syndromes such as autonomic nerves disturbance, muscle rigidity and exercise disturbance, etc. Since Sigmund Freud had separated anxiety disorder from neurasthenia, scholars around the world have begun large-scale studies on anxiety disorder and have accumulated a large amount of data. According to modern medical research, the etiology of anxiety disorder includes defects in psychological anatomy, neurotransmitter/modulator-receptor and neuro-endocrine system, etc.
The current mainstream anti-anxiety medicine is benzodiazepine the mechanism of which is to modulate the activity of the inhibitory neurotransmitter, gamma-aminobutyric acid (GABA), to reduce and relieve the symptoms. However, benzodiazepine has many side effects including insomnolence, allergy, muscle pain, weakness, nausea, exercise dysfunction, blurred vision, weariness, disturbance and delusion, etc.
In light of the current situation, the search for a new generation of pharmaceuticals with fewer side effects and more pronounced/potent anti-anxiety qualities has become the center of attention of the entire pharmaceutical world.
It is therefore attempted by the applicant to deal with the above situation encountered in the prior art.
The purpose of the present invention is to provide a pharmaceutical composition or a healthcare food to overcome the insufficiency of the currently available treatments for anxiety disorder. The pharmaceutical composition or a healthcare food is manufactured from the raw materials including ginsenoside Rg1 and Rb1, glycyrrhizic acid and jujuba cAMP for treating anxiety disorder. In particular, the new technical scheme offering definite functions and components, obvious curative effect, fewer side effects and high safety for long-term usage is provided.
The technical scheme of the present medicine is the result endeavored by the inventor. The scheme, employing three raw materials including ginseng, liquorice and jujuba, is developed based on the pathological and pharmacological theories of modern medicine for treating anxiety; specifically, it integrates past pharmaceutical-targeted research with the recent knowledge developed in post-receptor mechanism. Ginsenoside from ginseng has adenylate cyclase (AC) activity to stimulate cAMP synthesis and cAMP phosphodiesterase (CAPD) inhibitory activity to reduce cAMP breakdown; glycyrrhizic acid (and glycyrrhetinic acid) from liquorice are strong inhibitors of CAPD. Ginsenoside Rg1 and Rb1 and glycyrrhizic acid when paired and used collectively further increase the concentration and activity of cAMP and protein kinase A (PKA) respectively in the organism. The increasing concentration and activity of cAMP can catalyze the phosphorylation of GABA α/β subunits and phosphorylation of the β subunit thereof can amplify the inhibitory function of GABA on neurons to achieve significant anti-anxiety functions. Finally, jujuba cAMP from jujube, being the extrinsic non-hydrolyzable cAMP, can participate in the metastasis of cAMP in the organism, stimulating the enzyme function and effectively increasing the expression of cAMP and PKA in the organism, to further enhance the anti-anxiety function. Accordingly, the raw materials including ginsenoside Rg1 and Rb1, glycyrrhizic acid and jujuba cAMP are combined to maximize the effects of anti-anxiety function of the present invention. Ginseng, liquorice and jujuba are commonly used pharmaceutical materials in Chinese medicine and have been used in dietary nourishing medicinal meals for several thousand years. In this long clinical and dietary history, the safety and efficacy of combined use of ginseng, liquorice and jujuba have been sufficiently proven. The inventor's research and experimental results have shown that if these three pharmaceutical materials are only normally decocted and extracted to obtain the extract, the extract does not have significant anti-anxiety effect compared with the mainstream anti-anxiety medicines of the present technology. However, upon further purification of the extract of these three pharmaceutical materials to increase the concentration of the effective components containing ginsenoside Rg1 and Rb1, glycyrrhizic acid and jujuba cAMP, etc., as described in this invention, a pharmaceutical composition with significant anti-anxiety function is obtained. Animal experimental results clearly demonstrate that the manufactured pharmaceutical composition of the present invention has superior anti-anxiety effect compared with the pharmaceutical composition of the mainstream medicine, Diazepam, for treating anxiety disorder. Furthermore, taking ginseng, liquorice and jujuba would not generate side effects as taking the present mainstream medicines for treating anxiety. Patients would not cease or refuse the pharmaceutical therapy for worrying about the side effects. The inventor thus submits that ginsenoside Rg1 and Rb1, glycyrrhizic acid and jujuba cAMP be the raw materials for manufacturing the pharmaceutical composition or the healthcare food for treating anxiety disorder. In particular, the new technical scheme, which has definite functions and components, high safety for long-term usage without side effects, improves the drawbacks generated in the prior art.
Glycyrrhetinic acid has higher liposolubility than glycyrrhizic acid and can easily enter the brain through the blood-brain barrier. Since the glycyrrhizic acid is converted to glycyrrhetinic acid in the human body with almost 100% efficiency, the inhibition of CAPD by glycyrrhizic acid is proceeded by transforming glycyrrhizic acid to glycyrrhetinic acid in the body. Accordingly, glycyrrhizic acid or glycyrrhetinic acid can be the raw material for manufacturing the pharmaceutical composition of the present invention.
In accordance with one aspect of the present invention, a pharmaceutical composition for treating anxiety disorder is provided. The pharmaceutical composition includes: ginsenoside having Rg1 and Rb1; a glycyrrhizically related acid being one selected from a group consisting of glycyrrhizic acid, glycyrrhetinic acid and a combination thereof; and jujuba cAMP.
Preferably, the pharmaceutical composition includes 2˜24 parts by weight of ginsenoside, 3˜45 parts by weight of the glycyrrhizically related acid and 0.003˜0.4 parts by weight of jujuba cAMP.
Preferably, the pharmaceutical composition includes 4˜11 parts by weight of ginsenoside, 5˜14 parts by weight of the glycyrrhizically related acid and 0.01˜0.07 parts by weight of jujuba cAMP.
Preferably, ginsenoside is extracted from ginseng, the glycyrrhizically related acid is extracted from liquorice, and jujuba cAMP is extracted from jujuba.
Preferably, jujuba is extracted for obtaining a first extract having a first jujuba cAMP concentration, the first extract is further extracted for obtaining a second extract having a second jujuba concentration, and the second jujuba cAMP concentration is higher than the first jujuba cAMP concentration.
Preferably, the pharmaceutical composition further includes at least one of a pharmacologically acceptable carrier and an additive.
Preferably, the pharmaceutical composition has a dosage form selected from a group consisting of a tablet, a capsule, a powder, a pill, a dust, a solution, a microcapsule, a suspension, an emulsion, a particle, a dropping pill and a roll.
Preferably, the pharmaceutical composition is manufactured as one of a healthcare food and a supplement.
In accordance with another aspect of the present invention, a pharmaceutical composition for treating anxiety disorder is provided. The pharmaceutical composition includes: ginsenoside having Rg1 and Rb1; and a glycyrrhizically related acid being one selected from a group consisting of glycyrrhizic acid, glycyrrhetinic acid and a combination thereof.
Preferably, the pharmaceutical composition includes 2˜24 parts by weight of ginsenoside Rg1 and Rb1, and 3˜45 parts by weight of the glycyrrhizically related acid.
Preferably, the pharmaceutical composition includes 4˜11 parts by weight of ginsenoside Rg1 and Rb1, and 5˜14 parts by weight of the glycyrrhizically related acid.
In accordance with another aspect of the present invention, a pharmaceutical composition for treating anxiety disorder is provided. The pharmaceutical composition includes ginseng, liquorice and jujuba.
Preferably, the pharmaceutical composition includes 4˜58 parts by weight of ginseng, 2˜28 parts by weight of liquorice and 2˜38 parts by weight of jujuba.
Preferably, the pharmaceutical composition includes 10˜26 parts by weight of ginseng, 5˜13 parts by weight of liquorice and 4˜16 parts by weight of jujuba.
In accordance with another aspect of the present invention, a pharmaceutical composition for treating anxiety disorder is provided. The pharmaceutical composition includes ginseng and liquorice.
Preferably, the pharmaceutical composition includes 4˜58 parts by weight of ginseng and 2˜28 parts by weight of liquorice.
Preferably, the pharmaceutical composition includes 10˜26 parts by weight of ginseng and 5˜13 parts by weight of liquorice.
In accordance with another aspect of the present invention, a preparation method of jujuba cAMP of a pharmaceutical composition for treating anxiety disorder is provided. The preparation method includes steps of: (a) extracting jujuba for obtaining a first extract having a first jujuba cAMP concentration; and (b) purifying the first extract for obtaining a second extract having a second jujuba cAMP concentration. The second jujuba cAMP concentration is higher than the first jujuba cAMP concentration.
Preferably, step (b) is processed by chromatographing the first extract with a macroporous resin bound with an aldehyde group.
Preferably, step (b) further includes steps of: (b1) chromatographing the first extract with an OU-2 macroporous resin bound with an aldehyde group; and (b2) chromatographing the first extract with an ME-2 macroporous resin bound with the aldehyde group.
The pharmaceutical composition described in the specification and the claims of the present invention for treating anxiety disorder is the core content of the present invention. After the present invention is published, one skilled in the art can proceed the normal increase/decrease or substitute for other effective components of the herbal medicine (such as onjisaponin, saikosaponin and liquorice coumarin, etc.) having identical effects/functions to the above-mentioned medicine in accordance with the theory of Chinese medicine or related theory of modern pharmacology. The substitutions of this normal increase/decrease, the herbal medicine having similar mechanism, other identical CAPD inhibitor, AC activator, or corresponding effective components belong to the normal technical activities for one skilled in the art. Therefore, the substitutions are in the protecting scope of the present invention.
The above objectives and advantages of the present invention will become more readily apparent to those ordinarily skilled in the art after reviewing the following detailed descriptions and accompanying drawings, in which:
The present invention will now be described more specifically with reference to the following Embodiments. It is to be noted that the following descriptions of preferred Embodiments of this invention are presented herein for purpose of illustration and description only; it is not intended to be exhaustive or to be limited to the precise form disclosed.
In order to accomplish the purpose of the present invention, the technical schemes of the present invention are particularly provided as follows.
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials of ginseng and liquorice.
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials having 4˜58 parts by weight of ginseng and 2˜28 parts by weight of liquorice.
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials having 10˜26 parts by weight of ginseng and 5˜13 parts by weight of liquorice.
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials of ginseng, liquorice and jujuba.
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials having 4˜58 parts by weight of ginseng, 2˜28 parts by weight of liquorice and 2˜38 parts by weight of jujuba.
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials having 10˜26 parts by weight of ginseng, 5˜13 parts by weight of liquorice and 4˜16 parts by weight of jujuba.
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials of ginsenoside Rg1 and Rb1, and glycyrrhizic acid (or glycyrrhetinic acid).
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from 2˜24 parts by weight of ginsenoside Rg1 and Rb1, and 3˜45 parts by weight of glycyrrhizic acid (or glycyrrhetinic acid).
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from 4˜11 parts by weight of ginsenoside Rg1 and Rb1, and 5˜14 parts by weight of glycyrrhizic acid (or glycyrrhetinic acid).
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials of the ginseng extract having the above-mentioned parts by weight of ginsenoside Rg1 and Rb1, and the liquorice extract having the above-mentioned parts by weight of glycyrrhizic acid.
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials of ginsenoside Rg1 and Rb1, glycyrrhizic acid (or glycyrrhetinic acid) and jujuba cAMP.
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials having 2˜24 parts by weight of ginsenoside Rg1 and Rb1, 3˜45 parts by weight of glycyrrhizic acid (or glycyrrhetinic acid) and 0.003˜0.4 parts by weight of jujuba cAMP.
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials having 4˜11 parts by weight of ginsenoside Rg1 and Rb1, 5˜14 parts by weight of glycyrrhizic acid (or glycyrrhetinic acid) and 0.01˜0.07 parts by weight of jujuba cAMP.
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials of the ginseng extract having the above-mentioned parts by weight of ginsenoside Rg1 and Rb1, the liquorice extract having the above-mentioned parts by weight of glycyrrhizic acid, and the jujuba extract having the above-mentioned parts by weight of jujuba cAMP.
The pharmaceutical composition of the present invention is provided, wherein the raw material having jujuba cAMP is the second extract described as follows. First, jujuba is extracted for obtaining the first extract, then the first extract is further extracted for obtaining the second extract, wherein the jujuba cAMP concentration of the second extract is higher than that of the first extract.
The preparation method of the pharmaceutical composition including the raw material of jujuba cAMP is provided. The preparation method thereof includes the steps as follows.
(a) Jujuba is extracted for obtaining a first extract; and
(b) the first extract is further purified for obtaining a second extract, and the jujuba cAMP concentration of the second extract is higher than that of the first extract.
In the aforementioned preparation method, the step (b) is processed by chromatographing, absorbing and separating jujuba cAMP of the first extract with the macroporous resin bound with the aldehyde group.
In the aforementioned preparation method, the step (b) is processed by chromatographing, absorbing and separating jujuba cAMP of the first extract with the OU-2 macroporous resin bound with the aldehyde group.
In the aforementioned preparation method, the step (b) is processed by chromatographing, absorbing and separating jujuba cAMP of the first extract with the ME-2 macroporous resin bound with the aldehyde group.
The pharmaceutical composition of the present invention includes the pharmacologically acceptable carriers or additives.
The pharmaceutical composition of the present invention can be manufactured as a dosage form, and the dosage forms is selected from any one of a tablet, a capsule, a powder, a pill, a dust, a solution, a microcapsule, a suspension, an emulsion, a particle, a dropping pill, a roll and the pharmacologically oral pharmaceutical dosage form.
The pharmaceutical composition of the present invention further can be manufactured as healthcare food and nutrient supplements.
In order to accomplish the purpose of the present invention, the preparation methods of the pharmaceutical composition are provided as follows.
Method 1:
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the extract having ginsenoside Rg1 and Rb1 and glycyrrhizic acid, wherein the extract is extracted and purified from the raw materials having 4˜58 parts by weight of ginseng and 2˜28 parts by weight of liquorice.
Method 2:
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the extract having ginsenoside Rg1 and Rb1 and glycyrrhizic acid, wherein the extract is extracted and purified from the raw materials having 10˜26 parts by weight of ginseng and 5˜13 parts by weight of liquorice.
Method 3:
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the extract having ginsenoside Rg1 and Rb1, glycyrrhizic acid and jujuba cAMP, wherein the extract is extracted and purified from the raw materials having 4˜58 parts by weight of ginseng, 2˜28 parts by weight of liquorice and 2˜38 parts by weight of jujuba.
Method 4:
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the extract having ginsenoside Rg1 and Rb1, glycyrrhizic acid and jujuba cAMP, wherein the extract is extracted and purified from the raw materials having 10˜26 parts by weight of ginseng, 5˜13 parts by weight of liquorice and 4˜16 parts by weight of jujuba.
Method 5:
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from (1) the extracts having ginsenoside Rg1 and Rb1 extracted and purified from ginseng, and glycyrrhizic acid extracted and purified from liquorice; or (2) the prepared raw materials having ginsenoside Rg1 and Rb1, and glycyrrhizic acid (or glycyrrhetinic acid).
Method 6:
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials having 2˜24 parts by weight of ginsenoside Rg1 an Rb1, and 3˜45 parts by weight of glycyrrhizic acid (or glycyrrhetinic acid).
Method 7:
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials having 4˜11 parts by weight of ginsenoside Rg1 an Rb1, and 5˜14 parts by weight of glycyrrhizic acid (or glycyrrhetinic acid).
Method 8:
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from (1) the extracts having ginsenoside Rg1 and Rb1, glycyrrhizic acid and jujuba cAMP respectively extracted and purified from ginseng, liquorice and jujuba; or (2) the prepared raw materials having ginsenoside Rg1 and Rb1, glycyrrhizic acid (or glycyrrhetinic acid) and jujuba cAMP.
Method 9:
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials having 2˜24 parts by weight of ginsenoside Rg1 an Rb1, 3˜45 parts by weight of glycyrrhizic acid (or glycyrrhetinic acid) and 0.003˜0.4 parts by weight of jujuba cAMP.
Method 10:
The pharmaceutical composition of the present invention for treating anxiety disorder is manufactured from the raw materials having 4˜11 parts by weight of ginsenoside Rg1 an Rb1, 5˜14 parts by weight of glycyrrhizic acid (or glycyrrhetinic acid) and 0.01˜0.07 parts by weight of jujuba cAMP.
Method 11:
The preparation method of the pharmaceutical composition including the raw material of jujuba cAMP is provided. The preparation method thereof includes the steps as follows.
(a) Jujuba is extracted for obtaining a first extract; and
(b) the first extract is further purified for obtaining a second extract, and the jujuba cAMP concentration of the second extract is higher than that of the first extract.
Method 12:
In the aforementioned preparation method, the step (b) is processed by chromatographing, absorbing and separating jujuba cAMP of the first extract with the macroporous resin bound with the aldehyde group.
Method 13:
In the aforementioned preparation method, the step (b) is processed by chromatographing, absorbing and separating jujuba cAMP of the first extract with the OU-2 macroporous resin bound with the aldehyde group.
Method 14:
In the aforementioned preparation method, the step (b) is processed by chromatographing, absorbing and separating jujuba cAMP of the first extract with the ME-2 macroporous resin bound with the aldehyde group.
Method 15:
The pharmaceutical composition of the present invention includes the pharmacologically acceptable carriers or additives.
Method 16:
The pharmaceutical composition of the present invention can be manufactured as a dosage form, and the dosage forms is selected from any one of a tablet, a capsule, a powder, a pill, a dust, a solution, a microcapsule, a suspension, an emulsion, a particle, a dropping pill, a roll and the pharmacologically oral pharmaceutical dosage form.
Method 17:
The raw materials described in the present invention can be manufactured as the medicines, healthcare food and nutrient supplements for treating anxiety disorder in accordance with the Good Manufacturing Practice (GMP) pharmaceutical standards and the method of healthcare food producing/manufacturing standards.
The present invention is further illustrated as follows by combining the figures and the preferred embodiments.
Please refer to
Please refer to
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Please refer to
Afterwards, after 150 g of the ginseng extract and 200 g of the liquorice extract obtained in Embodiment 1 are pulverized and mixed with 3 g of the above-mentioned jujuba extract, and 353 g of the pharmaceutical composition (containing 22.5 g of ginsenoside Rg1 and Rb1, 20 g of glycyrrhizic acid and 0.03 g of jujuba cAMP) of the present invention is obtained (403).
Please refer to
Please refer to
1.1 Experimental animals: Kunming (KM) mice, male, 24˜26 g of body weight, secondary, are provided by the Experimental Animal Science Department of Capital Medical University, Beijing.
1.2 Experimental pharmaceuticals: The pharmaceutical of Embodiment 1 is provided by Beijing Wonner Biotech. Ltd. Co., and Diazepam is the product of Tianjin Jinhuei Amino Acid Co. Ltd.
1.3 Experimental equipment: Self-made light-dark transition box.
1.4 Dose designs: 1. High dose of Embodiment 4 (80 mg/kg/d); 2. middle dose of Embodiment 4 (40 mg/kg/d); and 3. low dose of Embodiment 4 (20 mg/kg/d).
1.5 Experimental Method and Result:
1.5.1 Group division and administration of drug: The mice are grouped randomly as 5 groups, and 10 mice are in each group. 1. High dose of Embodiment 1 (80 mg/kg); 2. middle dose of Embodiment 1 (40 mg/kg); 3. low dose of Embodiment 1 (20 mg/kg); 4. Diazepam (2.5 mg/kg); and 5. physiological saline (normal saline, NS). The drugs are fed into the mouse stomach once every day, and the mouse is administered for continuous 7 days. During the period of administration, the mouse eats and drinks freely, and the experiment is proceeded after 1 hour of the last administration of drug on the eighth day.
1.5.2 Experimental Method:
Mouse light-dark transition test: The dark chamber occupies one third of the light-dark transition chamber (44 cm×21 cm×21 cm), and the top is capped. The light chamber occupies two third thereof and is illuminated brightly. A door between two chambers is disposed for the passage of the mouse. The mouse is placed in the center of the light chamber when the experiment begins, and the mouse's back faces the dark chamber. The times that the mouse enters into the dark chamber and returns to the light chamber within 10 minutes are determined, and the times thereof are the index for evaluating the anti-anxiety function of the drugs.
1.5.3 Statistic calculation: The experimental data are represented as
1.5.4 Experimental result: Please refer to Table 1.
1.6 Description: The light-dark transition experiment adopted in the present experiment is built up on the basis that the mouse congenitally hates the bright light and the voluntary exploring behavior to the new environment. The clinical medicine (Diazepam) for treating anxiety in human beings and the Embodiment 1 have excellent correlation on improving the function of the increasing voluntary exploring behavior on this mouse model. According to the above experiment, it can be found that the high, middle and low doses of Embodiment 1 of the present invention and Diazepam all significantly increase the times that the mouse passes from the dark chamber to the light chamber, and have statistical meanings while comparing with the physiological saline. The experimental result has proven that the Embodiment 1 has anti-anxiety effect.
1.7 Conclusion: According to the above experimental result, it shows that the high, middle and low doses of Embodiment 1 of the present invention and Diazepam all significantly increase the times that the mouse passes from the dark chamber to the light chamber. The result shows the Embodiment 1 having anti-anxiety effect.
2.1 Experimental animals: Kunming (KM) mice, male, 24˜26 g of body weight, secondary, are provided by the Experimental Animal Science Department of Capital Medical University, Beijing.
2.2 Experimental pharmaceuticals: The pharmaceutical of Embodiment 4 is provided by Beijing Wonner Biotech. Ltd. Co., and Diazepam is the product of Tianjin Jinhuei Amino Acid Co. Ltd.
2.3 Experimental equipment: Self-made light-dark transition box.
2.4 Dose designs: 1. High dose of Embodiment 4 (80 mg/kg/d); 2. middle dose of Embodiment 4 (40 mg/kg/d); and 3. low dose of Embodiment 4 (20 mg/kg/d).
2.5 Experimental Method and Result:
2.5.1 Group division and administration of drug: The mice are grouped randomly as 5 groups, and 10 mice are in each group. 1. High dose of Embodiment 4 (80 mg/kg); 2. middle dose of Embodiment 4 (40 mg/kg); 3. low dose of Embodiment 4 (20 mg/kg); 4. Diazepam (2.5 mg/kg); and 5. physiological saline (normal saline, NS). The drugs are fed into the mouse stomach once every day, and the mouse is administered for continuous 7 days. During the period of administration, the mouse eats and drinks freely, and the experiment is proceeded after 1 hour of the last administration of drug on the eighth day.
2.5.2 Experimental Method:
Mouse light-dark transition test: The dark chamber occupies one third of the light-dark transition chamber (44 cm×21 cm×21 cm), and the top is capped. The light chamber occupies two third thereof and is illuminated brightly. A door between two chambers is disposed for the passage of the mouse. The mouse is placed in the center of the light chamber when the experiment begins, and the mouse's back faces the dark chamber. The times that the mouse enters into the dark chamber and returns to the light chamber within 10 minutes are determined, and the times thereof are the index for evaluating the anti-anxiety function of the drugs.
2.5.3 Statistic calculation: The experimental data are represented as
2.5.4 Experimental result: Please refer to Table 2.
2.6 Description: The light-dark transition experiment adopted in the present experiment is built on the basis that the mouse congenitally hates the bright light and the voluntary exploring behavior to the new environment. The clinical pharmaceutical (Diazepam) for treating anxiety in human beings and the Embodiment 4 have excellent correlation on improving the function of the increasing voluntary exploring behavior of the mouse on this model. According to the above experiment, it can be found that the high, middle and low doses of Embodiment 4 of the present invention and Diazepam all significantly increase the times that the mouse passes from the dark chamber to the light chamber, and have statistical meanings while comparing with the normal saline. The experimental result has proven that the Embodiment 4 has anti-anxiety effect.
2.7 Conclusion: According to the above experimental result, the high, middle and low doses of Embodiment 4 of the present invention and Diazepam all significantly increase the times that the mouse passes from the dark chamber to the light chamber. The result demonstrates the Embodiment 4 has anti-anxiety function.
The application scope of the pharmaceutical composition of the present invention for treating anxiety disorder lies in that:
1. the described pharmaceutical composition of the present invention for treating anxiety disorder can include the pharmacologically acceptable additives;
2. the described pharmaceutical composition of the present invention for treating anxiety disorder can be manufactured as the known dosage forms, such as powder, capsule, tablet, etc.; and
3. the described pharmaceutical composition of the present invention for treating anxiety disorder can be manufactured as the healthcare food for treating depression.
While the invention has been described in terms of what is presently considered to be the most practical and preferred Embodiments, it is to be understood that the invention needs not be limited to the disclosed Embodiments. On the contrary, it is intended to cover various modifications and similar arrangements included within the spirit and scope of the appended claims, which are to be accorded with the broadest interpretation so as to encompass all such modifications and similar structures.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/CN07/03398 | 11/30/2007 | WO | 00 | 8/23/2010 |
