Patent Application
20230022609
The present application claims priority to Chinese Patent Application Nos. 202110797470.5, filed on Jul. 14, 2021, and 202110797477.7, filed on Jul. 14, 2021, both of which are incorporated by reference for all purposes as if fully set forth herein.
The invention relates to the technical field of traditional Chinese medicine compositions and methods of preparing the same, in particular to a Polygoni Milletii Rhizome tincture, a Polygoni Milletii Rhizome poultice, and methods of preparing the same.
Polygoni Milletii Rhizome tablet has a small drug load and low bioavailability after oral administration. There is a need for Polygoni Milletii Rhizome compositions with high bioavailability.
In one embodiment, the present application discloses a method of preparing a Polygoni Milletii Rhizome tincture. The method includes: mixing 10-20 parts by mass of Polygoni Milletii Rhizome, 10-20 parts by mass of Gentianae Macrophyllae Radix, 5-10 parts by mass of Achyranthis Bidentatae Radix, 20-30 parts by mass of Salviae Miltiorrhizae Radix Et Rhizoma, 10-20 parts by mass of Acanthopanacis Cortex, 5-10 parts by mass of Valerianae Officinalis Rhizoma Et Radix, 5-10 parts by mass of Sambuci Rhizoma, and 5-10 parts by mass of Ampelopsis Humulifoliae Cortex to form a first mixture; extracting the first mixture with 70-90% ethanol under reflux condition to obtain a first extract solution; mixing 30-50 parts by mass of Angelicae Sinensis Radix, 20-30 parts by mass of Paridis Rhizoma, 1-3 parts by mass of Qingwaqi (Iris tectorum Maxim.), 1-3 parts by mass of Aconiti Radix, 1-3 parts by mass of Aconiti Kusnezoffii Radix, 1-3 parts by mass of Aconiti Penduli Radix, 1-3 parts by mass of Panacis Majoris Rhizoma, 5-10 parts by mass of Trachelospermi Caulisetfolium, 5-10 parts by mass of Aconitisungpanensis Radix, 5-10 parts by mass of Aucklandiae Radix, 5-10 parts by mass of Olibanum, 1-3 parts by mass of Daphnes Cortex, 1-5 parts by mass of Chloranthi Radix Et Rhizoma, 1-5 parts by mass of Hylomeconis Rhizoma, 10-20 parts by mass of Eucommiae Cortex, 5-10 parts by mass of Carthami Flos, 1-5 parts by mass of Silene Radix, 5-10 parts by mass of Myrrha, 1-5 parts by mass of Lycopodii Herba, 5-10 parts by mass of Polygoni Suffulti Rhizoma, and 5-10 parts by mass of Tupistrae Rhizoma to form a second mixture; extracting the second mixture with 50-70% ethanol to obtain a second extract solution; and mixing the first extract solution with the second extract solution to obtain the polygoni milletii rhizome tincture.
In another embodiment, the first extract solution and the second extract solution are mixed in a volume ratio of 2:3 to obtain the polygoni milletii rhizome tincture.
In another embodiment, the present application discloses a method of preparing a Polygoni Milletii Rhizome poultice. The method includes mixing 10-30 parts by mass of Polygoni Milletii Rhizome, 2-8 parts by mass of Silene Radix, 10-30 parts by mass of Acanthopanacis Cortex, 10-30 parts by mass of Eucommiae Cortex, 25-90 parts by mass of Angelicae Sinensis Radix, 1-4 parts by mass of Panacis Majoris Rhizoma, 1-4 parts by mass of Qingwaqi (Iris tectorum Maxim.), 5-15 parts by mass of Ampelopsis Humulifoliae Cortex, 10-30 parts by mass of Gentianae Macrophyllae Radix, 5-15 parts by mass of Aucklandiae Radix, 1-4 parts by mass of Daphnes Cortex, 5-15 parts by mass of Trachelospermi Caulisetfolium, 1-4 parts by mass of Aconiti Radix, 2-8 parts by mass of Chloranthi Radix Et Rhizoma, 1-4 parts by mass of Aconiti Penduli Radix, 1-4 parts by mass of Aconiti Kusnezoffii Radix, 2-8 parts by mass of Hylomeconis Rhizoma, 5-15 parts by mass of Polygoni Suffulti Rhizoma, 5-15 parts by mass of Carthami Flos, 5-15 parts by mass of Myrrha, 5-15 parts by mass of Tupistrae Rhizoma, 10-30 parts by mass of Valerianae Officinalis Rhizoma Et Radix, 2-8 parts by mass of Lycopodii Herba, 10-30 parts by mass of Achyranthis Bidentatae Radix, 15-40 parts by mass of Salviae Miltiorrhizae Radix Et Rhizoma, 5-15 parts by mass of Aconitisungpanensis Radix, 5-15 parts by mass of Sambuci Rhizoma, 15-40 parts by mass of Paridis Rhizoma, and 5-15 parts by mass of Olibanum to form a Polygoni Milletii Rhizome mixture; mixing the Polygoni Milletii Rhizome mixture and a skin penetration enhancer in water to form a first solution; mixing a moisturizing agent and a binder in water to form a second solution; adding a thickener in water to form a third solution; mixing methylparaben and ethylparaben in 90% ethanol to form a fourth solution; mixing the first solution, the second solution, the third solution, and the fourth solution to form a mixture; and applying the mixture on a non-woven fabric cloth and drying to form the Polygoni Milletii Rhizome poultice.
In another embodiment, the skin penetration enhancer is azone, oleic acid, or a mixture of azone and oleic acid; the moisturizing agent is glycerol, butylene glycol, or polyethylene glycol; the binder is sodium polyacrylate or kaolinite; and the thickener is sodium alginate, sodium carboxymethyl cellulose or sodium hydroxyethyl cellulose.
The present invention will be further described in detail below with reference to specific embodiments, which are to explain rather than limit the present invention.
10 g of Polygoni Milletii Rhizome, 10 of Gentianae Macrophyllae Radix, 5 g of Achyranthis Bidentatae Radix, 20 g of Salviae Miltiorrhizae Radix Et Rhizoma, 10 g of Acanthopanacis Cortex, 5 g of Valerianae Officinalis Rhizoma Et Radix, 5 g of Sambuci Rhizoma, and 5 g of Ampelopsis Humulifoliae Cortex were mixed and grinded, passed throught a 20 mesh sieve, added to 1,200 mL of 70% ethanol, refluxed and extracted three times, 1 hour each time, filtered, cooled down, and after 24 hours, filtered to obtain 1,118 mL of first extract solution. 30 g of Angelicae Sinensis Radix, 20 g of Paridis Rhizoma, 1 g of Qingwaqi (Iris tectorum Maxim.), 1 g of Aconiti Radix, 1 g of Aconiti Kusnezoffii Radix, 1 g of Aconiti Penduli Radix, 1 g of Panacis Majoris Rhizoma, 5 g of Trachelospermi Caulisetfolium, 5 g of Aconitisungpanensis Radix, 5 g of Aucklandiae Radix, 5 g of Olibanum, 1 g of Daphnes Cortex, 1 g of Chloranthi Radix Et Rhizoma, 1 g of Hylomeconis Rhizoma, 10 g of Eucommiae Cortex, 5 g of Carthami Flos, 1 g of Silene Radix, 5 g of Myrrha, 1 g of Lycopodii Herba, 5 g of Polygoni Suffulti Rhizoma, and 5 g of Tupistrae Rhizoma were added to 1,800 mL 50% ethanol, refluxed and extracted three times, 1 hour each time, filtered, cooled down, and after 24 hours, filtered to obtain 1,695 mL of second extract solution. The first extract solution and the second extract solution were mixed in a volume ratio of 2:3 to obtain 2,795 mL of polygoni milletii rhizome tincture.
Examples 2-5 were prepared in the same way as Example 1 but with diferent components as shown in the following table 1.
Comparative Examples 2-6 were prepared in the same way as Example 1 but with different components as shown in the following table 2.
tectorum Maxim.)
Analgesia experiment (twisting method) was conducted to determine the analgesic activity of the compositions of Examples 1-5 and Comparative Examples 1-6. The results are shown in Table 3.
Anti-inflammatory experiment (mouse auricle swelling method) was conducted to mesure, the anti-inflammatory activity of the compositions of Examples 1-5 and Comparative Examples 1-6. The results are shown in Table 4.
Anti-arthritis experiment (thirty-nine volunteers: 15 males and 14 females, divided into 13 groups.) was conducted to measure the anti-arthritis activities.
For the patients treated with the compositions of Examples 1-5, the redness and swelling disappeared within 11 days after the medication, and the pain disappeared within 14 days, no recurrence within 30 days.
For the patients treated with the compositions of Comparative Examples 1-6, the redness and pain disappeared within 26 days after the medication, and the recurrence rate was 22.2% within 30 days.
Polygoni Milletii Rhizome, Silene Radix, Acanthopanacis Cortex, Eucommiae Cortex, Angelicae Sinensis Radix, Panacis Majoris Rhizoma, Qingwaqi (Iris tectorum Maxim.), Ampelopsis Humulifoliae Cortex, Gentianae Macrophyllae Radix, Aucklandiae Radix, Daphnes Cortex, 5 Trachelospermi Caulisetfolium Aconiti Radix, Chloranthi Radix Et Rhizoma, Aconiti Penduli Radix, Aconiti Kusnezoffii Radix, Hylomeconis Rhizoma, Polygoni Suffulti Rhizoma, Carthami Flos, Myrrha, Tupistrae Rhizoma, Valerianae Officinalis Rhizoma Et Radix, Lycopodii Herba, Achyranthis Bidentatae Radix, Salviae Miltiorrhizae Radix Et Rhizoma were mixed in a ratio as shown in Table 5 to form a Polygoni Milletii Rhizome mixture;
Preparation of Polygoni Milletii Rhizome poultice:
(1) The Polygoni Milletii Rhizome mixture prepared above and 5 g of azone and oleic acid mixture (6:4) were added to 100 mL deionized water, and stirred to make evenly dispersed;
(2) 30 g of sodium polyacrylate was dispersed in 250 mL of glycerin, 420 mL of distilled water was added, and the mixture was stirred to make completely dissolved;
(3) 30 g of sodium alginate was dissolved in 150 mL of water, and let it stand overnight to fully swell and dissolve;
(4) 6 g of methylparaben and 6 g ethylparaben were dissolved in 70 mL of 90% ethanol to prepare a preservative solution;
(5) The solution of step (3) was added to the solution of (2), and the solution of step (1) and solution of step (4) were added consecutively to form a viscous fluid. The viscous fluid was immediately applied to 4 pieces of non-woven fabric cloth (55 cm*49 cm). The non-woven fabric cloth was dried in an oven at 40° C. The non-woven fabric cloth was cut into 70 pieces. Each piece contains 1.24 g of the Polygoni Milletii Rhizome poultice, which can effectively improve and treat arthritis.
Polygoni Milletii Rhizome, Silene Radix, Acanthopanacis Cortex, Eucommiae Cortex, Angelicae Sinensis Radix, Panacis Majoris Rhizoma, Qingwaqi (Iris tectorum Maxim.), Ampelopsis Humulifoliae Cortex, Gentianae Macrophyllae Radix, Aucklandiae Radix, Daphnes Cortex, 5 Trachelospermi Caulisetfolium Aconiti Radix, Chloranthi Radix Et Rhizoma, Aconiti Penduli Radix, Aconiti Kusnezoffii Radix, Hylomeconis Rhizoma, Polygoni Suffulti Rhizoma, Carthami Flos, Myrrha, Tupistrae Rhizoma, Valerianae Officinalis Rhizoma Et Radix, Lycopodii Herba, Achyranthis Bidentatae Radix, Salviae Miltiorrhizae Radix Et Rhizoma were mixed in a ratio as shown in Table 6 to form a Polygoni Milletii Rhizome mixture;
Preparation of Polygoni Milletii Rhizome poultice:
(2) 40 g of sodium polyacrylate was dispersed in 270 mL of glycerin, 600 mL of distilled water was added, and the mixture was stirred to make completely dissolved;
(3) 40 g of sodium alginate was dissolved in 180 mL of water, and let it stand overnight to fully swell and dissolve;
(4) 12 g of methylparaben and 12 g ethylparaben were dissolved in 70 mL of 90% ethanol to prepare a preservative solution;
(5) The solution of step (3) was added to the solution of (2), and the solution of step (1) and solution of step (4) were added consecutively to form a viscous fluid. The viscous fluid was immediately applied to 4 pieces of non-woven fabric cloth (55 cm*49 cm). The non-woven fabric cloth was dried in an oven at 40° C. The non-woven fabric cloth was cut into 70 pieces. Each piece contains 2.05 g of the Polygoni Milletii Rhizome poultice, which can effectively improve and treat arthritis.
Polygoni Milletii Rhizome, Silene Radix, Acanthopanacis Cortex, Eucommiae Cortex, Angelicae Sinensis Radix, Panacis Majoris Rhizoma, Qingwaqi (Iris tectorum Maxim.), Ampelopsis Humulifoliae Cortex, Gentianae Macrophyllae Radix, Aucklandiae Radix, Daphnes Cortex, 5 Trachelospermi Caulisetfolium Aconiti Radix, Chloranthi Radix Et Rhizoma, Aconiti Penduli Radix, Aconiti Kusnezoffii Radix, Hylomeconis Rhizoma, Polygoni Suffulti Rhizoma, Carthami Flos, Myrrha, Tupistrae Rhizoma, Valerianae Officinalis Rhizoma Et Radix, Lycopodii Herba, Achyranthis Bidentatae Radix, Salviae Miltiorrhizae Radix Et Rhizoma were mixed in a ratio as shown in Table 7 to form a Polygoni Milletii Rhizome mixture;
Preparation of Polygoni Milletii Rhizome poultice:
(1) The Polygoni Milletii Rhizome mixture prepared above and 15 g of azone and oleic acid mixture (6:4) were added to 100 mL deionized water, and stirred to make evenly dispersed;
(2) 60 g of sodium polyacrylate was dispersed in 300 mL of glycerin, 800 mL of distilled water was added, and the mixture was stirred to make completely dissolved;
(3) 60 g of sodium alginate was dissolved in 210 mL of water, and let it stand overnight to fully swell and dissolve;
(4) 20 g of methylparaben and 20 g ethylparaben were dissolved in 70 mL of 90% ethanol to prepare a preservative solution;
(5) The solution of step (3) was added to the solution of (2), and the solution of step (1) and solution of step (4) were added consecutively to form a viscous fluid. The viscous fluid was immediately applied to 4 pieces of non-woven fabric cloth (55 cm*49 cm). The non-woven fabric cloth was dried in an oven at 40° C. The non-woven fabric cloth was cut into 70 pieces. Each piece contains 3.99 g of the Polygoni Milletii Rhizome poultice, which can effectively improve and treat arthritis.
Example 12 was conducted in the same way as Example 10, except that 40 g of sodium polyacrylate was dispersed in 270 mL of butylene glycol (not glycerin). Each piece contains 2.06 g of the Polygoni Milletii Rhizome poultice, which can effectively improve and treat arthritis.
Example 13 was conducted in the same way as Example 10, except that 40 g of sodium polyacrylate was dispersed in 270 mL of polyethylene glycol (not glycerin). Each piece contains 2.06 g of the Polygoni Milletii Rhizome poultice, which can effectively improve and treat arthritis.
Example 14 was conducted in the same way as Example 10, except that 40 g of kaolinite (not sodium polyacrylate) was dispersed in 270 mL of glycerin. Each piece contains 2.05 g of the Polygoni Milletii Rhizome poultice, which can effectively improve and treat arthritis.
Example 15 was conducted in the same way as Example 10, except that the Polygoni Milletii Rhizome mixture and 10 g of azone (not azone and oleic acid mixture) were added to 100 mL deionized water. Each piece contains 2.05 g of the Polygoni Milletii Rhizome poultice, which can effectively improve and treat arthritis.
Example 16 was conducted in the same way as Example 10, except that the Polygoni Milletii Rhizome mixture and 10 g of oleic acid (not azone and oleic acid mixture) were added to 100 mL deionized water. Each piece contains 2.05 g of the Polygoni Milletii Rhizome poultice, which can effectively improve and treat arthritis.
Comparative Examples 7-13
Comparative Examples 7-13 were conducted in the same way Example 10, except Polygoni Milletii Rhizome was not added (Comparative Example 7), Paridis Rhizoma was not added (Comparative Example 8), Achyranthis Bidentatae Radix was not added (Comparative Example 9) Eucommiae Cortex was not added (Comparative Example 10), Acanthopanacis Cortex, Gentianae Macrophyllae Radix, and Valerianae Officinalis Rhizoma Et Radix were not added (Comparative Example 11), Salviae Miltiorrhizae Radix Et Rhizoma and Angelicae Sinensis Radix were not added (Comparative Example 12), and Aconiti Radix, Aconiti Kusnezoffii Radix, and Aconiti Penduli Radix were not added (Comparative Example 13).
Analgesia experiment (twisting method) was conducted to determine the analgesic activity of the compositions of Examples 9-11 and 15-16 and Comparative Examples 7-13. The results are shown in Table 8.
Anti-inflammatory experiment (mouse auricle swelling method) was conducted to mesure, the anti-inflammatory activity of the compositions of Examples 9-11 and 15-16 and Comparative Examples 7-13. The results are shown in Table 9.
Anti-arthritis experiment (forty-two volunteers: divided into 14 groups, 3 each group) was conducted to measure the anti-arthritis activities.
For the patients treated with the compositions of Examples 9-16, the redness and swelling disappeared within 11 days after the medication, and the pain disappeared within 21 days, no recurrence within 30 days.
For the patients treated with the compositions of Comparative Examples 7-13, the redness and pain disappeared within 28 days after the medication, and the recurrence rate was 47.6% within 30 days.
The above content is only to illustrate the technical idea of the present invention, and cannot limit the protection scope of the present invention. Any modification made on the basis of the technical solution proposed in accordance with the technical idea of the present invention falls within the scope of the claims of the present invention. within the scope of protection.
| Number | Date | Country | Kind |
|---|---|---|---|
| 202110797470.5 | Jul 2021 | CN | national |
| 202110797477.7 | Jul 2021 | CN | national |
