CN1265321A - Resina Draconis preparation as one Chinese medicine and its preparation process - Google Patents
Resina Draconis preparation as one Chinese medicine and its preparation process Download PDFInfo
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- CN1265321A CN1265321A CN 00114031 CN00114031A CN1265321A CN 1265321 A CN1265321 A CN 1265321A CN 00114031 CN00114031 CN 00114031 CN 00114031 A CN00114031 A CN 00114031A CN 1265321 A CN1265321 A CN 1265321A
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Abstract
The Resina Draconis preparation is one dispersive solid prepared through one mixing process to disperse Resina Draconis into very fine particle by means of water soluble dispersant. It has high water solubility and is easy to be absorbed by human body, so that it has very low consumption, about six to ten times lower than that of original Resina Draconis powder, in the case of reaching identical curative effect. Thus, the Resina Draconis preparation has the features of small dosage and high curative effect and this is favorable to protect the resource of Resina Draconis as one of valuable Chinese medicinal materials.
Description
The present invention relates to a kind of Chinese medicine Resina Draconis preparation as one and preparation method thereof.
The Ji Yuan of Chinese medicine Sanguis Draxonis comprises the not resin of the ten various plants different parts generation of equal genus such as Liliaceae, Palmae, pulse family, Euphorbiaceae, Agavaceae.Sanguis Draxonis in the record of China and use the history in existing more than 1,500 year at least, is one of traditional rare Chinese medicine kind as Chinese medicine.It has effects such as blood circulation promoting and blood stasis dispelling, putrefaction-removing granulation-promoting, hemostasis convergence, reducing swelling and alleviating pain, is described as " panacea of invigorating blood circulation ".At present, the Chinese medicine Sanguis Draxonis on China domestic market has import Sanguis Draxonis and domestic Dragon Blood.Domestic Dragon Blood be China this century the seventies develop from homemade Folium Dracaenae cambodianae, in order to the homemade Chinese crude drug of import substitution Sanguis Draxonis,, be listed in national Chinese crude drug and protect two class medical materials because resource is very limited.In recent years, to the basic research of Sanguis Draxonis with clinical practice deepens continuously and extensively, demonstrate the many-sided definite curative effect of Sanguis Draxonis, disclosing Sanguis Draxonis all has wide application prospect in fields such as internal medicine, surgery, department of obstetrics and gynecology, department of eye and Dermatologys.But because the dissolubility of Chinese medicine Sanguis Draxonis in water is very low, water-soluble hardly, its human bioavailability is very little.And up to the present, the production of Resina Draconis preparation as one and application also are in " original " state, promptly the water solublity and the human bioavailability of Sanguis Draxonis can be improved in the end, just grind to form the direct use of former medicated powder or former medicated powder is incapsulated use with the former medicine of Sanguis Draxonis, so, though each using dosage is bigger, but has only very the fraction utilization that is absorbed by the body, major part is excreted, and causes the significant wastage of resource, also increases the burden of consumer.
The purpose of this invention is to provide a kind of Chinese medicine Resina Draconis preparation as one than highly-water-soluble and bioavailability and preparation method thereof that has,, effectively utilize and protect this precious natural resources of Chinese medicinal materials of Sanguis Draxonis to reduce effective using dosage.
Chinese medicine Resina Draconis preparation as one of the present invention is a kind of Sanguis Draxonis fine-particle solid dispersion (Sanguis Draxonis solid dispersion), is mixed with solid dispersion and is made by Sanguis Draxonis, and the weight ratio of solid dispersion and Sanguis Draxonis is 16: 1～0.2: 1; Used solid dispersion is a cyclodextrin, or cellulose and derivant thereof, or Polyethylene Glycol, or poloxamer (Polyxamer) and sell and translate class (Myrij) surfactant.
In the above-mentioned Resina Draconis preparation as one weight ratio of solid dispersion and Sanguis Draxonis be preferably 8: 1～1: 1.Used Sanguis Draxonis can be an extensive stock Chinese medicine Sanguis Draxonis.
Above-mentioned said solid dispersion is generally: alpha-cyclodextrin, beta-schardinger dextrin-or gamma-cyclodextrin, or molecular weight is 1000～20000 Polyethylene Glycol, or methylcellulose (MC), ethyl cellulose (EC), hydroxypropyl methylcellulose (HPMC), cellulose acetate-phthalate (CAP), hydroxypropyl methylcellulose phthalate (HP-55), carboxymethylethylcellulose (CMEC) or microcrystalline Cellulose (MCC), or poloxamer (Polyxamer) 188 or Myrij class (Mymi) surfactant.
The amount of each composition involved in the present invention and proportioning unless otherwise indicated, all by weight calculating.
Chinese medicine Resina Draconis preparation as one of the present invention can adopt the preparation of wet grinding method.Concrete technology is: the water of solid dispersion with 0.3～3 times of amount is ground well, in solid dispersion: the ratio of Sanguis Draxonis=16: 1～0.2: 1 (being generally 8: 1～2: 1) adds the Sanguis Draxonis solution with the dissolution with solvents of 2～10 times of amounts, fully grind, make solid dispersion that Sanguis Draxonis is dispersed into superfine microgranule, dry then, sieve (can pulverize earlier before sieving), promptly get required Sanguis Draxonis fine-particle solid dispersion.
Used solvent can be ethanol, acetone or isopropyl alcohol in the invention described above method; Used drying means can be 40 ℃ of dryings, vacuum lyophilization or vacuum dryings.
Chinese medicine Resina Draconis preparation as one of the present invention also can adopt the preparation of dry grinding method.Concrete technology is: in solid dispersion: the ratio of Sanguis Draxonis=16: 1～0.2: 1, solid dispersion and the former medicated powder of Sanguis Draxonis are fully ground, and sieve then, promptly get required Sanguis Draxonis fine-particle solid dispersion.
Chinese medicine Resina Draconis preparation as one of the present invention---Sanguis Draxonis fine-particle solid dispersion can further be made capsule, tablet or regular dosage forms such as tincture, varnish according to a conventional method, uses with convenient.
Sanguis Draxonis fine-particle solid dispersion of the present invention is compared with the former medicated powder of Sanguis Draxonis, its water solublity greatly improves, the former medicated powder of Sanguis Draxonis is water-soluble hardly, and the water solubility of Sanguis Draxonis fine-particle solid dispersion of the present invention can be up to (being colloid solution) more than 60%, help organism and absorb, have high bioavailability.Prove that through animal experiment reaching under the prerequisite of equal curative effect, the effective dose of Sanguis Draxonis fine-particle solid dispersion of the present invention can be decreased to sixth to ten/one of the former medicated powder of Sanguis Draxonis, required dosage greatly reduces (referring to table 2, table 3).So the present invention can give full play to the effect of Sanguis Draxonis, improve curative effect, cut the waste, effectively utilize and protect this precious natural resources of Chinese medicinal materials of Sanguis Draxonis, also alleviated the burden of consumer simultaneously.
The invention will be further described to reach the test example by the following examples.
Embodiment 1 to 12: adopt the dry grinding method, each raw material and reagent dosage and conditional parameter are as shown in table 1.Concrete steps are: with reference to table 1, solid dispersion is ground well with water, add the Sanguis Draxonis solution with dissolution with solvents, fully grind evenly, then in 40 ℃ of dryings, pulverize the back and cross 50～80 mesh sieves, obtain required Sanguis Draxonis fine-particle solid dispersion.In the various embodiments described above, embodiment 1～9 solvent for use and solid dispersion are respectively ethanol and beta-schardinger dextrin-, embodiment 10 solvent for use and solid dispersion are respectively acetone and microcrystalline Cellulose (MC), embodiment 11 solvent for use and solid dispersion are respectively isopropyl alcohol and Polyethylene Glycol (molecular weight 4000～10000), and embodiment 12 solvent for use and solid dispersion are respectively ethanol and poloxamer (polyxamer) 188.Milling time in the table 1 is meant the milling time behind the adding Sanguis Draxonis solution.Temperature is a room temperature.
Embodiment 13: adopt the wet grinding method, 160 gram alpha-cyclodextrins and the former medicated powder of 10 gram Sanguis Draxonis are fully ground, sieve then, promptly get required product.
Embodiment 14: 80 gram carboxymethylethylcelluloses and the former medicated powder of 10 gram Sanguis Draxonis are fully ground, and other condition is with embodiment 13.
Embodiment 15: used carboxymethylethylcellulose is 10 grams, and other condition is identical with embodiment 14.
Embodiment 16: according to embodiment 14, carboxymethylethylcellulose wherein changes methylcellulose into, and other condition is identical.
The test example 1: the former medicated powder glue of Sanguis Draxonis solid dispersion of the present invention and existing Sanguis Draxonis assist (Sanguis Draxonis glue is assisted) to mice go out, clotting time influence comparison, laboratory animal is a white mice, does blank with 1%CMC-Na.The dosage of Sanguis Draxonis capsule and Sanguis Draxonis solid dispersion calculates by the amount of its contained Sanguis Draxonis.The mensuration in bleeding time adopts mice docking method, and the mensuration of clotting time adopts slide method.Result of the test is as shown in table 2.The result shows that Sanguis Draxonis solid dispersion oral administration of the present invention administration only needs capsular 1/6～1/10 dosage of Sanguis Draxonis, just can reach equal drug effect.
Test example 2: the former medicated powder glue of Sanguis Draxonis solid dispersion of the present invention and existing Sanguis Draxonis assists (Sanguis Draxonis glue is assisted) that the influence that rat suppository forms is compared.Laboratory animal is a rat, adopts oral administration, is blank with 1%CMC-Na.The dosage of Sanguis Draxonis capsule and Sanguis Draxonis solid dispersion calculates by the amount of its contained Sanguis Draxonis.Assay method adopts common carotid artery copper to practice the wet weight of thrombus method.Result of the test is as shown in table 3.The result shows that the administration group can make whole blood viscosity, plasma viscosity, whole blood reduced viscosity of blood stasis model etc. obviously alleviate, and the effect of invigorating blood circulation has been described, and the Sanguis Draxonis solid dispersion only needs capsular 1/8～～1/10 the dosage of Sanguis Draxonis just can reach equal drug effect.
Table 1 embodiment 1～12 (employing polishing)
| The embodiment numbering | Sanguis Draxonis (g) | Solvent (g) | Solid dispersion (g) | Water (g) | Milling time (min) | Solid dispersion in the product: Sanguis Draxonis (W/W) |
| ????1 ????2 ????3 ????4 ????5 ????6 ????7 ????8 ????9 ????10 ????11 ????12 | ??20 ??20 ??20 ??10 ??10 ??10 ???5 ???5 ???5 ??10 ??20 ??10 | ????50 ????100 ????200 ????50 ????100 ????80 ????10 ????20 ????30 ????50 ????50 ????50 | ????40 ????40 ????40 ????40 ????40 ????40 ????40 ????40 ????40 ???160 ????40 ?????2 | ??40 ??40 ??40 ??40 ??40 ??40 ??40 ??120 ??12 ??160 ??120 ??6 | ????10 ????20 ????40 ????20 ????40 ????10 ????40 ????10 ????20 ????20 ????20 ????20 | ????2∶1 ????2∶1 ????2∶1 ????4∶1 ????4∶1 ????4∶1 ????8∶1 ????8∶1 ????8∶1 ????16∶1 ????2∶1 ????0.2∶1 |
Table 2 Resina Draconis preparation as one to mice go out, the influence of clotting time (X ± SD, n=10)
Compare with the sodium carboxymethyl cellulose matched group: * P＞0.05, * * * P＜0.01
| Group | Dosage (mg/Kg) | Bleeding time (second) | Clotting time (second) |
| The low dose of group of dosage group dragon's blood solid dispersions in the heavy dose of group of the low dose of group of the dosage group dragon's blood capsule dragon's blood solid dispersions dragon's blood solid dispersions in the heavy dose of group of the blank group sodium carboxymethylcellulose control group dragon's blood capsule dragon's blood capsule | Etc. molten amounts 540 270 135 180 90 45 such as molten amounts | ??247.6±61.0* ??224.4±56.6 ??86.2±37.8*** ??104.5±43.0*** ??192.6±88.8* ??87.8±36.1*** ??130.5±57.8*** ??147.0±44.7*** | ????103.9±23.1* ????101.1±20.9 ????37.8±13.7*** ????57.7±26.9*** ????79.8±33.1* ????40.0±15.3*** ????47.5±9.6*** ????61.1±27.8*** |
The influence that table 3 Resina Draconis preparation as one forms rat suppository (X ± SD, n=9)
| Group | Dosage (mg/Kg) | Wet weight of thrombus (mg) |
| The low dose of group of dosage group dragon's blood solid dispersions in the heavy dose of group of the low dose of group of the dosage group dragon's blood capsule dragon's blood solid dispersions dragon's blood solid dispersions in the heavy dose of group of the blank group dragon's blood capsule dragon's blood capsule | ????540 ????270 ????135 ????180 ????90 ????45 | ????32.8±9.1 ????15.1±9.6*** ????18.4±13.5** ????27.4±10.9** ????5.3±2.5*** ????9.8±4.5*** ????17.9±12.9** |
Compare with the blank group: * * P＜0.05, * * * P＜0.01
Claims (5)
1, a kind of Chinese medicine Resina Draconis preparation as one is characterized in that said preparation is a kind of solid dispersion that is mixed and made into by Sanguis Draxonis and solid dispersion, and the weight ratio of solid dispersion and Sanguis Draxonis is 16: 1～0.2: 1; Said solid dispersion is a cyclodextrin, or cellulose and derivant thereof, or poloxamer and sell and translate the class surfactant.
2, according to the described Chinese medicine Resina Draconis preparation as one of claim 1, the weight ratio that it is characterized in that solid dispersion and Sanguis Draxonis is 8: 1～1: 1.
3, according to claim 1 or 2 described Chinese medicine Resina Draconis preparation as one, it is characterized in that said solid dispersion is alpha-cyclodextrin, beta-schardinger dextrin-or gamma-cyclodextrin, it perhaps is 1000～20000 Polyethylene Glycol for molecular weight, perhaps be methylcellulose, ethyl cellulose, hydroxypropyl emthylcellulose, cellulose acetate-phthalate, hydroxypropyl methylcellulose phthalate, carboxymethylethylcellulose or microcrystalline Cellulose, perhaps be poloxamer 188 or sell and translate the class surfactant.
4, the preparation method of the described Chinese medicine Resina Draconis preparation as one of claim 1, it is characterized in that adopting the wet grinding method: the water of getting solid dispersion and 0.3～3 times of weight grinds well, in solid dispersion: the ratio of Sanguis Draxonis=16: 1～0.2: 1 weight ratio adds the Sanguis Draxonis solution with the dissolution with solvents of 2～10 times of weight, fully grind, dry then, sieve, promptly get required Sanguis Draxonis fine-particle solid dispersion; Solvent for use is ethanol, acetone or isopropyl alcohol.
5, the preparation method of the described Chinese medicine Resina Draconis preparation as one of claim 1, it is characterized in that adopting the dry grinding method: in solid dispersion: the ratio of Sanguis Draxonis=16: 1～0.2: 1, solid dispersion and the former medicated powder of Sanguis Draxonis are fully ground, sieve, promptly get required Sanguis Draxonis fine-particle solid dispersion.
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| CN00114031A CN1096852C (en) | 2000-01-21 | 2000-01-21 | Resina Draconis preparation as one Chinese medicine and its preparation process |
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| CN00114031A CN1096852C (en) | 2000-01-21 | 2000-01-21 | Resina Draconis preparation as one Chinese medicine and its preparation process |
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| CN1265321A true CN1265321A (en) | 2000-09-06 |
| CN1096852C CN1096852C (en) | 2002-12-25 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104572792A (en) * | 2013-10-21 | 2015-04-29 | 财团法人工业技术研究院 | Image indexing method, image indexing device and computer readable medium |
| CN104706895A (en) * | 2015-03-02 | 2015-06-17 | 李仲昆 | Preparation of dragon's blood beta-cyclodextrin skin external preparation |
| CN104997752A (en) * | 2015-06-30 | 2015-10-28 | 陈晓芳 | Resina draconis rapid release capsule, and preparation method thereof |
| CN116407518A (en) * | 2021-12-31 | 2023-07-11 | 云南圣科药业有限公司 | Preparation method of pseudo-ginseng dragon's blood capsule |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN86108273A (en) * | 1986-12-15 | 1988-07-06 | 广西壮族自治区林业科学研究所 | The preparation method of Sanguis Draxonis |
| CN1203812A (en) * | 1998-03-04 | 1999-01-06 | 深圳南方制药厂 | Daemonorops draco Chinese medicine preparation for curing diabetes and its preparing method |
-
2000
- 2000-01-21 CN CN00114031A patent/CN1096852C/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104572792A (en) * | 2013-10-21 | 2015-04-29 | 财团法人工业技术研究院 | Image indexing method, image indexing device and computer readable medium |
| CN104706895A (en) * | 2015-03-02 | 2015-06-17 | 李仲昆 | Preparation of dragon's blood beta-cyclodextrin skin external preparation |
| CN104997752A (en) * | 2015-06-30 | 2015-10-28 | 陈晓芳 | Resina draconis rapid release capsule, and preparation method thereof |
| CN104997752B (en) * | 2015-06-30 | 2018-07-20 | 陈晓芳 | A kind of Resina Draconis quick-release capsules and preparation method thereof |
| CN116407518A (en) * | 2021-12-31 | 2023-07-11 | 云南圣科药业有限公司 | Preparation method of pseudo-ginseng dragon's blood capsule |
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| CN1096852C (en) | 2002-12-25 |
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