CN1823931A - Chinese medicine Hulisan for treating wind damp and knocks and falls - Google Patents
Chinese medicine Hulisan for treating wind damp and knocks and falls Download PDFInfo
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- CN1823931A CN1823931A CN 200510121171 CN200510121171A CN1823931A CN 1823931 A CN1823931 A CN 1823931A CN 200510121171 CN200510121171 CN 200510121171 CN 200510121171 A CN200510121171 A CN 200510121171A CN 1823931 A CN1823931 A CN 1823931A
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- hulisan
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Abstract
A Chinese medicine Hulisan in the form of tablet for treating rheumatism, bone fracture and injury is prepared from 4 Chinese-medicinal materials including wallich swallowwort root, notoginseng, wild aconite root, etc through superfine pulverizing, mixing with medicinal additives, granulating and tabletting.
Description
Technical field
The present invention relates to contain the pharmaceutical product that plant is a primary raw material improvement that is specifically related to treat rheumatism He falls the Chinese medicine HULI SAN dosage form that reaches damage.
Background technology
HULISAN JIAONANG and HULI SAN powder have the Lixing whole body, As the medicine took effect, the symptoms lessened, the special effect function that pain disappears and hides, cure mainly: lumbago, cervical spondylosis and sciatica, traumatic injury due to rheumatism, rheumatoid arthritis, preceding arthritis, scapulohumeral periarthritis, the strain of waist thigh, the intervertebral disk retrogression pathological changes etc., wound is bled etc., and diseases such as rheumatism, rheumatoid and osteoarthrosis are had the treating both the principal and secondary aspects of a disease effect.The HULISAN JIAONANG total effective rate reaches more than 90%.Now recorded in the powder and the capsule of the HULI SAN of the tenth in national drug standards Chinese traditional patent formulation preparation, it is to be made by the weight portion of 1 part of Chinese crude drug Radix cynanchi wallichii, 2 parts of Radix Notoginseng, 3 parts of BAIYUNSHEN, 14 parts of Radix Aconiti Kusnezoffii Preparatas, its powder and capsule all are the four Chinese medicine material to be ground into to be packaged into powder or to incapsulate behind the fine powder make capsule, described fine powder is that the particle diameter of medicinal powder is at 150~180 μ m, because its particle diameter is thicker, be unfavorable for the absorption of body to the effective ingredient of medicine, and powder take inconvenience, mouthfeel is poor.And Chinese crude drug Radix cynanchi wallichii, Radix Notoginseng, BAIYUNSHEN are more valuable medical materials, resource scarcity, we are necessary to utilize fully these effective herb resources to improve the bioavailability of medicine, give full play to the curative effect of medical material, so be necessary existing product is made improvements.
Summary of the invention
The purpose of this invention is to provide a kind of raising curative effect of medication, product is stable, is easy to preserve the treatment rheumatism of taking convenience and fall the Chinese medicine HULI SAN novel form that reaches damage.
Technical scheme of the present invention provides a kind of Chinese medicine HULI SAN tablet for the treatment of rheumatism and traumatic injury, it is the technology of preparing that is adopted micronizing by the weight portion of 1 part of Chinese crude drug Radix cynanchi wallichii, 2 parts of Radix Notoginseng, 3 parts of BAIYUNSHEN, 14 parts of Radix Aconiti Kusnezoffii Preparatas, Chinese crude drug Radix cynanchi wallichii, Radix Notoginseng, BAIYUNSHEN, Radix Aconiti Kusnezoffii Preparata are ground into≤medicated powder of 50 μ m, 20~50% pharmaceutic adjuvants that add the Chinese crude drug gross weight, after mix homogeneously is granulated, be pressed into tablet, every contains medicated powder 0.3g.
Said pharmaceutic adjuvant can be film-making agent adhesive commonly used, filler, lubricant, disintegrating agent etc., according to experiment sieving, preferred microcrystalline Cellulose, dextrin, low-substituted hydroxypropyl cellulose, the carboxymethyl starch sodium of adopting made filler, disintegrating agent, polyvinylpolypyrrolidone is made binding agent, magnesium stearate is made lubricant, prepares tablet of the present invention and preferably makes with the raw material of following percent by weight:
Medicated powder 66~84% microcrystalline Cellulose or dextrin 5~15%
Low-substituted hydroxypropyl cellulose 2~10% polyvinylpolypyrrolidone 2~10%
Carboxymethylstach sodium 2~10% magnesium stearate 0.5~2%.
In order to improve the stability of tablet, extend the shelf life, the tablet of above-mentioned gained can be made the thin membrane coated tablet of stomach dissolution type with conventional art for coating behind tabletting.
The film coating liquid of stomach dissolution type can also adopt the coating pre-mixing agent.
Because it is Chinese crude drug Radix cynanchi wallichii, Radix Notoginseng, BAIYUNSHEN, Radix Aconiti Kusnezoffii Preparata to be ground into≤micropowder of 50 μ m that the present invention adopts, so make easier absorption behind the drug oral, directly improved bioavailability, and micropowder should not be made powder and encapsulated, for tablet is made in the convenient oral event.
Below by the test example beneficial effect of the present invention is described:
Test example 1 collapses the test of Jie's degree
Method: undertaken by the inspection method under Chinese Pharmacopoeia version appendix in 2005 item disintegration.
Sample (following test example together): HULISAN JIAONANG adopts the product of Yunhe Pharamceutical Co., Ltd., Yunnan.
The HULI SAN sheet adopts the sample of following embodiment 5.
Result of the test:
Sample | Disintegration time | ||
Test 1 | Test 2 | Test 3 | |
HULISAN JIAONANG | 17 minutes | 18 minutes | 20 minutes |
The HULI SAN sheet | 8 minutes | 7 minutes | 6 minutes |
Test example 2 stability tests
Undertaken by the accelerated test under two stability items of Chinese Pharmacopoeia version in 2005.Concrete grammar is: capsule and tablet in terms of packing underlying climatic chamber, at 37~40 ℃ ± 2 ℃, are investigated 6 months under the condition of RH75% ± 5%, the results are shown in following table:
Result of the test | |||
Appearance character | Moisture | Disintegration time | |
HULISAN JIAONANG | Caking phenomenon is arranged | 8.1% | 25 minutes |
The HULI SAN sheet | No change | 3.5% | 7 minutes |
Test example 3 tests of pesticide effectiveness
Sample HULI SAN tablet and capsule with test example 1 give rat respectively, effect experiment to its experimentizing property adjuvant arthritis, experimental technique: get the SD rat, be divided into 4 groups: model group, HULISAN JIAONANG group and HULI SAN tablet group, and prednisolone acetate matched group by weight average.Be injected in the rat foot pad with freund ' s Freund's complete adjuvant 0.1ml, injection began administration the same day, and model group and matched group give with the volume distilled water, observed continuously 15 days, and the foot volume of wasting time calculates the difference of administration front and back and also calculates the swelling percentage rate about measuring respectively.The results are shown in following table:
The HULI SAN preparation causes the influence of scorching foot to the rat experiment adjuvant arthritis
Group | Dosage g/kg | Mus number (only) | Cause scorching back different time (my god) swelling percentage rate (X ± SD) (10%) | ||||
1 | 3 | 8 | 12 | 15 | |||
Model group | 10 | 105.5±23.3 | 104.5±13.9 | 114.5±16.1 | 98.7±21.7 | 93.5±19.3 | |
The HULI SAN sheet | 0.3 | 10 | 88.6±18.08* | 95.7±16.7 | 90.8±17.6 | 85.9±19.5 | 70.6±15.6* |
HULISAN JIAONANG | 0.3 | 10 | 93.1±13.2 | 97.1±18.2 | 92.7±15.4 | 89.4±17.6 | 74.6±13.2* |
The prednisolone acetate group | 0.006 | 10 | 95.3±15.4 | 95.9±21.8 | 91.9±15.2 | 87.3±20.7 | 73.7±19.4* |
Annotate: compare with model group:
*P<0.05
Test example 4: HULI SAN preparation analgesic test
Get 40 of mices, body weight 20~22 grams, male and female half and half are divided into four groups at random.Gavage HULI SAN tablet and capsule, XIAOHUOLUO WAN, matched group awards the equivalent distilled water.After the administration 60 minutes, 0.2 milliliter of each Mus lumbar injection 0.6% acetum/only.Observation is also write down the writhing response number of times of each mice in 20 minutes, calculates the analgesia percentage rate of each group.The results are shown in following table:
HULI SAN preparation analgesic test result
Group | Mus number (only) | Dosage (g/kg) | Turn round body number of times (X ± SD) | Analgesia rate (%) |
Model group | 10 | 21.5±6.1 | ||
The HULI SAN sheet | 10 | 0.32 | 5.80±4.65** | 73.02% |
HULISAN JIAONANG | 10 | 0.32 | 6.65±5.41** | 69.10% |
XIAOHUOLUO WAN | 10 | 7.73 | 9.91±6.31* | 53.91% |
Annotate: compare with model group:
*P<0.05 and model group ratio
*P<0.01
From above-mentioned result of the test beneficial effect of the present invention is described:
1, the disintegration time of tablet of the present invention is obviously short than capsule, rapid-action.
2, product is stable, long shelf-life.
3, under tablet of the present invention and the capsule situation with dosage, antiinflammatory and analgesic effect tablet are stronger than existing capsule.
4, the outward appearance of product has more aesthetic feeling, convenient oral.
Set forth further technical scheme of the present invention below by specific embodiment.
The specific embodiment
The plain sheet of embodiment 1 HULI SAN
Pulverize with super micron mill after taking by weighing Radix cynanchi wallichii 15g, Radix Notoginseng 30g, BAIYUNSHEN 45g, Radix Aconiti Kusnezoffii Preparata 210g mixing, cross 300 mesh sieves, get the ultramicro medicine powder of≤50 μ m, add the microcrystalline Cellulose of 15g, the low-substituted hydroxypropyl cellulose of 15g, the carboxymethyl starch sodium of 18g again, mix homogeneously, the polyvinylpolypyrrolidone of reuse 15g is made into 8% alcoholic solution as binding agent, granulates, and adds the magnesium stearate of 1.5g after the drying, mixing, tabletting is made 1000, and quality inspection, packing are promptly.
The plain sheet of embodiment 2 HULI SAN
Pulverize with super micron mill after taking by weighing Radix cynanchi wallichii 15g, Radix Notoginseng 30g, BAIYUNSHEN 45g, Radix Aconiti Kusnezoffii Preparata 210g mixing, cross 300 mesh sieves, get the ultramicro medicine powder of≤50 μ m, add the dextrin of 45g and low-substituted hydroxypropyl cellulose, the 30g carboxymethylstach sodium mix homogeneously of 24g, the polyvinylpolypyrrolidone of reuse 15g is made into 12% alcoholic solution as binding agent, granulate, the magnesium stearate that adds 3g after the drying, mixing, tabletting, make 1000, quality inspection, branch packing are promptly.
The plain sheet of embodiment 3 HULI SAN
Pulverize with super micron mill after taking by weighing Radix cynanchi wallichii 15g, Radix Notoginseng 30g, BAIYUNSHEN 45g, Radix Aconiti Kusnezoffii Preparata 210g mixing, cross 300 mesh sieves, get the ultramicro medicine powder of≤50 μ m, add the microcrystalline Cellulose of 30g and low-substituted hydroxypropyl cellulose, the 15g carboxymethylstach sodium of 6g, mix homogeneously, the polyvinylpolypyrrolidone of reuse 6g is made into 12% alcoholic solution as binding agent, granulates, and adds the magnesium stearate of 3g after the drying, mixing, tabletting is made 1000, and quality inspection, branch packing are promptly.
Embodiment 4 HULI SAN coated tablet
Take by weighing Radix cynanchi wallichii 15g, Radix Notoginseng 30g, BAIYUNSHEN 45g, Radix Aconiti Kusnezoffii Preparata 210g mixes the back and pulverizes with super micron mill, cross 300 mesh sieves, get the ultramicro medicine powder of≤50 μ m, add the dextrin of 30g and the low-substituted hydroxypropyl cellulose of 24g, carboxymethyl starch sodium 30g, mix homogeneously, the polyvinylpolypyrrolidone of reuse 15g is made into 12% alcoholic solution as binding agent, granulates, and adds the magnesium stearate of 3g after the drying, mixing, tabletting is made 1000, adopts the gastric solubility coating material (Opadry) of the happy Kanggong of card department, coating method packs film-coat routinely, and packing is divided promptly in the qualified back of quality inspection.
Embodiment 5 HULI SAN coated tablet
Take by weighing Radix cynanchi wallichii 15g, Radix Notoginseng 30g, BAIYUNSHEN 45g, Radix Aconiti Kusnezoffii Preparata 210g mixes the back and pulverizes with super micron mill, cross 300 mesh sieves, get the ultramicro medicine powder of≤50 μ m, add the dextrin of 60g and the low-substituted hydroxypropyl cellulose of 24g, carboxymethyl starch sodium 30g, mix homogeneously, the polyvinylpolypyrrolidone of reuse 15g is made into 12% alcoholic solution as binding agent, granulates, and adds the magnesium stearate of 6g after the drying, mixing, tabletting is made 1000, adopts the gastric solubility coating material (Opadry) of the happy Kanggong of card department, coating method packs film-coat routinely, and packing is divided promptly in the qualified back of quality inspection.
Claims (3)
1, a kind ofly treats rheumatism and fall the Chinese patent medicine HULI SAN novel form that reaches damage, it is to be made by the weight portion of 1 part of Chinese crude drug Radix cynanchi wallichii, 2 parts of Radix Notoginseng, 3 parts of BAIYUNSHEN, 14 parts of Radix Aconiti Kusnezoffii Preparatas, it is characterized in that adopting the technology of preparing of micronizing, Chinese crude drug Radix cynanchi wallichii, Radix Notoginseng, BAIYUNSHEN, Radix Aconiti Kusnezoffii Preparata are ground into≤medicated powder of 50 μ m, 20~50% pharmaceutic adjuvants that add the Chinese crude drug gross weight, mix homogeneously is pressed into tablet after granulating, and every contains medicated powder 0.3g.
2,, it is characterized in that said tablet is to be made by the raw material of following percent by weight according to the said HULI SAN novel form of claim 1:
Medicated powder 66~84% microcrystalline Cellulose or dextrin 5~15%
Low-substituted hydroxypropyl cellulose 2~10% polyvinylpolypyrrolidone 2~10%
Carboxymethylstach sodium 2~10% magnesium stearate 0.5~2%
3,, it is characterized in that said tablet makes the thin membrane coated tablet of stomach dissolution type with conventional art for coating behind tabletting according to the said HULI SAN novel form of claim 1.
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CN 200510121171 CN1823931A (en) | 2005-12-30 | 2005-12-30 | Chinese medicine Hulisan for treating wind damp and knocks and falls |
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CN 200510121171 CN1823931A (en) | 2005-12-30 | 2005-12-30 | Chinese medicine Hulisan for treating wind damp and knocks and falls |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101011474B (en) * | 2007-02-08 | 2011-01-05 | 南昌弘益科技有限公司 | Limitary determination of traditional medicine aconitine containing radix aconiti kusnezoffii praeparata |
-
2005
- 2005-12-30 CN CN 200510121171 patent/CN1823931A/en active Pending
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101011474B (en) * | 2007-02-08 | 2011-01-05 | 南昌弘益科技有限公司 | Limitary determination of traditional medicine aconitine containing radix aconiti kusnezoffii praeparata |
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