CN1327830C - Traditional Chinese medicine Babuji for treating arthritis, omitis and hyperosteogeny and its prepn. method - Google Patents

Traditional Chinese medicine Babuji for treating arthritis, omitis and hyperosteogeny and its prepn. method Download PDF

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CN1327830C
CN1327830C CNB2004100467829A CN200410046782A CN1327830C CN 1327830 C CN1327830 C CN 1327830C CN B2004100467829 A CNB2004100467829 A CN B2004100467829A CN 200410046782 A CN200410046782 A CN 200410046782A CN 1327830 C CN1327830 C CN 1327830C
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parts
cataplasma
medicine
cataplasm
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CN1751738A (en
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段立新
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Hunan Jiudian Pharmaceutical Co Ltd
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Hunan Jiudian Pharmaceutical Co Ltd
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Abstract

The present invention relates to a traditional Chinese medicinal cataplasm for treating arthritis, scapulohumeral periarthritis and hyperosteogeny, and a preparation method thereof. Active components of the cataplasm are prepared from the raw materials of the following proportion by weight: 90 to 300 shares of hot pepper, 10 to 20 shares of sanchi, 50 to 150 shares of zingiber and 0.5 to 3 shares of musk. The cataplasm is a Chinese medicine for external application, which has the characteristics of precise formula, cost saving and good curative effect. The cataplasm is a kind of paste with good flexibility and stickiness, which can greatly enhance release property and infiltration of the medicine. The cataplasm can reduce pollution to clothes, can overcome the defect of inconvenient use, etc. The cataplasm has the advantages that the medicine takes effect rapidly, patients feel comfortable when sticking the cataplasm, and less skin allergy happens to patients, so the cataplasm is convenient for popularization and application in clinic.

Description

The Chinese medicine patcher of a kind of treatment of arthritis, scapulohumeral periarthritis and hyperosteogeny
Technical field
The present invention relates to a kind of Chinese medicine preparation, particularly a kind of external used medicine of Chinese medicine safely and effectively for the treatment of joint due to the cold blood stasis, myalgia, local cold type of pain and preparation method thereof.
Background technology
The plaster of existing market treatment arthralgia, scapulohumeral periarthritis and lumbago and backache etc., common has: Musk Analgesic Plaster, musk rheumatic Dieda plaster for curing traumatic injury, Moschus pain-stopping plaster, SHANGSHI ZHITONG GAO, compound Nanxing pain paste, Radix aconiti szechenyiani ZHITONG GAO, ZHUANGGU SHEXIANG ZHITONG GAO, wound ZHITONG GAO etc.The patent No. of Chen Wen wound is 00129194.7, and name is called 20 pleasant impressions such as containing Radix Notoginseng 15 grams, Moschus 2 grams, Fructus Capsici ash 0.25 gram in the spinal hyperosteogeny ointment, and penetration is strong, and instant effect, therapeutic effect are good.The patent No. of Yao Xuelian is 01106473.0, and name is called " a kind of treatment hyperosteogeny and arthropathic plaster ", is made by medicines such as Agkistrodon, Cortex Cinnamomi, Borneolum Syntheticum, muscone, Fructus Capsici fluidextract, Oleum menthae, Camphora, Semen daturae fluid extract, azones.Medicine Moschus blood-circulation and removing blood stasis ointment blood circulation promoting and blood stasis dispelling promulgated by the ministries or commissions of the Central Government, anti-inflammatory analgetic, be used for articular sprain, soft tissue contusion, acute lumbar muscle sprain, lumbar muscle strain, scapulohumeral periarthritis, routed chilblain, erythema nodosum is made up of Moschus, Radix Notoginseng, Flos Carthami, Radix Salviae Miltiorrhizae, boric acid, Camphora, Sanguis Draxonis, carbamide, Semen daturae fluid extract, diphhydramine hydrochloride, procaine hydrochloride etc.Medicine anisodamine-musk cream invigorating blood circulation analgesia promulgated by the ministries or commissions of the Central Government, expelling wind and removing dampness is used for rheumatic arthralgia, arthritis, rheumatoid arthritis, the pain of diseases such as traumatic injury.By Moschus, Rhizoma Zingiberis, Borneolum Syntheticum, Tang Gute winter daphne, Olibanum, Camphora, Radix Anisodi Tangutici, Myrrha, methyl salicylate prescription.Arthritis cream dispel the wind Shujin, promoting blood circulation and stopping pain are used for arthralgia, and waist, shoulder, the back of the body are ached, diseases such as rheumatoid redness, prescription: paprika, Rhizoma Zingiberis, the Radix Angelicae Dahuricae, Semen Strychni, Camphora, Borneolum Syntheticum, wintergreen oil.In sum, each flavour of a drug can sporadically appear in relevant report in dosage form of the present invention and the prescription, be included in the compound recipe of 8-20 flavor more, as, the patent No. of Taiyangdao Pharmaceutical Factory is 00110089.0, and name is called " bone-strengthening musk plaster ", and totally 23 flavors make up a prescription; Its patent No. is 00110090.4, and name is called shaolin plaster for rheumatism and wound, and 23 flavors are also arranged, and contains Radix Notoginseng; Undeclared is in the report of cataplasma, and Chen Wen wound patent spinal hyperosteogeny ointment contains Radix Notoginseng 15 grams, Moschus 2 grams, Fructus Capsici ash 0.25 gram, totally two ten pleasant impressions.
But it is complicated that above-mentioned these medicaments are all being deposited medication, and manufacturing process is also comparatively complicated, the cost height, thereby also easily produce more side effect comparatively speaking.For diseases such as arthralgia, scapulohumeral periarthritis, hyperosteogenys, but how to accomplish that not only medication is rigorous but also can reach optimum curative effect, cost-saved again, be the required problem of facing of Chinese medicine worker.
Summary of the invention
The object of the invention aims to provide a kind of diseases such as arthralgia, scapulohumeral periarthritis and hyperosteogeny of more effectively treating cold blood stasis, can reach again with rigorous, saves the Chinese medicine patcher of a kind of treatment of arthritis, scapulohumeral periarthritis and the hyperosteogeny of cost.
Another object of the present invention aims to provide the preparation method of the Chinese medicine patcher of a kind of treatment of arthritis, scapulohumeral periarthritis and hyperosteogeny.
The present invention gropes in a large number to sum up through the inventor and draws each amounts of components for to have better curative effect in the following weight parts scope.
The present invention is made up of active constituents of medicine and cataplasma adjuvant, and wherein active constituents of medicine is made up of the raw material of following weight parts: Fructus Capsici 90-300 part, Radix Notoginseng 10-20 part, Rhizoma Zingiberis 50-150 part, Moschus 0.5-3 part.
The preferable weight portion of active constituents of medicine of the present invention consists of: Fructus Capsici 150-250 part, Radix Notoginseng 12-17 part, Rhizoma Zingiberis 70-120 part, Moschus 1-2 part.
The preferable weight portion of active constituents of medicine of the present invention consists of: 180 parts in Fructus Capsici, 15 parts of Radix Notoginseng, 100 parts of Rhizoma Zingiberiss, 1 part in Moschus.
Described active constituents of medicine: the percentage by weight of cataplasma adjuvant is 1: 0.4-6.
Described active constituents of medicine: the preferable percentage by weight of cataplasma adjuvant is 1: 1-3.
The cataplasma adjuvant comprises polyvinyl alcohol 20-30 part, gelatin 18-40 part, Kaolin 0.8-4 part, Resina persicae 50-100 part, sodium polyacrylate 20-40 part, xanthan gum 1-8 part, glycerol 100-200 part, citric acid 1-5 part, tween 80 1-4 part, azone 30-48 part, 1 among the present invention, 2-propylene glycol 30-45 part, by weight.
Cataplasma adjuvant preferred range is polyvinyl alcohol 25-30 part, gelatin 25-35 part, Kaolin 1-3 part, Resina persicae 70-90 part, sodium polyacrylate 25-35 part, xanthan gum 3-7 part, glycerol 150-180 part, citric acid 2-5 part, tween 80 2-4 part, azone 30-40 part, 1 among the present invention, 2-propylene glycol 30-40 part, by weight.
The present invention can adopt following optimum weight part raw material: 38 parts in 180 parts in Fructus Capsici, 15 parts of Radix Notoginseng, 100 parts of Rhizoma Zingiberiss, 1 part in Moschus, 25 parts of polyvinyl alcohol, 31 parts in gelatin, 2 parts of Kaolin, 80 parts of Resina persicaes, 30 parts of sodium polyacrylate, 5 parts of xanthan gum, 150 parts of glycerol, 3 parts of citric acids, 3 parts of tween 80s, azone, 1,38 parts of 2-propylene glycol.
The preparation method of cataplasma is among the present invention:
A. polyvinyl alcohol, gelatin are added on 65-85 ℃ of dissolving preparation composite gelatin liquid down;
B. Moschus powder is broken into fine powder, Radix Notoginseng powder is broken into superfine powder, and is standby;
C. Fructus Capsici, ginger powder are broken into coarse powder, are solvent soaking 20-30 hour with 80-95% ethanol, and percolation is collected and to be oozed deer liquid, to the percolate color be the fragrance of pungent, Rhizoma Zingiberis of pale red, Fructus Capsici and pungent thin till; 60 ℃ of fluid extracts that are concentrated into d=1.22 are standby;
D. Moschus, Radix Notoginseng micropowders and C are gone on foot in fluid extract adding A preparation that makes and the substrate that gets, stir, adding tween 80, xanthan gum stir 65-80 ℃ of insulation;
E. get in the glycerol that sodium polyacrylate and Resina persicae add above-mentioned umber mixing;
F. D being gone on foot gained spice adding citric acid is prepared from the aqueous solution;
G. with E gained spice, azone, 1, the 2-propylene glycol adds in the spice of F, and 60-70 ℃ stirs, 55-65 ℃ cream refining 1-3 hour, be coated with, cover lining, cut into slices in 55-65 ℃.
The present invention can adopt the preparation method of following the best and get:
Take off the preparation component of stating weight portion: Fructus Capsici 180 grams, Radix Notoginseng 15 grams, Rhizoma Zingiberis 100 grams, Moschus 1 gram, polyvinyl alcohol 25 grams, gelatin 31 grams, Kaolin 2 grams, Resina persicae 80 grams, sodium polyacrylate 30 grams, xanthan gum 5 grams, glycerol 150 grams, citric acid 3 grams, tween 80 3 grams, azone 38 grams, 1,2-propylene glycol 38 grams;
A. polyvinyl alcohol, gelatin are added on 70 ℃ of dissolving preparation composite gelatin liquid down;
B. XIANGFEN is broken into fine powder, Radix Notoginseng powder is broken into superfine powder, and is standby;
C. Fructus Capsici, ginger powder are broken into coarse powder, are solvent soaking 24 hours with 90% ethanol, and percolation is collected and to be oozed deer liquid, to the percolate color be the fragrance of pungent, Rhizoma Zingiberis of pale red, Fructus Capsici and pungent thin till; 60 ℃ of fluid extracts that are concentrated into d=1.22 are standby;
D. Moschus, Radix Notoginseng micropowders and extractum add the A preparation and substrate in, stir, add tween 80, xanthan gum stirs 70 ℃ of insulations;
E. sodium polyacrylate and Resina persicae add in the glycerol, mixing,
F. D being gone on foot gained spice adding citric acid is prepared from the 300ml aqueous solution;
Gained spice, azone, 1 in G.E step, 2-propylene glycol add in the F step gained spice, and 60-70 ℃ stirs, and 60 ℃ of cream refinings 2 hours are coated with, cover lining, section in 60 ℃, pack and are prepared into 1000.
Diseases such as scapulohumeral periarthritis, osteoarthritis, lumbar muscle strain mainly show as joint, myalgia, all belong to traditional Chinese medical science numbness disease (arthralgia aggravated by cold) category, and the traditional Chinese medical science thinks that its pathogenesis mainly is wind, cold, wet invasion and attack human body, the resistance of the passages through which vital energy circulates stasis of blood.Said as " interior warp ": " wind, assorted the causing of cold, wet three gas, close and be numbness also.Its migratory BI-syndrome caused mainly by pathogenic wind, BI-syndrome caused mainly by pathogenic cold being called painful BI, the BI syndrome caused mainly by pathogenic dampness being called fixed BI ".Because of the cold YIN pathogen that belongs to, main spasm, sluggish." element is asked the regulating menstruation opinion " said: " vim and vigour person, happiness temperature and aversion to cold is cold then puckery, not fluence." so the cold-evil invade human body, can cause the QI-blood circulation sluggishness, also as " element ask lift pain note " what is called: " passages through which vital energy circulates is popular more than, and ring week endlessly.Cold go into through and check late, tears and not all right, visitor's insufficiency of blood outside arteries and veins: visitor's flow of QI being obstructed then in arteries and veins, so yet the soldier bitterly." therefore, the arthralgia of cold blood stasis, scapulohumeral periarthritis and hyperosteogeny diseases, although sick position is different, we think that the cold-evil invades human body, the QI-blood circulation sluggishness is their common pathogenesis.According to " cold person's using warming therapy ", " pain is then obstructed ", the theory of " general rule is not bitterly ", dispelling cold by warming the meridian, promoting blood circulation and stopping pain are its principle of treatment, and the Ji cold-evil go, and blood vessels are smooth, and it is normal that QI-blood circulation is recovered, and do not have the anxiety of joint, myalgia.The present invention develops just in view of the above, its prescription derive from Mr. Hou Xigui through proved recipe, clinical application for many years, the pain that various diseases such as, neuralgia outstanding to arthritis, soft tissue injury, tenosynovitis, lumbar vertebra, hyperosteogeny, coeliac disease cause all has better therapeutic effect.
The present invention is made up of Fructus Capsici, Radix Notoginseng, Rhizoma Zingiberis, Moschus, is monarch with the Fructus Capsici, and Radix Notoginseng is a minister, and Rhizoma Zingiberis is assistant, and Moschus makes for assistant.Effect with dispelling cold by warming the meridian, promoting blood circulation and stopping pain cures mainly arthralgia, scapulohumeral periarthritis and the hyperosteogeny etc. of cold blood stasis.The innovative point of this product has three: one, at the basic pathogenesis of cold blood stasis, selects the active drug of dispelling cold by warming the meridian, promoting blood circulation and stopping pain for use.The prescription medication, pathogenesis links closely.The 2nd, compatibility is rigorous, and medicine letter power is special.With " promoting the circulation of blood of dispeling the wind, cold expelling resolving depression ", both " warming spleen and stomach for dispelling cold, remove wind diaphoresis ", Fructus Capsici that also can " row expectorant dries " is monarch.With merit special " hemostasis, loose blood, analgesic therapy " (Compendium of Material Medica), benefaction stagnates and promotes blood circulation, and promoting flow of qi by warming channel, the Typhonium flagelliforme (Lodd.) Blume of reducing swelling and alleviating pain are minister.With energy " dismission anemofrigid-damp arthralgia " " control in the waist kidney painful cold, cold air. removing blood stasis, remove wind, logical extremities joint is opened the vital organs of the human body. go the cold numbness of pathogenic wind toxic " Rhizoma Zingiberis be assistant.Strong with the fragrant virtue of gas, walk to scurry and fly upward, can lead to the unfavorable of all keys, open the heap soil or fertilizer over and around the roots of meridians and hold back, interior deep marrow, the Moschus of outer thorough fur makes for assistant.Four medicines are assisted mutually, and the effect of dispelling cold by warming the meridian, promoting blood circulation and stopping pain is strong.The 3rd, fully use the modern scientific research achievement.The equal modern study of selected medicine confirms to have effects such as analgesia, calmness, hypnosis, and arthralgia, scapulohumeral periarthritis and the lumbar muscle strain of treatment cold blood stasis have sufficient clinical experimental research foundation.Fructus Capsici suffering, temperature in the side.Return spleen, stomach warp. warm in nature and and smooth, Xin Wen wanders away, can smooth blood vessels, loosing stagnates that gas, row are stopped up knot, the meridian dredging, pain relieves the pain, " promoting the circulation of blood of dispeling the wind, cold expelling resolving depression " (" medicine inspection "), both " warming spleen and stomach for dispelling cold; remove the wind diaphoresis " also can " row expectorant dries " (" food be examined ").Be the key medicine of dispelling cold by warming the meridian, so monarch drug in the side of being.Radix Notoginseng sweet in the mouth, little hardship, warm in nature.Return liver, stomach, the heart, lung, large intestine channel, merit is " hemostasis, loose blood, analgesic therapy " (Compendium of Material Medica) specially, and benefaction stagnates and promotes blood circulation, promoting flow of qi by warming channel, and reducing swelling and alleviating pain, principal drug assistance temperature promoting blood circulation, so the analgesic therapy of invigorating blood circulation is ministerial drug in the side of being; Rhizoma Zingiberis is hot, returns spleen, stomach, the heart, lung meridian.The hot Wen Dare of its property, energy " dismission anemofrigid-damp arthralgia " (" book on Chinese herbal medicine covers and signs "), and pain relieving." property of medicine opinion " call its " control in the waist kidney painful cold, cold air. removing blood stasis, remove wind, logical extremities joint is opened the vital organs of the human body. go the cold numbness of pathogenic wind toxic ".Can strengthen the effect of monarch drug dispelling cold by warming the meridian, so adjuvant drug in the side of being.Moschus suffering, temperature.GUIXIN, spleen channel, the fragrant virtue of gas is strong, walks to scurry and flies upward, and can lead to the unfavorable of all keys, and open the heap soil or fertilizer over and around the roots of meridians and hold back, interior deep marrow, outer thorough fur had both helped the Fructus Capsici dispelling cold by warming the meridian, helped the pseudo-ginseng blood-circulation-invigovating detumescence again, so for Fang Zhongzuo makes, four medicines are harmonious, played the effect of dispelling cold by warming the meridian, promoting blood circulation and stopping pain altogether.
In sum, it is rigorous that the present invention has medication, and good effect can reduce the generation of side effect widely, has the effect of dispelling cold by warming the meridian, promoting blood circulation and stopping pain.And required crude drug is to be easy to get most, and cost is low, also is incomparable with other medicine of kind.
The present invention is a kind of the possess good pliability and patch of tackness.Can strengthen medicine releasability and transdermal characteristic widely.Can reduce the pollution clothes, use shortcomings such as inconvenience, it is rapid to have drug effect, is pasting comfortablely, and the advantage that skin allergy is few is convenient to clinical application.
The present invention is made up of Chinese medicines such as Moschus, Radix Notoginseng, Fructus Capsici, Rhizoma Zingiberiss, the clinical treatment that is used for diseases such as cold blood stasis arthritis, scapulohumeral periarthritis, lumbar muscle strain.
Medicine of the present invention has the effect of the joint of treatment due to the cold blood stasis, myalgia, local cold type of pain, below further sets forth the beneficial effect of medicine of the present invention by testing example.These tests have comprised the pharmacodynamics and the anxious poison test of long poison of medicine of the present invention.
Test routine pharmacological toxicology research
One, antiinflammatory action
1. to the influence of mice ear: cataplasma 110 of the present invention, 220mg crude drug/kg can obviously suppress the mice auricle swelling that dimethylbenzene causes, has antiinflammatory action.
To the influence of mice ear (n=10, X ± SD)
Group Dosage (mg/kg) Swelling degree (mg)
Matched group SHEXIANG ZHUANGGU GAO cataplasma of the present invention cataplasma of the present invention cataplasma of the present invention 291.2 55 110 220 14.94±2.69 11.65±2.62* 13.36±2.49 12.23±3.03* 10.50±1.87**
Compare * P<0.05, * * P<0.01 with matched group.
2. to the influence of rat Ovum Gallus domesticus album foot swelling: cataplasma 38mg crude drug/kg of the present invention is in causing scorching back 1 ~ 2h, and (76,1 ~ 2h can obviously suppress sole of the foot swelling in the clear property of rat to cataplasma of the present invention behind the Yu Zhiyan of 152mg crude drug/kg), has antiphlogistic effect.
To the influence of rat Ovum Gallus domesticus album pedal swelling (n=10, X ± SD)
Group Dosage mg/kg Cause scorching front foot sole of the foot volume (ml) Cause scorching back different time swelling degree (ml)
1h 2h 4h 6h
Control group SHEXIANG ZHUANGGU GAO cataplasm of the present invention cataplasm of the present invention cataplasm of the present invention - 201.6 38 76 152 1.57±0.10 1.59±0.12 1.55±0.14 1.60±0.11 1.54±0.14 0.51±0.11 0.35±0.10** 0.41±0.10* 0.37±0.11* 0.36±0.10** 0.53±0.10 0.38±0.10** 0.42±0.11* 0.39±0.10** 0.37±0.09** 0.47±0.09 0.31±0.08** 0.41±0.11 0.33±0.08** 0.32±0.10** 0.38±0.09 0.22±0.08** 0.33±0.12 0.23±0.10** 0.20±0.11**
Compare * P<0.05, * * P<0.01 with matched group
3. to the swollen influence that forms of rat granuloma: (38,76,152mg crude drug/kg) can obviously suppress the bullate formation of rat granuloma has antiphlogistic effect to cataplasma of the present invention.
To the influence of granuloma induced by implantation of cotton pellets (n=10, X ± SD)
Group Dosage (mg/kg) Granuloma weight (mg) Suppression ratio (%)
Matched group SHEXIANG ZHUANGGU GAO cataplasma of the present invention cataplasma of the present invention cataplasma of the present invention 201.6 38 76 152 57.81±15.57 30.93±9.92** 43.70±10.76* 38.71±12.18** 32.81±8.81** 46.5 24.4 32.9 43.2
Compare * P<0.05, * * P<0.01 with matched group.
Two, analgesic activity
1. mice hot plate method: carry out statistical procedures with the t check, (the 110mg crude drug/kg) the 1h pain threshold can obviously improve cataplasma of the present invention behind medicine, (the 220mg crude drug/kg) the 1h-2h pain threshold can obviously improve red seven Moschus moschiferous analgesic ointment behind medicine, points out red seven Moschus moschiferous analgesic ointment to have the analgesic effect.
Analgesic activity (hot plate method) (n=10, X ± SD)
Group Dosage (mg/kg) Normal value Different time pain threshold (second) after the administration
1h 2h
Matched group SHEXIANG ZHUANGGU GAO cataplasma of the present invention cataplasma of the present invention cataplasma of the present invention 291.2 55 110 220 23.2±5.1 23.0±4.4 22.7±4.6 22.0±4.6 22.9±3.5 24.7±8.1 36.6±12.2* 29.1±8.9 35.9±9.4* 36.2±7.8** 25.0±8.2 35.9±11.0* 27.1±10.9 31.0±9.2 33.0±8.0*
Compare * P<0.05, * * P<0.01 with matched group.
2. mouse writhing method: with t check carrying out group difference significance relatively, result's (seeing Table 5) shows that (110, the 220g crude drug/kg) the writhing response number of times of mice obviously reduces cataplasma of the present invention, has the analgesic effect.
Analgesic activity (writhing method) (n=10, X ± SD)
Group Dosage (mg/kg) Turn round the body number of times (inferior/20min)
Matched group SHEXIANG ZHUANGGU GAO cataplasma of the present invention cataplasma of the present invention cataplasma of the present invention - 291.2 55 110 220 25.1±7.0 12.1±7.7** 21.4±5.9 18.6±4.8* 14.4±8.7**
Compare * P<0.05, * * P<0.01 with matched group.
Three, to the repair of rat acute soft tissue injury: perusal demonstration cataplasma of the present invention (38,76,152mg crude drug/kg) can obviously alleviate damaged tissue enlargement and ecchymosis degree.Tectology observe to show that (38,76, the inflammatory cell such as neutrophil that alleviates that 152mg crude drug/kg) has in various degree oozes out, takes off granule to cataplasma of the present invention, alleviates inflammation after the wound, promotes the effect of tissue repair.
Cataplasma of the present invention is to rat acute soft tissue injury perusal result
Group Dosage Number of animals (only) Lesion degree The P value
- + ++ +++
Normal group model group SHEXIANG ZHUANGGU GAO cataplasm of the present invention cataplasm of the present invention cataplasm of the present invention 201.6 38 76 152 10 10 10 10 10 10 10 2 7 6 7 9 0 3 3 3 3 1 0 5 0 1 0 0 0 0 0 0 0 0 <0.01 (1) <0.05 (2) <0.05 (2) <0.05 (2) <0.01 (2)
Annotate: statistical method: Ridit check. (1)Compare with normal group, (2)Compare with model group.
Cataplasma of the present invention is to rat acute soft tissue injury microscopic examination result
Group Dosage (mg/kg) Number of animals (only) Lesion degree The P value
- + ++ +++
Normal group model group SHEXIANG ZHUANGGU GAO cataplasm of the present invention cataplasm of the present invention cataplasm of the present invention 201.6 38 76 152 10 10 10 10 10 10 10 0 0 0 1 1 0 1 7 6 7 8 0 8 3 4 2 1 0 1 0 0 0 0 <0.01 (1) <0.05 (2) <0.05 (2) <0.01 (2) <0.01 (2)
Annotate: statistical method: Ridit check. (1)Compare with normal group, (2)Compare with model group.
Four, function of promoting blood circulation to disperse blood clots: carry out statistical procedures with the t check.(38,76,152mg crude drug/kg) has reduction whole blood contrast viscosity and plasma viscosity in various degree to cataplasma of the present invention, improves the effect of hemorheological property.
Cataplasma of the present invention to the influence of rat blood rheological characteristic (n=10,
Figure C20041004678200101
)
Group Dosage (mg/kg) Whole blood viscosity (mpa.s -1) Plasma viscosity (mpa.s -1)
Height is cut In cut Low cutting
Control group model group SHEXIANG ZHUANGGU GAO cataplasm of the present invention cataplasm of the present invention cataplasm of the present invention 201.6 38 76 152 3.914±1.058 5.570±1.168 4.515±0.919 4.856±0.904 4.086±1.126 3.863±1.020* 6.058±1.186 8.150±1.176 △△ 6.771±1.052 7.202±1.344 6.375±1.456* 6.112±1.118** 13.142±1.961 16.084±2.526 12.980±1.501* 13.604±1.559 13.076±1.982 12.871±1.080* 1.734±0.285 2.186±0.398 1.611±0.279* 1.898±0.324 1.688±0.416 1.618±0.313*
Compare with matched group P<0.05, △ △P<0.01; Compare * P<0.05, * * P<0.01 with model group.
Five, the pathological examination result shows: cataplasma of the present invention can obviously alleviate the soft tissue inflammation extent of reaction of rat soft tissue injury model, and its action intensity is similar to positive control drug.
Influence to rat soft tissue injury model histopathology
Group The pathological changes classification The P value
- + ++ +++
The positive group of normal group model group 10 0 0 0 1 7 0 8 3 0 1 0 <0.01 (1) <0.05 (2)
Cataplasma of the present invention (low) cataplasma of the present invention (in) cataplasma of the present invention (height) 0 1 1 6 7 8 4 2 1 0 0 0 <0.05 (2) <0.01 (2) <0.01 (2)
Statistical method: Ridit check. (1)Compare with normal group, (2)Compare with model group.
Six, acute toxicity test: rabbit gives not see whole body poisoning manifestations and death condition behind the red seven Moschus moschiferous analgesic ointment that the weight of animals increases, and breathing, circulation, central nervous system, extremity activity etc. are not had influence.To normal skin, the damaged skin individual animal has slight erythema and does not have edema, and 24h promptly disappears after the drug withdrawal, medication district drug residue free speckle.To rabbit normal skin and damaged skin administration, be equivalent to 213.4 times of clinical dosage approximately, there is not tangible toxic reaction.
Cataplasma skin The acute toxicity tests of the present invention
Group Behavioral activity The outward appearance sign Body weight (0 day) Body weight (7 days)
Normal skin matched group medicine group Normal Normal 2.38±0.23 2.33±0.24 2.47±0.23 2.45±0.22
Damaged skin matched group medicine group Normal Normal 2.38±0.21 2.37±0.25 2.50±0.19 2.48±0.22
Seven, long term toxicity test: cataplasma rabbit percutaneous drug delivery of the present invention, the safe dose in continuous 13 weeks is about 0.3g/kg, is equivalent to 42.7 times of clinical dosage approximately.
1. overview: each treated animal outward appearance sign during the administration, behavioral activity are normal.Body weight all increases.Damaged skin group individual animal has slight erythema and does not have edema, but medicine group and matched group are relatively, and difference does not have the significance meaning.Food-intake, defecation Non Apparent Abnormality.There is not animal dead during the administration.
2. hematological indices: administration mid-term, latter stage and convalescent period, the every index of hematology (RBC, Hb, WBC, GRAN, MID, LYM, CT), medicine group and matched group relatively, difference does not have the significance meaning.
3. blood parameters: administration mid-term, latter stage and convalescent period, the every index of blood biochemical (AST, ALT, ALP, BUN, TP, ALB, GLU, T-BIL, Crea, T-CHO), medicine group and matched group relatively, difference does not have the significance meaning.
4. system's postmortem and histopathologic examination: each treated animal internal organs no abnormality seen of perusal.Internal organs such as the heart, liver, spleen, lung, kidney, adrenal gland, brain, testis, uterus are weighed, calculate organ coefficient, medicine group and matched group compare as a result, and difference does not have the significance meaning.To histopathology histological examinations such as the heart, liver, spleen, lung, kidney, adrenal gland, thymus, pancreas, thyroid, prostate, testis, epididymis, uterus, ovary, brain, stomach, duodenum, bladder, skins, except that the indivedual internal organs of individual animal have the slight pathological changes, other shows no obvious abnormalities.Infer that thus this medicine does not have the obvious impairment effect to animal viscera.
Eight, skin irritation and skin allergy Journal of Sex Research: the rabbit single and repeatedly give cataplasma of the present invention after, do not see skin irritation such as erythema, edema occur reaction at the intact skin agents area; And to damaged skin, single and repeatedly behind the coating, slight irritant reaction all appears in agents area.Cavia porcellus is coated with behind the cataplasma of the present invention, does not find that anaphylaxiss such as erythema, edema appear in the local skin that is tried Cavia porcellus.
Conclusion: the repair that has tangible anti-inflammatory and antalgic, blood circulation promoting and blood stasis dispelling and promotion soft tissue injury by the above the present invention of experimental results show that.And there is not the reaction of toxicity and skin hypersensitivity.
The specific embodiment
Embodiment 1
Take off the preparation component of stating weight portion: Fructus Capsici 100 grams, Radix Notoginseng 18 grams, Rhizoma Zingiberis 60 grams, Moschus 2.8 grams, polyvinyl alcohol 25 grams, gelatin 35 grams, Kaolin 1 gram, Resina persicae 80 grams, sodium polyacrylate 20 grams, xanthan gum 6 grams, glycerol 180 grams, citric acid 1 gram, tween 80 1 gram, azone 45 grams, 1,2-propylene glycol 30 grams.
A. polyvinyl alcohol, gelatin are added on 65 ℃ of dissolving preparation composite gelatin liquid down;
B. XIANGFEN is broken into fine powder, Radix Notoginseng powder is broken into superfine powder, and is standby;
C. Fructus Capsici, ginger powder are broken into coarse powder, are solvent soaking 24 hours with 80% ethanol, and percolation is collected and to be oozed deer liquid, to the percolate color be the fragrance of pungent, Rhizoma Zingiberis of pale red, Fructus Capsici and pungent thin till; 60 ℃ of fluid extracts that are concentrated into d=1.22 are standby;
D. Moschus, Radix Notoginseng micropowders and extractum add the A preparation and substrate in, stir; Adding tween 80, xanthan gum stir 70 ℃ of insulations;
E. sodium polyacrylate and Resina persicae add in the glycerol, mixing,
In the 300ml aqueous solution that F.D gained spice adding citric acid is prepared from;
G. with E gained spice, azone, 1, the 2-propylene glycol adds in the F gained spice, and 60~70 ℃ stir, and 60 ℃ of cream refinings 2 hours are coated with, cover lining, section in 60 ℃, and packing is prepared into 100 subsides.
Using method: one day subsides 1-2 sheet.
Embodiment 2
Take off the adjuvant that each base of system of stating weight portion is held: Fructus Capsici 280 grams, Radix Notoginseng 12 grams, Rhizoma Zingiberis 120 grams, Moschus 0.8 gram, polyvinyl alcohol 20 grams, gelatin 20 grams, Kaolin 3.5 grams, Resina persicae 55 grams, sodium polyacrylate 40 grams, xanthan gum 2 grams, glycerol 100 grams, citric acid 5 grams, tween 80 3 grams, azone 33 grams, 1,2-propylene glycol 40 grams.
A. polyvinyl alcohol, gelatin are added on 85 ℃ of dissolving preparation composite gelatin liquid down;
B. XIANGFEN is broken into fine powder, Radix Notoginseng powder is broken into superfine powder, and is standby;
C. Fructus Capsici, ginger powder are broken into coarse powder, with 95% ethanol is solvent soaking 24 hours, according to (appendix IO of Pharmacopoeia of People's Republic of China version in 2000) percolation down, collect and ooze deer liquid, to the percolate color be the fragrance of pungent, Rhizoma Zingiberis of pale red, Fructus Capsici and pungent thin till; 60 ℃ of fluid extracts that are concentrated into d=1.22 are standby;
D. Moschus, Radix Notoginseng micropowders and extractum add the A preparation and substrate in, stir, add tween 80, xanthan gum stirs 70 ℃ of insulations;
E. sodium polyacrylate and Resina persicae add in the glycerol, mixing,
F.D gained spice adds citric acid and is prepared from the 300ml aqueous solution;
G. with E gained, azone, 1,2-propylene glycol gained spice adds in the F gained spice, and 60~70 ℃ stir, and 60 ℃ of cream refinings 2 hours are coated with, cover lining, section in 60 ℃, and packing is prepared into 100 subsides.
Using method: one day subsides 1-2 sheet.
Embodiment 3
Take off the preparation component of stating weight portion: Fructus Capsici 180 grams, Radix Notoginseng 15 grams, Rhizoma Zingiberis 100 grams, Moschus 1 gram, polyvinyl alcohol 25 grams, gelatin 31 grams, Kaolin 2 grams, Resina persicae 80 grams, sodium polyacrylate 30 grams, xanthan gum 5 grams, glycerol 150 grams, citric acid 3 grams, tween 80 3 grams, azone 38 grams, 1,2-propylene glycol 38 grams.
A. polyvinyl alcohol, gelatin are added on 70 ℃ of dissolving preparation composite gelatin liquid down;
B. Moschus powder is broken into fine powder, Radix Notoginseng powder is broken into superfine powder, and is standby;
C. Fructus Capsici, ginger powder are broken into coarse powder, are solvent soaking 24 hours with 90% ethanol, and percolation is collected and to be oozed deer liquid, to the percolate color be the fragrance of pungent, Rhizoma Zingiberis of pale red, Fructus Capsici and pungent thin till; 60 ℃ of fluid extracts that are concentrated into d=1.22 are standby;
D. Moschus, Radix Notoginseng micropowders and extractum add the A preparation and substrate in, stir, add tween 80, xanthan gum stirs 70 ℃ of insulations;
E. sodium polyacrylate and Resina persicae add in the glycerol, mixing,
In the 300ml aqueous solution that F.D gained adding citric acid is prepared from;
G. with E gained, azone, 1, the 2-propylene glycol adds among the F, and 60~70 ℃ stir, and 60 ℃ of cream refinings 2 hours are coated with, cover lining, section in 60 ℃, and packing is prepared into 100 subsides.
Using method: one day 1-2 sheet.
Embodiment 4
Get Fructus Capsici 150 grams, Radix Notoginseng 12 grams, Rhizoma Zingiberis 70 grams, Moschus 1 gram, other is with embodiment 3.
Embodiment 5
Get Fructus Capsici 250 grams, Radix Notoginseng 17 grams, Rhizoma Zingiberis 120 grams, Moschus 2 grams, other is with embodiment 3.

Claims (6)

1, the Chinese medicine patcher of a kind of treatment of arthritis, scapulohumeral periarthritis and hyperosteogeny, be made up of active constituents of medicine and cataplasma adjuvant, the weight portion of raw material that it is characterized in that preparing the active constituents of medicine of described cataplasma is: Fructus Capsici 90-300 part, Radix Notoginseng 10-20 part, Rhizoma Zingiberis 50-150 part, Moschus 0.5-3 part.
2, Chinese medicine patcher according to claim 1, the weight portion that it is characterized in that preparing the thing active component raw material of described cataplasma medicine is: Fructus Capsici 150-250 part, Radix Notoginseng 12-17 part, Rhizoma Zingiberis 70-120 part, Moschus 1-2 part.
3, Chinese medicine patcher according to claim 1, the parts by weight of raw materials that it is characterized in that preparing the active constituents of medicine of described cataplasma is: 180 parts in Fructus Capsici, 15 parts of Radix Notoginseng, 100 parts of Rhizoma Zingiberiss, 1 part in Moschus.
4, according to each described Chinese medicine patcher of claim 1-3, it is characterized in that preparing the raw material of described cataplasma active constituents of medicine: the percentage by weight of cataplasma adjuvant is 1: 0.4-6, the adjuvant of cataplasma is by polyvinyl alcohol 20-30 part of weight portion meter, gelatin 18-40 part, Kaolin 0.8-4 part, Resina persicae 50-100 part, sodium polyacrylate 20-40 part, xanthan gum 1-8 part, glycerol 100-200 part, citric acid 1-5 part, tween 80 1-4 part, azone 30-48 part, 1, and 2-propylene glycol 30-45 part is formed.
5, according to each described Chinese medicine patcher of claim 1-4, it is characterized in that preparing the raw material of the active constituents of medicine of described cataplasma: the percentage by weight of cataplasma adjuvant is 1: 1-3, the adjuvant of cataplasma is by weight portion meter polyvinyl alcohol 25-30 part, gelatin 25-35 part, Kaolin 1-3 part, Resina persicae 70-90 part, sodium polyacrylate 25-35 part, xanthan gum 3-7 part, glycerol 150-180 part, citric acid 2-5 part, tween 80 2-4 part, azone 30-40 part, 1, and 2-propylene glycol 30-40 part is formed.
6, according to each described Chinese medicine patcher of claim 1-5, it is characterized in that the raw material for preparing described cataplasma active constituents of medicine is made up of for 1 part 100 parts of 15 parts of 180 parts in Fructus Capsici, Radix Notoginseng, Rhizoma Zingiberiss, the Moschus of weight portion meter, the adjuvant of preparation cataplasma is by 38 parts of 3 parts of 3 parts of 1 50 parts of 5 parts of 30 parts of 80 parts of 2 parts of 31 parts in 25 parts of polyvinyl alcohol, gelatin, Kaolin, Resina persicaes, sodium polyacrylate, xanthan gum, glycerol, citric acids, tween 80s, the azones of weight portion meter, 1,38 parts of compositions of 2-propylene glycol.
CNB2004100467829A 2004-09-21 2004-09-21 Traditional Chinese medicine Babuji for treating arthritis, omitis and hyperosteogeny and its prepn. method Expired - Fee Related CN1327830C (en)

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CN101406565B (en) * 2007-10-12 2012-03-21 沈阳红药制药股份有限公司 Pepper Babu plaster for rheumatism and method for producing the same
CN101780169A (en) * 2010-03-10 2010-07-21 广州白云山制药股份有限公司白云山何济公制药厂 Traumatic injury analgesic cataplasm preparation and preparation method thereof
CN103952268A (en) * 2013-10-04 2014-07-30 史文革 Pseudo-ginseng health care wine
CN106822716A (en) * 2017-03-27 2017-06-13 贵州康源铁皮石斛农业科研开发有限公司 A kind of exterior-applied medical wine for treating rheumatic spur
CN108404082B (en) * 2018-04-24 2022-05-17 湖南九典制药股份有限公司 Compound traditional Chinese medicine preparation with effects of promoting blood circulation and relieving pain and preparation method thereof
CN110187031A (en) * 2019-06-12 2019-08-30 贵州联盛药业有限公司 The measuring method of urea content in a kind of Moschus blood-circulation and removing blood stasis ointment
CN110934737A (en) * 2019-12-06 2020-03-31 湖南富兴飞鸽药业有限公司 Traditional Chinese medicine plaster for moxibustion and preparation method thereof

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CN1471976A (en) * 2002-07-30 2004-02-04 天津宝方生物医药有限公司 Babu agent matrix and its preparing method

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