WO2006076844A1

WO2006076844A1 - Traditional chinese medicament for treating injuries from falls, rheumatism and ostealgia and method for manufacture thereof

Info

Publication number: WO2006076844A1
Application number: PCT/CN2005/001679
Authority: WO
Inventors: Feiyan Wei
Original assignee: Guangxi Huahong Pharmaceutical Co., Ltd.
Priority date: 2005-01-18
Filing date: 2005-10-12
Publication date: 2006-07-27
Also published as: CN1660355A

Abstract

The present invention provides a Traditional Chinese Medicament for treating injuries from falls, rheumatism and ostealgia and method for manufacture thereof. The present medicament is manufactured from 21 TCM materials, such as Radices saussureae, Radices sileris, Herba schizeneptae, Herba asari, Cortex acanthopanacis, Ramulus, Radix achyranthis, Rhizoma ligustici, etc. Zoological studies and clinical trials indicate that the present medicament is capable of being effective in relieving arthralgia caused by rheumatism, periomitis, injuries from falls, such as acute sprain and contusion, anonymous intumescence, parotitis.

Description

Traditional Chinese medicine preparation for treating bruises and rheumatic bone pain and preparation method thereof

The invention relates to a pharmaceutical preparation containing an active ingredient of a Chinese herbal medicine, in particular to a traditional Chinese medicine preparation for treating bruises and rheumatic bone pain and a preparation method thereof. Background technique

According to the "Study on the Epidemiological Survey of Rheumatism in China", the incidence rate of natural diseases of rheumatism in China is 14%, and the special industry (textile, steel machinery, chemical industry, mining oil, port, army) is as high as 23.1%. The main patient population of rheumatism is 40 to 60 years old; at present, there are an estimated 182 million people suffering from rheumatism in China, and 94.46 million people over 40 years old. Rheumatism causes inconvenience to the patient in daily life and work, and the disability rate is high, which has a great impact on the patient's own physiology and psychology, and imposes a great burden on the society. Although there are many traditional Chinese medicine preparations for treating bruises and rheumatism and bone pain, the clinical effects are not satisfactory, and there are certain discomforts and side effects. Summary of the invention

The object of the present invention is to provide a traditional Chinese medicine preparation which has remarkable curative effect, rapid action and small side effects for treating bruises and rheumatism.

Another object of the present invention is to provide a process for the preparation of the above-mentioned traditional Chinese medicine preparation.

The technical solution of the present invention is as follows:

Most of the rheumatism and bone pain is caused by wind, cold and dampness invading the human body, blocking the meridians, and the blood and blood are not running smoothly. The bruises can cause blood stasis and obstruction of the meridians. These two conditions usually lead to muscles, bones and joints in the clinic. Symptoms such as soreness, numbness, heavyness, swelling, and poor flexion and extension, etc., therefore, the present invention According to the theory of traditional Chinese medicine that "the general rule is not painful, the pain is not feasible", according to the etiological mechanism of the disease, the principle of "reducing swelling and relieving pain, promoting blood circulation to remove blood, relieving wind and collaterals, and phlegm and phlegm and dampness" has been formulated. The preparation of the traditional Chinese medicine preparation prepared by the invention has remarkable curative effect on bruises and rheumatoid bone pain, and is clinically applicable to, for example, wind-cold dampness, frozen shoulder, acute contusion, anonymous swollen poison, sputum, Glandular swelling and other diseases.

Unless otherwise stated, the pharmaceutical drug substances provided by the present invention are all in parts by weight.

The invention provides a Chinese medicine preparation for treating bruises and rheumatic bone pain as follows:

Windproof 30-80 Nepeta 30-80 Asarum 30-80

Knee 30-80 Chuanxi 30-80 Xu Changqing 30-80 Qishu 30-80 Da Luo Umbrella 85-120 Ronaldinho 55-90 Double-sided needle 85- 120 Triangular 55-90.

The preferred scheme of the traditional Chinese medicine preparation for treating bruises and rheumatic bone pain is as follows: windproof 30-80 Nepeta 30-80 Asarum 30-80

Achyranthes 30-80 Chuanxiong 30 - 80 Xu Changqing 30-80 莪 30 30 - 80 大罗伞 85-120 小罗伞 55-90 Two-sided needle 85- 120 三棱 55-90 Camphor 40-90 Menthol 40-90.

Another preferred embodiment of the traditional Chinese medicine preparation for treating bruises and rheumatic bone pain according to the present invention is: Windproof 30-80 Nepeta 30-80 Asarum 30-80

Achyranthes 30-80 Chuanxiong 30-80 Xu Changqing 30-80 Qishu 30-80 Da Luo Umbrella 85-120 Ronaldo Umbrella 55-90 Double-sided needle 85- 120 Triangular 55- 90 Camphor 40-90 Menthol 40-90 Guizhi 30-80 白芷30-80 Red Eucommia 55-90.

A further preferred embodiment of the traditional Chinese medicine preparation for treating bruises and rheumatic bone pain according to the present invention is: windproof 30-80 Nepeta 30-80 Asarum 30-80 Achyranthes 30-80 Chuanxi 30-80 Xu Changqing 30-80 30-80 大罗伞85-120 小罗伞55-90 两面针85- 120 三棱55-90 camphor 40-90 menthol 40-90 桂枝30-80 白芷30-80 红杜仲55-90 木香30-80 Wujiapi 30-80 Huangteng 80-105 Scorpion 85-120.

The most preferable scheme of the traditional Chinese medicine preparation for treating bruises and rheumatic bone pain is the windproof 30-80 Nepeta 30-80 Asarum 30-80 Achyranthes 30-80 Chuanxi 30-80 Xu Changqing 30-80 Qishu 30- 80 大罗伞85-120 小罗伞55-90 Double-sided needle 85-120 三棱55-90 Camphor 40-90 Menthol 40-90 Guizhi 30-80 白芷30 - 80 红杜仲55-90 木香30- 80 five plus skin 30-80 yellow rattan 8G-105 scorpion 85-120 agarwood 20-40.

The traditional Chinese medicine preparation of the present invention may be any pharmaceutically acceptable dosage form prepared by a conventional formulation process in the art. An expectorant, a liquid, an emulsion or the like is preferred.

In the present invention, the preferred ratio of the above-mentioned drug substance is:

Woody 70 windproof 60 Nepeta 70

Asarum 70 Wujiapi 60 Guizhi 50

Achyranthes 70 Sichuan Chuan 50 Xu Changqing 40 白芷70 莪术60 红杜仲70

Big Luo umbrella 110 small Luo umbrella 60 double needle 100

Yellow vine 85 栀子 90 三棱 85

Agarwood 25 camphor 80 menthol 50

In the present invention, the amount ratio of the above-mentioned drug substance is also preferably:

Woody 47 windproof 47 Nepeta 47

Asahi 47 Wujiapi 47 Guizhi 47

Achyranthes 47 Chuanxi 47 Xu Changqing 47

3⁄4芷 70 莪 47 47 Red Eucommia 70

Big Luo umbrella 100 small Luo umbrella 70 double needle 100

Yellow vine 80 scorpion 1GQ three-sided 70

Agarwood 32. 5 camphor 55 menthol 55

Woody 35 windproof 60 Nepeta 35

Asahi 40 Wujipi 80 Guizhi 40

Achyranthes 40 Chuanxiong 50 Xu Changqing 40

White 芷 35 莪 50 50 Red Eucommia 80

Big Luo umbrella 110 small Luo umbrella 80 double needle 90

Yellow rattan 95 scorpion 110 triangular 80

Agarwood 40 camphor 4G menthol 80

The traditional Chinese medicine tanning agent can be prepared according to the following preparation process:

The above raw materials such as camphor and menthol are pulverized into coarse powder according to the method of preparing a liquid extracting agent and an extracting agent (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition). 7000 ~ 8000 parts by weight of 50-95% ethanol as solvent, after immersion for 15-30 hours, slowly ooze at a rate of about 1-10 ml per minute, collect sputum, and store it; take camphor, menthol plus After 500-800 parts by weight of 50-95% ethanol is dissolved, it is mixed with the above-mentioned mash, allowed to stand for 20-72 hours, and filtered to obtain.

Usage and dosage of traditional Chinese medicine preparation of the invention: external use, rubbing the affected area. Oral, if necessary, before meals, 5 ~ 10ml, - 1 ~ 2 times a day. Note: Pregnant women should not take it; it should not be rubbed when used externally. Store in a sealed place and place in a cool place.

The main active ingredient of the drug substance of the present invention and the action thereof are as follows: woody, wherein the Yunmuxiangcai contains volatile oil 0. '3 ~ 3%, wherein the components are single taxane, α-Rolandone, β-celery Isoene, scutellarin, citronella, eucaly, woody acid, woody alcohol, alpha-woody hydrocarbon, beta-woody hydrocarbon, woody lactone, decene, water phlegm, dehydrogenated woody Lactone, dihydrodehydroxylactone, and the like. In addition, the roots also contain sterol, betulin, resin, inulin and eucalyptus. Its pharmacological effects are: 1 antispasmodic and antihypertensive effects, 2 antibacterial effects. Indications include qi and pain relief, warm stomach and stomach. Treatment of cold qi stagnation, chest and abdomen pain, vomiting, diarrhea, squatting in the squat, heavy, cold. Windproof, containing volatile oil, mannitol, bitter miso, etc. Its pharmacological effects are: 1 antipyretic effect, 2 analgesic effect, 3 antibacterial effect. The main function of the function is to publish, hurricane, win the wet, and relieve pain. Exogenous cold, headache, dizziness, strong, cold and dampness, sore throat, limbs urgency, tetanus. Nepeta, containing volatile oil 1.8%, the main component of the oil is dextrin, racemic menthone, a small amount of d-limonene. Its pharmacological effects are: artificially heated rabbits, oral schisandra and 2 grams of extract (raw drug) / kg, no heat. In vitro, high concentrations (1: 100) have the effect of anti-tuberculosis. The main function of the function is to publish, hurricane, and blood; Treatment of cold fever, headache, sore throat, stroke sputum, vomiting blood, blood stasis, blood in the stool; uterine bleeding, postpartum blood halo; bloated, sore, phlegm. The effect of schisandra chinensis is the same, but the strength of scatter is stronger. Asarum, Liao Xixin contains volatile oil, the main component of volatile oil is decyl eugenol, Others include xanthine, β-pinene, eucalyptone, phenolic substances, etc.; Hua Xixin contains volatile oil 2.75%, 1.9%. Volatile oil mainly contains decyl eugenol (about 50 ° /.), as well as asarone, terpene, eucalyptone, xanthine, 1, 8-alpha, I-asarone (about 0 . 2% ) and so on. The variation of Huaxinxin and the composition of volatile oil are similar to those of Huaxin; the volatile oil of Asarum sinensis contains 6% of eucalyptone, 8% of borneol or lycopene, 4% of eucalyptus 4%, and 2% of lin. , methyl eugenol 15%, xanthine 10%, ketone 10%, eucalyptus 8%, less octyl ketone 0.2%, linalool, big cattle trienol, 2-methyl- 2-vinyl-3-isopropenyl-5-isopropylidenecyclohexanol; etc.; Astragalus sinensis contains flavonoid glycosides, amino acids, sugars and volatile oils. Its pharmacological effects are: 1 local anesthetic effect, 2 antipyretic, analgesic effect, 3 antibacterial effect, 4 effects on blood pressure. Indications: Hurricane, cold, water, open. Treatment of cold headache, nose, toothache, phlegm and cough, rheumatism and pain. Wujiapi, Wujia's root bar contains volatile oil (for 4-methyl salicylaldehyde, etc.), tannin, palmitic acid, linolenic acid and vitamin bismuth, B _{l D} sessile root plus sesamin, sprinkle Ning, syrup resin phenolic monoglucoside (five plus bismuth B) and mannose glucoside (five plus 甙 D) and other lignan components, also contains carotenol, cardiac sputum and saponin. Further, it contains a water-soluble polysaccharide such as polyglucose and an alkali-soluble polysaccharide, and the latter is hydrolyzed to produce galacturonic acid, glucose, arabinose, rhamnose, xylose and the like. The root of Acanthopanax senticosus contains a variety of glycocalyx, including carrot sterol, 7-hydroxy-6, 8-dimethoxy coumarin ct-glucoside, ethyl alpha-galactose, syringe phenol glucoside, Lilac and so on. In addition, it also contains sesamin and polysaccharide (2.3 to 5. 7 ° /.). The stem contains sugar V. 6 ~ 1. 5%). The fruit contains 17-20% water-soluble polysaccharide, which contains pectin shield. Its pharmacological effects are: 1. Pharmacological action of sessile sessile plus 1 anti-inflammatory effect, 2 analgesic, antipyretic effect, 3 cardiovascular effects; Pharmacological action of Acanthopanax senticosus, Acanthopanax senticosus is better than ginseng "Adapt to the original, and the role of the function. Indications: Rheumatism, strong bones, blood circulation to go to the phlegm. Treatment of cold and dampness, rapid bones and muscles, low back pain, impotence, weak feet, late child, edema, athlete's foot, sore throat, swelling, pain, Bruises and bruises. Guizhi, its pharmacological effects are: 1 antibacterial effect, 2 antiviral effect, 3 diuretic use. The main functions are: sweating and relieving muscles, warming the veins. Treatment of cold and cold syndrome, shoulder and back muscles are sore, chest and drink. Achyranthes, its root contains triterpenoid saponin, hydrolyzed to form oleanolic acid, and contains a lot of potassium salt. The seeds also contain triterpenoid saponins, which are the same as those contained in the roots. It also contains ecdysterone, and cofone. Its pharmacological effects are: 1 the effect on the uterus, 2 on the intestinal tract, 3 on the cardiovascular system, 4 analgesic effect. The main function of the function is: the use of scattered blood, dissipate swelling. Gonorrhea, hematuria, amenorrhea, symptoms, dystocia, cytoplasmic, postpartum bloody abdominal pain, throat, bloated, bruises. Cooked liver and kidney, strong bones and muscles. Treating the waist and knee pain, hehe. Chuanxiong, its roots contain volatile oil, alkaloids, phenolic components, lactones, ferulic acid. Its pharmacological effects are: 1 the role of the central nervous system, 2 antihypertensive effect, 3 pairs of smooth muscle, 4 antibacterial effects. Function and Indications: Live blood, hurricane and pain. For irregular menstruation, menstrual dysmenorrhea, symptoms of abdominal pain, chest pain, tingling, swelling, pain, headache, rheumatism and pain. Xu Changqing, the whole grass contains peony phenol about 1 ° /», and finds the substance which is very similar to the meat coral 甙 yuan, the deacetylated cow 甙、 yuan, the hairy milk vine and the acyl radix and the acetic acid, cinnamon Acid, etc. The root contains flavonoid glycosides, sugars, amino acids, and peony. Function and Indications: phlegm and dampness, relieve pain and relieve itching. For rheumatic pain, stomach pain, fullness, toothache, low back pain, falling pubar damage; urticaria, eczema. % 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 24 Hangbai glutinous root contains six kinds of furan coumarin: iso-Parsin B, isoflavin B, bergamot lactone, coralin, oxidized praerupin, hydrated oxidized praer. Its pharmacological action is: antibacterial effect. Function and Indications: Disperse wind and dehumidification, relieve pain, relieve swelling and discharge pus. For cold headache, eyebrow pain, stuffy nose, nose, toothache, vaginal discharge, sore throat.莪 ,, function and indications: qi and blood, eliminate the pain. For syndromes, blood stasis, food and pain; early cervical cancer. Red Eucommia, Source: This product is a bamboo. ^ > Branch plant Red eucommia Parabarium chunianum Ts iang, Phyllostachys pubescens Parabarium huait ingi i Chun et Tsiang, eucommia Parabarium micranthun (A. DC.) Pierre or flower vine vine Ecdysanthera Ut il is Hay. et Kaw. Dry bark, function and indications: hurricane active, strong waist and knees, strong bones, swelling. For polio, rheumatism, bruises, bruises. Big Luo Umbrella, Source: Dry roots of the legumes Mi l lettia pulchra ( Colebr. ) Kurz forma laxior Dunn. Small Luo umbrella, Source: Dry root of Ardis ia crenata Sims. Function and Indications: Blood circulation and menstruation, hurricane dehumidification. Treatment of menstruation, dysmenorrhea, rheumatism, pain, bruises. Double-sided needle, function and indications: qi and pain, blood circulation, phlegm and wind. It is used for stagnation and blood stasis caused by stagnation of blood stasis, rheumatism, stomach pain, toothache, poisonous snake bite; external treatment of soup fire burns. Function and use: This product is a stupid and phenanthridine alkaloid. The survival rate of P388 and L1210 leukemia mice is better, the life extension rate of Ehrlich ascites mice is '250%, and the life extension rate of AL771 is about 150%. HeLa cells have a significant cytotoxic effect at 1 μg/ml. It is possible to extract amphoteric alkaloids such as amphotericin 26 and chlorinated amphotericin 27. Huang Teng, Function and Indications: Detoxification. For gynecological inflammation, surgical infections, bacillary dysentery, enteritis, respiratory and urinary tract infections, conjunctivitis. The roots of the yellow vine include palmophylline, radix decoction, arbutin, scutellaria, scutellaria, yellow vine lactone, and sterol. Scorpion, function and indications: diarrhea in addition to annoyance, heat diuretic, cooling blood detoxification. For fever, upset, jaundice, red blood, bloody pain, bloody vomiting, red eyes and swelling, fire sores; external treatment, contusion and pain. 05%。 The rim, the small black triangle with volatile oil 0. 05%. Function and Indications: Breaking blood and eliminating qi, relieving pain. For the symptoms of sputum, blood stasis, food and pain. Agarwood, containing agarwood spirulina, a-agarfurfuran, B-agarfurfuran, dihydrofuran furan, demethylfuran, 4-hydroxydihydrofuran, 3,4-dihydroxydihydrofuran, eugenol; Function and Indications: Qi and pain, warm and stop vomiting, gas and asthma. For chest and abdomen swelling and pain, stomach cold vomiting hiccups, kidney deficiency gas and asthma.

In the group of the invention, the big Luo umbrella is used for swelling, relieving pain, phlegm, sputum, blood stasis, rheumatism, Xu Changqing, phlegm, pain relief, and collateral. With three edges, scorpion, two-sided needle, Chuanxiong, Achyranthes Such as activating blood circulation to remove phlegm, in order to strengthen the main medicine swelling and pain relief effect, and with cassia twig, schizonepeta, wind, spleen, wind and cold, woody, agarwood, white peony, camphor qi and pain, swelling and dampness, It is supplemented with Wujiapi, Eucommia with strong bones, Tongjingluo and Rheumatoid arthritis. In the above-mentioned warm medicine, the yellow vine and the scorpion with the cold and cool products are used as the adjuvant for cooling blood and detoxification. The opposite is multiplied. It is then blended with menthol to repel and repel various medicines for use in the skin or mucous membranes to produce a cool feeling. The combination of various medicines has the effects of reducing swelling and relieving pain, promoting blood circulation and removing blood stasis, driving wind and collaterals, and relieving cold and dampness. It is used for cold and dampness, frozen shoulder, and acute contusion. detailed description

Example

Example 1

Windproof 47 Nepeta 70 Asarum 50

Achyranthes 70 Sichuan Chuan 50 Xu Changqing 30

莪术 60 大罗伞 110 小罗命 55

Double-sided needle 100 three-sided 85

The above-mentioned raw materials other than camphor and menthol are pulverized into coarse powder according to the method of preparing a liquid extracting agent and an extracting agent (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 7200 parts by weight of 85% ethanol as a solvent. After immersion for 15 hours, slowly percolate at a rate of about 5 ml per minute, collect the sputum, and store it again; take camphor and menthol and add 550 parts by weight of 75% ethanol to dissolve, mix with the above sputum, and let stand. After 28 hours, it was filtered to obtain the expectorant of the present invention.

Example 2

Windproof 60 Nepeta 80 . Asahi 50

Achyranthes 55 Chuanxi 65 Xu Changqing 75 莪术47 大罗伞110 小罗伞85

Double-sided needle 110 Triangular 85 Camphor 90

Menthol 40

The above raw materials other than camphor and menthol are pulverized into coarse powder, according to the method of preparing a liquid extracting agent and a leaching agent (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 7000 parts by weight of 53% ethanol as a solvent. After immersion for 15 hours, slowly percolate at a rate of about 5 ml per minute, collect the sputum, and store it again; take camphor and menthol and add 500 parts by weight of 95% ethanol to dissolve, mix with the above sputum, and let stand. After 20 hours, it was filtered to obtain the expectorant of the present invention.

Example 3

Windproof 47 Nepeta 65 Asa 47

桂枝 47 Achyranthes 47 Chuanxiong 30

徐长卿 47 白芷 70 莪术 30

Red Eucommia 70 Daluo Umbrella 100 Ronaldo Umbrella 70

Double-sided needle 120 triangular 55 camphor 55

Menthol 90

The above raw materials other than camphor and menthol are pulverized into coarse powder.

The osmosis method of the agent and the extract (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 8000 parts by weight of 75% ethanol as a solvent, immersing for 30 hours, slowly oozing at a rate of about 3 ml per minute, collecting sputum, The device was preserved; the camphor and menthol were added with 800 parts by weight of 53% ethanol to dissolve, and then mixed with the above mash, allowed to stand for 24 hours, and filtered to obtain the elixirs of the present invention.

Example 4

Woody 30 Windproof 80 Nepeta 30

Asahi 30 five plus skin 80 cassia 30 Achyranthes 30 Chuanxi 50 Xu Changqing 60

White 芷 30 莪 50 50 Red Eucommia 55

Big Luo umbrella 120 small Luo umbrella 80 double needle 85

Yellow vine 80 scorpion 110 Triangular 90

Camphor 40 menthol 80

An emulsion is prepared according to a conventional formulation process in the art.

Example 5

Woody 47 windproof 30 Nepeta 47

Asarum 67 Wujiapi 47 Guizhi 80

Achyranthes 80 Chuanxiong 80 Xu Changqing 80

白芷 80 莪术 80 Red Eucommia 90

Big Luo umbrella 85 Luo Luo umbrella 90 double needle 110

Yellow vine 90 栀子 85 三棱 70

Agarwood 20 camphor 70 menthol 55

Except for the above camphor and menthol, the other raw materials are pulverized into coarse powder, according to the percolation method for preparing the extract extract and the extract (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 7500 parts by weight of 95% ethanol as a solvent. , immersed for 28 hours, slowly permeate at a rate of about 3 ml per minute, collect sputum, recover alcohol, and obtain clear paste; take camphor, menthol and add 650 parts by weight of 70% ethanol to dissolve, mix with the above-mentioned clear paste After standing for 48 hours, filtering, adding 3000 parts by weight of water to adjust the water agent of the present invention.

Example 6

Woody 55 windproof 60 Nepeta 35

Asahi 4G Five Plus Skin 47 Guizhi 47 Achyranthes 40 Chuanxi 50 Xu Changqing 40

White 芷 35 莪 47 47 Red Eucommia 80

Big Luo umbrella 110 small Luo umbrella 90 double needle 90

Yellow vine 85 栀子 85 三棱 70

Agarwood 32. 5 camphor 70 menthol 55

Except for the above camphor and menthol, the other raw materials are pulverized into coarse powder. According to the method of preparing the infiltrative paste and the extracting agent (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), 7600 parts by weight of 79% ethanol is used as a solvent. After immersion for 28 hours, slowly percolate at a rate of about 3 ml per minute, collect sputum, recover alcohol, and obtain a clear paste; take camphor, menthol and add 700 parts by weight of 85% ethanol to dissolve, and mix with the above-mentioned clear paste. , standing for 48 hours _: filtration, adding 8000 parts by weight of water to adjust the water agent of the present invention.

Example 7

Woody 60 Windproof 75 Nepeta 80

Asarum 65 Wujipi 60 Guizhi 65

Achyranthes 70 Sichuan Chuan 80 Xu Changqing 80

白芷 65 莪术 70 红乌仲 90

Big Luo umbrella 110 small Luo umbrella 80 double needle 100

Yellow vine 90 栀子 85 三棱 70

Agarwood 20 camphor 60 menthol 55

Except for the above camphor and menthol, the other raw materials are pulverized into coarse powder. According to the method of preparing the infiltrative solution and the extracting agent (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), 7500 parts by weight of 90% ethanol is used as a solvent. , immersed for 28 hours, slowly permeate at a rate of about 3 ml per minute, collect sputum, recover alcohol, and obtain clear paste; take camphor, menthol and add 650 parts by weight of 70% ethanol to dissolve Thereafter, it was mixed with the above-mentioned clear paste and allowed to stand for 48 hours: filtered, and adjusted to 4500 parts by weight of water to obtain the aqueous preparation of the present invention.

Example 8

Woody 80 windproof 60 Nepeta 70

Asahi 70 Wujiapi 30 Guizhi 50

Achyranthes 70 Sichuan Chuan 50 Xu Changqing 40

White 芷 70 莪 60 60 Red Eucommia 70

Big Luo umbrella 110 small Luo umbrella 60 double needle 100

Yellow vine 105 栀子 120 三棱 85

Agarwood 40 camphor 80 menthol 50

The above nineteen flavored raw materials other than menthol are pulverized into coarse powder, according to the method of preparing the infiltrative paste and the extracting agent (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 7500 parts by weight 80% Ethanol as a solvent, immersed for 15 hours, slowly permeate at a rate of about 5 ml per minute, collect sputum, and store it again; take camphor, menthol and 600 parts by weight of 85% ethanol to dissolve, mix with the above mash After standing for 72 hours and filtering, the tincture of the present invention is obtained.

Example 9

Woody 47 windproof 47 Nepeta 47

Asahi 47 Wujiapi 47 Guizhi 47

Achyranthes 47 Chuanxi 47 Xu Changqing 47

白芷70 莪术 47 红杜仲 70

Big Luo umbrella 100 small Luo umbrella 70 double needle 100

Yellow rattan 80 scorpion 100 three-sided 70

Agarwood 32. 5 camphor 55 menthol 55 The above nineteen flavors of the raw materials other than camphor and menthol are pulverized into coarse powder, according to the method of preparing the infiltrative paste and the extracting agent (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 7200 parts by weight 70% Ethanol as solvent, immersed for 15 hours, slowly permeate at a rate of about 5 ml per minute, collect sputum, and store it again; take camphor, menthol and add 700 parts by weight of 65% ethanol to dissolve, mix with the above mash After standing for 36 hours and filtering, the tincture of the present invention was obtained.

Example 10

Woody 70 windproof 60 Nepeta 70

Asarum 70 Wujiapi 60 Guizhi 50

Achyranthes 70 Sichuan Chuan 50 Xu Changqing 40

White 芷 70 莪 60 60 Red Eucommia 70

Big Luo umbrella 110 small Luo umbrella 60 double needle 100

Yellow vine 85 栀子 90 三棱 85

Agarwood 25 camphor 80 menthol 50

The above nineteen flavored raw materials other than camphor and menthol are pulverized into coarse powder according to the method of preparing a liquid extracting agent and an extracting agent (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 7800 parts by weight and 60%. Ethanol as a solvent, immersed for 15 hours, slowly permeate at a rate of about 5 ml per minute, collect sputum, and store it again; take camphor, menthol and add 700 parts by weight of 60% ethanol to dissolve, mix with the above mash After standing for 60 hours and filtering, the tincture of the present invention was obtained.

Example 11

Woody 35 windproof 60 Nepeta 35

Asahi 40 Wujipi 80 Guizhi 40

Achyranthes 40 Chuanxiong 50 Xu Changqing 40

White 芷35 莪术50 Red Eucommia 80 Big Luo umbrella 110 small Luo umbrella 80 double needle 90

Yellow rattan 95 scorpion 110 triangular 80

Agarwood 40 camphor 40 menthol 80

The above nineteen flavored raw materials other than camphor and menthol are pulverized into coarse powder according to the method of preparing the infiltrative solution of the flow extract and the extract (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 7500 parts by weight 80%. Ethanol as a solvent, immersed for 15 hours, slowly permeate at a rate of about 5 ml per minute, collect sputum, and store it again; take camphor, menthol and 600 parts by weight of 60% ethanol to dissolve, mix with the above mash After standing for 24 hours and filtering, the tanning agent of the present invention was obtained.

The pharmacodynamic test data of the traditional Chinese medicine preparation of the invention is as follows: The anti-tumor and analgesic tincture is a traditional Chinese medicine preparation tincture developed by Guangxi Liuzhou Traditional Chinese Medicine General Factory. Pharmacodynamic tests showed that: local application can significantly expand the capillaries of mouse ear canal, and obviously promote the absorption of blood spots in rabbit ears; local application and ig administration can inhibit the swelling and smallness of mouse ear canal caused by croton oil. The proliferation of cotton granuloma in the subcutaneous skin of rats; but the administration of ig has no obvious effect on the percolation of peritoneal inflammation caused by acetic acid; local application and ig administration have certain analgesic effect on the pain caused by hot plate in mice, ig The drug has obvious analgesic effect on the stimulation of acetic acid in mice. The topical application has the effect of promoting the repair of soft tissue contusion in mice. The minimum inhibitory concentration against Escherichia coli in vitro is 1:10, against Staphylococcus aureus and B. Streptococcus is 1:20.

[This product and test article]

It is a traditional Chinese medicine tincture developed by Guangxi Liuzhou Traditional Chinese Medicine Factory. It contains 55% alcohol. It is used for bruises, rheumatoid bone pain, nameless swollen, parotid swelling and pain. Apply a proper amount to the affected area; if necessary, take it orally before meals, 5-10 ml each time, 2 times per sputum.

Test sample: This product (batch number 940402) and its 2 times concentrated liquid (55% alcohol), provided by Liuzhou Chinese Medicine General Factory. The doses described herein are expressed in "this product ml".

[Experimental Materials]

Kunming mice, ordinary grade, ? δ is used in combination, supplied by the animal room, feeding the pellet feed. Japanese big white rabbit, ? ί用用, Weight 2. 5 — 3. 0kg, provided by our animal room. Feed solid feed and greens.

Species: Escherichia coli (44102), Staphylococcus aureus (26003), Streptococcus mutans (32172), provided by China National Institute for the Control of Pharmaceutical and Biological Products.

Bacterial culture medium: common broth medium, eosin blue agar medium, mannitol high salt agar medium, blood lipid medium, serum broth medium, prepared by our antibiotic room according to the Ministry of Health "Drug Hygiene Test Method" .

Feng rheumatoid beaten medicinal liquor: produced by Foshan Pharmaceutical First Factory, Guangdong, batch number 9309086, containing alcohol 35-45%. When used, it can be concentrated in 6 (TC water bath to half of the original volume, and part of the ethanol is removed, and water is added to the required volume.

Absolute ethanol: produced by Anhui Super-Grade General Factory, batch number 9312 ² 0. Dilute the appropriate concentration with deionized water for testing.

Croton oil mixed inflammatory agent: This room is prepared. 0. 5% Evans Blue: This room is prepared. 0. 7% acetic acid This room is prepared.

Sterilized dry cotton balls (20mg / only): Prepared in this room.

CHEM-5 semi-automatic biochemical analyzer: produced by Japan ERBA.

[Experimental conditions]

Experimental room temperature 25 ° 1 °C (air conditioning), relative humidity 65 ± 5%, see "Experimental materials" for other conditions.

[Experimental methods and results] 1. Effect of external application of this product on microvessels in mouse ear canal

Take 50 mice, weighing 18-21g, ? S is used in combination, and is randomly divided into 5 groups. Each mouse was anesthetized with barbiturate sodium, and the left auricle was coated with paraffin oil on a glass slide. After anesthesia for 10 minutes, the auricle tip A was observed under a microscope equipped with a ruler (10 X 4 times). The diameter of the capillary at the branch (scale unit), as a pre-medication value, immediately administered: high and low dose group according to the product 0. 2ml / ear (use this product 2 times concentrated liquid 0. 1 / ear ), 0. 1ml / ear lightly on the auricle; ethanol group with 55% ethanol drop auricle. The dosage volume of each group was 0.1 ml/ear. The blood vessel diameter of the same site was observed every 5 minutes after the drug for 15 minutes. The maximum value of the blood vessel diameter was used as the drug value. The vasodilation rate and vasodilatation degree were calculated according to the following formula, and compared with the blank group, the t-test was performed between groups. The results are shown in Table 1.

Vasodilatation rate ₌ two female _x simple

Drug value

Vasodilatation = post-drug value - pre-medication value

Table 1. Results of mouse auricle microvessels (±SD)

Dose pre-drug value

Group n expansion rate

(ml/ear) (scale unit) (scale unit) high dose group 10 0.2 3.5 ±0.53 0.60 ±0.39*** 17.9 ±11.8***

Low dose group 10 0.1 3.50 ±0.53 0.70 ±0.59** 21.7 ±19· 6**

Feng's sexual group 10 0.1 3.75 ±0.79 0.65 ± 0.41*** 19.8 ±13.7**

Blank group 10 0.1 3.35 ±0.47 0.10 ±0.21 3.1 ±6.5

Ethanol group 10 0.1 3.42 ±0.51 0.25 ±0.23* 9.3 ±11.4*

Note: Compared with the blank group, *P.>0.05, **p< 0.05, ***p< o.01, the same as the ethanol group, P>0.05, P<0.05 P<0.01, the same below

The results showed that the vasodilation and the tensor rate of the high- and low-dose groups were higher than those in the blank group and the ethanol group. The difference was significant or very significant, suggesting that the product of the auricle skin drops the mouse auricle capillaries. There is a certain expansion effect.

2. Effect of external application of this product on the absorption of blood spots under rabbit skin

Take 30 rabbits, each half, randomly divided into 5 groups, each rabbit is used for subcutaneous blood spotting of the auricle: Inject 0.2 ml of anti-coagulant liquid into the blood mound under the skin of the ear, and press with a glass tube with an inner diameter of 1.6 cm. Around the blood dome, the blood core is gently pressed from the glass tube with a diameter of the front end of the curved section, forming an area of about 2CM ² blood spots. Two blood spots per ear, about 3CM apart. 4h after modeling, the area of each blood spot was measured as the pre-medication value, and the administration was as follows: The high- and low-dose groups were respectively 0.2 ml/shift (0.1 ml/class of 2 times concentrated solution of this product), 0.1 ml/class This product; the positive control group and the blank control group were given 0. lml/ spot respectively to Feng medicinal liquor and deionized water; alcohol group to 55% ethanol 0.1 heml / spot, all blood spots (surface skin coating, Once a day. The blood spot area was measured once every 24 hours after administration, and the blood spot absorption rate X 100% was calculated. The value before the drug was compared with the blank group to make an inter-group t test.

Drug value

The results are shown in Table 2.

Table 2. Effect of subcutaneous blood spot absorption on rabbit ears (Soil SD) Dose Pre-medication value Blood spot absorption rate after drug

Group another ' J n

(ml/spot) (cm ² )

24h 48h 72h 96h high dose group 6 0.2 2.18±0.36 2.4 ±44.5* 67.1 ± 13.3*** 93.0±9.8*** 100.0± 0*** Low dose group 6 0.1 2.29 ±0.26 3.8 + 23.6* 48.7 + 9.6* ** 69.9 ±13.5* 91.8 ±21.3* Vortex group 6 0.1 2.30 ±0.29 20.4 ±24.2*** 41.6 ±17.7** 71.0±20.8* 90.7 ±14.6* Blank group 6 0.1 2.14 ±0.25 - 9.1±25.1 26.0 ±18.4 62.0±24.2 73.1±20.6 Ethanol group 6 0.1 2.08 ±0.17 4.1±18.6* 37.1±22.3* 69.1 ±21.4* 81.3 ±17.1*

The results showed that the blood spot absorption rate of this product was higher than that of the blank group after high dose,

The difference of blood spot absorption rate at 48h, 72h and 96h was very significant. The blood spot absorption rate of the low dose group was 48 h after the drug was higher than that of the blank group. The difference was significant. The absorption of subcutaneous blood spots has a certain promoting effect.

3. Effect of topical application of this product on swelling of mouse ear caused by croton

Take 84 mice, weighing 22-24g, ? δ is used in combination and is randomly divided into 7 groups. The four dose groups of this product, the Feng control group, the ethanol control group and the blank control group were given this product, Fengjiu medicinal liquor, 55% ethanol and deionized water, all of which were slowly dripped on both sides of the left auricle of each mouse. , 0. 1ml / ear. After the administration of lh, 7 groups of mice ^ croton oil mixed inflammatory agent 0.1 1 / ear drops on both sides of the left auricle to cause inflammation. The product group 1, the phosic group, the ethanol group, and the blank group were administered in the same way after 1, 2, and 3 hours after the inflammation; the second group and the third group of the product were the first group after the inflammation. The same method is administered once more (5 ml of this product plus 55% ethanol is added to 10 ml for the third group, and the product is 2. 5 ml plus 55% ethanol to 10 ml for the fourth group). 4 hours after the inflammation, the mice were sacrificed by pulling the neck, and the left and right auricles were cut out. The left and right ear slices were respectively punched in the corresponding parts with a diameter of 8 mm, and weighed separately. The difference between the left and right ear weights is used as the swelling degree, and the swelling rate is compared with the blank group.

Inter-group t test. The results are shown in Table 3. Table 3 Effect of application of this product on croton ophthalmitis in mice ( soil SD )

Group n dose (ml / kg) Swelling degree (mg) Swelling rate (%) This product group 1 12 20 6. 5 ± 5. 1 *** 36. 1 ± 29. 5*** This product 2 group 12 10 11. 1 ± 4. 2* 66. 4 ± 25. 9* 3 groups of this product 12 5 13. 2 + 5. 4* 80. 1 ± 34. 1* 4 groups of this product 12 2. 5 11. 5 ± 3. 8* 73. 3 ± 23* Feng group 12 20 6. 3 ± 4. 4*** 41. 8 ± 29. 8*** Ethanol group 12 20 12. 8 ± 3. 9* 82. 2 ± 24. 9* blank group 12 20 14. 2 ± 3. 8 90. 2 ± 29. 4* As a result, the swelling degree and swelling rate of each group were smaller than those of the blank group. The difference in swelling degree and swelling rate of the first group of this product was very significant. Sexual significance, the difference in swelling rate of the second group of this product was significant, and the difference between the third and fourth groups was not significant.

The inhibitory effect of the outer coating on the swelling of the croton oil to the ear lobes showed a certain dose-effect relationship. It is suggested that the administration of the ear canal has a certain inhibitory effect on the swelling of the mouse ear canal caused by croton oil.

4, the effect of this product ig ^ medicine on the swelling of mouse ear lobes caused by croton oil

Take 72 mice, weighing 17-22g, ? δ is used in combination, and is divided into 6 groups at random. The high, medium and low dose groups are given 10ml/kg (5ml with twice the concentration of this product), 5ml/kg, 2. 5ml /kg respectively. The group, the ethanol control group and the blank control were given 10 ml / kg of von red wine (spent part of ethanol, see material item), 27% ethanol 10 ml / kg, deionized water 10 ml / kg, and the volume of each group was 10 ml/kg, continuous ig administration for 2 days. One hour after the administration of the overseas Chinese, the left ear of each mouse was coated with croton without mixing inflammatory agent 0. lml to cause inflammation, 4 hours after inflammation, the mice were sacrificed by pulling the neck, and the left and right ear lobes were cut. 8 wake up the puncher in the corresponding parts, respectively, the left and right ear discs, accurately weighed, the difference between the weight of the left ear and the weight of the right ear; the swelling rate, with ji3⁄4 as the swelling rate, and the blank group For comparison, a t-test between groups was performed. The results are shown in Table 4.

Right ear weight

Table 4. Effect of administration on croton oil ototoxicity in mice (Soil SD)

Group n dose (ml / kg) Swelling degree (mg) Swelling rate (%) High dose group 12 10 13. 5 ± 5. 5** 85. 8 ± 36. 2** Medium dose group 12 5 14. 8 ± 5. 0** 95. 9 ± 29. 2* Low dose group 12 2. 5 16. 2 ± 5. 0* 107. 3 ± 33. 2* Vonogenic group 12 10 13. 0 ± 5. 0** 86. 7 ± 32. 7** Ethanol group 12 10 16. 8 ± 6. 7* 169. 9 + 47. 3* blank group 12 10 17. 9 ± 4. 8 120. 9 ± 32. 8 The results show that the high dose group and the von group The length and swelling rate were lower than the blank group, and the difference was significant. It suggested that the ig administration of this product inhibited the swelling of mouse ear lobes caused by croton oil at higher doses.

5, this product ig to the effect of acetic acid-induced peritoneal exudation test 78 mice, weighing 18-22g, both, randomly divided into 6 groups, high, medium and low dose groups respectively according to 10ml / kg ( Use this product's 2 concentrating solution 5ml), 5ml /kg, 2. 5 ml/kg to give this product, the positive control group and the ethanol control group respectively give Fengjiu medicinal liquor 10ml/kg (spent part of ethanol, See material item) and 27% ethanol; blank control group for water supply. The administration volume was 10 ml/kg, and continuous ig administration was carried out for 4 days. 30 min after the last administration, each mouse was injected with 0.5% Evans blue 5 ml/kg, followed by ipO. 7% acetic acid 10 ml/kg, 30 min after ig vinegar weight, the mice were sacrificed by pulling the neck, and the amount of normal saline was used. Rinse the abdominal cavity, collect all the washing liquid and add the weight of saline to 10ml/kg. After centrifugation, take the supernatant and measure the DD value at 578mm. The DD value indicates the content of Evans blue in the washing liquid, indirectly, reflecting the peritoneal inflammation exudation. Degree. Compared with the ethanol level, an inter-group t-test was performed. The results are shown in Table 5. Table 5. Results of infiltration of peritoneal inflammation in mice induced by acetic acid

Liquid OD ( χ士

Group n dose (ml / kg) inhibition rate (%)

SD) High dose group 13 10 0. 240 ± 0. 071* 6. 7 Medium dose group 13 5 0. 213 ± 0. 046* 5. 3 Low dose group 13 2.5 0.230 ± 0.040* 2.2 von group. 13 10 0.179 soil 0.034 *** 20.4

Ethanol group 13 10 10.025 ± 0.066*

The blank group 10 10 0.244 ±0.044 The results showed that the D values of the high, medium and low dose groups of the product were similar to those of the ethanol group and the blank group, and the difference was not significant. The difference between the von group and the low group was very significant (P <Q. Gl. It is suggested that this product ig administration has no inhibitory effect on peritoneal inflammation exudation induced by acetic acid in mice.

6. The effect of external application of this product on the proliferation of mouse cotton granuloma;

Take 72 mice, weighing 24-26g, ? δ is used in combination and is randomly divided into 5 groups. Each mouse was anesthetized with sodium pentobarbital, and the sterilized dry cotton ball was embedded under the aseptic operation to the right side of the back, about 2.5 cm from the surgical incision. The next day after the operation, the surface of the cotton ball was depilated 2 X 2cm ² , apply the liquid to the skin of the hair removal area. The high and low doses are given according to 20ml /kg (10ml of concentrated solution of this product) and 5ral/kg respectively. Positive control group and ethanol control group And the blank control group were given Fengjiu medicinal liquor, 55% ethanol, deionized water; each group was administered with a volume of 5 ml/kg per dose, once a day (two doses of this product in high dose group), 7 days in a row. On the next day after the last administration, the mice were sacrificed by pulling the neck, and the cotton granuloma was taken out and placed in an oven at 60 ° C for 12 hours, then accurately weighed, minus the weight of the original dry cotton ball (20 mg / only) to obtain granuloma. weight. The t-test between groups was compared with the blank group. The results are shown in Table 6.

Table 6. Results of the external application of this product on the proliferation of mouse cotton ball

Group n dose (ml / kg) granuloma weight (mg) inhibition rate (%) high dose group 14 20 27.0 ± 7.2** 32.5

Low dose group 14 5 32.1±7.9* 22.1

Feng's sexual group 15 5 20.1±6.0** 31.8

Blank group 15 5 42.2 ±17.8 Ethanol group 14 5 36. 3 ± 9· 5* The results showed that the weight of granuloma in the high and low dose levels was 32.5% and 22.1% lower than the blank level, respectively, and the difference in the high dose group was significant. The difference in the ethanol group was also significant. It is suggested that the local skin application of this product can inhibit the proliferation of subcutaneous cotton granuloma in mice.

7. Effect of ig administration on the proliferation of cotton granuloma in mice

72 mice were taken, weighing 22-24 g, and $ δ was used together and randomly divided into 6 groups. Each mouse was anesthetized with sodium pentobarbital, and the sterile dry cotton ball (20 mg) was immersed in the right side of the back under the aseptic operation, about 2. 5 cm from the surgical incision. The next day after administration: high, medium, The low-dose group was given 10 ml/kg (5 ml concentrated solution of this product, 5 ml/kg, 2.5 ml/kg); the positive control group was given 10 ml/kg of medicinal liquor (waxing part of ethanol) , see material item); ethanol group gives 27% ethanol; blank control group gives water. The administration volume of each group was 10 ml/kg (partial ethanol was removed, see material item); ethanol group was given 27% ethanol; blank control group was given water. The dosage volume of each group was 10 ml/kg, igl times per day for 7 consecutive days. On the next day after the last administration, the mice were sacrificed by necking, and the cotton granuloma was taken out and placed in an oven at 60 ° C for 16 hours, then accurately weighed, minus the original dry cotton ball (20 ml / only). Swelling, compared with the blank group, for t-test between groups. The results are shown in Table 7.

Table 7. Effect of cotton granuloma on mouse cotton granuloma

Group n dose (ml / kg) Granuloma weight (mg, X soil SD) Swelling rate (%) High dose group 12 10 24. 5 ± 8. 2* 21. 1 Medium dose group 12 5 24. 6 ± 9 0* 20. 5 Low dose group 12 2. 5 22. 4 ± 6. 5** 20. 2 Feng group 12 10 20. 1 ± 5. 1*** 35. 3

Ethanol group 12 10 31. 2 ± 9. 9

Blank group 12 10 27. 5 + 8. 7* The results showed that the granuloma weights in the high, medium and low dose groups were 21. 4%, 20.5%, 28. 2% lower than those in the blank group, respectively. The inhibition rates of the three groups were close, and the difference in the low dose group was significant. It suggests that the ig administration of this product may have a certain inhibitory effect on the proliferation of subcutaneous cotton granuloma in mice.

8. Test of the effect of topical application of this product on heat-induced pain in mice (hot plate method):

50 mice with a pain threshold of 10-20 seconds were selected, and the total weight was 20-24 g, which were randomly divided into 5 groups. The pain was measured by the hot plate method: the mice were placed in an iron box with a bottom plate temperature of 55 ± 0.5 ° C, and the time from the time when the mouse was put into the iron box to the time when the foot was added was used as the pain threshold. 30 minutes after the pre-dose pain threshold, the high, medium and low dose groups were respectively treated with 16 ml/kg of this product 2 times concentrated solution), 8 ml/kg, 5 ml/kg to the base of the product; The medicinal liquor 8ml/kg was coated with double soles; the blank group was coated with water; both groups were coated with 8ml/kg. The pain thresholds of each rat were measured at 30 min, 60 min, and 90 min after drug application. The post-dose pain threshold was compared with the blank group for t-test. The results are shown in Table 8.

Table 8. Results of local application of drug on the hot plate of mice (S. Soil SD)

Dosing

Group n pre-drug pain threshold

(ml /kg) 30min 60min 90min High dose group 10 16 14.75 ±3, 33 - 0.07 ±8.29* 1.24 ±7.15* A 0.16 ±4.43* medium dose group 10 8 14.2 ± 3.37 1.23 ±4.24* 4.27 + 4.21*** 4.11 ±3.98* Low dose group 10 5 13.30 ±3.29 A2.54 ±4.05* 0.18 ±4.67* 3.19 ±4.77* Vortex group 10 8 13.5 ±3.23 3.45 ±5.19*** 3.25 ±6.92 2.24 ±4.23* Blank group 10 0 14.1±2.95 -2.20 ±4.22* -4.10 ±3.24* -0.78 ±5.06*

The results showed that the value of the 60mim and 90mim pain valves in the middle dose group of this product was higher than that in the blank group. The difference was significant, suggesting that the product has a certain analgesic effect on the hot plate breeding of mice.

9. The effect of ig administration on the pain caused by hot plate in mice (hot plate method)

Choose the pain threshold in 7-20 seconds? Sixty mice, weighing 22-25 g, were randomly divided into 5 groups. The pain was measured by the hot plate method: the mice were placed in an iron box with a bottom plate temperature of 55 ± 0.5 ° C, and the time from the time when the mouse was put into the addition of the hind foot was used as the pain threshold. 30mim after the pre-dose pain threshold was measured, and the high, medium and low dose groups were given 10ml/kg (5ml of pesticide solution 2 times), 5ml/kg, 2.5ml/kg, respectively; Sexual medicinal liquor 10ml/kg (spent part of ethanol, see material item); blank control group water supply; ethanol group gave 27% ethanol. Each group of ig administration volume was 10 ml/kg. The pain thresholds of each rat were measured at 30 mim, 60 mim, and 90 mim after administration, and the post-dose pain threshold was compared with the blank group for t-test. The results are shown in Table 9.

Table 9. Effect of ig administration on the pain caused by hot plate in mice

Dosing

Group . n Pre-drug pain threshold

(ml /kg) 30min 60rain 90min High dose group 10 10 13.94 ±4.41* 10.22 ±10.70** 10.99 ± 6.27*** 7.66 ±6.92* Medium dose group 10 5 13.66 ±3.25* - 0.05 ±5.22* 4.08 ±5.99* 2.90 + 5.42* Low dose group 10 2.5 14.33 ±4.50* - 0.74 ± 5.47* -1.25 ±4.62* 1.19 ±5.74* Vonogenic group 10 10 13.5 soil 3.98* 4.61 + 6.38*** 6.67 + 6.14*** 7 · 82±7.41* blank group 10 10 14.69 ±3.42 one 2.79 ±4.03 -3.18 ± 3.74 1.31 ±6.98 ethanol group 10 10 13.72 ±4.21* 2.17 ±1.23* 1.52 ±1.01* 2.61 ±1.92*

The results showed that the value of the pain valve at 30 min and 60 min after the high-dose group was significantly higher than that of the blank group. The difference was significant, suggesting that the product was sensitized to the hot plate of the mouse at higher doses. It has a certain analgesic effect and the duration of action is about 60 minutes. This effect appears to be caused by non-ethanol.

10, the effect of this product ig administration on the stimulation of acetic acid induced pain in mice

Take 60 mice, weighing 22-25g, ? Each half is divided into 6 groups. The high, medium and low dose groups were given 10 ml/kg (5 ml concentrated solution of this product, 5 ml/kg, 2. 5 ml/kg), and the positive control group was given 10 ml/kg of Fengjiu medicinal liquor ( Part of the ethanol was removed, see material item); blank control group was given water; ethanol group was given 27% ethanol. All were administered by ig, and the administration volume was 10 ml/kg. After the rats were administered lh, igO.7% acetic acid 10 ml/kg, the number of writhings in ig vinegar ^^ 15 min was recorded, and compared with the blank group, t-test was performed between groups. The results are shown in Table 10.

Table 10. Results of the effects of acetic acid-induced irritation in mice

The results showed that compared with the blank group, the number of writhing in the high, medium and low dose groups of the product was reduced by 76.9%, 68.8%, and 47. 2%, respectively. The difference was very significant. There was a significant difference in the ethanol group, suggesting that this product has an analgesic effect on the stimulation of acetic acid in mice. Compared with the blank group, the difference between the ethanol group and the blank group was also significant. It can be seen that 10 ml/kg body weight is 27%. Ethanol may affect the analgesic effect of this product.

11. Effect of external application on the repair of soft tissue contusion in mice. Take δ mice and weigh 29-33g. Soft tissue contusion after depilation of the right hind leg of each mouse: Place the right hind leg of the mouse on the rubber pad, paste the rootstock on the corresponding part of the hind leg, use the 500g method to freely fall from the height of 14cm, and shoot the rootstock. The muscles of the rats are pressed, causing soft tissue contusion in the right hind leg of the mouse, and the skin is damaged. After modeling, the rats were randomly divided into 5 groups according to the injury, and then administered immediately: 10 ml of the product in the high, medium and low dose groups (5 ml of the concentrated solution of this product), 5 ml/kg, 2. 5 ml / kg The positive control group and the ethanol control group were given Fengjiu medicinal liquor and 55% ethanol in 10 ml/kg, respectively. Divided twice a day, the dosage volume was 10ml/kg, and the drug was continuously administered for 7 days. Each mouse was scored every day from the 3rd day of administration (see Table 11-1 for the scoring criteria), and the scores of each group were compared with the ethanol group for t-test between groups. The results are shown in Table 11-2. Four hours after the last administration, the mice were sacrificed, and the skin of the right hind leg was removed, and the soft tissue contusion repair was observed. The results are shown in Table 11-3 and attached photos. Table 11-1, Contusion Repair Scoring Criteria

Red spot swelling swollen plaque score score performance score

Skin wrinkles, swelling 25% left

There are red spots 0 0. 5 fades around 75% 0. 5 right

Red spot disappears 0. 5 1. 0 Freckle all disappears 1. 0 Swells about 75%

1. 5

Swelling Table 11-2 scores of each group (SSD)

Dose

Group n Day 3 Day 4 Day 5 Day 6

(ml /kg) High dose group 10 10 1.35 ± 0.41** 1.55 ±0.41** 2.15 + 0.34*** 2.65 soil 0.34*** Medium dose group 10 5 1, 10 ±0.52* 1.35 ±0.63* 1.90±0.52 * 2.30 ±0.63* Low dose group 10 2.5 1.00 ±0.33* 1.35 ±0.41* 1.00 ±0.54* 2.15 ±0.67* Vonogenic group 10 10 1.25 ± 0.49* 1.55 soil 0.06** 1.95 + 0.55* 2.40 ± 0.61* Ethanol Group 10 10 0.05 ±0.41 1.00 ±0.47 1.40 ±0.70 1.70±0.79

Table 11-3, post-medication soft tissue contusion repair (only)

The results show that the product is high, medium and low.

The scores on the 3rd-6th day after the dose group were higher than those in the ethanol group, and the difference in the high dose group was significant. The recovery of the high, medium and low dose groups on the 7th day after the drug was higher than that of the ethanol. Group, suggesting that the local skin application of this product has a certain promoting effect on the repair of soft tissue contusion in mice.

12. In vitro antibacterial test of this product

Preparation of a medicated medium;

Take this product (containing 55% of ethanol) and use the common broth medium and serum broth medium for double translation, into a series of drug-containing medium, and take 55% ethanol for the same method to dilute the drug. Pack the tubes in tubes, 1 ml per tube.

Preparation of bacterial solution: Escherichia coli, Staphylococcus aureus, and Streptococcus mutans were placed in the corresponding medium, and cultured at 36 ° C for 24 hours for testing.

Determination of the most d, bacteriostatic concentration: Escherichia coli and S. aureus were inoculated into each tube containing medicinal broth medium; Streptococcus mutans inoculated in various drug-containing serum broth In the meantime, for each tube, the inoculum was inoculated with 0.1 ml, and cultured at 36 ± 1 °C for 24 hours. Escherichia coli cultures, Staphylococcus aureus cultures, and Streptococcus mutans cultures were streaked onto Eosin blue agar plates, mannitol high-salt agar plates, and blood agar plates at 36 ± 1 °C. The cells were cultured for 24 hours to observe the presence or absence of bacterial growth. The results are shown in Table 12-1 and Table 12-2. Repeat test Times, the results are the same.

Table 12-1 Results of in vitro antibacterial test of this product

Note: "One" means no bacterial growth, "+," indicates bacterial growth.

Table 12-2 Results of in vitro antibacterial test of 55% ethanol

Blank 55% ethanol dilution

Strain

Control 1: 2. 5 1: 5 1: 10 1: 20 1: 40 1: 80 1: 160 1: 320 E. coli + ― - + + + + + + Staphylococcus aureus + - - + + + + + + Streptococcus B + - - + + + + + +

The results showed that the product was determined by the 2-fold dilution method for the small inhibitory concentration of each test strain, E. coli was 1:10; Staphylococcus aureus and Streptococcus mutans were 1:20. The antibacterial effect of this product is stronger than 55% ethanol.

[End]

In summary, the results show that: the local application of this product has a significant expansion effect on the auricle capillaries of mice, and has a certain promoting effect on the absorption of blood spots under the ears of rabbits. The topical application of the product and ig administration have a certain inhibitory effect on the swelling of the mouse ear caused by croton oil, and also have a certain inhibitory effect on the proliferation of the subcutaneous cotton granuloma in mice; , no significant effect on the peritonitis inflammatory exudation induced by acetic acid in mice. The topical application of this product and ig administration have certain analgesic effects on the pain caused by hot plate in mice. The topical application of this product has a certain promoting effect on the repair of soft tissue damage in mice. The in vitro antibacterial test results showed that the minimum inhibitory concentration of this product on E. coli was 1:10, and that of Staphylococcus aureus and Streptococcus mutans was 1:20. The above-mentioned effects of promoting blood circulation, eliminating inflammation, relieving analgesia, antibacterial, and promoting soft tissue damage provide a certain animal test basis for clinical application of this product.

The summary report of the clinical report of the treatment of acute contusion and rickets in the treatment of acute swelling and pain relief of the present invention: From May to July 1994, the First Affiliated Hospital of Guangxi College of Traditional Chinese Medicine, the Second Affiliated Hospital, and the Guangxi People's Hospital adopted a randomized and controlled method. 324 patients with acute contusion and rickets (175 patients in the control group) were clinically validated. The results showed that Xiaozhongzhitongjing has the effects of reducing swelling and relieving pain, relaxing the muscles and promoting blood circulation and removing blood stasis. The total effective rate of this group in the treatment of acute contusion and rickets was 93.3% and 92.6%, respectively. The curative effect was not significantly different from that produced by Yulin Pharmaceutical Factory. This product has no obvious toxic and side effects. Individual patients may develop contact dermatitis for external use, and may have nausea symptoms when taken orally.

Swelling and relieving pain is a pure Chinese medicine preparation produced by Guangxi Liuzhou Traditional Chinese Medicine Factory. Pain, Shujin Huoxue, the effect of promoting blood circulation and removing blood stasis, suitable for bruises, rheumatism and bone pain. In order to prove its efficacy, according to the approval of Guangxi Health Department and Guiwei Pharmaceuticals No. 1994. 23 on the clinical verification of swelling and painkilling, Guangxi Affiliated Hospital of the First Affiliated Hospital of the Chinese Academy of Sciences, the Second Affiliated Hospital, Guangxi People's Hospital, 324 patients Clinical validation was carried out, combined with the comprehensive report as follows:

clinical information

A total of 499 patients were treated in the treatment group and the control group. There were 159 cases observed in the First Affiliated Hospital of Guangxi College of Traditional Chinese Medicine, 180 cases in the Second Affiliated Hospital of Guangxi College of Traditional Chinese Medicine, and 160 cases in the Guangxi People's Hospital.

-, normal information

The subjects included were all patients with acute contusion within 3 days of the disease and those who met the diagnostic criteria of Chinese medicine for diagnosis of phlegm and blood stasis. In the treatment group, 324 patients were treated with Xiaozhongzhitongjing. In the control group, 175 cases were treated with Yunxiangjing produced by Guangxi Yulin Pharmaceutical Factory. There were no significant differences in gender and age distribution between the two groups, as shown in Table 1.

Second, the diagnostic criteria:

(1) Acute contusion:

1. There is a history of obvious trauma, and the course of the disease is within 3 days.

2. Sprains are indirect violence that causes the joint to undergo a torsion that exceeds normal limits, causing partial tearing of the ligaments, tendons, and joints attached to the joints. Often occurs in the ankle, knuckles and lumbar push, manifested as local pain, swelling, ecchymosis and joint movement disorders.

3. Contusion is the damage of subcutaneous tissue and muscle caused by blunt object impact or collision. It is characterized by pain, swelling, bruising of the skin, hematoma and tenderness. In severe cases, there are fascia, muscle fiber tears or deep hematoma.

(2) rickets

1. Diagnostic criteria for Chinese medicine: pain in joints, skin, bones, etc., or swelling of morning stiffness, hemp The wood is heavy, or the flexion and extension are unfavorable, and even the joints are swollen and deformed, the stiffness is not stretched, and the muscles are atrophied.

The type of syndrome of cold and dampness obstruction in rickets is selected as the object of observation. The syndrome criteria are as follows: limb joints are cold and painful, or swollen, local chills, skin color is not red, touch is not hot, cold and pain increase, The heat is reduced, the tongue is fat, the quality is light, the moss is greasy or white, and the pulse string is tight or the string is slow.

2. Diagnostic Criteria for Western Medicine: The Western medicine disease involved in this card is administered according to the latest diagnostic criteria for the disease. Refer to the “Clinical Disease Diagnosis Based on Cure Improvement Standard”. Observation method

A total of 499 cases were observed and randomly divided into 2 groups. Among them, 324 patients in the treatment group were treated with Xiaozhongzhitongjing. In the control group, 175 cases were treated with Yunxiangjing produced by Yulin Pharmaceutical Factory. Usage: External application of sputum to the affected area, every 15 minutes, 3 times a day, oral lml each time, warm water after meals, 2 times a day, acute contusion for 5 days, rickets for 12 days. The subject is routinely examined in detail before the face is tested, and those who meet the criteria for case selection can be included in the subject. After the test, patients with acute contusion were followed up for 1st, 3rd, and 5th, and patients with rickets were followed up once every 3 days. The medication was asked and the condition and side effects were recorded. The therapeutic effect was assessed by a score method.

The efficacy judgment is directly made by the observer. No other drugs were used during the observation period.

Result

First, the efficacy evaluation criteria:

(1) Evaluation criteria for the efficacy of acute contusion:

1. Recovery: The pain was relieved within 1 day, the swelling began to decrease within 2 days, the swelling and pain disappeared within 3 days, and the joint function returned to normal.

2. Significant effect: The pain was relieved within 1 day, the swelling began to decrease within 2 days, the swelling and pain disappeared within 5 days, and the joint function returned to normal. 3. Effective: The pain was relieved within 1 day, the swelling began to decrease within 2 days, the swelling and pain were significantly relieved within 5 days, and the joint function was significantly improved.

4. Invalid: Those who fail to meet the above criteria.

(2) Evaluation criteria for the efficacy of rickets (mainly observe the effect of recent swelling and pain relief):

1. Recent clinical cure: All symptoms disappeared and functional activities returned to normal. Witness the total points reduced by 100%.

2, markedly effective: all symptoms are eliminated or the main symptoms are eliminated, joint function is basically restored, can participate in normal work and labor, witness the total score reduced by more than 61%.

3. Effective: The main symptoms are basically eliminated, the main joint functions are basically restored or have significant progress, life can not be self-reasonable to be able to take care of themselves, or the loss of work and labor ability to work and work ability recovery, witness the total score reduced by 31-60 %.

4. Invalid: Compared with before treatment, there is no improvement in all aspects, and the total score is reduced to less than 30%.

Second, the treatment effect:

(1) Effects on various symptoms and signs: See Table 11-4. It can be seen from the table that the scores of the witnesses in the two treatment groups and the control group decreased significantly after treatment (p < 0.01), suggesting that both drugs have acute contusion and cold-dampness rickets. Good therapeutic effect, the symptoms and signs improved after treatment is very obvious. From Table 3, it can be seen that the swelling time of the acute contusion treatment group was significantly shorter than that of the control group (p < 0.05].

(2) Comparison between the treatment group and the control group: 150 cases of acute contusion in the treatment group, the effective rate and total effective rate were 52% and 93.3%, respectively; 148 cases of rickets (external), significant efficiency and total effective rate respectively 41.9% and 92.6%; 26 cases of rickets (external + internal), the effective rate and total effective rate were 46.2% and 92.3%, respectively; 70 cases of acute contusion in the control group, markedly efficient The total effective rate is 45.7% And 80%; rickets (external) in 76 cases, the marked efficiency and total effective rate were 46.1 ° /. And the total effective rate was 41.4% and 86.2%, respectively, in 29 cases of rickets (external and internal). There was no significant difference between the treatment group and the control group by Ridi t analysis (p>0.05).

There were 324 patients in the treatment group. During the observation period, 4 patients with acute contusion (p=0.061, no significant) developed mild contact dermatitis, and the skin was itchy after treatment; 1 patient with rickets (P=0. 5 Disgusting after oral administration, disappeared after stopping the drug. In the control group, 175 patients had contact dermatitis in 3 patients with acute contusion during the observation period (P=0.122), and nausea occurred in 2 patients with rickets (p=0. 25).

Clinical study on the treatment of phlegm and cold phlegm and phlegm and acute contusion in the treatment of cold and dampness syndrome. Xiaojie Xiaozhongzhitong 酊 is a traditional Chinese medicine preparation produced by Guangxi Huahong Pharmaceutical Factory based on traditional Chinese medicine theory and experience. It has cold and dampness, and it is popular. Collateral, activating blood circulation, relieving swelling and relieving pain, used for cold and dampness, joint pain, bruises, hemorrhage and so on. Our hospital conducted a clinical trial on swelling and painkillers from May 2001 to September 2001. The results are summarized as follows: Objects and methods

This verification determines the diagnostic criteria, inclusion criteria, exclusion criteria, case grouping, usage and dosage of the two groups of drugs, observation items and methods, efficacy criteria, adverse reaction observations, and statistical treatment methods for qualified subjects. The implementation of the clinical trial plan for the treatment of phlegm and acute contusion in the treatment of wind and cold dampness syndrome.

1. Grouping: Check the random row list, and the treatment group and the control group are randomly grouped by 5:3.

2. Dosage treatment and administration method: (1) Treatment group and open treatment group: 100 cases were treated with swelling and painkilling, and the drug solution was applied to the affected area, sputum, 6 times per sputum.

(2) Control group: 30 cases, using painful swelling [produced by Guangxi Longzhou Pharmaceutical Factory, Guiwei Medicine Zhunzi (1982) No. 04101], applying the liquid to the affected area, sputum, rickets daily 3 Times, acute contusion, 6 times per sputum.

(3) Treatment and: 7 days.

(4) Other similar drugs were discontinued during the trial treatment.

3. Statistical methods: Grade data is analyzed by Ridit, count data is analyzed by X ² , and measurement data is checked by t (u).

Result

I. General information and comparability check:

1. Gender comparison:

Table 1 Gender (example) Comparison (X ² test)

Note: The treatment group was compared with the control group, X ² =1.78, P>0.05, no significant difference.

2. Age comparison:

Table 2 Age (years) Comparison ( Ridit analysis)

Number of cases -27 -37 -47 -57 -58 Treatment group 50 12 15 7 11 5 Control group 30 12 8 4 3 3 Open group 50 7 20 10 10 3 Note: The treatment group was compared with the control group, X ² = 1.39, P> 0.05, no significant difference.

3. Comparison of disease types:

Table 3 Comparison of disease types (X ² test)

Note: The treatment group and the control group have the same distribution, no difference.

4, the two groups of disease comparison:

Table 4 Comparison of disease duration (days) between two groups (Ridit analysis)

Note: Compared with the control group, the acute torsion treatment group had U=0.54, P>0.05, and the difference was not significant.

5. Comparison of total points before treatment:

Table 5 Total score before treatment (± SD) Comparison (t test) 痹 number of cases before treatment points

Open group 50 23.29 ± 2.34 Acute contusion injury number before treatment in the treatment group 50 19.71 ± 5.13 Control group 30 21.80 ± 4.97 Note: The total score of the acute contusion treatment group and the control group before treatment, U = 1.80, Ρ > 0.05, The difference was not significant. The above pre-treatment comparison showed that there was no significant difference between the two groups in terms of gender, age, disease type, disease course, and pre-treatment condition. It is suggested that the main factors affecting the prognosis of the two groups are balanced.

Second, the efficacy comparison:

1, the total effect comparison:

Table 6 Comparison of total efficacy (Ridit analysis)

Note: The total efficacy of the treatment group and the control group were compared, U=0.44, P>0.05, the difference was not significant. 2. Comparison of efficacy of different diseases:

(1) Distribution of curative effect:

Table 7 Distribution of caries

The number of cases is markedly effective ( ) is valid (% ) is invalid ( % ) is always valid (% ) Open Group 50 16 ( 32.0) 28 (56.0) 6 (12.0) 44 (88.0)

(2) Comparison of the effects of acute contusion:

Table 8 Comparison of the effects of acute contusion ( Ridit analysis)

Note: The total efficacy of the treatment group and the control group, U = 0.44, P > 0.05, the difference was not significant. 3. Comparison of clinical symptoms after treatment:

(1) Comparison of clinical symptoms after treatment of rickets (Ridit analysis):

Table 9 Comparison of clinical symptoms after treatment of rickets

Note: After treatment in the open treatment group, the symptoms were significantly improved, P < G.01.

(2) Comparison of clinical symptoms after treatment of patients with acute contusion (Ridit analysis) Table 10 Comparison of clinical symptoms after treatment of patients with acute contusion

Number of cases Improved Level 3 Improvement Level 2 Improvement Level 1 No improvement U value * Self-conscious pain Treatment group 50 1 18 31 0 0. 9 Control group 30 0 8 22 0

Pain treatment group 50 1 23 25 1 0. 7 Control group 30 0 17 11 2

Swollen treatment group 42 2 6 31 3 1. 31 control group 27 1 10 14 2

痹 spot treatment group 43 0 15 26 2 1. 05 control group 29 1 15 9 4

Activity disorder treatment group 37 2 16 19 0 0. 85 control group 25 1 8 16 0

Note: * The devaluation value was compared between the treatment group and the control group.

After treatment, the symptoms of both groups of patients with acute contusion were significantly improved, Ρ<0.01; however, compared with the control group, Ρ>0.05, the difference was not significant.

(3) Time to reduce pain after treatment (X soil SD) Comparison (U test):

Table 11 Time to reduce pain after treatment (days)

* The U value was compared between the control group and the control group.

After the treatment of the acute contusion treatment group and the control group, there was no significant difference in the time of pain reduction, Ρ>0.05.

Fourth, security testing:

(1) Blood routine: 67 cases were detected before treatment, and 67 cases were reviewed after treatment in the normal range, and no abnormalities were found.

(2) Urine routine: 67 cases were detected before treatment, and 67 cases in the normal range were reviewed after treatment. No abnormalities were found.

(3) Stool routine: 67 cases were detected before treatment, and 67 cases were treated after normal treatment, and no abnormalities were found.

(4) Electrocardiogram: 67 cases were detected before treatment, and 67 cases were reviewed after treatment in the normal range. No abnormalities were found.

(5) ALT: 67 cases were detected before treatment, of which 67 cases were treated after the normal range, No abnormalities.

(6) BCr: 67 cases were detected before treatment, and 67 cases were reviewed after treatment in the normal range. No abnormalities were found.

(7) BUN: 67 cases were detected before treatment, and 67 cases were reviewed after treatment in the normal range. No abnormalities were found.

2. Control group:

(1) Blood routine: 20 cases were detected before treatment, and 20 cases were reviewed after treatment in the normal range. No abnormalities were found.

(2) Urine routine: 20 cases were detected before treatment, and 20 cases were reviewed after treatment in the normal range. No abnormalities were found.

(3) Stool routine: 20 cases were detected before treatment, and 20 cases were treated after normal treatment, and no abnormalities were found.

(4) Electrocardiogram: 73 cases were detected before treatment, and 73 cases in the normal range were reviewed after treatment. No abnormalities were found.

(5) ALT: 20 cases detected before treatment, wherein the treatment of the normal range after review of ²⁰ patients were normal.

(6) BCr: 73 cases were detected before treatment, and 73 cases in the normal range were reviewed after treatment, and no abnormalities were found.

(7) BUN: before treatment examined ²⁰ cases, ²⁰ cases of normal after treatment range review, were normal.

V. Observation of adverse reactions: No adverse reactions were observed after administration of the two groups.

Claims

Rights request

A traditional Chinese medicine preparation for treating bruises and rheumatic bone pain, characterized in that the traditional Chinese medicine preparation comprises the following raw materials and pharmaceutically acceptable excipients or excipients:

Windproof 30- 80 Nepeta 30-80 Asarum 30-80 Achyranthes 30-80 Chuanxi 30-80 Xu Changqing 30 - 80 Qishu 30-80 Da Luo Umbrella 85- 120 Ronaldinho 55-90 Double-sided needle 85- 120 Triangular 55-90.

2. A traditional Chinese medicine preparation for treating bruises and rheumatic bone pain according to claim 1, characterized in that the traditional Chinese medicine preparation further comprises the following bulk parts of the bulk drug and the pharmaceutically acceptable excipient or auxiliary:

Camphor 40-90 Menthol 40-90.

3. A traditional Chinese medicine preparation for treating bruises and rheumatic bone pain according to claim 2, characterized in that the traditional Chinese medicine preparation further comprises the following bulk parts of the bulk drug and the pharmaceutically acceptable excipient or auxiliary:

Guizhi 30 - 80 White Stork 30- 80 Red Eucommia 55-90.

4. A traditional Chinese medicine preparation for treating bruises and rheumatic bone pain according to claim 3, characterized in that the traditional Chinese medicine preparation further comprises the following bulk ingredients:

Woody 30-80 Wujiapi 30-80 Huangteng 80-105 Scorpion 85-120.

5. A traditional Chinese medicine preparation for treating bruises and rheumatoid bone pain according to claim 4, wherein the traditional Chinese medicine preparation further comprises the following weight parts of the raw material medicine:

Agarwood 20-40.

6. The traditional Chinese medicine preparation according to claim 5, wherein the weight ratio of the raw material medicine is:

Woody 70 windproof 60 Nepeta 70

Asarum 70 Wujiapi 60 Guizhi 50

Achyranthes 70 Sichuan Chuan 50 Xu Changqing 40

White 芷 70 莪 60 60 Red Eucommia 70

Big Luo umbrella 110 small Luo umbrella 60 double needle 100

Yellow vine 85 栀子 90 三棱 85

Agarwood 25 camphor 80 menthol 50.

7. The traditional Chinese medicine preparation according to claim 5, wherein the weight ratio of the raw material medicine is:

Woody 47 windproof 47 Nepeta 47

Asahi 47 Wujiapi 47 Guizhi 47

Achyranthes 47 Chuanxi 47 Xu Changqing 47

白芷70 莪术 47 红杜仲 70

Big Luo umbrella 100 small Luo umbrella 70 double needle 100

Yellow rattan 80 scorpion 100 three-sided 70

Agarwood 32. 5 Camphor 55 Menthol 55.

8. The traditional Chinese medicine preparation according to claim 5, wherein the weight ratio of the raw material medicine is:

Woody 35 windproof 60 Nepeta 35

Asahi 40 Wujipi 80 Guizhi 40

Achyranthes 40 Chuanxi 50 Xu Changqing 40 White 芷35 莪术50 Red Eucommia 80

Big Luo umbrella 110 small Luo umbrella 80 double needle 90

Yellow rattan 95 scorpion 110 triangular 80

Agarwood 40 camphor 40

The traditional Chinese medicine preparation according to any one of claims 1 to 8, characterized in that the traditional Chinese medicine preparation is an expectorant, a seventh dose, or an emulsion.

10. A method for preparing a traditional Chinese medicine preparation for treating bruises and rheumatic bone pain, which comprises the following steps:

The above-mentioned other raw materials other than camphor and menthol are pulverized into a coarse powder, and immersed for 15-30 hours by using 7000 to 8000 parts by weight of 50-95% ethanol as a solvent according to a percolation method for preparing a flow extract and an extract. After that, slowly percolate at a rate of 1-10 ml per minute at room temperature, collect the sputum, and store it again; take the camphor and menthol and add 500-800 parts by weight of 50-95% ethanol to dissolve, and the above sputum Mix well, let stand for 20-72 hours, filter, and get the tincture.

The traditional Chinese medicine preparation according to claim 9, which is characterized in that it is impregnated with 53% of ethanol as a solvent for 28 hours.