CN101991811A

CN101991811A - Traditional Chinese medicine composition for treating rheumatism arthralgia, cold headache, abdominal cavity pain and chilblain and preparation method thereof

Info

Publication number: CN101991811A
Application number: CN2009101143374A
Authority: CN
Inventors: 钟技; 欧彪; 叶志文; 赵平; 何丹璇; 潘兰
Original assignee: YULIN PHARMACEUTICAL CO Ltd GUANGXI
Current assignee: GUANGXI YULIN PHARMACEUTICAL GROUP CO., LTD.
Priority date: 2009-08-26
Filing date: 2009-08-26
Publication date: 2011-03-30
Anticipated expiration: 2029-08-26
Also published as: CN101991811B

Abstract

The invention discloses a traditional Chinese medicine composition for treating rheumatism arthralgia, cold headache, abdominal cavity pain and chilblain, which is prepared by the raw materials of 22 kinds of traditional Chinese medicinal herbs: angelica dahurica, Chinese honey locust, cassia twig, costustoot, rhizoma zedoariae, securidaca inappendieulata hassk, mountain spicy tree root and rhizome, philippine flemingia root, ardisia crenata, inula cappa, fenghegui, giant knotweed, sweetberry jointfir, climbing entada, Guangxi futokadsura stem, chuangbifeng, cinnamomum camphora presl, cynanchum paniculatum, subprostrate sophora, asarum, menthol and camphor. The traditional Chinese medicine composition has the effects of expelling wind, removing dampness, promoting blood circulation and stopping pain, and is used for treating rheumatism arthralgia, cold headache, abdominal cavity pain and chilblain. The invention also discloses a preparation method of the medicine.

Description

A kind of Chinese medicine composition for the treatment of Fengshi Guanjie pain, headache due to common cold, epigastric pain, chilblain and preparation method thereof

Invention field

The present invention relates to a kind of Chinese medicine composition, the present invention also relates to the preparation method of this Chinese medicine composition with expelling wind and removing dampness, promoting blood circulation and stopping pain effect.

Background technology

Fengshi Guanjie pain, headache due to common cold, epigastric pain, chilblain etc. are common clinically, multiple disease.In the medicine of above-mentioned commonly encountered diseases, the application of Chinese medicine and western medicine emphasizes particularly on different fields, and Chinese medicine has also occupied certain market share with the little advantage of its side effect.In the Chinese patent medicine of present numerous treatment Fengshi Guanjie pain, existing oral as Sinomenium acutum rheumatism wine, rheumatism wine, Agkistrodon rheumatism wine, antirheumatic medicinal liquor, also have oral double external as FENGLIAOXING FENGSHI DIEDA YAOJIU, traumatic injury and rheumatism wine, Medicinal liquor for traumatic injuries, also have that the repercussive and analgesic tincture only for external, two tiger are rather swollen and ache, Shaolin bonesetting essence, the clever tincture of osteopatia sprain, a gram tincture bitterly.All there are problems such as production technology falls behind, control of product quality standard technique level is low, and curative effect is general to some extent in these kinds." Drug Standard of Ministry of Public Health of the Peoples Republic of China (the 18 in Chinese traditional patent formulation preparation) " discloses the cloud raw material for essence on June 6th, 1994 is the Radix Angelicae Dahuricae, Fructus Gleditsia, Ramulus Cinnamomi, the Radix Aucklandiae, Rhizoma Curcumae, five tastes rattan, Lignum Aquilariae Resinatum, Radix Flemingiae Philippinensis, Radix Ardisiae Crenatae, Herba Inulae cappae, Sassafras tsumu Hemsl., Rhizoma Polygoni Cuspidati, two iron wire, Caulis Entadae, Radix seu Caulis fici Martinii, Cauliset Folium Piperis Hancei, Radix Crotonis Crassifolii, Radix Cynanchi Paniculati, Radix Sophorae Tonkinensis, Herba Asari, Mentholum, Camphora, but does not disclose amounts of components.Be to obtain better therapeutic, the raw material that the inventor is better or best with curative effect on this basis and selected with measure feature has especially been finished the present invention through pharmacology and clinical control demonstration test.

Goal of the invention

The purpose of this invention is to provide a kind of Chinese medicine composition with expelling wind and removing dampness, promoting blood circulation and stopping pain effect.

Another object of the present invention provides the preparation method of this Chinese medicine composition.

Summary of the invention

Medicine of the present invention is made up of effective ingredient and/or pharmaceutically acceptable excipient, and wherein said effective ingredient is to be made by the raw material of Chinese medicine of following percentage by weight consumption:

The Radix Angelicae Dahuricae 1.0%～6.0%, Chinese honey locust (fruit) 1.0%～6.0%, Ramulus Cinnamomi 2.0%～10.0%, the Radix Aucklandiae 1.0%～8.0%, Rhizoma Curcumae 1.0%～8.0%, five tastes rattan 3%～12.0%, Radix Litseae 2.0%～10.0%, Radix Flemingiae Philippinensis 2.0%～10.0%, Radix Ardisiae Crenatae 2.0%～10.0%, Herba Inulae cappae 2.0%～10.0%, Sassafras tsumu Hemsl. 2.0%～10.0%, Rhizoma Polygoni Cuspidati 2.0%～10.0%, Caulis Gneti 2%～12.0%, Caulis Bauhihiae Championii 3%～13.0%, Guangxi Caulis Piperis Kadsurae 3%～13.0%, Cauliset Folium Piperis Hancei 2%～12.0%, Radix Cinnamomi porrecti 3%～13.0%, Radix Cynanchi Paniculati 0.5%～2.0%, Radix Sophorae Tonkinensis 0.5%～2.0%, Herba Asari 0.5%～2.0%, Mentholum 2.0%～10.0%, Camphora 2.0%～10.0%.

In order to obtain better therapeutic, the consumption of preferred raw material of Chinese medicine is following percentage by weight:

The Radix Angelicae Dahuricae 2.0%～5.0%, Chinese honey locust (fruit) 2.0%～5.0%, Ramulus Cinnamomi 3.0%～8.0%, the Radix Aucklandiae 2.0%～6.0%, Rhizoma Curcumae 2.0%～6.0%, five tastes rattan 5%～10.0%, Radix Litseae 3.0%～8.0%, Radix Flemingiae Philippinensis 3.0%～8.0%, Radix Ardisiae Crenatae 3.0%～8.0%, Herba Inulae cappae 3.0%～8.0%, Sassafras tsumu Hemsl. 3.0%～8.0%, Rhizoma Polygoni Cuspidati 3.0%～8.0%, Caulis Gneti 4%～10.0%, Caulis Bauhihiae Championii 5%～11.0%, Guangxi Caulis Piperis Kadsurae 5%～11.0%, Cauliset Folium Piperis Hancei 4%～10.0%, Radix Cinnamomi porrecti 5%～11.0%, Radix Cynanchi Paniculati 1.0%～1.6%, Radix Sophorae Tonkinensis 1.0%～1.6%, Herba Asari 1.0%～1.6%, Mentholum 3.0%～8.0%, Camphora 3.0%～8.0%.

In order to obtain optimum curative effect, more preferably the consumption of raw material of Chinese medicine is following percentage by weight:

The Radix Angelicae Dahuricae 2.42%, Chinese honey locust (fruit) 2.42%, Ramulus Cinnamomi 4.85%, the Radix Aucklandiae 3.60%, Rhizoma Curcumae 3.60%, five tastes rattan 7.19%, Radix Litseae 4.85%, Radix Flemingiae Philippinensis 4.85%, Radix Ardisiae Crenatae 4.85%, Herba Inulae cappae 4.85%, Sassafras tsumu Hemsl. 4.85%, Rhizoma Polygoni Cuspidati 4.85%, Caulis Gneti 6.02%, Caulis Bauhihiae Championii 7.19%, Guangxi Caulis Piperis Kadsurae 7.19%, Cauliset Folium Piperis Hancei 6.02%, Radix Cinnamomi porrecti 7.19%, Radix Cynanchi Paniculati 1.17%, Radix Sophorae Tonkinensis 1.17%, Herba Asari 1.17%, Mentholum 4.85%, Camphora 4.85%.

The method for preparing effective ingredient of the present invention is: take by weighing raw material, with four flavor Chinese medicines such as Radix Cynanchi Paniculati, Radix Sophorae Tonkinensis, Herba Asari and part five tastes rattan (30～50%), pulverize separately becomes coarse powder, and is standby; With the Radix Angelicae Dahuricae, Chinese honey locust (fruit), Ramulus Cinnamomi, the Radix Aucklandiae, Rhizoma Curcumae, Radix Litseae, Radix Flemingiae Philippinensis, Radix Ardisiae Crenatae, Herba Inulae cappae, Sassafras tsumu Hemsl., Rhizoma Polygoni Cuspidati, Caulis Gneti, Caulis Bauhihiae Championii, Guangxi Caulis Piperis Kadsurae, Cauliset Folium Piperis Hancei, Radix Cinnamomi porrecti and remaining five tastes rattan, put in the reflux, extract, jar, the alcoholic solution that adds 3～10 times of amount 20%～50% concentration, airtight, after the heating and refluxing extraction 5～9 hours, distill, collect distillate; Get above-mentioned Radix Cynanchi Paniculati, Radix Sophorae Tonkinensis, Herba Asari and five tastes rattan coarse powder, add in the distillate of above-mentioned collection, stir evenly, flooded 24～72 hours.Get impregnation liquid, add Mentholum, Camphora, stir and make dissolving, filter, promptly obtain effective ingredient.

The preparation method of preferred effective ingredient of the present invention is: take by weighing raw material, with Radix Cynanchi Paniculati, Radix Zanthoxyli, Lignum Dalbergiae Odoriferae and (35～45%) five tastes rattan, pulverize separately becomes coarse powder, and is standby; With the Radix Angelicae Dahuricae, Chinese honey locust (fruit), Ramulus Cinnamomi, the Radix Aucklandiae, Rhizoma Curcumae, Radix Litseae, Radix Flemingiae Philippinensis, Radix Ardisiae Crenatae, Herba Inulae cappae, Sassafras tsumu Hemsl., Rhizoma Polygoni Cuspidati, Caulis Gneti, Caulis Bauhihiae Championii, Guangxi Caulis Piperis Kadsurae, Cauliset Folium Piperis Hancei, Radix Cinnamomi porrecti and remaining five tastes rattan, put in the reflux, extract, jar, the alcoholic solution that adds 25%～40% concentration of 4～8 times of amounts, airtight, after the heating and refluxing extraction 7 hours, distill, collect the about 1200ml of distillate; Get above-mentioned Radix Cynanchi Paniculati, Radix Sophorae Tonkinensis, Herba Asari and five tastes rattan coarse powder, add in the distillate of above-mentioned collection and stir evenly, flooded 36～60 hours, get impregnation liquid, add Mentholum, Camphora, stir and make dissolving, filter, promptly.

Most preferably the preparation method of effective ingredient of the present invention is: take by weighing raw material, with Radix Cynanchi Paniculati, Radix Zanthoxyli, Lignum Dalbergiae Odoriferae and 41.86% five tastes rattan, pulverize separately becomes coarse powder, and is standby; With the Radix Angelicae Dahuricae, Chinese honey locust (fruit), Ramulus Cinnamomi, the Radix Aucklandiae, Rhizoma Curcumae, Radix Litseae, Radix Flemingiae Philippinensis, Radix Ardisiae Crenatae, Herba Inulae cappae, Sassafras tsumu Hemsl., Rhizoma Polygoni Cuspidati, Caulis Gneti, Caulis Bauhihiae Championii, Guangxi Caulis Piperis Kadsurae, Cauliset Folium Piperis Hancei, Radix Cinnamomi porrecti and remaining five tastes rattan, put in the reflux, extract, jar, the alcoholic solution that adds 30% concentration of 6 times of amounts, airtight, after the heating and refluxing extraction 7 hours, distill, collect the about 1200ml of distillate; Get above-mentioned Radix Cynanchi Paniculati, Radix Sophorae Tonkinensis, Herba Asari and five tastes rattan coarse powder, add in the distillate of above-mentioned collection and stir evenly, flooded 48 hours, get impregnation liquid, add Mentholum, Camphora, stir and make dissolving, filter, promptly.

Effective ingredient of the present invention can be prepared into various external preparation such as liquid preparation (oral administration), spray, aerosol, ointment etc. with acceptable accessories.

Medicine of the present invention has the effect of expelling wind and removing dampness, promoting blood circulation and stopping pain.Can be used for treating numbness disease (Fengshi Guanjie pain) that wind-cold damp pathogen causes, flu, gastric abscess, chilblain etc.According to " provisions for new drugs approval " with reference to " new Chinese medicine clinical research guideline ", first Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi (110 example), Guilin city institute of traditional Chinese medicine (60 example), Yulin City of Guangxi Zhuang Autonomous institute of traditional Chinese medicine (70 example), Beihai, Guangxi institute of traditional Chinese medicine (60 example) and Liuzhou city institute of traditional Chinese medicine (60 example) have carried out clinical trial 360 examples to the invention medicine of embodiment 1, the sick obvious effective rate of treatment numbness, effective percentage are respectively 47.00%, 45.00%, total effective rate 92.00%; Treatment flu clinical recovery rate, obvious effective rate, effective percentage are respectively 63.00%, 26.00%, 10.00%, and total effective rate is 97.00%.Treatment gastric abscess obvious effective rate, effective percentage are respectively 29.00%, 67.00%, and total effective rate is 96.00%.Treatment chilblain clinical recovery rate, obvious effective rate, effective percentage are respectively 51.65%, 21.67%, 18.33%, total effective rate 91.67%.The invention medicine of prompting embodiment 1 has clinical efficacy preferably to numbness disease, flu, gastric abscess, the chilblain that wind-cold damp pathogen causes.Conscious cold type of pain, numbness, the joint stuffiness of numbness disease after the patient; Heating, headache, nasal obstruction, the watery nasal discharge of flu; Symptom and signs such as the redness of the pain of gastric abscess, poor appetite, loose stool and chilblain, cold type of pain, pruritus all have clear improvement.The invention medicine of prompting embodiment 1 can significantly improve the various common symptoms of numbness disease, flu, gastric abscess and chilblain.

This research has been carried out blood, routine urianlysis to nearly 260 routine patients, and the heart, liver, kidney function test are not all found obvious adverse reaction and toxic and side effects.The invention clinical drug of prompting embodiment 1 is safe and reliable.

Medicine of the present invention is tincture (external is held concurrently for oral administration), and its usage and consumption are oral, a 0.5～2ml, and 2～3 times on the one, external is got in right amount, puts the affected part on the skin.

Specific embodiment

Further specify the present invention below by embodiment.It should be understood that embodiments of the invention are to be used to illustrate the present invention rather than limitation of the present invention.Essence according to the present invention all belongs to the scope of protection of present invention to the simple modifications that the present invention carries out.Except as otherwise noted, the percent among the present invention is meant percetage by weight.

Embodiment 1: the preparation of tincture (external is held concurrently for oral administration)

Take by weighing Radix Angelicae Dahuricae 29g, Chinese honey locust (fruit) 29g, Ramulus Cinnamomi 58g, Radix Aucklandiae 43g, Rhizoma Curcumae 43g, five tastes rattan 86g, Radix Litseae 58g, Radix Flemingiae Philippinensis 58g, Radix Ardisiae Crenatae 58g, Herba Inulae cappae 58g, Sassafras tsumu Hemsl. 58g, Rhizoma Polygoni Cuspidati 58g, Caulis Gneti 72g, Caulis Bauhihiae Championii 86g, Guangxi Caulis Piperis Kadsurae 86g, Cauliset Folium Piperis Hancei 72g, Radix Cinnamomi porrecti 86g, Radix Cynanchi Paniculati 14g, Radix Sophorae Tonkinensis 14g, Herba Asari 14g, Mentholum 58g, Camphora (synthesizing) 58g.

More than 22 the flavor medicines, remove Radix Cynanchi Paniculati, Radix Sophorae Tonkinensis, Herba Asari, Mentholum, Camphora and part five tastes rattan and (account for 41.86%, heavily about 36g) outside, the five tastes rattan of ten Six-elements such as all the other Radixs Angelicae Dahuricae and remainder, put in the reflux, extract, jar, add the alcoholic solution of 30% concentration of 6 times of amounts, airtight, after the heating and refluxing extraction 7 hours. distill, collect distillate 1200ml.Get Radix Cynanchi Paniculati, Radix Sophorae Tonkinensis, Herba Asari and five tastes rattan pulverize separately and become coarse powder, add in the above-mentioned distillate, stir evenly, flooded 48 hours.Get impregnation liquid, add Mentholum, Camphora, stir and make dissolving, filter, adjust total amount, promptly get tincture to 1000ml.

Embodiment 2: the preparation of tincture

Take by weighing Radix Angelicae Dahuricae 16g, Chinese honey locust (fruit) 16g, Ramulus Cinnamomi 40g, Radix Aucklandiae 30g, Rhizoma Curcumae 30g, five tastes rattan 60g, Radix Litseae 40g, Radix Flemingiae Philippinensis 40g, Radix Ardisiae Crenatae 40g, Herba Inulae cappae 40g, Sassafras tsumu Hemsl. 40g, Rhizoma Polygoni Cuspidati 40g, Caulis Gneti 50g, Caulis Bauhihiae Championii 55g, Guangxi Caulis Piperis Kadsurae 55g, Cauliset Folium Piperis Hancei 50g, Radix Cinnamomi porrecti 55g, Radix Cynanchi Paniculati 10g, Radix Sophorae Tonkinensis 10g, Herba Asari 10g,, Mentholum 50g and Camphora (synthesizing) 50g.

More than 22 the flavor medicines, remove Radix Cynanchi Paniculati, Radix Sophorae Tonkinensis, Herba Asari, Mentholum, Camphora and part five tastes rattan and (account for 41.86%, heavily about 25g) outside, the five tastes rattan of ten Six-elements such as all the other Radixs Angelicae Dahuricae and remainder, put in the reflux, extract, jar, add 40% alcoholic solution of 8 times of amounts, airtight, after the heating and refluxing extraction 7 hours. distill, collect distillate 1200ml.Get Radix Cynanchi Paniculati, Radix Sophorae Tonkinensis, Herba Asari and five tastes rattan pulverize separately and become coarse powder, add in the above-mentioned distillate, stir evenly, flooded 48 hours.Get impregnation liquid, add Mentholum, Camphora, stir and make dissolving, filter, adjust total amount, promptly get tincture to 1000ml.

Embodiment 3: the preparation of spray

Take by weighing Radix Angelicae Dahuricae 20g, Chinese honey locust (fruit) 20g, Ramulus Cinnamomi 50g, Radix Aucklandiae 30g, Rhizoma Curcumae 40g, five tastes rattan 70g, Radix Litseae 50g, Radix Flemingiae Philippinensis 50g, Radix Ardisiae Crenatae 40g, Herba Inulae cappae 50g, Sassafras tsumu Hemsl. 50g, Rhizoma Polygoni Cuspidati 50g, Caulis Gneti 60g, Caulis Bauhihiae Championii 70g, Guangxi Caulis Piperis Kadsurae 70g, Cauliset Folium Piperis Hancei 60g, Radix Cinnamomi porrecti 70g, Radix Cynanchi Paniculati 10g, Radix Sophorae Tonkinensis 10g, Herba Asari 10g, Mentholum 30g, Camphora 50g.

The effective ingredient preparation process is with embodiment 1.Get impregnation liquid, add Mentholum, Camphora, stir and make dissolving, filter, adjust total amount, carry out packing with sprayer bottle (not needing propellant), promptly to 1000ml.

Embodiment 4: the preparation of aerosol

Take by weighing Radix Angelicae Dahuricae 44g, Chinese honey locust (fruit) 44g, Ramulus Cinnamomi 30g, Radix Aucklandiae 21g, Rhizoma Curcumae 21g, five tastes rattan 90g, Radix Litseae 29g, Radix Flemingiae Philippinensis 29g, Radix Ardisiae Crenatae 29g, Herba Inulae cappae 29g, Sassafras tsumu Hemsl. 29g, Rhizoma Polygoni Cuspidati 29g, Caulis Gneti 40g, Caulis Bauhihiae Championii 90g, Guangxi Caulis Piperis Kadsurae 90g, Cauliset Folium Piperis Hancei 87g, Radix Cinnamomi porrecti 90g, Radix Cynanchi Paniculati 10g, Radix Sophorae Tonkinensis 10g, Herba Asari 10g, Mentholum 30g, Camphora 30g.

The effective ingredient preparation process is with embodiment 1.Get impregnation liquid, add Mentholum, Camphora, stir and make dissolving, filter, adjust total amount,, fill propellant, promptly with the packing of aerosol bottle to 1000ml.

Embodiment 5: the preparation of ointment

Take by weighing Radix Angelicae Dahuricae 16g, Chinese honey locust (fruit) 16g, Ramulus Cinnamomi 65g, Radix Aucklandiae 55g, Rhizoma Curcumae 55g, five tastes rattan 60g, Radix Litseae 60g, Radix Flemingiae Philippinensis 50g, Radix Ardisiae Crenatae 40g, Herba Inulae cappae 50g%, Sassafras tsumu Hemsl. 50g, Rhizoma Polygoni Cuspidati 50g, Caulis Gneti 60g, Caulis Bauhihiae Championii 60g, Guangxi Caulis Piperis Kadsurae 60g, Cauliset Folium Piperis Hancei 60g, Radix Cinnamomi porrecti 60g, Radix Cynanchi Paniculati 15g, Radix Sophorae Tonkinensis 15g, Herba Asari 15g, Mentholum 40g, Camphora 40g.

The effective ingredient preparation process is with embodiment 1.Get impregnation liquid, filter, as water; As oil phase, add ointment base respectively after Mentholum, the Camphora congruent melting, emulsifying is even, promptly.

The research of test example 1 main pharmacodynamics

Material:

1. tried thing and medicine: (1) present embodiment 1 medicine (hereinafter to be referred as: medicine I), Yulin Pharmaceutical Co., Ltd., Guangxi provides; (2) HUOXIANGZHENGQI KOUFUYE, No. (1997) 005300, the accurate word of medicine are defended in the Chongqing, lot number 980529051, Tai Ji group Fuling Pharmaceutical Factory is produced; (3) FENGLIAOXING FENGSHI DIEDA YAOJIU, Guangdong are defended the accurate word (1996) of medicine No. 601073, lot number 9803005, and pharmacy one factory in Foshan produces; (4) paracetamol tablet, No. the 211712nd, the accurate word (1984) of Su Wei medicine, lot number 980607, Yancheng, Jiangsu Province pharmaceutical factory produces; (5) cyclophosphamide, Hualian Pharmaceutical Co., Ltd., Shanghai produces, lot number 980605, the accurate word (1995) of medicine is defended No. 012034 in Shanghai; (6) bifendate, Wenling, Zhejiang pharmaceutical factory produces, lot number 9804292, the accurate word (1996) of medicine is defended No. 178301 in Zhejiang; (7) aspirin sheet, Henan nova Pharmaceutical limited company produces, lot number 980102, the accurate word (1994) of medicine is defended No. 126089 in Henan.

2. animal: Kunming mouse, regular grade, body weight 18～24g, animal housing of Guangxi Medical University provides; The Wistar rat, regular grade, body weight 180～240g, Guangxi treatment and prevention of tumour institute animal housing provides.

Experimental technique and result

One, to the influence of adjuvant-induced arthritis

1, oral route

35 of rats, behind every left thereafter limb of rat measurement, right limb ankle joint girth, injection Freund's complete adjuvant 0.06ml, animal random packet then on the left hind foot sole of the foot skin: (1) blank group (distilled water 10ml/kg, ig); (2) the solvent matched group (solvent 1ml/kg, ig); (3) positive controls (FENGLIAOXING FENGSHI DIEDA YAOJIU 5ml/kg, ig); (4) medicine I low dose group (medicine I 0.5ml/kg, ig); (5) medicine I high dose group (medicine I 1ml/kg, ig).

Promptly begin administration after the grouping, each is organized the administration volume and is 10ml/kg (with distilled water diluting to suitable concentration), administration every day 1 time, successive administration 7 days, after giving adjuvant the 3rd, 5,7,9 day, every morning is measured left back ankle joint girth respectively, observes the influence of medicine to the adjuvant-induced arthritis primary lesion.

After giving adjuvant the 13rd day, each group began administration again, every day 1 time, continuous 7 days.After giving adjuvant the 15th, 17,19,21 day, every morning was measured right back ankle joint girth respectively, observed the influence of medicine to the adjuvant-induced arthritis secondary lesion.

The result shows that medicine I oral administration high dose group has the obvious suppression effect to the adjuvant-induced arthritis primary lesion, and secondary lesion is also had inhibitory action trend.See Table 1.

Table 1 oral drugs I is to the influence of rat assist agent arthritis

Compare * P＞0.05, * * P＜0.05 with the blank group; Compare △ P＞0.05, △ △ P＜0.05 with the solvent matched group.

2, external approach

35 of rats, behind every left thereafter limb of rat measurement, right limb ankle joint girth, left hind foot plantar subcutaneous injection Freund's complete adjuvant 0.06ml is then with animal random packet (same oral route).

Promptly begin administration after the grouping.Medication: left back foot is each to soak corresponding medicinal liquid, steeps 1cm place to the ankle joint, and except that the each soaking medicated liquid of medicine I low dose group 1 minute, all the other administration groups were soaked corresponding medicinal liquid 3 minutes.Administration every day 2 times, successive administration 7 days.Observe the influence (method same oral route) of medicine to adjuvant-induced arthritis primary lesion and secondary lesion.

The result shows that medicine I external has the obvious suppression effect to the adjuvant-induced arthritis primary lesion, and secondary lesion is also had certain inhibitory action.See Table 2.

Table 2 external used medicine I is to the influence of rat assist agent arthritis

Compare * P＞0.05, * * P＜0.05, * * * P＜0.01 with the blank group;

Compare △ P＞0.05, △ △ P＜0.05 with the solvent matched group.

Two, on Carrageenan causes the influence of rat paw edema (experimental arthroncus)

1, oral route

40 of rats are measured right thereafter limb ankle joint girth to every rat, right sufficient plantar subcutaneous injection 1% carrageenin 0.1ml behind every rat then, and the animal random packet: (1) blank group (distilled water 10ml/kg, ig); (2) the solvent matched group (solvent 1ml/kg, ig); (3) positive controls (FENGLIAOXING FENGSHI DIEDA YAOJIU 5ml/kg, ig); (4) medicine I low dose group (medicine I 0.5ml/kg, ig); (5) medicine I high dose group (medicine I 1ml/kg, ig).

After the grouping administration 1 time, administration 1 time again in 4 hours, 25 hours behind the Yu Zhiyan.Each is organized the administration volume and is 10ml/kg (with distilled water diluting to suitable concentration).Measured right ankle joint girth behind every rat behind the Yu Zhiyan in 6,8,24,30 hours respectively,,, estimate the inhibitory action that the medicine on Carrageenan causes experimental arthroncus as the swelling degree of the paw index with its difference relatively of value before the medicine.

The result shows that medicine I oral administration on Carrageenan causes rat experiment arthritis certain inhibitory action.See Table 3.

Table 3 oral drugs I on Carrageenan causes the arthritic influence of rat experiment

Compare with the blank group, △ P＞0.05 is compared with the solvent matched group in * P＞0.05.

2, external approach

35 of rats, every rat is measured right thereafter limb ankle joint girth, right sufficient plantar subcutaneous injection 1% carrageenin 0.1ml behind every rat then, animal random packet (same oral route).

Promptly begin administration 1 time after the grouping, respectively administration 1 time again in 2,6,25 hours behind the Yu Zhiyan.Medication: the right foot in back is each to soak corresponding medicinal liquid, steeps 1cm place to the ankle joint, and except that the each soaking medicated liquid of medicine I low dose group 1 minute, all the other administration groups were soaked corresponding medicinal liquid 3 minutes.

Measured right ankle joint girth behind every rat behind the Yu Zhiyan in 6,8,24 and 30 hours respectively,,, estimate the inhibitory action that the medicine on Carrageenan causes experimental arthroncus as the swelling degree of the paw index with its difference relatively of value before the medicine.

The result shows that medicine I external on Carrageenan causes rat experiment arthritis the obvious suppression effect.See Table 4.

Table 4 external used medicine I on Carrageenan causes the arthritic influence of rat experiment

Compare * P＞0.05, * * P＜0.05, * * * P＜0.01 with the blank group;

Compare △ P＞0.05, △ △ P＜0.05, △ △ △ P＜0.01 with the solvent matched group.

Three, to the influence of mice foot sole of the foot soft tissue injury

1, oral route

Make the garden tube that internal diameter is slightly larger than 200 gram counterweights with ground paper, long 30cm places desktop with the right back foot of mice, vola upwards, the garden tube is vertically placed the vola face, directly fall to hitting down from tube top, garden with 200 gram counterweights then, cause sufficient sole of the foot soft tissue serious contusion, blood stasis and edema.Random packet after mice is caused injury: (1) blank group (distilled water 10ml/kg, ig); (2) the solvent matched group (solvent 2ml/kg, ig); (3) positive controls (FENGLIAOXING FENGSHI DIEDA YAOJIU 5ml/kg, ig); (4) medicine I low dose group (medicine I 1ml/kg, ig); (5) medicine I high dose group (medicine I 2ml/kg, ig).Promptly begin administration after the grouping.Administration every day 1 time, continuous 5 days, put to death mice on the 6th day, biped is equal to part behind the clip, accurately weigh, with about sufficient weight difference as the swelling degree, estimate the influence of medicine to the mice soft tissue injury.

The result shows that medicine I oral administration improves significantly to organize blood stasis, the edema that the mice soft tissue injury causes.See Table 5.

Table 5 oral drugs I is to the influence of mice soft tissue injury

Compare * P＞0.05, * * * P＜0.01 with the blank group; Compare △ △ △ P＜0.01 with the solvent matched group.

2, external approach

Mice soft tissue injury model preparation method and the same oral route of random packet.Promptly begin administration after the grouping.Medication: the corresponding medicinal liquid of the each immersion of the right foot in back, steep to ankle, except that the each soaking medicated liquid of medicine I low dose group 1 minute, all the other administration groups were soaked corresponding medicinal liquid 3 minutes.Administration every day 2 times, delivery time are 6 hours, continuous 5 days, put to death mice on the 6th day, biped is equal to part behind the clip, accurately weigh, with about sufficient weight difference as the swelling degree, estimate the influence of medicine to the mice soft tissue injury.

The result shows that medicine I external improves significantly to mice soft tissue blood stasis, edema.See Table 6.

Table 6 external used medicine I is to the influence of mice soft tissue injury

Four, analgesic test

1, oral route

(1) hot plate method

Regulate thermostat and make hot plate temperature be controlled at 55 ± 0.5 ℃, screen qualified mice then, get female mice number, put 1 at every turn on hot plate, observe mice from being placed on the hot plate until the pain threshold of metapedes required time (second) occurring licking as this Mus.Allly lick the foot time less than 5 seconds or give it up greater than 30 seconds or leaper.Repeat to survey its normal pain threshold twice, get its meansigma methods as this Mus administration before pain threshold, then with the mice random packet: (1) blank group (distilled water 10ml/kg, ig); (2) the solvent matched group (solvent 2ml/kg, ig); (3) positive controls (HUOXIANG ZHENGQI SHUI 5ml/kg, ig); (4) medicine I low dose group (medicine I 1ml/kg, ig); (5) medicine I high dose group (medicine I 2ml/kg, ig).Promptly begin administration after the grouping.Administration every day 1 time, continuous 4 days.After the last administration 60 minutes, survey every mice pain threshold respectively.

The result shows that medicine I oral administration can significantly improve the pain threshold of mice, shows that it has significant analgesic activity.See Table 7.

Table 7 oral drugs I is to the influence of mice soft tissue injury

(hot plate method)

Compare * P＞0.05, * * P＜0.05 with value before the medicine; * * P＜0.01.

(2) writhing method

Get 50 of mices, grouping, the same hot plate method of dosage, promptly begin administration after the animal grouping, every day 1 time, for three days on end, after the last administration 60 minutes, every mouse peritoneal is injected 0.6% acetic acid 0.5ml, observes every mice writhing response number of times that 5 to 20 minutes (in 15 minutes) occur after injecting acetic acid.

The result shows that medicine I oral administration can significantly reduce the mouse writhing number of times, shows that medicine I has significant analgesic activity.See Table 8.

The analgesic activity of table 8 oral drugs I

Compare * P＞0.05, * * P＜0.05 with the blank group; * * P＜0.01;

Compare △ △ P＜0.05, △ △ △ P＜0.01 with the solvent matched group.

2, external approach

(1) hot plate method

The same oral route of pain threshold method before screening qualified mice and measuring administration.With the mice random packet: (1) blank group (being coated with distilled water outward); (2) solvent matched group (being coated with solvent outward); (3) positive controls (being coated with FENGLIAOXING FENGSHI DIEDA YAOJIU outward); (4) medicine I low dose group (medicine for external application I); (5) medicine I high dose group (medicine for external application I).Promptly begin administration after the grouping.Medication: the back biped soaks corresponding medicinal liquid, steeps to ankle, soaks 1 minute except that medicine I low dose group is each, and all the other administration groups were soaked 3 minutes.Every day 2 times, dosing interval is 6 hours, continuous 4 days.After the last administration 60 minutes, survey the mice pain threshold respectively.

The result shows that medicine I topical administration can significantly improve the pain threshold of mice, shows that it has significant analgesic activity.See Table 9.

The analgesic activity of table 9 external used medicine I

(hot plate method)

Compare * P＞0.05, * * P＜0.05 with value before the medicine; * * P＜0.01.

(2), writhing method

Get 50 of mices, random packet is with the hot plate method of external approach.Promptly begin administration after the grouping, every day 2 times, outside the mouse web portion both sides, be coated with corresponding medicinal liquid (medicine I low dose group medicine for external application I 50% diluent) at every turn, every side 0.2ml, for three days on end, after the last administration 60 minutes, every mouse peritoneal is injected 0.6% acetic acid 0.5ml, observes every mice writhing response number of times that 5 to 20 minutes (in 15 minutes) occur after injecting acetic acid.

The result shows that medicine I topical administration can significantly reduce the mouse writhing reaction times, shows that it has significant analgesic activity.See Table 10.

Table 10 external used medicine I is to the analgesic activity of mice

(writhing method)

Five, the influence that the mice granuloma induced by implantation of cotton pellets is formed

1, oral route

Laboratory mice, under the ether light anaesthesia, 1 of 5mg cotton balls (autoclaving) is imbedded in the right oxter of every Mus, skin suture, sterilization, postoperative the 2nd day is with the mice random packet: (1) blank group (distilled water 10ml/kg, ig); (2) the solvent matched group (solvent 2ml/kg, ig); (3) positive controls (FENGLIAOXING FENGSHI DIEDA YAOJIU 5ml/kg, ig); (4) medicine I low dose group (medicine I 1ml/kg, ig); (5) medicine I high dose group (medicine I 2ml/kg, ig).Promptly begin administration after the grouping, every day 1 time, continuous 7 days, put to death mice on the 8th day, take out the cotton balls granulation, in 70 ℃ of oven dry 1 hour, accurately weigh, deduct the raw cotton ball weight and be granuloma weight.

The result shows that medicine I oral administration high dose group is formed with the obvious suppression effect to the mice granuloma induced by implantation of cotton pellets.See Table 11.

Table 11 oral drugs I is to the influence of mice granuloma induced by implantation of cotton pellets

2, external approach

The same oral route of experimental technique and random packet.Promptly begin administration after the grouping, every day 2 times, outside burying cotton balls local skin place, be coated with corresponding medicinal liquid 0.2ml (medicine I low dose group medicine for external application I 50% diluent) at every turn.Successive administration 7 days was put to death mice in the 8th day, took out the cotton balls granulation, in 70 ℃ of oven dry 1 hour, accurately weighed, and deducted the raw cotton ball weight and was granuloma weight.

The result shows that medicine I topical administration high dose group is formed with the obvious suppression effect to the mice granuloma induced by implantation of cotton pellets.See Table 12.

Table 12 external used medicine I is to the influence of mice granuloma induced by implantation of cotton pellets

Compare * P＞0.05, * * P＜0.05 with the blank group; Compare △ △ P＜0.05 with the solvent matched group.

Six, medicine I oral administration Dichlorodiphenyl Acetate causes the influence that the mouse peritoneal capillary permeability increases

60 of mices, random packet.Promptly begin administration after the grouping, successive administration 5 days, once a day, in the last administration after 1 hour, every mouse tail vein injection 0.5% azovan blue normal saline 0.1ml/10g, lumbar injection 0.6% acetic acid 0.2ml put to death mice after 20 minutes immediately, with 10ml normal saline washing abdominal cavity, the sucking-off washing liquid centrifugal 10 minutes, is got supernatant and is measured its OD value in the 590nm place, with the seepage discharge of OD value reflection mouse peritoneal azovan blue, estimate the influence of medicine to the abdominal cavity capillary permeability.

The result shows that medicine I Dichlorodiphenyl Acetate causes abdominal cavity capillary permeability increase and do not see obvious influence.See Table 13.

Table 13 oral drugs I Dichlorodiphenyl Acetate causes the influence that the abdominal cavity capillary permeability increases

Seven, medicine I oral administration is to Immune Effects

1, to the influence of mice specific humoral immunity function (generation of sheep red blood cell antibody)

60 of mices, random packet: (1) blank group (distilled water 10ml/kg, ig); (2) the solvent matched group (solvent 2ml/kg, ig); (3) the cyclophosphamide group (cyclophosphamide 10mg/kg, sc) (4) positive controls (FENGLIAOXING FENGSHI DIEDA YAOJIU 5ml/kg, ig); (5) medicine I low dose group (medicine I 1ml/kg, ig); (6) medicine I high dose group (medicine I 2ml/kg, ig).Promptly begin administration after the grouping, administration every day 1 time, continuous 8 days, in administration in the 4th day after 1 hour, the sheep erythrocyte suspension 0.1ml/10g of every ip in mice 3: 5 (V/V) is in administration in the 8th day after 2 hours, every mice is won eyeball and gets blood, separation of serum is measured hemolysin level, obtains half hemolysis value (HC ₅₀).

The result shows that medicine I high dose group is formed with the obvious suppression effect to hemolysin.See Table 14.

The influence that table 14 oral drugs I forms the mice hemolysin

Compare * P＞0.05, * * * P＜0.01 with the blank group; Compare △ P＞0.05 with the solvent matched group.

2, to the influence of mice reticuloendothelial system phagocytic function

60 of mices, be divided into 6 groups at random, promptly begin administration after the grouping, successive administration 5 days, every day 1 time, administration was after 1 hour in the 5th day, every mouse tail vein injection burnt black ink (0.05ml/10g) 2 minutes and 12 minutes, is got blood 50 μ l respectively and is added the 3ml0.1% sodium carbonate liquor from the optical fundus, measure the OD value at 675nm wavelength place, by formula calculate corridor clear index K (K=1/10lgOD ₂/ OD ₁₂).

The result shows that medicine I does not have tangible influence to the carbon clearance index, sees Table 15.

Table 15 oral drugs I is to the influence of mice reticuloendothelial system phagocytic function

Compare * P＞0.05, * * P＜0.05 with the blank group; Compare △ P＞0.05 with the solvent matched group.

3, to 2, the 4-dinitrochlorobenzene causes the influence of delayed hypersensitivity

60 of mices, random packet: (1) blank group (distilled water 10ml/kg, ig); (2) the solvent matched group (solvent 2ml/kg, ig); (3) the aspirin group (aspirin 10mg/kg, ig) (4) positive controls (FENGLIAOXING FENGSHI DIEDA YAOJIU 5ml/kg, ig); (5) medicine I low dose group (medicine I 1ml/kg, ig); (6) medicine I high dose group (medicine I 2ml/kg, ig).Each organizes every mouse subcutaneous injection 1.25%2,4-dinitrochlorobenzene acetone solution 0.02ml/ only, sensitization begins administration one day after, every day 1 time, continuous 9 days, the 10th day with 0.25%2,4-dinitrochlorobenzene acetone solution subcutaneous injection is in the middle of the right foot pad of mice, 0.02ml/ only, acetone solution to parapodum injection same volume compares, and cuts the back biped from ankle after 38 hours, accurately weighs, as the swelling degree, estimate the influence of medicine with the weight difference of biped and the ratio of the weight of animals (g/100gbw) to delayed hypersensitivity.

The result shows, medicine I is to 2, and delayed hypersensitivity has certain inhibitory action due to the 4-dinitrochlorobenzene, but does not see notable difference, sees Table 16.

Table 16 oral drugs I is to the influence of delayed hypersensitivity

Compare * P＞0.05, * * * P＜0.05 with the blank group; Compare △ P＞0.05 with the solvent matched group.

Eight, the perspiration of medicine I oral administration (colouring)

50 of mices, random packet: (1) blank group (distilled water 10ml/kg, ig); (2) the solvent matched group (solvent 2ml/kg, ig); (3) positive controls (HUOXIANG ZHENGQI SHUI 5ml/kg, ig); (4) medicine I low dose group (medicine I1ml/kg, ig); (5) medicine I high dose group (medicine I 2ml/kg, ig).Each is organized every mouse skin and is coated with and gives 2% iodine tincture, and it is standby to do the back, and each gets the even spreading of dry starch on the mice whole skin after organizing administration 1 time immediately, observe the coloring reaction of skin after 40 minutes in administration, by diaphoresis scope and degree visual score, standards of grading: 0 grade: the fur drying, lossless; 1 grade: the fur pine, lossless; 2 grades: the fur pine, abdominal part or breast neck have antiperspirant; 3 grades: the fur pine, breast, abdominal part all have antiperspirant; 4 grades: the fur pine, lower jaw to abdominal part all has antiperspirant.Estimate the perspiration of medicine with each group diaphoresis grade mean.

The result shows that medicine I has tangible perspiration.See Table 17.

The perspiration of table 15 oral drugs I

Compare * P＞0.05, * * P＜0.05, * * * P＜0.01 with the blank group; Compare △ P＞0.05 with the solvent matched group.

Nine, to the influence of mice tolerance to cold

1, oral route

100 of mices, the same perspiration of random packet and dosage.Promptly begin administration after the grouping, successive administration 5 days after 60 minutes is put into mice-5 ℃ of refrigerator-freezers in last administration every day 1 time, after 2 hours mice is taken out, and statistics is respectively organized mice survival number, calculates and respectively organizes the mice percentage survival.

The result shows that medicine I oral administration high dose group can significantly improve the survival rate of mice in cold, shows that it has the effect of dispeling cold.See Table 18.

Table 18 oral drugs I is to the influence of mice tolerance to cold

2, external approach

100 of mices, random packet is the same.Promptly begin administration after the grouping, every day 2 times, outside the mouse web portion both sides, be coated with corresponding medicinal liquid (medicine I low dose group medicine for external application I 50% diluent), every side 0.2ml at every turn.Successive administration 5 days after 60 minutes is put into mice-5 ℃ of refrigerator-freezers in last administration, after 2 hours mice is taken out, and statistics is respectively organized mice survival number, calculates and respectively organizes the mice percentage survival.

The result shows that medicine I topical administration high dose group can significantly improve the survival rate of mice in cold, shows that it has the effect of dispeling cold.See Table 19.

Table 19 external used medicine I is to the influence of mice tolerance to cold

Ten, medicine I topical administration is to microcirculatory influence

50 of mices are divided into 5 groups (with external approach groups of mice tolerance to cold test) at random.Each group all is coated with corresponding medicinal liquid (medicine I low dose group medicine for external application I 50% diluent) 0.1ml outside auris dextra.After the anesthesia of animal pentobarbital sodium, under the cold light source transillumination, observe the situation of mouse right ear auricular microcirculation before administration earlier with 100 times of mirrors, every group of mice administration 1 time, similarity condition is observed the external caliber and the point of intersect of the capillary network (blood capillary opening amount) of auricle arteriole (A) and thin vein (V) after 5 minutes, judges that microcirculation improves situation.

The result shows that medicine I can make auricle arteriole and thin vein bore increase, and the blood capillary opening amount increases, and illustrates that it has tangible blood vessel dilating and microcirculation improvement effect.See Table 20.

Table 20 external used medicine I is to the influence of Mice Auricle external caliber and blood capillary opening amount

Compare * P＞0.05, * * P＜0.05 with the blank group;

11, medicine I oral administration on Carrageenan causes the influence of rat fever

Rat is used in experiment, and every rat is surveyed the anus temperature 2 times every day, for three days on end, chooses the body temperature fluctuation and is no more than 0.5 ℃ rat, right hind foot plantar subcutaneous injection 1% carrageenin 0.1ml, random packet then.Promptly begin administration 1 time after the grouping, the administration again 1 time that causes scorching back 4 hours.Each is organized the administration volume and is 10ml/kg.Cause scorching back 2,6,8 hours in giving carrageenin, survey every rat temperature respectively, and relatively, observe the influence that medicine raises to rat temperature with normal body temperature (cause scorching preceding 3 days body temperature and measure average).

The result shows that medicine I on Carrageenan causes the rat temperature rising and do not see that refrigeration function is arranged, and sees Table 21.

Table 21 oral drugs I on Carrageenan causes the influence of rat fever

12, to the influence (spasmolysis) of guinea pig ileum smooth muscle

Get one section of guinea pig ileum and be fixed in (Maxwell) bath (in tyrode's solution 10ml is arranged, logical nitrogen), an end is connected with transducer, usefulness MS302 multimedia physiological and pharmacological monitor analytic record smooth muscle active situation.Treat that ileum stablized 10 minutes, write down one section normal activity curve, add then and be subjected to behind the reagent liquid ileum smooth muscle activity curve in the record 5 minutes, change the ileum repeated experiments.Observe 5 sections ileum smooth muscle active situation altogether for every group.The blank group adds normal saline 0.02ml in Magnus' bath, the solvent matched group adds solvent 0.02ml (final concentration 1: 500) in Magnus' bath, and the HUOXIANG ZHENGQI SHUI group adds HUOXIANG ZHENGQI SHUI 0.02ml (concentration 1: 500), and the acetylcholine group adds 10 ^-5M ACh0.1ml (final concentration 10 ^-7M), medicine I low dose group adds medicine I 0.01ml (final concentration 1: 1000), and medicine I high dose group adds medicine I 0.02ml (final concentration 1: 500).Observation medicine I and HUOXIANG ZHENGQI SHUI are to add medicine I (1: 500) or HUOXIANG ZHENGQI SHUI (1: 500) after 2 minutes, adding ACh 10 again to the antagonism of acetylcholine ^-7M writes down the smooth muscle active situation equally.

The result shows that cloud essence can significantly suppress the contraction movement of intestinal tube smooth muscle, makes smooth muscle relaxation, and the smooth muscle spasm effect due to the energy antagonism ACh, with matched group significant difference (P＜0.01) is arranged relatively, sees Table 22.

Table 22 medicine I is to the influence of ileum smooth muscle

Compare * P＞0.05, * * P＜0.05, * * * P＜0.01 with the blank group;

Compare △ P＞0.05, △ △ △ P＜0.01 with the solvent matched group;

Compare P＜0.01 with the acetylcholine group.

The main pharmacodynamics research conclusion:

Result of the test shows, medicine I has significant antiinflammatory action to the arthroncus that experimental (adjuvanticity) arthritis constitutional inflammation and carrageenin cause, the experimental arthritis secondary lesion is also had certain inhibitory action; Blood stasis, edema that medicine I causes soft tissue injury improve significantly; Hot plate method and writhing method test show that all medicine I has significant analgesia role; Chronic granulation tissue formation had the obvious suppression effect; Immunological testing the results are shown in medicine I, and (hemolysin formation) has inhibitory action to the specific humoral immunity function, and delayed hypersensitivity is had certain inhibitory action, and phagocytic function is not seen obvious influence.

In addition, medicine I has the effect of tangible diaphoresis and raising animal tolerance to cold, and can obviously improve the spastic contraction of auricular microcirculation, releasing intestinal tube smooth muscle.

Above result shows aspect effects such as medicine I has antiinflammatory, analgesia, blood circulation promoting and blood stasis dispelling, diaphoresis, dispels cold, spasmolytic, and for it is used for rheumatic ostalgia clinically, grain is ached, Common Cold, headache, belly pain, chilblain etc. provide certain experimental basis.

Clinical trial final reports such as the numbness disease that test example 2 medicine I treatment wind-cold damp pathogen causes, flu, gastric abscess, chilblain

Object and method

One, tcm diagnosis standard:

(1) numbness disease (Fengshi Guanjie pain):

1. tcm diagnosis foundation:

(1) main clinical manifestation: position pain such as joint, skin, muscles and bones, or swelling deadlock in morning, numbness is weighing, or joint stuffiness, and joint swelling deformation is not very then tetanicly stretched amyotrophy etc.

(2) characteristics of incidence: how relevant with climate change.

(3) sex age characteristics: good sending out in person between twenty and fifty, the woman is more than the man.

(4) physico-chemical examination: anti-" O " increases, or erythrocyte sedimentation rate speeds, or the rheumatoid factor positive, the visible sclerotin infringement of X line.Possess above-mentioned (1), (4) two, in conjunction with (2) or (3), can make a definite diagnosis.

2. Chinese medical discrimination (syndrome of cold-dampness blocking collaterals): the limbs joint cold type of pain is heavy, or swelling, and local fear of cold, color of the leather are not red, and that touches is not hot, pain increase in intensity under coldness, and pain alleviated while getting warmth, enlarged tongue, matter is light dark, the greasy in vain or whiten of tongue, stringy and tense pulse or string are slow.

(2) flu:

1. tcm diagnosis foundation:

(1) symptoms such as aversion to cold, heating, nasal obstruction watery nasal discharge, sneeze, cough, headache, general malaise.

(2) light red tongue or limit point are red, thin fur or Huang, floating pulse.

(3) adverse weather or daily life cause sudden onset accidentally.

2. Chinese medical discrimination (wind-cold syndrome): aversion to cold is heavy, and heating is light, and is lossless, headache, limb aching pain, it is low voice speaking have a stuffy nose, the time snivel, sneeze, throat itching and cough, the thin color of coughing up phlegm is white, mouthful not thirsty or thirsty desire for hot drinks, thin white fur of tongue and moisten floating pulse or tightly floating.

(3) gastric abscess (epigastric pain):

1. tcm diagnosis foundation:

(1) gastral cavilty portion pain and gastrointestinal disease symptom.

(2) history of repeated attack is arranged.

(3) premorbid has obvious inducement more.

Above-mentioned (1) must possess, and should have all the other 1～2 concurrently, and is promptly diagnosable.

2. Chinese medical discrimination (coagulated cold syndrome):

Primary symptom: (1) stomachache is done cruelly, and based on angor, meets and coldly promptly send out or increase the weight of, pain alleviated while getting warmth, morbidity is many brought out by exogenous cold or eating cold and uncooked food excessively by dashing forward; (2) tongue is white, tense pulse or string.

Inferior disease: (1) loss of appetite, then happiness heat of food; (2) tastelessness, general vomiting watery fluid; (3) big loose stool is thin, clear urine in large amounts.

Possess 2 of above-mentioned primary symptoms, and should have 2 of time diseases concurrently, promptly diagnosable.

(4) chilblain:

1. tcm diagnosis foundation: be mainly in health tip and exposure portion such as hands, foot, nose, auricle and buccal.From the beginning of earlier pale at the position skin of enduring cold, it is then red and swollen to continue, or scleroma, speckle are arranged, and the edge is red, and central authorities are livid purple, conscious causalgia, and pruritus, or sense is numb.

2. Chinese medical discrimination (coagulated cold syndrome): coldness of the body with chills, the local pain happiness is warm, light red tongue and dark, deep-thready pulse.

Two, Western medicine diagnose standard: the doctor trained in Western medicine disease that this test relates to, carry out by this sick newest standards.Can be with reference to " clinical disease diagnosis be according to curing the improvement standard ".

Three, test case standard

(1) includes standard in: meet one of routine condition person down, can include the object of observation in.

(1) Chinese medical discrimination belongs to syndrome of cold-dampness blocking collaterals numbness patient.

(2) Chinese medical discrimination belongs to wind-cold syndrome flu patient.

(3) Chinese medical discrimination belongs to coagulated cold syndrome gastric abscess patient.

(4) Chinese medical discrimination belongs to coagulated cold syndrome chilblain patient.

(2) exclusion standard (comprising inadaptation or rejecting standard):

Take Western medicine or other drug and late deformity, maimed person, disability's numbness patient for a long time.Used the flu patient of Chinese and western medicine influenza Drug therapy.Malignant tumor and gastric abscess patient with surgery situation.General chilblain and II degree, III degree locality chilblain patient.Age is at under-18s or over-65s, gestation or women breast-feeding their children, allergic constitution or to this medicine allergy sufferers.Be associated with serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, the psychotic.Do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect, or data is not congruent affects the treatment or safety judgement person.

Four, clinical trial method:

(1) medication and the course of treatment:

(1) the numbness patient is oral, 1 0.5ml, and warm water delivery service 3 times on the one, is got an amount of outer wipe affected part, 3 times on the one simultaneously.1 week was a course of treatment.

(2) the flu patient is oral, 1 0.5ml, and warm water delivery service 3 times on the one, is got 3ml simultaneously and is added shower in the 15L warm water, once a day.3 days is a course of treatment.

(3) the gastric abscess patient is oral, 1 0.5ml, warm water delivery service, 3 times on the one.3 days is a course of treatment.

(4) the chilblain patient gets an amount of outer wipe affected part, 3 times on the one.1 week was a course of treatment.

(2) viewing duration relates to the sick medicine of planting of this observation without other treatment.The curative effect judgement is directly made by the observer.

Five, observation index

(1) safety observation 1, general physical examination; 2, routine blood test, routine urinalysis, stool routine examination; 3, cardiac function (electrocardiogram), liver function (ALT), renal function (Grea, BUN).

(2) health giving quality is observed the situation of change of cardinal symptom; The variation of picture of the tongue and pulse condition.

Six, efficacy assessment standard

(1) numbness disease (this product is mainly observed analgesic effect)

Produce effects: pain begins to alleviate in the medication 3 days, obviously alleviates in 5 days, and function of joint is obviously improved.Effectively: pain begins to alleviate in the medication 5 days, obviously alleviates in 7 days, and function of joint is obviously improved.Invalid: medication does not reach above standard person in 7 days.

(2) flu

Recovery from illness: it is normal to treat in 3 days temperature recovery, and the symptom of flu all disappears.Produce effects: it is normal to treat in 3 days temperature recovery, most of transference cure of flu.Effectively: treat the more preceding reduction of body temperature in 3 days, the cardinal symptom of flu partly disappears.Invalid: as not reach above standard person.

(3) gastric abscess (this product is mainly observed analgesic effect)

Produce effects: pain begins to alleviate in the medication 1 day, obviously alleviates in 2 days, and simultaneous phenomenon obviously improves.Effectively: pain begins to alleviate in the medication 2 days, obviously alleviates in 3 days, and simultaneous phenomenon obviously improves.Invalid: medication does not reach above standard person in 3 days.

(4) chilblain

Recovery from illness: symptom all disappears, and therapeutic index is 100%.Produce effects: symptom is obviously improved, and therapeutic index is 61～99%.Effectively: symptom makes moderate progress, and therapeutic index is 31～60%.Invalid: as not reach above standard person.

Seven, the processing of clinical trial data and summary

Picking out the case standard does not meet this programme and includes standard person in; Belong to the object of observation, but do not affect the treatment and safety judgement person entirely because of observations; Because of the course of treatment of drug withdrawal person is not midway finished in unsatisfactory curative effect and untoward reaction; Use instead or add with other relevant medicine and Therapeutic Method person.

Statistics are tested all data and are all imported computer and carry out statistical analysis, and measurement data is checked with t, enumeration data x ²Check.

The result

One, physical data is observed 360 examples altogether, adopts own control, opening, polycentric method to test.The test case adopts inpatient and clinic case, and clinic case should strict control variable factor.Among the 360 routine qualified experimenters, sick 100 examples of numbness, 100 examples of catching a cold, gastric abscess 100 examples, chilblain 60 examples; Inpatient's 40 examples, outpatient's 320 examples; Male's 143 examples, women's 217 examples; Maximum 65 years old age, minimal ages 18 years old, 42.67 ± 11.90 years old mean age; The sick course of disease of numbness 2.58 ± 1.96 years, the flu course of disease 2.03 ± 1.35 days, the gastric abscess course of disease 2.39 ± 2.15 years, the chilblain course of disease 30.8 ± 15.93 days.

Two, clinical efficacy

(1) total clinical efficacy distributes

Subordinate list 1 curative effect distribution situation (unit: example)

The result shows that medicine I is used for the treatment of numbness disease, flu, gastric abscess and chilblain curative effect preferably, and total effective rate reaches 92.00%, 97.00%, 96.00% and 91.67% respectively.

(2) to the improvement effect (seeing attached list 2) of symptom and sign

Subordinate list 2 is respectively seen disease keep the score before and after the treatment improvement after relatively (t check) and the medication, disappearance situation

Annotate: before and after the treatment relatively, P all＜0.05, difference has the significance meaning.

Three, the onset of cardinal symptom and extinction time after the medication:

Treatment numbness disease, pain on average began to alleviate (totally 94 examples) in 3.89 ± 1.35 days; On average in pain disappearance (totally 69 examples) in 6.14 ± 0.89 days.

The treatment flu, 93 routine febrile diseases are ruled 37.53 ± 0.51 ℃ of precursor temperature average out to by men, control 36.65 ± 0.35 ℃ of back body temperature average out to.Body temperature on average recovered normal (totally 82 examples) in 2.44 ± 0.52 days.

The treatment gastric abscess, pain on average began to alleviate (totally 97 examples) in 1.69 ± 0.60 days; On average in pain disappearance (totally 82 examples) in 2.43 ± 0.77 days.

Four, safety detects:

Routine blood test: detected 287 before the treatment wherein in the 277 example treatment back checks of normal range, there is no unusual.

Routine urinalysis: detected 269 examples before the treatment, wherein, there is no unusual in the 269 example treatment back checks of normal range.

Electrocardiogram: detected 245 examples before the treatment, wherein, there is no unusual in the 245 example treatment back checks of normal range.

Liver function (ALT): detected 240 examples before the treatment, wherein, there is no unusual in the 240 example treatment back checks of normal range.

Renal function (Grea, BUN): detected 236 examples before the treatment, wherein, there is no unusual in the 236 example treatment back checks of normal range.

Five, untoward reaction is observed:

Only 1 routine numbness patient took medicine and the tending to vomit symptom of feeling sick occurred after the 3rd day, advised the back transference cure of taking medicine after meal, did not do other special handlings.All the other patients do not see that obvious toxic-side effects and untoward reaction occur.

Claims

1. a Chinese medicine composition for the treatment of Fengshi Guanjie pain, headache due to common cold, epigastric pain, chilblain is made up of effective ingredient and/or acceptable accessories, and wherein said effective ingredient is made by following raw materials by weight percent:

2. according to the described Chinese medicine composition of claim 1, wherein the raw material consumption is:

3. according to the described Chinese medicine composition of claim 2, wherein the raw material consumption is:

4. according to any one described Chinese medicine composition among the claim 1-3, it is hold concurrently tincture, spray, aerosol or the ointment of oral administration of external.

5. the preparation method of claim 1 or 2 or 3 described Chinese medicine compositions is characterized in that the preparation method of effective ingredient is: take by weighing raw material, with four flavor Chinese medicines such as Radix Cynanchi Paniculati, Radix Sophorae Tonkinensis, Herba Asari and 30～50% five tastes rattans, pulverize separately becomes coarse powder, and is standby; With the Radix Angelicae Dahuricae, Chinese honey locust (fruit), Ramulus Cinnamomi, the Radix Aucklandiae, Rhizoma Curcumae, Radix Litseae, Radix Flemingiae Philippinensis, Radix Ardisiae Crenatae, Herba Inulae cappae, Sassafras tsumu Hemsl., Rhizoma Polygoni Cuspidati, Caulis Gneti, Caulis Bauhihiae Championii, Guangxi Caulis Piperis Kadsurae, Cauliset Folium Piperis Hancei, Radix Cinnamomi porrecti and remaining five tastes rattan, put in the reflux, extract, jar, the alcoholic solution that adds 3～10 times of amount 20%～50% concentration, airtight, after the heating and refluxing extraction 5～9 hours, distill, collect distillate; Get above-mentioned Radix Cynanchi Paniculati, Radix Sophorae Tonkinensis, Herba Asari and five tastes rattan coarse powder, add in the distillate of above-mentioned collection, stir evenly, flooded 24～72 hours; Get impregnation liquid, add Mentholum, Camphora, stir and make dissolving, filter, promptly.

6. the preparation method of Chinese medicine composition according to claim 5, it is characterized in that the effective ingredient preparation method of medicine is: take by weighing raw material, with Radix Cynanchi Paniculati, Radix Zanthoxyli, Lignum Dalbergiae Odoriferae and 38%～45% five tastes rattan, pulverize separately becomes coarse powder, and is standby; With the Radix Angelicae Dahuricae, Chinese honey locust (fruit), Ramulus Cinnamomi, the Radix Aucklandiae, Rhizoma Curcumae, Radix Litseae, Radix Flemingiae Philippinensis, Radix Ardisiae Crenatae, Herba Inulae cappae, Sassafras tsumu Hemsl., Rhizoma Polygoni Cuspidati, Caulis Gneti, Caulis Bauhihiae Championii, Guangxi Caulis Piperis Kadsurae, Cauliset Folium Piperis Hancei, Radix Cinnamomi porrecti and remaining five tastes rattan, put in the reflux, extract, jar, the alcoholic solution that adds 4～8 times of amount 25%～40% concentration, airtight, after the heating and refluxing extraction 7 hours, distill, collect distillate; Get above-mentioned Radix Cynanchi Paniculati, Radix Sophorae Tonkinensis, Herba Asari and five tastes rattan coarse powder, add in the distillate of above-mentioned collection and stir evenly, flooded 36～60 hours.Get impregnation liquid, add Mentholum, Camphora, stir and make dissolving, filter, promptly.

7. the preparation method of Chinese medicine composition according to claim 6 is characterized in that the effective ingredient preparation method of medicine is: take by weighing raw material, with the five tastes rattan of Radix Cynanchi Paniculati, Radix Zanthoxyli, Lignum Dalbergiae Odoriferae and 41.86%, pulverize separately becomes coarse powder, and is standby; With the Radix Angelicae Dahuricae, Chinese honey locust (fruit), Ramulus Cinnamomi, the Radix Aucklandiae, Rhizoma Curcumae, Radix Litseae, Radix Flemingiae Philippinensis, Radix Ardisiae Crenatae, Herba Inulae cappae, Sassafras tsumu Hemsl., Rhizoma Polygoni Cuspidati, Caulis Gneti, Caulis Bauhihiae Championii, Guangxi Caulis Piperis Kadsurae, Cauliset Folium Piperis Hancei, Radix Cinnamomi porrecti and remaining five tastes rattan, put in the reflux, extract, jar, the alcoholic solution that adds 6 times of amount 30% concentration, airtight, after the heating and refluxing extraction 7 hours, distill, collect distillate; Get above-mentioned Radix Cynanchi Paniculati, Radix Sophorae Tonkinensis, Herba Asari and five tastes rattan coarse powder, add in the distillate of above-mentioned collection and stir evenly, flooded 48 hours.Get impregnation liquid, add Mentholum, Camphora, stir and make dissolving, filter, promptly.

8. according to the preparation method of the Chinese medicine composition of one of claim 5-7, it is characterized in that preparing tincture.

9. any one described Chinese medicine composition is preparing the purposes for the treatment of Fengshi Guanjie pain, headache due to common cold, epigastric pain, chilblain disease medicine among the claim 1-4.