CN1861184A - Application of composition for preparing medicine to treat chilblain disease - Google Patents

Abstract

An application of the composition composed of 21 Chinese-medicinal materials including aucklandia root, etc in preparing the medicines for treating the chilblain is disclosed. It has high curative effect (94.4-98.9%).

Description

The application of a kind of compositions in preparation treatment chilblain disease medicine

Technical field

The present invention relates to the new purposes of a kind of Chinese medicine composition, relate to a kind of application of pharmaceutical composition in the treatment chilblain disease that constitutes by Chinese medicines such as the Radix Aucklandiae specifically.

Background technology

Chilblain is meant that human body is subjected to it is attacked by the cold and evil, stagnation of QI-blood, thus cause the damage of locality or general.The person of freezing, the heresy of impression cold also.Skin ulcer person, wound also.

Theory of Chinese medical science thinks that chilblain is that integumentary musculature is attacked by severe cold, and QI-blood circulation does not freely cause coagulation of QI-blood and forms, and the weak or overfatigue of QI and blood is freezing heat cruelly usually, and sudden high fever to freeze primary disease is generated.So the tcm clinical practice treatment is with dispelling cold by warming the meridian, blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain are main.

At present, also effectively not reliable medicine is used for the treatment of chilblain, adopts physiotherapy usually, and as hot compress, massage etc. are controlled table not effect a permanent cure, and can not solve patient's pain at all.

" the reducing swelling and alleviating pain pharmaceutical composition " of open report can suppress the growth of staphylococcus aureus, beta hemolytic streptococcus, escherichia coli, Bacillus typhi, vibrio cholera etc. in the 12 of Ministry of Health of the People's Republic of China's " drug standard " (Chinese traditional patent formulation preparation).Usually only be used for to the killing of pathogenic bacterium, to reach the purpose of reducing swelling and alleviating pain.Can use it for the treatment chilblain,, have bigger clinical value to expand its range of application.

Summary of the invention

The technical issues that need to address of the present invention are to disclose the application of a kind of Chinese medicine compositions in the treatment chilblain, to overcome the defective that prior art exists, expand the purposes of reducing swelling and alleviating pain pharmaceutical composition.

The composition of said Chinese medicine compositions has been open report in the 12 of Ministry of Health of the People's Republic of China's " drug standard " (Chinese traditional patent formulation preparation), is the feedstock production that adopts following parts by weight:

1～100 part of 1～100 part of Herba Asari of 1～100 portion of Herba Schizonepetae of 1～100 part of Radix Saposhnikoviae of the Radix Aucklandiae

1～100 part of 1～100 part of Rhizoma Chuanxiong of 1～100 part of Radix Achyranthis Bidentatae of 1～100 part of Ramulus Cinnamomi of Cortex Acanthopancis

1～200 part of 1～100 part of Radix seu Caulis Parabarii of 1～200 part of Rhizoma Curcumae of 1～100 part of Radix Angelicae Dahuricae of Radix Cynanchi Paniculati

1～200 part of 1～300 portion of Caulis Fibraureae of 1～200 portion of Radix Zanthoxyli of 1～300 part of Radix Ardisiae punctatae of DALUOSAN

1～100 part of 1～100 part of Camphora of 1～200 portion of Lignum Aquilariae Resinatum of 1～300 part of rhizoma sparganic of Fructus Gardeniae

1～100 part of Mentholum.

Preferred parts by weight are:

47 parts of 47 parts of Herba Asaris of 47 portions of Herba Schizonepetae of 47 parts of Radix Saposhnikoviaes of the Radix Aucklandiae

47 parts of 47 parts of Rhizoma Chuanxiongs of 47 parts of Radix Achyranthis Bidentataes of 47 parts of Ramulus Cinnamomi of Cortex Acanthopancis

70 parts of 47 parts of Radix seu Caulis Parabarii of 70 parts of Rhizoma Curcumae of 47 parts of Radixs Angelicae Dahuricae of Radix Cynanchi Paniculati

95 parts of 100 portions of Caulis Fibraureaes of 70 portions of Radix Zanthoxylis of 100 parts of Radix Ardisiae punctatae of DALUOSAN

55 parts of 32.5 parts of Camphoras of 70 portions of Lignum Aquilariae Resinatum of 100 parts of rhizoma sparganic of Fructus Gardeniae

55 parts of Mentholums.

Preferred parts by weight are:

Radix Aucklandiae 47g Radix Saposhnikoviae 100g Herba Schizonepetae 47g Herba Asari 47g

Cortex Acanthopancis 100g Ramulus Cinnamomi 47g Radix Achyranthis Bidentatae 47g Rhizoma Chuanxiong 100g

Radix Cynanchi Paniculati 47g Radix Angelicae Dahuricae 70g Rhizoma Curcumae 100g Radix seu Caulis Parabarii 70g

DALUOSAN 100g Radix Ardisiae punctatae 70g Radix Zanthoxyli 100g Caulis Fibraureae 95g

Fructus Gardeniae 100g rhizoma sparganic 100g Lignum Aquilariae Resinatum 32.5g Camphora 60g

Mentholum 65g.

The inventor finds in secular clinical practice, adopts the pharmaceutical composition of above-mentioned feedstock production that chilblain is had therapeutical effect preferably, can be used to prepare the medicine for the treatment of chilblain.

Pharmaceutical composition of the present invention can tincture form be applied in patient's chilblain place, one is for several times, before smearing, earlier the chilblain place is washed with warm water, after smearing, preferably carries out suitable massage.

Term " tincture " refers to the ethanol water of medicine, and wherein, alcoholic acid volumetric concentration is 35～75%, preferred water 51～55%, and more preferably 53%, in the ethanol water, the weight content of active component is 0.5～5%;

Openly reported preparation of drug combination method of the present invention in the 12 of Ministry of Health of the People's Republic of China's " drug standard " (Chinese traditional patent formulation preparation), specifically comprised the steps:

With above 20 simply, except that Camphora, Mentholum, 19 flavors such as all the other Radix Aucklandiae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (an appendix I of Chinese Pharmacopoeia version in 2000 O), with volumetric concentration is that 35～75% ethanol is made solvent, floods after 24～32 hours, with the speed of the about 1～5ml of per minute percolation slowly, the collection liquid of filtering, device is preserved in addition; After getting Camphora, Mentholum and adding ethanol 700g and make dissolving,, leave standstill, filter, promptly with the above-mentioned liquid mixing of filtering.

Animal experiment and clinical observation prove, pharmaceutical composition of the present invention can effectively be treated I degree chilblain, and total obvious effective rate and total effective rate reach 55.6% and 94.4% respectively after treating 7 days; Total obvious effective rate and total effective rate reach 83.3% and 98.9% respectively after treating 14 days.

The specific embodiment

Embodiment 1

Make pharmaceutical composition 6000g:

1, raw material is formed

Radix Aucklandiae 47g Radix Saposhnikoviae 47g Herba Schizonepetae 47g Herba Asari 47g

Cortex Acanthopancis 47g Ramulus Cinnamomi 47g Radix Achyranthis Bidentatae 47g Rhizoma Chuanxiong 47g

Radix Cynanchi Paniculati 47g Radix Angelicae Dahuricae 70g Rhizoma Curcumae 47g Radix seu Caulis Parabarii 70g

DALUOSAN 100g Radix Ardisiae punctatae 70g Radix Zanthoxyli 100g Caulis Fibraureae 95g

Fructus Gardeniae 100g rhizoma sparganic 70g Lignum Aquilariae Resinatum 32.5g Camphora 55g Mentholum 55g

2, method for making:

More than 20 simply, except that Camphora, Mentholum, 19 flavors such as all the other Radix Aucklandiae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (appendix IO of Chinese Pharmacopoeia version in 2000), with volumetric concentration is that 53% ethanol is made solvent, floods after 28 hours, with the speed of the about 3ml of per minute percolation slowly, the collection liquid 5300g that filters, device is preserved in addition; After getting Camphora, Mentholum and adding ethanol 700g and make dissolving,, leave standstill, filter, promptly with the above-mentioned liquid mixing of filtering.

Embodiment 2

Make pharmaceutical composition 10000g:

1, raw material is formed

Radix Aucklandiae 47g Radix Saposhnikoviae 100g Herba Schizonepetae 47g Herba Asari 47g

Cortex Acanthopancis 100g Ramulus Cinnamomi 47g Radix Achyranthis Bidentatae 47g Rhizoma Chuanxiong 100g

Radix Cynanchi Paniculati 47g Radix Angelicae Dahuricae 70g Rhizoma Curcumae 100g Radix seu Caulis Parabarii 70g

DALUOSAN 100g Radix Ardisiae punctatae 70g Radix Zanthoxyli 100g Caulis Fibraureae 95g

Fructus Gardeniae 100g rhizoma sparganic 100g Lignum Aquilariae Resinatum 32.5g Camphora 60g Mentholum 65g

2, method for making:

More than 20 simply, except that Camphora, Mentholum, 19 flavors such as all the other Radix Aucklandiae are ground into coarse powder, according to the percolation under fluid extract and the extractum item (an appendix I of Chinese Pharmacopoeia version in 2000 O), make solvent with 75% ethanol, flood after 24 hours, with the speed of the about 3ml of per minute percolation slowly, the collection liquid 9200g that filters, device is preserved in addition; After getting Camphora, Mentholum and adding ethanol 800g and make dissolving,, leave standstill, filter, promptly with the above-mentioned liquid mixing of filtering.

Embodiment 3

Adopt the tincture of embodiment 1 to carry out pharmacodynamic study:

1. detumescence effect

6 of every group of Japan large ear rabbits play cropping in the 8cm zone with have sharp ears, put freezing 70s in the freezing tank (18 ± 1 ℃), after freezing 24 hours, begin administration at freezing place, totally 3 groups of administration groups, every group of administration 10ml, 7ml or 5ml, successive administration 7 days.The result shows, compares with the blank group, and the tincture of middle and high dose delivery example 1 obviously alleviates the red and swollen inflammatory reaction of cold injury tissue, prevents that blister from producing and tissue necrosis.This prompting, the tincture of embodiment 1 has the trend of treatment chilblain.

2. to the influence of the rabbit ear perfusion flow that exsomatizes

5 of every group of Japan large ear rabbits, the dosage of the tincture of embodiment 1 is 5ml or 10ml.The rabbit ear that make to exsomatize, the perfusion krebs solution is 10 minutes before administration, after the administration (every rabbit ear is smeared 5ml or 10ml) 10 minutes, 20 minutes, 30 minutes, the perfusion flow of 40 minutes and 60 minutes measurement rabbit ears.The result shows, the rabbit ear was smeared behind the repercussive and analgesic tincture 20 minutes, and rabbit ear perfusion flow is obviously greater than before the administration.This prompting, the tincture of embodiment 1 has blood vessel dilating, the effect of blood circulation promoting.

3. analgesic effect

12 of every group of mices, male and female half and half.With the qualified mice of hot plate method (55 ℃) screening pain threshold, smear the metapedes administration continuous 3 times, each 2 hours at interval, each 1ml.After the last administration 0.5 hour, measure pain threshold.The result shows, compares with the blank group, and administration group mice pain threshold obviously increases.This prompting, the tincture of embodiment 1 has significant analgesia role.

4. antiinflammatory action

12 of every group of mices, male and female half and half.Dimethylbenzene 0.05ml is applied to two sides, mouse right ear front and back, and left ear is not coated with in contrast.Cause scorching back 30 minutes, causing 3 coatings of scorching punishment, each 2 hours at interval.After the last administration 2 hours, relatively two ears are with the weight difference of position homalographic auricle.The result shows, compares with matched group, and administration group mice auricle swelling degree obviously alleviates.This prompting, the local tincture of embodiment 1 that uses has antiinflammatory action.

Pharmacodynamic experiment shows before clinical, the local effect of using repercussive and analgesic tincture to have detumescence, antiinflammatory, pain relieving and blood circulation promoting.This prompting, the tincture of embodiment 1 has the potentiality of treatment chilblain clinically.

Embodiment 4

Clinical observation on the therapeutic effect

One. case is selected:

Collect 1 degree chilblain (being local no blister of chilblain or necrosis) patient's 90 examples and set up matched group 90 examples simultaneously for the treatment group.Aspects such as treatment group and matched group patient sex, age and the state of an illness are basic identical.Two groups of no significant differences of contrast, P＞0.05 has comparability.

Two, diagnostic criteria:

(1), Western medicine diagnose standard:

1. the cold injury history is arranged, mostly occur in low-temperature cold season;

2. be the locality chilblain, mainly betide health tip and exposure portion such as the back of the hand, heel, auricle, nose;

3. the chilblain place is obviously red and swollen, conscious pain or have an itch;

(2), Syndrome in TCM marquis diagnostic criteria: syndrome of coagulation cold due to blood deficiency

Syndrome: coldness of the body with chills, the local pain happiness is warm.Light red tongue is and dim, and tongue is white, deep-thready pulse.

(3), include standard in:

1, meets the Western medicine diagnose standard;

2, meet Syndrome in TCM marquis diagnostic criteria;

3, patient age: 18～60 years old;

4, treatment was not used the medicine relevant with primary disease in preceding 7 days;

(4), exclusion standard:

1, gestation or women breast-feeding their children;

2, allergic constitution or to this medicine allergy sufferers;

3, be associated with serious primary disease such as cardiovascular and cerebrovascular vessel, liver, kidney or hemopoietic system, psychotic;

4, there is epidermis breakage person the chilblain part;

5, do not meet other cases of the standard of including in;

Two, Therapeutic Method:

The treatment group: the tincture that gives embodiment 1 is wiped the affected part in right amount, 3～5 times/day;

Matched group: every day, temperature was applied the affected part for several times, did not give other drug and handled;

Three, efficacy determination

1, clinical complete: clinical symptoms, sign disappear or basic the disappearance;

2, produce effects: clinical symptoms, sign are obviously improved;

3, effective: clinical symptoms, sign all take a favorable turn;

4, invalid: clinical symptoms, sign do not have improvement, even increase the weight of;

Four, clinical effectiveness:

1, treat result after 7 days:

Group (routine number)	Recovery rate (%/routine number)	Obvious effective rate (%/routine number)	Effective percentage (%/routine number)	Inefficiency (%/routine number)	Total effective rate (%/routine number)
						Treatment group (90)	18.9/17	36.7/33	38.9/35	5.6/5	94.4/85

Matched group (90)	1.1/1	11.1/10	14.4/13	73.3/66	26.7/24
						The data contrast	P＞0.05	P＞0.05	P＞0.05	P＞0.05	P＞0.05

The result shows: treat after 7 days the treatment group and compare with the every data of matched group and significant difference is all arranged, P＞0.05

2, treat result after 14 days:

Group (routine number)	Recovery rate (%/routine number)	Obvious effective rate (%/routine number)	Effective percentage (%/routine number)	Inefficiency (%/routine number)	Total effective rate (%/routine number)
						Treatment group (90)	48.9/44	34.4/31	15.6/14	1.1/1	98.9/89
Matched group (90)	10.0/9	24.4/22	22.2/20	43.3/39	56.7/24
						The data contrast	P＞0.05	P＜0.05	P＜0.05	P＞0.05	P＞0.05

The result shows: treat that treatment group and matched group relatively have significant difference in recovery rate, total effective rate data, P＞0.05 after 14 days

Five, the tincture of conclusion: embodiment 1 can effectively be treated I degree chilblain, and total obvious effective rate and total effective rate reach 55.6% and 94.4% respectively after treating 7 days; Total obvious effective rate and total effective rate reach 83.3% and 98.9% respectively after treating 14 days.

Claims (3)

1. the application of the pharmaceutical composition of following portions by weight in preparation treatment chilblain disease medicine:

1～100 part of 1～100 part of Herba Asari of 1～100 portion of Herba Schizonepetae of 1～100 part of Radix Saposhnikoviae of the Radix Aucklandiae

1～100 part of 1～100 part of Rhizoma Chuanxiong of 1～100 part of Radix Achyranthis Bidentatae of 1～100 part of Ramulus Cinnamomi of Cortex Acanthopancis

1～200 part of 1～100 part of Radix seu Caulis Parabarii of 1～200 part of Rhizoma Curcumae of 1～100 part of Radix Angelicae Dahuricae of Radix Cynanchi Paniculati

1～200 part of 1～300 portion of Caulis Fibraureae of 1～200 portion of Radix Zanthoxyli of 1～300 part of Radix Ardisiae punctatae of DALUOSAN

1～100 part of 1～100 part of Camphora of 1～200 portion of Lignum Aquilariae Resinatum of 1～300 part of rhizoma sparganic of Fructus Gardeniae

1～100 part of Mentholum.

2. application according to claim 1 is characterized in that, parts by weight are:

47 parts of 47 parts of Herba Asaris of 47 portions of Herba Schizonepetae of 47 parts of Radix Saposhnikoviaes of the Radix Aucklandiae

47 parts of 47 parts of Rhizoma Chuanxiongs of 47 parts of Radix Achyranthis Bidentataes of 47 parts of Ramulus Cinnamomi of Cortex Acanthopancis

70 parts of 47 parts of Radix seu Caulis Parabarii of 70 parts of Rhizoma Curcumae of 47 parts of Radixs Angelicae Dahuricae of Radix Cynanchi Paniculati

95 parts of 100 portions of Caulis Fibraureaes of 70 portions of Radix Zanthoxylis of 100 parts of Radix Ardisiae punctatae of DALUOSAN

55 parts of 32.5 parts of Camphoras of 70 portions of Lignum Aquilariae Resinatum of 100 parts of rhizoma sparganic of Fructus Gardeniae

55 parts of Mentholums.

3. application according to claim 1, its feature like this, parts by weight are:

Radix Aucklandiae 47g Radix Saposhnikoviae 100g Herba Schizonepetae 47g Herba Asari 47g

Cortex Acanthopancis 100g Ramulus Cinnamomi 47g Radix Achyranthis Bidentatae 47g Rhizoma Chuanxiong 100g

Radix Cynanchi Paniculati 47g Radix Angelicae Dahuricae 70g Rhizoma Curcumae 100g Radix seu Caulis Parabarii 70g

DALUOSAN 100g Radix Ardisiae punctatae 70g Radix Zanthoxyli 100g Caulis Fibraureae 95g

Fructus Gardeniae 100g rhizoma sparganic 100g Lignum Aquilariae Resinatum 32.5g Camphora 60g

Mentholum 65g.