CN100352479C - Medicament for treating leucoderma and prepartion method - Google Patents
Medicament for treating leucoderma and prepartion method Download PDFInfo
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Abstract
The present invention relates to a medicament and a preparing method thereof. The present invention needs to provide the ingredients of a medicine for treating leukoderma, the dosage proportion of the ingredients and a method for preparing the medicine. The present invention uses the formula mode of traditional medicine for determining the ingredients of the medicine of the following dosage proportion by weight percentage: 10% to 20% of herba ecliptae, 3% to 10% of Chuanxiong rhizome, 5% to 15% of milkvetch seed, 4% to 15% of malaytea scurfpea fruit, 5% to 15% of prepared fleeceflower root, 3% to 10% of angelica, 3% to 10% of red sage root, 3% to 10% of lithospermi, 3% to 10% of bupleurum root, 3% to 8% of atractylodes rhizome, 3% to 10% of flavescent sophora root, 3% to 10% of rhizoma paridis, 5% to 15% of tribulus fruit and 5% to 15% of dahurian angelica root. The present invention adopts the technology, such as pulverization (such as the Chuanxiong rhizome, the prepared fleeceflower root, the angelica, the atractylodes rhizome, the tribulus fruit and the dahurian angelica root), extration with alcohol (such as the malaytea scurfpea fruit, the red sage root, the lithospermi and the flavescent sophora root), extraction with water (such as dregs of medicines, which are extracted with alcohol, and residual medicinal materials), reduced pressure distillation, concentration, low temperature drying, etc., to provide the medicament for treating leukoderma and the preparing method thereof) The medicine which is prepared according to the present invention has the advantages of exact therapeutic effect, little side effect, etc.
Description
One, technical field: the invention belongs to medical preparation field, is a kind of preparation method for the treatment of the vitiligo medicine.
Two, background technology: vitiligo is a kind of posteriority limitation depigmentation dermatosis, population of China prevalence about 0.1%～2%.The pathogeny of primary disease is still not fully aware of, studies show that at present: the inhibition of leukodermic generation and enzyme system, the generation of melanosome and function, melanism process obstacle, melanocyte form and are suppressed relevant, and relevant with damage, tyrosine and the copper zinc ion shortage etc. of heredity, autoimmune, spiritual neural factor, endocrine, metabolism, keratinocyte dysfunction, free radical.Since the nineties, the immunological theory on the vitiligo pathogeny is supported in existing increasing research.The method that western medical treatment adopts whole body therapeutic to combine with topical therapeutic more.Single western medical treatment though its means and method are more advanced, has also been obtained certain curative effect, because there is certain difficulty in the restriction of side effects of pharmaceutical drugs or some condition in therapeutic process.Chinese medicine has special advantages in this respect, and " prescriptions worth thousand gold " adopts Fructus Tribuli, Zhang Jiaju to cooperate sun exposure, Zhu Zhenting to use Semen Astragali Complanati, have treatment vitiligo such as human psoralea tincture all to obtain certain effect in addition with angelica anomala.But primary disease belongs to difficult disease, and treatment time is long, and curative effect is poor, does not still have specific medicine at present.
Three, goal of the invention: the purpose of this invention is to provide leukodermic medicament of a kind of treatment and preparation method thereof.
Four, technical scheme: the present invention is achieved through the following technical solutions: according to the prescription theory of traditional medicine, catch caused by liver and kidney deficiency, fur loses supports; Qi-blood disharmony, ailment said due to cold or exposure is attacked table; Qi depression to blood stasis, etiology and pathogenesis such as failure of skin and muscle to be nourished or retention of damp-heat in the interior, adopt nourishing the liver and kidney, blood-activating and qi-promoting, be aided with removing damp-heat, the method of dispelling wind for relieving itching, select Herba Ecliptae for use, Rhizoma Chuanxiong, Semen Astragali Complanati, Fructus Psoraleae, Radix Polygoni Multiflori Preparata, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Radix Arnebiae (Radix Lithospermi), Radix Bupleuri, Rhizoma Atractylodis, Radix Sophorae Flavescentis, Rhizoma Paridis, Fructus Tribuli, 14 kinds of herbal prescriptions such as the Radix Angelicae Dahuricae, its usage ratio (percentage by weight %) is: Herba Ecliptae 10-20%, Rhizoma Chuanxiong 3-10%, Semen Astragali Complanati 5-15%, Fructus Psoraleae 4-15%, Radix Polygoni Multiflori Preparata 5-15%, Radix Angelicae Sinensis 3-10%, Radix Salviae Miltiorrhizae 3-10%, Radix Arnebiae (Radix Lithospermi) 3-10%, Radix Bupleuri 3-10%, Rhizoma Atractylodis 3-8%, Radix Sophorae Flavescentis 3-10%, Rhizoma Paridis 3-10%, Fructus Tribuli 5-15%, Radix Angelicae Dahuricae 5-15%.Preparation technology is: with Fructus Tribuli, Radix Polygoni Multiflori Preparata, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Atractylodis, Radix Angelicae Dahuricae oven dry, it is standby to be ground into fine powder; Radix Salviae Miltiorrhizae, Radix Arnebiae (Radix Lithospermi), Radix Sophorae Flavescentis, Fructus Psoraleae soak with the 50-95% medical ethanol or extract with pharmaceutical equipment, concentrate standby; Medicinal residues after the extraction add the residue medical material, decoct with water 2-3 time, concentrate the back and add the medical ethanol concentrated solution, continue to be condensed into extractum, add medicated powder, mixing, and drying is pulverized, and sieves; Directly or add medical acceptable auxiliary and make powder, capsule, tablet, pill etc.
Five, beneficial effect:
1. case choice criteria: " vitiligo Clinical typing and criterion of therapeutical effect (revised draft in 2003) " and " Surgery of Chinese Medicine ", " skin cypridology ", " diagnosis and treatment of Dermatology ﹠ STD Dept. disease that calls for specialized treatment tcm clinical practice " that case selection is formulated with reference to Chinese combination of Chinese and Western medicine dermatosis association pigment disease group, draft leukodermic diagnostic criteria: skin lesion is the depigmentation speckle that local color of the leather goes down, bleaches, and speckle or patch are creamy white; Form, not of uniform size, the white macula edge is unclear or clear; The decolouring speckle is divided a word with a hyphen at the end of a line to normal skin, and the gap development increases gradually, enlarges, or development is very fast, and colleague's reaction is arranged; One or several white maculas are limited to a position or are distributed widely in body surface, far-end of limb etc., also have minority case white macula to be fused into sheet mutually, general whole body such as map shape.Case selection all meets above diagnostic criteria.
2. the object of observation: vitiligo can be for the statistics patient, and the age is between 10～60 years old, the course of disease 1 week～20 year, and the skin lesion area accounts for 2%～30% of whole body surface area; In 8 weeks not system used corticosteroids and immunosuppressant; Do not used the irradiation of psoralen or long wave ultraviolet (PUVA) in 4 weeks; Short wave ultraviolet (UVB) irradiation and other topical therapeutics had not been used in 2 weeks; Viscera disease or immunodeficiencies such as no severe cardiac, liver, kidney; Non-pregnancy and women breast-feeding their children or do not prepare conceived person in nearly 1 year; Require contraception during women of child-bearing age's treatment, and require treatment to finish fertility in back 1 year.
3. divide into groups and medication: select October calendar year 2001～2003 year JIUYUE to be diagnosed as leukodermic patient's 256 examples by Puyang the People's Hospital department of dermatologry, male 172 examples, women 84 examples, wherein, topical type 86 examples, general hair style 170 examples.According to the group forming criterion of randomized, double-blind, be divided into treatment group and matched group, wherein 128 examples are organized in treatment, male 88 examples, women 40 examples, 18.4 years old mean age (10 years old～60 years old), average course of disease 1.83 (15 days～19 years); Matched group 128 examples, male 84 examples, women 44 examples, 18.6 years old mean age (10.5 years old～58 years old), average course of disease 1.87 (20 days～20 years).Between two groups at aspects such as case load, sex ratio, mean age, the courses of disease there are no significant difference.Oral this product is organized in treatment, is grown up one time 5 (child below 15 years old, one time 3) 3 times on the one; Matched group becomes the human oral vitiligo capsule, 2 times on the one, one time 4.All strengthen nutrition for two groups during the medication, notice that spirit regulates, the product of diet delicious food, greasy, pungent and smelling of fish or mutton wind symptom.Infect severe patient and give antibiotic therapy.More than two groups of the 4th, 8,16,24,36 all observe the curative effect behind begin treatment respectively.
4. observation index: health giving quality index: before the treatment, treatment back target infringement area.Safety indexes: general physical examination; Routine blood test, routine urinalysis, just conventional; Electrocardioscopy, liver function, kidney function test; The untoward reaction that may occur.Safety evaluatio standard: 1 grade: safety, there is not any untoward reaction; 2 grades: compare safety,, need not do any processing, can continue administration if any untoward reaction; 3 grades: safety issue is arranged, moderate untoward reaction is arranged, can continue administration after processing; 4 grades: because of the violent termination test of untoward reaction.
5. efficacy determination:, draft target infringement curative effect determinate standard: therapeutic index=[(treatment front target infringement area-treatment back target infringement area)/treatment front target damages area] * 100% according to " vitiligo Clinical typing and criterion of therapeutical effect (revised draft in 2003) " that Chinese combination of Chinese and Western medicine dermatosis association pigment disease group is formulated; 1. recovery from illness: white macula all disappears, it is normal that the colour of skin is recovered, therapeutic index=100%, 2. produce effects: white macula partly disappears or dwindles, therapeutic index 〉=50%, 3. effective: white macula partly disappears or dwindles, therapeutic index 10%～50%, 4. invalid, white macula no change or dwindle, or white macula continues to increase therapeutic index＜10%.Cure rate: (recovery from illness case load/qualified case load) * 100%; Effective percentage: [(recovery from illness case load+produce effects case load)/qualified case load] * 100%.
6. therapeutic outcome: see the following form
Two groups of clinical efficacy contrasts (being matched group in the bracket) after the treatment of 4～36 weeks
| Time | Case load | Recovery from illness | Produce effects | Effectively | Invalid | Cure rate (%) | True efficient (%) |
| 24 all 36 weeks of 16 weeks in 8 weeks in 4 weeks | 128(128) 128(128) 128(128) 128(128) 128(128) | 0(0) 10(2) 22(8) 42(18) 78(26) | 2(0) 2202) 28(26) 34(42) 22(40) | 20(8) 38(20) 46(38) 30(34) 12(26) | 106(120) 58(94) 32(56) 22(34) 16(36) | 0(0) 8.0(1.6) 17.0(6.0) 33.0(14.0) 61.0(20.0) | 1.6(0) 25.0(11.0) 39.0(27.0) 59.0(47.0) 78.0(52.0) |
Efficacy analysis: statistical analysis shows at cure rate and the effective percentage of treatment during the 8th, 16,24,36 weeks significant difference (p＜0.05) is arranged all between two groups.
Safety analysis: abnormal change, do not take place in all patient's blood of treatment group and matched group, routine urinalysis and liver, renal function after the medication.In therapeutic process, the treatment group has 10 examples untoward reaction to occur, mainly shows as giddy, feels sick, diarrhoea etc.Matched group successively has 22 examples untoward reaction to occur, pruritus 10 examples wherein, and local drug eruption 12 examples, higher to treat in 1 week incidence rate.All can very fast alleviation after the above untoward reaction drug withdrawal, to compare for two groups, the untoward reaction of treatment group is few and slighter.In patient's observation process, 4 grades of adverse effectes do not take place all.
The present invention compared with prior art its superiority is: effective in cure reliable by pure Chinese medicine, be processed into easy method, and advantage such as side effect is little.
7. case summary
1: Zhang, woman, 49 years old.Have a medical check-up: skin lesion is creamy white, and general, skin lesion district hair bleaches, to photaesthesia, and xerosis cutis, the companion feels dizzy, soreness of the waist and knees, red tongue, tongue is few, thready and rapid pulse.The dermatologist is diagnosed as vitiligo, 5/time of administrations, 3 times/day.The back check of one week, skin lesion no longer increases, the clothes first quarter moon that continues, skin lesion begins to dwindle, and takes continuously 3 months again, and the skin lesion white macula all disappears, and recovers the normal colour of skin.Do not find untoward reaction during the medication.Follow up a case by regular visits to after half a year, not recurrence.
2: Liu, man, 23 years old.White macula because of about 2cm * 1.5cm of left facial part appearance comes hospital admission November 5 calendar year 2001, is diagnosed as vitiligo.Its oral this product of doctor's advice, one time 5,3 times on the one.Take medicine after February, white macula disappears and takes off, and skin pigment recovers fully.
3: Cui, the woman 38 years old, goes to see a doctor on March 21st, 2002.This patient before 1 year neck, hand circular white macula appears, clear border differs in size, no conscious sympton.Once sought medical advice in many ways, therapeutic effect is not obvious.Back white macula increases the weight of, the slight pruritus in conscious white macula place and secondary white macula place, near the eyes, forehead, shirtfront, waist occur white macula in succession, and constantly enlarge.With dizzy, tinnitus, wiry and frequent pulse, red tongue with yellow fur.Genus excessive rising of liver-YANG, liver-wind are attacked table, the fur space between skin and muscles does not have fluent machine, and mistake is supported and caused.Belong to " general hair style vitiligo ".Promptly give this product treatment, oral, one time 5,3 times on the one, take January.Subjective symptoms disappears after January.The bimester that continuation being treated with this product, this patient's recovery from illness.
4: Zhao, the man, 56 years old, on July 5th, 2003 went to a doctor.It is surplus February to tell the trouble vitiligo, and the ointment of external vitiligo is once smeared treatment, does not see to be clearly better, and is depressed on ordinary days.Have a medical check-up: bottom right jaw, skin of neck as seen be dispersed in 9 differ in size, depigmentation speckle in irregular shape, red tongue, yellow fur, stringy pulse.Card belongs to qi depression to blood stasis, qi-blood disharmony, and method is when depressed liver-energy dispersing and QI regulating, QI and blood regulating, and through this product treatment January, skin lesion transfers pale red to, and peripheral skin is seen obvious pigmentation, sees in the bigger skin lesion of area to be dispersed in the normal skin of point-like island.Continue and treat March with this product, when examining, 9 skin lesion all return to the normal colour of skin again.
5: Lee, man, 24 years old.Going to a doctor has the big white macula of a Semen Glycines before the discovery the first half volume, and it is big to be developed to two coin-dividings after January, the right side cervical region is also found a Semen Glycines Great White Spot simultaneously, examines to be vitiligo.All invalid through multi-treatment.Come to give this product treatment behind the hospital admission.After treating 2 months, the cervical region white macula disappears substantially, and the white macula pigment is existing calm before the volume, and color obviously deepens.
6: poplar, the woman, 11 years old, on May 27th, 2003 went to see a doctor.Found before January that facial lower right side is dispersed in two of white maculas, about 1.0cm * 1.0cm, neat in edge is random, smooth surface, the red tongue tongue is white, once smears the affected part treatment with ointment and does not have obviously change.Through the department of dermatologry diagnosis is vitiligo.The treatment that follows the doctor's advice, 3 of oral this product one time, 3 times on the one, take skin lesion place pigmentation after month, month white macula of clothes that continues disappears.
7: Wei, woman, 53 years old, because of right neck, left eye angle place white macula half a year, come institute to go to a doctor on August 11st, 2002, self-induction giddy, lower limb are weak, xerostomia, the heating of brothers' heart, through looking into red tongue, yellow fur, the about 1.0cm * 0.8cm of right neck white macula, the about 0.6cm of left eye angle white macula, boundary clear, edge were irregular, through this Drug therapy 40 days, place, left eye angle white macula disappears, right neck white macula obviously dwindles, about 0.3 centimetre of scope, the patient adheres to treatment, the back cures.
8: the side certain, the man, 14 years old, in first visit on March 13 in 2003.Facial, skin of neck was dispersed in white macula three months.Have a medical check-up: patient's lower jaw place skin has an about 2cm * 3cm white macula, and its neat in edge is random, smooth surface, no sufferings, pale tongue with white fur, stringy and thready pulse.Patient's first quarter moon of taking medicine, the pigment island appears in the white macula center, and brown appears in the edge.Continue medication one month, patient's subjective symptoms disappears, and most of white macula disappears, only the remaining 1cm of left side cervical region * 0.5cm white macula.Obeyed again 1 month, white macula all disappears.
9: Zheng, the woman, 62 years old, recently because of the illing skin pruritus unbearably, come hospital admission on April 26th, 2002.The patient tells that to suffer from existing 15 years of vitiligo surplus, and facial cervical region many places are dispersed in white macula.Oral this product two months, the skin pruritus symptom is eliminated, and the pigment island appears in the white macula center, the white macula sx.
Six, accompanying drawing: (no accompanying drawing)
Seven: embodiment:
Inventive embodiment: ten four Chinese medicine materials such as Herba Ecliptae, Rhizoma Chuanxiong, Semen Astragali Complanati, Fructus Psoraleae, Radix Polygoni Multiflori Preparata, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Radix Arnebiae (Radix Lithospermi), Radix Bupleuri, Rhizoma Atractylodis, Radix Sophorae Flavescentis, Rhizoma Paridis, Fructus Tribuli, the Radix Angelicae Dahuricae are selected, drink precrushing, take by weighing by following usage ratio: Herba Ecliptae 200g, Rhizoma Chuanxiong 90g, Semen Astragali Complanati 120g, Fructus Psoraleae 90g, Radix Polygoni Multiflori Preparata 120g, Radix Angelicae Sinensis 60g, Radix Salviae Miltiorrhizae 60g, Radix Arnebiae (Radix Lithospermi) 90g, Radix Bupleuri 60g, Rhizoma Atractylodis 48g, Radix Sophorae Flavescentis 60g, Rhizoma Paridis 60g, Fructus Tribuli 120g, Radix Angelicae Dahuricae 120g.Fructus Tribuli, Radix Polygoni Multiflori Preparata, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Atractylodis, the Radix Angelicae Dahuricae are ground into fine powder, sieving for standby; Radix Salviae Miltiorrhizae, Radix Arnebiae (Radix Lithospermi), Radix Sophorae Flavescentis, Fructus Psoraleae stir constantly with one week of 70% ethanol merceration, filter decompression recycling ethanol; Medicinal residues add the residue medical material, decoct with water twice, 2.0 hours for the first time, 1.5h hour for the second time, collecting decoction left standstill, filter, filtrate and alcohol extract merge, and continue to be concentrated into relative density and are about 1.20 (70 ℃), cooling adds above-mentioned fine powder, mixing, cold drying (70 ℃), pulverize, sieve, by every 0.5g 0# capsule of packing into.
Claims (1)
- The leukodermic medicament of a kind of treatment, this medicament can obtain with the following method: get 14 flavor Chinese herbal medicine such as Herba Ecliptae, Rhizoma Chuanxiong, Semen Astragali Complanati, Fructus Psoraleae, Radix Polygoni Multiflori Preparata, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Radix Arnebiae (Radix Lithospermi), Radix Bupleuri, Rhizoma Atractylodis, Radix Sophorae Flavescentis, Rhizoma Paridis, Fructus Tribuli, the Radix Angelicae Dahuricae, with Fructus Tribuli, Radix Polygoni Multiflori Preparata, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Atractylodis, Radix Angelicae Dahuricae oven dry, it is standby to be ground into fine powder; Radix Salviae Miltiorrhizae, Radix Arnebiae (Radix Lithospermi), Radix Sophorae Flavescentis, Fructus Psoraleae soak with the 50-95% medical ethanol or extract with pharmaceutical equipment, concentrate standby; Medicinal residues after the extraction add all the other medical materials, decoct with water 2-3 time, concentrate the back and add the medical ethanol concentrated solution, continue to be condensed into extractum, add medicated powder, mixing, and drying is pulverized, and sieves; Directly or add medical acceptable auxiliary and make powder, capsule, tablet, pill, it is characterized in that: the component of each raw material is Herba Ecliptae 10-20%, Rhizoma Chuanxiong 3-10%, Semen Astragali Complanati 5-15%, Fructus Psoraleae 4-15%, Radix Polygoni Multiflori Preparata 5-15%, Radix Angelicae Sinensis 3-10%, Radix Salviae Miltiorrhizae 3-10%, Radix Arnebiae (Radix Lithospermi) 3-10%, Radix Bupleuri 3-10%, Rhizoma Atractylodis 3-8%, Radix Sophorae Flavescentis 3-10%, Rhizoma Paridis 3-10%, Fructus Tribuli 5-15%, Radix Angelicae Dahuricae 5-15%.
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| CN100352479C true CN100352479C (en) | 2007-12-05 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101199589B (en) * | 2007-12-13 | 2011-09-21 | 孙瑞龙 | Tincture medicament for treating face vifiligo |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101049374B (en) * | 2007-04-25 | 2011-04-06 | 王家成 | Oral liquid for treating leucoderma, and preparation method |
| CN103536740A (en) * | 2013-09-24 | 2014-01-29 | 席公训 | Traditional Chinese medicine formula for treating vitiligo |
| CN103599195B (en) * | 2013-11-12 | 2015-02-04 | 于志红 | Traditional Chinese medicine composition for treating leucoderma |
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| CN1082907A (en) * | 1992-12-11 | 1994-03-02 | 张才 | Vifiligo pill |
| CN1124636A (en) * | 1994-12-16 | 1996-06-19 | 陈秋林 | Wulong Qubai powder |
| CN1200293A (en) * | 1997-05-22 | 1998-12-02 | 李英志 | Bolus (or pills) for treating leukodermia |
| CN1217201A (en) * | 1997-11-14 | 1999-05-26 | 黄国泉 | Oral medicine for treating leucoderma and preparation method therefor |
| CN1273847A (en) * | 1999-05-14 | 2000-11-22 | 王志明 | Chinese medicine for treating dermatopathy |
| CN1486716A (en) * | 2003-08-11 | 2004-04-07 | 合肥神鹿双鹤药业有限责任公司 | Chinese medicine for treating leukoderma and the prepn process of the tablets |
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2004
- 2004-12-29 CN CNB2004100823556A patent/CN100352479C/en not_active Expired - Fee Related
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| CN1082907A (en) * | 1992-12-11 | 1994-03-02 | 张才 | Vifiligo pill |
| CN1124636A (en) * | 1994-12-16 | 1996-06-19 | 陈秋林 | Wulong Qubai powder |
| CN1200293A (en) * | 1997-05-22 | 1998-12-02 | 李英志 | Bolus (or pills) for treating leukodermia |
| CN1217201A (en) * | 1997-11-14 | 1999-05-26 | 黄国泉 | Oral medicine for treating leucoderma and preparation method therefor |
| CN1273847A (en) * | 1999-05-14 | 2000-11-22 | 王志明 | Chinese medicine for treating dermatopathy |
| CN1486716A (en) * | 2003-08-11 | 2004-04-07 | 合肥神鹿双鹤药业有限责任公司 | Chinese medicine for treating leukoderma and the prepn process of the tablets |
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Cited By (1)
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| CN101199589B (en) * | 2007-12-13 | 2011-09-21 | 孙瑞龙 | Tincture medicament for treating face vifiligo |
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| CN1795911A (en) | 2006-07-05 |
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