CN102772547B - A kind of Chinese medicine composition for the treatment of lupus erythematosus - Google Patents
A kind of Chinese medicine composition for the treatment of lupus erythematosus Download PDFInfo
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Abstract
The invention discloses a kind of Chinese medicine composition for the treatment of lupus erythematosus, this Chinese medicine composition is made up of the water extract of five kinds of crude drug of following weight portion or water extracting alcohol hypostasis: Radix Rehmanniae 5-30 part, Caulis Lonicerae 5-30 part, Gypsum Fibrosum 5-30 part, Radix Sophorae Flavescentis 5-20 part, Radix Scutellariae 5-20 part.Adopt the method for water extraction or water extract-alcohol precipitation to obtain extract, prepare oral medicinal herb preparation.Chinese medicine composition of the present invention effectively can treat lupus erythematosus, for meeting medicinal demand and the market demand, significant.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, particularly relate to a kind of Chinese medicine composition for the treatment of lupus erythematosus.
Background technology
Systemic lupus erythematosus (sle) (systemic lupus erythematosus, SLE) be the struvite connective tissue disease of a kind of autoimmune chronic, pathological changes involves multisystem, multiple organ, has a strong impact on health, and be a lifelong participation disease, and need lifelong medication treatment.
The cause of disease of lupus erythematosus still imperfectly understands, and finds now relevant to its morbidity have: inherited genetic factors, infective agent, endocrine factors, environmental factors.
The number of the infected of the annual lupus erythematosus in the whole world is 4,000,000 people to 500 ten thousand people, and according to the EPDML preliminary survey of China, prevalence is 70 ~ 1,00/,100,000 people, about has about 1,000,000 patients at present, and is also rising year by year along with environmental pollution number of patients.
Because the SLE cause of disease, pathology disclose not yet completely, and its clinical manifestation is without fixed model, the course of disease is longer, recurrent exerbation, so be together called as again the large difficult and complicated illness in the world three with cancer, acquired immune deficiency syndrome (AIDS), no matter all has great hazardness to patient or to society, be mainly manifested in: medical history is long, serious symptom mortality rate is high, activeness is strong; pathological changes involves multiple organ, is mainly in women, patients ' psychological burden is heavy; be mainly in youth, social danger is very big.
In treatment, doctor trained in Western medicine mainly adopts nonsteroidal antiinflammatory drug, as indometacin, aspirin etc.; Glucocorticoid and immunosuppressant, as 17-hydroxy-11-dehydrocorticosterone, cyclophosphamide (CTX), azathioprine (AZP), and antimalarial chloroquine etc.The short term efficacy of this kind of medicine is relatively good, the life of many acute and critically ill patients can be saved, mortality rate is obviously reduced, but its toxic and side effects is obvious, as adopted non-steroidal drug very easily to cause patient's lesions of liver and kidney, immunosuppressant often causes the various toxic and side effects such as bone marrow depression, gonad atrophy, teratogenesis tire.And due to systemic lupus erythematosus (sle) be lifelong participation disease, to patient body infringement greatly, and after decrement or drug withdrawal, the state of an illness of many patients there will be bounces life-time service chemicals repeatedly, increases the weight of the state of an illness.
Chinese traditional treatment SLE is the method for many employings clinically at present, particularly for patients with mild and the patient needing long-term taking.The traditional Chinese medical science is many to patient's visceral organ injury according to SLE, the numerous and diverse problem such as changeable of symptom, from globality treatment, catches the essence of this disease, by the environment of integrated regulation human body, reaches the object of curing primary disease, reducing recurrence.Simultaneously in conjunction with the situation of different patient, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, achieves good therapeutic effect.Because Chinese patent medicine toxic and side effects is little, cheap, be applicable to long-term taking, Chinese patent medicine used becomes the important selection for the treatment of SLE day by day.
But by inquiry, having the Chinese patent medicine of state approval code very few in the market, is main mainly with auxiliary therapy, and it is large to there is prescription, expensive, there is animal drugs or toxicity medical material, unsuitable long-term taking.Therefore, to chronic systemic lupus erythematosus patient, there is good effect in the urgent need to one clinically, toxicity is little, can hormones be removed, the Chinese patent medicine that can take all the life.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of Chinese medicine composition for the treatment of lupus erythematosus.
For solving the problems of the technologies described above, the invention provides a kind of Chinese medicine composition for the treatment of lupus erythematosus, described Chinese medicine composition is made up of the water extract of five kinds of crude drug of following weight portion or water extracting alcohol hypostasis: Radix Rehmanniae 5-30 part, Caulis Lonicerae 5-30 part, Gypsum Fibrosum 5-30 part, Radix Sophorae Flavescentis 5-20 part, Radix Scutellariae 5-20 part.
Crude drug is preferably: 20 parts, the Radix Rehmanniae, Caulis Lonicerae 20 parts, Gypsum Fibrosum 20 parts, Radix Sophorae Flavescentis 20 parts, Radix Scutellariae 20 parts.
The present invention selects Radix Rehmanniae 5-30 part, Caulis Lonicerae 5-30 part, Gypsum Fibrosum 5-30 part, Radix Sophorae Flavescentis 5-20 part, Radix Scutellariae 5-20 part to combine, and makes each efficacy of drugs produce synergism the combination of these medical materials, thus effectively can treat lupus erythematosus.Each medical material all records in " Chinese Pharmacopoeia ".Wherein, the Radix Rehmanniae is the fresh or dried root of scrophulariaceae rehmannia glutinosa plant Rehmannia glutinosa Libosch..Radix Rehmanniae is slowly cured to about 1 thousand.Main component is catalpol, and Radix Rehmanniae is sweet, cold.GUIXIN, liver, kidney channel, Radix Rehmanniae clearing away heat and cooling blood, the raw Feng of yin nourishing.Enter nutrient blood for heat, maculae caused by violent heat pathogen, hematemesis and epistaxis, consumption of YIN caused by febrile disease, crimson tongue excessive thirst, Feng hinders constipation, fever due to yin deficiency, and hectic fever due to YIN-deficiency consumptive fever, interior-heat is quenched one's thirst.Caulis Lonicerae is the dry stem branch of caprifoliaceae plant Radix Ophiopogonis Lonicerajaponica Thunb., and main component is chlorogenic acid, loganin, and this product can heat-clearing and toxic substances removing, dispelling wind dredging collateral.For epidemic febrile disease heating, toxic-heat and blood stasis, carbuncle skin infection, beriberoid pyretic arthralgia, redness and swelling of joints burning pain.Gypsum Fibrosum this product is Sulfates mineral anhydrite race Gypsum Fibrosum, main containing hydrous calcium sulfate (CaSO
42H
2o), after excavating, removing silt and assorted stone, clearing away heat-fire, relieving restlessness is quenched the thirst.For fever caused by exogenous pathogenic factors, high hot excessive thirst, dyspnea and cough due to lung-heat, the high Sheng of stomach-fire, headache, toothache.Radix Sophorae Flavescentis is leguminous plant Radix Sophorae Flavescentis Sophora, the dry root of flavescens Ait..Spring, Qiu Erji excavate, removing root head and little supporting root, cleaning, drying, or take advantage of fresh slices, and dry, main component is matrine (C
15h
24n
2and oxymatrine (C O)
15h
24n
2o), heat clearing and damp drying, worm, diuresis.For hematodiarrhoea, have blood in stool, jaundice urine retention, leucorrhea with red and white discharge, swelling of the vulva pudendal pruritus, eczema, eczema, skin pruritus, scabies leprosy. external treatment trichomonal vaginitis.Radix Scutellariae is the dry root of labiate Radix Scutellariae Scutellaria baicalensisGeorgi.Spring, Qiu Erji excavate, removing fibrous root and silt, and hit rough bark after solarization, dry, main component is baicalin, heat clearing and damp drying, eliminating fire and detoxication, and hemostasis is antiabortive.For hygropyrexia, fever disease in summer, vomiting and nausea uncomfortable in chest, damp and hot feeling of fullness, dysentery, jaundice, cough due to lung-heat, high hot excessive thirst, heat in blood tells nosebleed, carbuncle sore tumefacting virus, frequent fetal movement.
Chinese medicine composition of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any one oral preparations.Such as in the crude drug of a certain amount of, definite composition, can add a certain amount of water, heating and refluxing extraction 2 times respectively, the time is respectively 2h, 1h, filters, combining extraction liquid, concentrated, obtains intermediate.Pharmaceutical carrier or dressing can be added in described intermediate, make the oral medicinal herb preparation of different dosage form.Preferably, described oral medicinal herb preparation is granule, tablet, capsule or oral liquid.
The consumption of Chinese medicine composition of the present invention and the course for the treatment of can appropriately adjust according to the light and heavy degree of the age of dosage form, patient, disease, but be generally oral 3 times of every day, each 4 ~ 6 (grains), every sheet (grain) 0.5 gram, or each 1 bag (8g/ bag), be a course for the treatment of with 3 months, 2 courses for the treatment of or longer time can be used continuously.
The present invention has following beneficial effect: find through pharmacodynamic study, Chinese medicine composition of the present invention (Radix Rehmanniae 5-30 part, Caulis Lonicerae 5-30 part, Gypsum Fibrosum 5-30 part, Radix Sophorae Flavescentis 5-20 part, Radix Scutellariae 5-20 part) each time point after rat Arthus reaction model is formed all can suppress rat Arthus to react, the determined curative effect of traditional Chinese medicine composition for treating lupus erythematosus of the present invention, effect is unique, economize on resources, environmental, with low cost, promote harmonious prolonged application, safe and reliable.Therefore, the medicine of research and development treatment lupus erythematosus, has good social benefit and optimistic market prospect, for meeting medicinal demand and the market demand, significant.
Accompanying drawing explanation
Fig. 1 is that in test example 1, each group rat antigen attacks the red and swollen diameter time plot of rear different time skin of back.
Detailed description of the invention
The invention will be further elaborated by the following examples:
Embodiment 1
Weighting raw materials: Radix Rehmanniae 15g, Caulis Lonicerae 15g, Gypsum Fibrosum 15g, Radix Sophorae Flavescentis 15g, Radix Scutellariae 15g
By medicinal for above-mentioned raw materials water boiling and extraction 2 times, first time extracts 15 times that amount of water is dose, and extraction time is 3 hours; Second time extracts 10 times that amount of water is dose, and extraction time is 3 hours; Add ethanol precipitate with ethanol, regulate alcoholic degree to be 30%, filter, concentrated alcohol deposit fluid; Adopt vacuum drying to carry out drying, vacuum drying temperature controls at 50 DEG C; After dry, drug extract moisture Control is below 5%; Appropriate amount of auxiliary materials micropowder silica gel is added, dextrin, starch in drug extract; By above mixing of materials, adopt wet granulation, drying, after granulate, granule is made in fill, is packaged into bag, often packed 8 grams.
By medicinal for above-mentioned raw materials water boiling and extraction 2 times, it is dose 10 times that first time extracts amount of water, and extraction time is 2 hours; Second time amount of water is dose 7 times, and extraction time is 2 hours; Filter, merging filtrate, concentrated; Adopt vacuum drying to carry out drying, vacuum drying temperature controls at 70 DEG C; After dry, drug extract moisture Control is below 5%; Appropriate amount of auxiliary materials micropowder silica gel is added, starch, microcrystalline Cellulose in drug extract; By above mixing of materials, adopt wet granulation, drying, tabletting after granulate, makes tablet, every sheet 0.5 gram.
Embodiment 2
Weighting raw materials: Radix Rehmanniae 15g, Caulis Lonicerae 15g, Gypsum Fibrosum 15g, Radix Sophorae Flavescentis 2.5g, Radix Scutellariae 2.5g
By medicinal for above-mentioned raw materials water boiling and extraction 2 times, first time extracts 6 times that amount of water is dose, and extraction time is 0.5 hour; Second time extracts 4 times that amount of water is dose, and extraction time is 0.5 hour; Filter, merging filtrate, concentrated; Adopt spraying dry to carry out drying, spraying dry be by concentration of liquid medicine to 1.1g/ml (60 DEG C heat survey) time, inlet temperature controls at 150 DEG C, and leaving air temp controls at 80 DEG C; After dry, drug extract moisture Control is below 5%; Appropriate amount of auxiliary materials micropowder silica gel is added, dextrin in drug extract; By above mixing of materials, adopt wet granulation, drying, fill capsule after granulate, 0.5 gram every.
Embodiment 3
Weighting raw materials: Radix Rehmanniae 5g, Caulis Lonicerae 15g, Gypsum Fibrosum 15g, Radix Sophorae Flavescentis 10g, Radix Scutellariae 5g
By medicinal for above-mentioned raw materials water boiling and extraction 2 times, it is dose 10 times that first time extracts amount of water, and extraction time is 2 hours; Second time amount of water is dose 7 times, and extraction time is 2 hours; Filter, merging filtrate, concentrated; Adopt vacuum drying to carry out drying, vacuum drying temperature controls at 70 DEG C; After dry, drug extract moisture Control is below 5%; Appropriate amount of auxiliary materials micropowder silica gel is added, starch, microcrystalline Cellulose in drug extract; By above mixing of materials, adopt wet granulation, drying, tabletting after granulate, makes tablet, every sheet 0.5 gram.
Embodiment 4
Weighting raw materials: Radix Rehmanniae 5g, Caulis Lonicerae 10g, Gypsum Fibrosum 10g, Radix Sophorae Flavescentis 12.5g, Radix Scutellariae 12.5g
By medicinal for above-mentioned raw materials water boiling and extraction 2 times, it is dose 10 times that first time extracts amount of water, and extraction time is 2 hours; Second time amount of water is dose 7 times, and extraction time is 2 hours; Filter, merging filtrate, concentrated; Adopt spraying dry to carry out drying, spraying dry be by concentration of liquid medicine to 1.05g/ml (60 DEG C heat survey) time, inlet temperature controls at 100 DEG C, and leaving air temp controls at 70 DEG C; After dry, drug extract moisture Control is below 5%; Appropriate amount of auxiliary materials dextrin is added, starch in drug extract; By above mixing of materials, adopt wet granulation, drying, fill capsule after granulate, 0.5 gram every.
Embodiment 5
Weighting raw materials: Radix Rehmanniae 15g, Caulis Lonicerae 5g, Gypsum Fibrosum 15g, Radix Sophorae Flavescentis 7.5g, Radix Scutellariae 7.5g
By medicinal for above-mentioned raw materials water boiling and extraction 2 times, first time extracts 6 times that amount of water is dose, and extraction time is 0.5 hour; Second time extracts 4 times that amount of water is dose, and extraction time is 0.5 hour; Filter, merging filtrate, concentrated; Adopt spraying dry to carry out drying, spraying dry be by concentration of liquid medicine to 1.2g/ml (60 DEG C heat survey) time, inlet temperature controls at 200 DEG C, and leaving air temp controls at 100 DEG C; After dry, drug extract moisture Control is below 5%; Appropriate amount of auxiliary materials dextrin is added, starch, microcrystalline Cellulose in drug extract; By above mixing of materials, adopt wet granulation, drying, after granulate, granule is made in fill, is packaged into bag, often packed 8 grams.
Embodiment 6
Weighting raw materials: Radix Rehmanniae 15g, Caulis Lonicerae 15g, Gypsum Fibrosum 5g, Radix Sophorae Flavescentis 10g, Radix Scutellariae 5g
By medicinal for above-mentioned raw materials water boiling and extraction 2 times, first time extracts 15 times that amount of water is dose, and extraction time is 3 hours; Second time extracts 10 times that amount of water is dose, and extraction time is 3 hours; Add ethanol precipitate with ethanol, regulate alcoholic degree to be 90%, filter, concentrated alcohol deposit fluid; Adopt vacuum drying to carry out drying, vacuum drying temperature controls at 80 DEG C; After dry, drug extract moisture Control is below 5%; Appropriate amount of auxiliary materials micropowder silica gel is added, dextrin, microcrystalline Cellulose in drug extract; By above mixing of materials, adopt wet granulation, drying, after granulate, granule is made in fill, is packaged into bag, often packed 8 grams.
Below by way of test example, beneficial effect of the present invention is further elaborated:
In following test example, " BBYH " represents the Chinese medicine composition of the present invention prepared by embodiment 1.
Test example 1
One, materials and methods
1, experiment material
1.1 experiment reagent
Freund's complete adjuvant (Sigma, F5881-6X10L, 050M8701)
Incomplete Freund's adjuvant (Sigma, F5506-6X10ML, 098K8724)
Ovalbumin (Sigma, A5503-1G, 118K7002)
1.2 experimental article
Slide gauge
1.3 laboratory animal
Rat, Wistar system, female, 160g, often organizes 10.
1.4 sample
091102), sample A (embodiment 1 prepare Chinese medicine composition BBYH of the present invention) positive drug Tripterygium wilfordii Polyglycosidium Tablets (ShangHai Fudan Fuhua Pharmaceutical Co., Ltd, lot number:.
2, experimental technique
2.1 preparation of reagents
The preparation of sensitizing agent: every rat 0.3mg OVA powder is dissolved in 0.25ml normal saline, then mix to complete emulsifying with the adjuvant of equivalent 0.25ml, matching while using.
1% egg albumin solution: the ratio being dissolved in 100ml normal saline according to 1g ovalbumin, prepares on demand.
2.2 experimentation
Every Mus is intramuscular injection 0.5ml sensitizing agent sensitization weekly, totally 6 times, is 3 times the Emulsion prepared by equivalent Freund's complete adjuvant and ovalbumin albumen, and rear is for 3 times ovalbumin-Freund's incomplete adjuvant.Last sensitization same day, SD rat is divided into 4 groups at random by body weight, often organizes 10, is divided into Normal group, model control group, sample A experimental group and positive drug control group.Model group and normal (contrast) group gavage give distilled water (1ml/100g), and each sample experimental group gives corresponding dosage by test product, every day 1 time, successive administration 10d.At 9d, back cropping.10d, 70% ethanol position to be injected, rat back intradermal injection 1% ovalbumin (antigen attack), often some injection volume 0.2ml.After antigen is attacked 2,3,4,6,8,24h observes the diameter of often some red swelling of the skin and the degree of reaction, and compares.
Two, experimental result
As shown in table 1 and Fig. 1, after antigen attacks 2h, except normal rats, all the other are congested, the obvious red and swollen and erythema of group rat dorsum skin appearance respectively, model group is compared with normal group, the red and swollen diameter of each time point skin of back all has pole significant difference (P < 0.01), shows that rat Arthus reaction model is formed.
Compared to model group, the red and swollen diameter in back of positive drug Tripterygium wilfordii Polyglycosidium Tablets group, sample A experimental group all has minimizing in various degree, Tripterygium wilfordii Polyglycosidium Tablets group shows significant difference (P < 0.05) at 3h, 6h and 24h, shows pole significant difference (P < 0.01) at 4h and 8h; Sample A group shows significant difference (P < 0.05) at 6h and 24h, all shows pole significant difference (P < 0.01) at 2h, 3h, 4h and 8h.
Comparatively speaking, sample A each time point after rat Arthus reaction model is formed all can suppress rat Arthus to react to three screening of medicaments, and Tripterygium wilfordii Polyglycosidium Tablets group wherein several time point demonstrate difference and all do not demonstrate difference at each time point.Visible, sample A and Chinese medicine composition of the present invention each time point after rat Arthus reaction model is formed all can suppress rat Arthus to react, and effectively can treat lupus erythematosus, and its therapeutic effect is compared existing positive drug Tripterygium wilfordii Polyglycosidium Tablets and wanted better.
Table 1: each group rat antigen is attacked the red and swollen diameter of rear different time skin of back and compared
Compare with model group,
*p < 0.05,
*p < 0.01; Compare with normal group,
△ △p < 0.01
Test example 2
Clinical observation research is carried out to the patient meeting lupus erythematosus; Wherein male 56 example, women 44 example, age 47-65 year; Medicine: Radix Rehmanniae 30g, Caulis Lonicerae 30g, Gypsum Fibrosum 30g, Radix Sophorae Flavescentis 30g, Radix Scutellariae 30g (being obtained by embodiment 1); Dosage and instructions of taking: oral, a daily dose 150g, short-term: observe 3 months, long-term: observation time was to 1 year (patient that compliance is good).
Use the present invention to treat light, middle disease and refuse to obey that the SLE patient 100 of hormone is routine, with the same period corticosteroid therapy 100 examples as a control group, the clinical manifestation of patient obtains remarkable improvement, at elimination erythema, arthritis, oral ulcer, erythra, low grade fever, urine protein, improve hemogram, oromeningitis, minimizing hormone dosage, and improve the aspects such as hormone complication and be obviously better than matched group (P < 0.05).Resuming work and in marriage fertility, be also obviously better than matched group (P < 0.05).
Claims (3)
1. treat a Chinese medicine composition for lupus erythematosus, it is characterized in that, described crude drug is 20 parts, the Radix Rehmanniae, Caulis Lonicerae 20 parts, Gypsum Fibrosum 20 parts, Radix Sophorae Flavescentis 20 parts, Radix Scutellariae 20 parts.
2. the Chinese medicine composition for the treatment of lupus erythematosus according to claim 1, is characterized in that, described Chinese medicine composition makes oral medicinal herb preparation.
3. the Chinese medicine composition for the treatment of lupus erythematosus according to claim 2, is characterized in that, described oral medicinal herb preparation is granule, tablet, capsule or oral liquid.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1348787A (en) * | 2001-08-09 | 2002-05-15 | 沈丕安 | Chinese medicine prepn for treating lupus erythematosus |
| CN102772548A (en) * | 2011-05-13 | 2012-11-14 | 上海中药制药技术有限公司 | Preparation method of Chinese medicinal composition treating lupus erythematosus |
-
2011
- 2011-05-12 CN CN201110122977.7A patent/CN102772547B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1348787A (en) * | 2001-08-09 | 2002-05-15 | 沈丕安 | Chinese medicine prepn for treating lupus erythematosus |
| CN102772548A (en) * | 2011-05-13 | 2012-11-14 | 上海中药制药技术有限公司 | Preparation method of Chinese medicinal composition treating lupus erythematosus |
Non-Patent Citations (2)
| Title |
|---|
| 楼绍来，等.心怀慈悯意，矢志射天狼.《沪上中医名家名科》.上海中医药大学出版社,2006,83-85. * |
| 洪强;沈丕安;苏晓.红斑汤治疗活动期系统性红斑狼疮32例疗效观察.《新中医》.2002,21-22. * |
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