CN101530438A - Medicine for treating thrombocytopenic purpura and preparation method thereof - Google Patents
Medicine for treating thrombocytopenic purpura and preparation method thereof Download PDFInfo
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- CN101530438A CN101530438A CN200910038720A CN200910038720A CN101530438A CN 101530438 A CN101530438 A CN 101530438A CN 200910038720 A CN200910038720 A CN 200910038720A CN 200910038720 A CN200910038720 A CN 200910038720A CN 101530438 A CN101530438 A CN 101530438A
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Abstract
The invention relates to a medicine for treating thrombocytopenic purpura and a preparation method thereof, belonging to the field of traditional Chinese medicines. The medicine comprises 30-90 weight parts of dry extract powder of selaginella moellendorfii and 10-70 weight parts of pharmaceutical adjuvant and is prepared into tablets, capsules, granules and pills by various methods. The preparation process is simple, the cost is low and the prepared preparations have excellent performance and stable quality and are convenient for the patients to take. Clinical trials show that the medicine can achieve better clinical results and has no obvious side effects when being applied to treating thrombocytopenic purpura and other hemorrhagic diseases.
Description
Technical field
The present invention relates to a kind of medicine for the treatment of thrombocytopenic purpura, specifically be meant with the Herba Selaginellae Involventis medical material to be the preparation prescription of feedstock production, the invention still further relates to the preparation method of this medicine.
Background technology
Thrombocytopenic purpura is a kind of common hemorrhage, accounts for 70% of hemorrhage, and the trend that increases is year by year arranged.First attack is many below 30 years old, and is hemorrhage serious during morbidity, causes mucocutaneous widely blood point or ecchymosis in blocks even ecchymosis, prolonged and repeated hemorrhage and cause anemia and symptoms such as low grade fever, weak, dizziness occur.
The reason that causes thrombocytopenic purpura is owing to exist platelet-associated antibody to make platelet destroy increase in macrophage in patient's microcirculqtory system the peripheral blood platelet to be descended, thereby causes a series of bleeding.This is sick to divide acute and chronic two kinds, and acute has certain self limiting, and the course of disease is many in 1 year, if malpractice as easy as rolling off a logly transfers to chronicly, it is high that the adult transfers chronic ratio to, reaches more than 90%, in case transfer to chronicly, treatment is quite difficult.
Both at home and abroad to the primary disease treatment, mainly adopt glucocorticoid, immunosuppressant etc. to treat, but have many problems at present:
1. need prolonged and repeated administration, side effect is quite big, causes digestive system and cardiovascular complications, even brings out and increase the weight of and infect.
2. the prednisone class medicine that is used for the treatment of thrombocytopenic purpura clinically easily causes side effect such as class hypercortisolism, virilization, hypertension, weakening human body resistance; Immunosuppressant cyclophosphamide class medicine can suppress the hemopoietic function of bone marrow; Danazol (Danazol) class medicine has the hurtful side effect of pair liver function.
3. curative effect is bad, has 25% conditions of patients to can not get control.
Though the relevant Chinese patent medicine of some treatments is also arranged, because effect is not fairly obvious, patient's Western medicine of still having to depend on.
Summary of the invention
The purpose of this invention is to provide a kind of medicine for the treatment of thrombocytopenic purpura and other hemorrhages, reduce, alleviate hemorrhage..
Another object of the present invention provides the preparation method of this treatment thrombocytopenic purpura medicine.
Herba Selaginellae is a pteridophyta, and physiological action and pharmacological action are widely arranged.Be used for promoting blood circulation to restore menstrual flow, amenorrhea dysmenorrhea, traumatic injury.Herba Selaginellae Involventis is a Spikemoss plant, contains amentoflavone, isopimpinellin, adenosine, cupreol, aldehydes and aldehydes matter, and the south of the River one is with the haemostatic medicament that is commonly used to as treatment hepatitis, various hemorrhage and traumatic hemorrhage among the people.It mainly is water soluble ingredient that the styptic activity composition that studies show that Herba Selaginellae Involventis is arranged.The main constituent of the Herba Selaginellae Involventis preparation that we invent is that Herba Selaginellae Involventis water is carried dried cream powder.
The present invention is achieved in that the medicine of treatment thrombocytopenic purpura, form by Herba Selaginellae Involventis dried cream powder and pharmaceutic adjuvant, wherein pharmaceutic adjuvant is selected from one or more in diluent, disintegrating agent, binding agent, the lubricant, the Herba Selaginellae Involventis dried cream powder is the 30-90 weight portion, and pharmaceutic adjuvant is the 10-70 weight portion;
Medicament contg component preferable range of the present invention is made by following component by weight:
Herba Selaginellae Involventis dried cream powder 50-85
Diluent 2-30
Disintegrating agent 5-15
Binding agent 4-22
Lubricant 0.5-2
Adjuvant of the present invention, diluent are one or more in mannitol, Icing Sugar, lactose, starch, aluminium hydroxide, the dextrin, and main uses is in order to improve the inert substance that dilutes that the preparation performance is added; Disintegrating agent selects that carboxymethylstarch is received for use, in cross-linked carboxymethyl cellulose sodium, carboxylic third cellulose, starch, microcrystalline Cellulose, polyvinylpolypyrrolidone one or more, and tablet is split rapidly in the intestines and stomach liquid be broken into short grained material, thus convenient the absorption; Binding agent is selected sucrose, arabic gum, pregelatinized Starch, soluble starch, dextrin, polyvidone, carmethose, methylcellulose, hypromellose for use, is used for host and adjuvant are bonded together.Lubricant is selected from one or more in Pulvis Talci, magnesium stearate, Stepanol MG, sodium lauryl sulphate or the micropowder silica gel.
The prescription of preparation medicine of the present invention more preferably weight (part) ratio range is:
Herba Selaginellae Involventis dried cream powder 50-85 weight portion, aluminium hydroxide 2-8 weight portion, hyprolose 2-8 weight portion, starch 4-40 weight portion, carboxymethyl starch sodium 2-10 weight portion, magnesium stearate 0.5-2 weight portion.
The method for preparing treatment thrombocytopenic purpura medicine of the present invention is by following steps:
(a) impurity is cleaned and removed to the Herba Selaginellae Involventis medical material;
(b) add 10-30 decocting doubly and boil 2-3 time, each 1-3 hour, collecting decoction, filtration also is concentrated into filtrate the cream of relative density 1.05-1.3;
(c) drying under reduced pressure is pulverized and is made the Herba Selaginellae Involventis dried cream powder;
(d) in the Herba Selaginellae Involventis dried cream powder, add adjuvant, mixing;
(e) prepare the Herba Selaginellae Involventis medicine by the pharmaceutical preparation conventional method.
Herba Selaginellae Involventis pharmaceutical preparation of the present invention is simple, preparation is functional, steady quality.Clinical use result shows that it has the following advantages:
1. the present invention selects for use natural plant as raw material, and each component meets the pharmaceutical control law regulation, utilizes various active constituents of medicine comprehensive function treatment thrombocytopenic purpura, poisons less to human body.
2. all can promote platelet aggregation in vivo and in vitro, have the characteristics of conventional haemostatic medicament, can significantly improve the platelet count of animal, promote hematoblastic aggregation capability, reduce hematoblastic destruction, and can suppress the humoral immunization of animal under the hypersensitive state.The above-mentioned effect of Herba Selaginellae Involventis medicine and etamsylate, cyclophosphamide are suitable, and do not have the side effect of said medicine, can replace bigger Western medicine of side effect and expensive imported medicine.
3. light disease person can use separately, serious symptom person can be used with other haemostatic medicaments, can significantly reduce drug use amount and frequency, and can alleviate or eliminate other complication significantly, other the hemorrhage outside the idiopathic thrombocytopenic purpura is also had therapeutical effect preferably.
Be the specific embodiment of the present invention below, but the present invention is not limited to this.
Embodiment 1
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is host 50 by weight, adjuvant 53, host is Herba Selaginellae Involventis dried cream powder 50, in the adjuvant starch be 25, aluminium hydroxide 8, hypromellose 8, carboxymethylstach sodium 10, magnesium stearate 2.
The preparation method of preparation tablet class medicine is as follows:
(a) get Herba Selaginellae Involventis medical material 3900g, remove impurity after it is cleaned, through being up to the standards;
(b) decocting that adds 10 times boiled 3 hours, the elimination decocting liquid, and filtrate is concentrated into the clear paste of relative density 1.05;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 190g;
(d) add adjuvant aluminium hydroxide 30.6g, hyprolose 30.4g, starch 95g, carboxymethylstach sodium 38g mixing at the Herba Selaginellae Involventis dried cream powder, the ethanol that stirs back adding 40% is as wetting agent;
(e) cross screen cloth, granulate, and dry down at 90 ℃;
(f) granulate adds the 7.6g magnesium stearate, deposits behind tabletting, the coating behind the mix homogeneously.
Embodiment 2
The Herba Selaginellae Involventis preparation, be made of host and adjuvant, its each component is host 85 by weight, adjuvant 15, host is Herba Selaginellae Involventis dried cream powder 85, and adjuvant arabic gum 4, starch 4, aluminium hydroxide are 2, carboxymethylstach sodium 2, carboxylic third methylcellulose 2.5, Pulvis Talci 0.5.
The preparation method of preparation tablet class medicine is as follows:
(a) get Herba Selaginellae Involventis medical material 6700g, remove impurity after it is cleaned, be up to the standards;
(b) decocting that adds 20 times boiled 2 hours, the elimination decocting liquid, and filtrate is concentrated into the clear paste of relative density 1.25;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 320g;
(d) add adjuvant arabic gum 15.2g, aluminium hydroxide 7.53g, the carboxylic third methylcellulose 9.4g, carboxymethylstach sodium 7.53g at the Herba Selaginellae Involventis dried cream powder, mixing and stirring back add 70% ethanol as wetting agent;
(e) cross screen cloth, granulate, and dry down at 70 ℃;
(f) after the screen cloth granulate, add 1.9g Pulvis Talci, 15.2g starch, deposit behind tabletting, the coating behind the mix homogeneously.
Embodiment 3
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is host 68 by weight, adjuvant 33.5, and host is Herba Selaginellae Involventis dried cream powder 68, adjuvant mannitol 10, starch 10, hyprolose 8, hypromellose 5, magnesium stearate 0.5.
The preparation method of preparation tablet class medicine is as follows:
(a) get Herba Selaginellae Involventis medical material 4300g, remove impurity after it is cleaned, be cut into segment through after the assay was approved;
(b) decocting that adds 30 times boiled 1 hour, the elimination decocting liquid, and filtering residue is handled 1 time by aforementioned condition again, merging filtrate, and filtrate is concentrated into the clear paste of relative density 1.28;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 217.6g;
(d) add adjuvant mannitol 32.3g, starch 26.8g, hyprolose 25.6g at the Herba Selaginellae Involventis dried cream powder, the carboxylic third methylcellulose 16.4g, mixing and stirring back add 50% ethanol as wetting agent;
(e) cross screen cloth, granulate, and dry down at 60 ℃;
(f) after the screen cloth granulate, add 1.6g magnesium stearate, 6g starch, deposit behind tabletting, the coating behind the mix homogeneously.
Embodiment 4
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is host 65 by weight, adjuvant 35, and host is Herba Selaginellae Involventis dried cream powder 65, supplementary product starch 22, aluminium hydroxide are 3.8, carboxymethylstach sodium 5.0, hyprolose 3.0, magnesium stearate 1.2.
The preparation method of preparation tablet class medicine is as follows:
(a) get Herba Selaginellae Involventis medical material 5000g, remove impurity, through pulverizing after the assay was approved;
(b) add 30 times decocting in water 2 times, each 1 hour, collecting decoction filtered and filtrate is concentrated into the cream of relative density 1.15;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 246g;
(d) add at the Herba Selaginellae Involventis dried cream powder that supplementary product starch 62g, aluminium hydroxide are 14.4, carboxymethylstach sodium 19, hyprolose 11.2, mix also and stir;
(e) cross screen cloth, pharmacy, and dry down at 60 ℃;
(f) after screen cloth, add 4.5g magnesium stearate, starch 21g, deposit behind tabletting, the coating behind the mix homogeneously.
Embodiment 5
The Herba Selaginellae Involventis preparation, be made of host and adjuvant, its each component is host 80 by weight, adjuvant 20, host is Herba Selaginellae Involventis dried cream powder 80, and microcrystalline cellulose excipients 4, starch 4, aluminium hydroxide are 3.5, carboxymethylstach sodium 4.5, hyprolose 2, Stepanol MG 2.
The preparation method of preparation tablet class medicine is as follows:
(g) get Herba Selaginellae Involventis medical material 5000g, remove impurity, through pulverizing after the assay was approved;
(h) add 30 times decocting in water 2 times, each 1 hour, collecting decoction filtered and filtrate is concentrated into the cream of relative density 1.15;
(i) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 258g;
(j) add microcrystalline cellulose excipients 12.9g, 12.9g starch, aluminium hydroxide 11.3g, hyprolose 6.45g at the Herba Selaginellae Involventis dried cream powder, mix and stirring;
(k) cross screen cloth, pharmacy, and dry down at 60 ℃;
(l) after screen cloth, add 6.45g Stepanol MG, carboxymethylstach sodium 14.5g, deposit behind tabletting, the coating behind the mix homogeneously.
Embodiment 6
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is as follows by weight, and host is Herba Selaginellae Involventis dried cream powder 90, and adjuvant is a dextrin 10, pregelatinized Starch 5.
The preparation method of preparation capsule class medicine is as follows:
(a) get Herba Selaginellae Involventis medical material 6000g, remove impurity after it is cleaned, through pulverizing after the assay was approved;
(b) decocting that adds 30 times boiled 1 hour, the elimination decocting liquid, and filtering residue is handled 2 times by aforementioned condition again, and filtrate is concentrated into the clear paste of relative density 1.30;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 323g;
(d) add dextrin 36g at the Herba Selaginellae Involventis dried cream powder, pregelatinized Starch 18g, mixing and stirring back add 40% ethanol as wetting agent;
(e) granulate, fill, deposit after making capsule.
Embodiment 7
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is as follows by weight, and host is Herba Selaginellae Involventis dried cream powder 80, and adjuvant is an Icing Sugar 15, pregelatinized Starch 5.
The preparation method of preparation capsule class medicine is as follows:
(a) get Herba Selaginellae Involventis medical material 6700g, remove impurity after it is cleaned, through being up to the standards;
(b) decocting that adds 20 times boiled 2 hours, the elimination decocting liquid, and filtrate is concentrated into the clear paste of relative density 1.25;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 323g;
(d) add adjuvant Icing Sugar 61g at the Herba Selaginellae Involventis dried cream powder, pregelatinized Starch 20.2g, mixing and stirring back add 60% ethanol as wetting agent;
(e) granulate, fill, deposit after making capsule.
Embodiment 8
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is as follows by weight, and host is Herba Selaginellae Involventis dried cream powder 60, and adjuvant is a starch 40.
The preparation method of preparation capsule class medicine is as follows:
(a) get Herba Selaginellae Involventis medical material 4300g, remove impurity after it is cleaned, be cut into segment through after the assay was approved;
(b) decocting that adds 30 times boiled 1 hour, the elimination decocting liquid, and filtering residue is handled 1 time by aforementioned condition again, merging filtrate, and filtrate is concentrated into the clear paste of relative density 1.28;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 223.6g;
(d) add supplementary product starch 149.0g at the Herba Selaginellae Involventis dried cream powder, mixing and stirring back add 50% ethanol as wetting agent;
(e) granulate, fill, deposit after making capsule.
Embodiment 9
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is as follows by weight, and host is Herba Selaginellae Involventis dried cream powder 60, and adjuvant is a dextrin 38, micropowder silica gel 2.
The preparation method of preparation capsule class medicine is as follows:
(m) get Herba Selaginellae Involventis medical material 3900g, remove impurity, be cut into segment through after the assay was approved;
(n) decocting that adds 15 times boils 2 times, and each 1 hour, collecting decoction filtered and filtrate is concentrated into the cream of relative density 1.15;
(o) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 190g;
(p) add adjuvant dextrin 120.2g at the Herba Selaginellae Involventis dried cream powder, mixing and stirring back add 50% ethanol as wetting agent;
(q) granulate, mix micropowder silica gel 6.3g outward, fill, deposit after making capsule.
Embodiment 10
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is as follows by weight, and host is Herba Selaginellae Involventis dried cream powder 90, adjuvant dextrin 10.
The preparation method of its preparation granule class medicine is as follows:
(a) 5500g Herba Selaginellae Involventis medical material is cleaned and removed impurity, be cut into segment through after the assay was approved;
(b) decocting that adds 15 times boils 3 times, and each 2 hours, collecting decoction filtered and filtrate is concentrated into the cream of relative density 1.20;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 190g;
(d) adding the adjuvant dextrin at the Herba Selaginellae Involventis dried cream powder is 21g, and mixing and stirring back add 80% ethanol as wetting agent;
(e) mixing is granulated, sieves, and granulate, packing gets granule.
Embodiment 11
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is as follows by weight, and host is Herba Selaginellae Involventis dried cream powder 30, adjuvant dextrin 70.
The preparation method of its preparation granule class medicine is as follows:
(a) 6700g Herba Selaginellae Involventis medical material is cleaned and removed impurity, be cut into segment through after the assay was approved;
(b) decocting that adds 15 times boils 2 times, and each 1 hour, collecting decoction filtered and filtrate is concentrated into the cream of relative density 1.25;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 323g;
(d) add adjuvant dextrin 754g at the Herba Selaginellae Involventis dried cream powder, mixing and stirring back add 80% ethanol as wetting agent;
(e) mixing is granulated, sieves, and granulate, packing gets granule.
Embodiment 12
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is as follows by weight, and host is Herba Selaginellae Involventis dried cream powder 40, adjuvant lactose 58.8, sodium lauryl sulphate 1.2.
The preparation method of its preparation granule class medicine is as follows:
(a) 4300g Herba Selaginellae Involventis medical material is cleaned and removed impurity, be cut into segment through after the assay was approved;
(b) decocting that adds 15 times boils 3 times, and each 2 hours, collecting decoction filtered and filtrate is concentrated into the cream of relative density 1.20;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 223.6g;
(d) add adjuvant lactose 329.0g at the Herba Selaginellae Involventis dried cream powder, mixing and stirring back add 50% ethanol as wetting agent;
(e) mixing is granulated, and sieves, and granulate is mixed sodium lauryl sulphate 6.7g outward, and packing gets granule.
Embodiment 13
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is as follows by weight, and host is Herba Selaginellae Involventis dried cream powder 50, adjuvant sucrose 49, micropowder silica gel 1.
The preparation method of its preparation granule class medicine is as follows:
(a) impurity is cleaned and removed to 5000g Herba Selaginellae Involventis medical material, through pulverizing after the assay was approved;
(b) decocting that adds 15 times boils 3 times, and each 2 hours, collecting decoction filtered and filtrate is concentrated into the cream of relative density 1.20;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 259g;
(d) add adjuvant sucrose 255.2g at the Herba Selaginellae Involventis dried cream powder, mixing and stirring back add 70% ethanol as wetting agent;
(e) mixing is granulated, and sieves, and granulate is mixed micropowder silica gel 5.2g outward, and packing gets granule.
Embodiment 14
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is host 55 by weight, adjuvant 45, and host is Herba Selaginellae Involventis dried cream powder 55, adjuvant comprises arabic gum 18, polyvinylpolypyrrolidone 15, hypromellose 12.
The preparation method of its preparation pill class medicine is as follows:
(a) impurity is cleaned and removed to 5500g Herba Selaginellae Involventis medical material, through pulverizing after the assay was approved;
(b) decocting that adds 15 times boils 3 times, and each 2 hours, collecting decoction filtered and filtrate is concentrated into the cream of relative density 1.20;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 190g;
(d) add adjuvant arabic gum 62.1g, polyvinylpolypyrrolidone 51.8g, hypromellose 41.45g at the Herba Selaginellae Involventis dried cream powder;
(e) sieve, mixing is used water pill, drying;
(f) coating, polishing, drying are deposited after making pill.
Embodiment 15
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is host 70 by weight, adjuvant 30, and host is Herba Selaginellae Involventis dried cream powder 70, adjuvant comprises sucrose 13, cross-linked carboxymethyl cellulose sodium 8, polyvidone 9.
The preparation method of its preparation pill class medicine is as follows:
(a) 6700g Herba Selaginellae Involventis medical material is cleaned and removed impurity, be cut into segment through after the assay was approved;
(b) decocting that adds 15 times boils 3 times, and each 2 hours, collecting decoction filtered and filtrate is concentrated into the cream of relative density 1.20;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 323g;
(d) add adjuvant sucrose 59.8g, cross-linked carboxymethyl cellulose sodium 36.9g, polyvidone 41.5g at the Herba Selaginellae Involventis dried cream powder;
(e) sieve, mixing is used water pill, drying;
(f) coating, polishing, drying are deposited after making pill.
Embodiment 16
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is host 78 by weight, adjuvant 22, and host is Herba Selaginellae Involventis dried cream powder 78, adjuvant comprises soluble starch 13, modified starch 5, carmethose 4.
The preparation method of its preparation pill class medicine is as follows:
(a) 4300g Herba Selaginellae Involventis medical material is cleaned and removed impurity, be cut into segment through after the assay was approved;
(b) decocting that adds 15 times boils 3 times, and each 2 hours, collecting decoction filtered and filtrate is concentrated into the cream of relative density 1.20;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 223.6g;
(d) add adjuvant soluble starch 37.31g, modified starch 14.3g, carmethose 11.5g at the Herba Selaginellae Involventis dried cream powder;
(e) sieve, mixing is used water pill, drying;
(f) coating, polishing, drying are deposited after making pill.
Embodiment 17
The Herba Selaginellae Involventis preparation is made of host and adjuvant, and its each component is host 85 by weight, adjuvant 15, and host is Herba Selaginellae Involventis dried cream powder 85, adjuvant comprises arabic gum 5, carboxymethylstach sodium 5, methylcellulose 4, Pulvis Talci 1.
The preparation method of its preparation pill class medicine is as follows:
(a) 5000g Herba Selaginellae Involventis medical material is cleaned and removed impurity, through being up to the standards;
(b) decocting that adds 15 times boils 3 times, and each 2 hours, collecting decoction filtered and filtrate is concentrated into the cream of relative density 1.20;
(c) drying under reduced pressure is pulverized and is made Herba Selaginellae Involventis dried cream powder 258g;
(d) add adjuvant arabic gum 15.2g, methylcellulose 12.14g, carboxymethylstach sodium 15.2g, Pulvis Talci 3.04g at the Herba Selaginellae Involventis dried cream powder;
(e) sieve, mixing is used water pill, drying;
(f) coating, polishing, drying are deposited after making pill.
For showing the therapeutic effect of medicine of the present invention to thrombocytopenic purpura, the present invention carries out clinical observation to a plurality of cases of Guangdong People's Hospital, second the People's Hospital, Shanghai, ITP diagnostic criteria with reference to formulation in 1984, all patients are clinical all have hemorrhage in various degree, as subcutaneous hemorrhage, purpura, gingival hemorrhage, women's menorrhagia etc., check that repeatedly platelet count is low, myelogram turns out to be ITP simultaneously, abbreviate (1) ITP as, also have 62 examples only not have myelogram to turn out to be ITP, this paper abbreviates (2) ITP as.Idiopathic thrombocytopenic purpura is called for short ITP, and secondary thrombocytopenic purpura is abbreviated as pl.
The employed Herba Selaginellae Involventis sheet of following clinical experiment and zoopery makes by embodiment 4.
Instructions of taking: oral 5-6 sheet/time, day clothes three times, ante cibum, boiled water was taken after mixing it with water.Clinical experiment result such as table 1, table 2.
Table 1 Herba Selaginellae Involventis sheet treatment thrombocytopenic purpura and other hemorrhage curative effect situations
As can be seen from Table 1, clinical by measuring with Herba Selaginellae Involventis treatment idiopathic thrombocytopenic purpura 233 examples, M-F is about 1:1.95, show by the curative effect testing result, total effective rate is 75.53%, produce effects 31 examples (13.3%) wherein, effective 73 examples (31.33%), improve 72 examples (30.9%), treatment back stopped bleeding has 164 examples (70.39%);
Herba Selaginellae Involventis is pine treatment idiopathic thrombocytopenic purpura 52 examples intentinonally, produce effects 10 examples (19.23%) wherein, effective 19 examples (36.53%), improve 17 examples (32.69%), total effective rate is 88.46%, treatment back stopped bleeding 40 examples (76.96%) are close with simple curative effect with the Herba Selaginellae Involventis sheet;
Prednisone treatment idiopathic thrombocytopenic purpura 33 examples.Produce effects 15 examples (45.45%) wherein, effective 9 examples (27.27%) are improved 1 example (3.03%), and total effective rate is 75.75%, illustrates that Herba Selaginellae Involventis is also having significant effect aspect other hemorrhages of treatment.
In three kinds of methods, Herba Selaginellae Involventis and prednisone are used best results.Above-mentioned three groups of data show single Herba Selaginellae Involventis tablet of using, the level of the curative effect approaching idiopathic thrombocytopenic purpura of control at present state of an illness choice drug prednisone on aggregate level.
Table 2 Herba Selaginellae Involventis sheet treatment secondary thrombocytopenic purpura curative effect situation
Table 2 is the treatment situation of Herba Selaginellae Involventis sheet to other secondary thrombocytopenic purpuras, comprises 13 kinds of hemorrhages due to the disease, and total effective rate is 83.33%.
Below by Experiment of Zoology, investigate the pharmacotoxicological effect of Herba Selaginellae Involventis sheet, and inquire into the mechanism of its treatment thrombocytopenic purpura.Required Herba Selaginellae Involventis sheet is made by embodiment 4.
1 Herba Selaginellae Involventis sheet is to the rat influence in docking bleeding time
Get 62 of SD rat, ♀ ♂ has concurrently, and body weight 140～220g is divided into 5 groups at random, and than 23 dosage groups of establishing Herba Selaginellae Involventis, in addition 2 groups is distilled water blank group and etamsylate positive controls ig (filling stomach) * 8 days by adjacent doses.Each group all after administration in the 8th day 1 hour with pentobarbital sodium ip anesthesia, cut off at distance Mus tail point 3cm place, blood flows out naturally, gently dips in blood with filter paper at the tail point, every 30s once until stopped bleeding, writes down the bleeding time.Experiment all at room temperature (20～25 ℃) is carried out.The results are shown in Table 3:
Table 3 Herba Selaginellae Involventis sheet is to the influence in rat docking bleeding time (X ± SD)
Each dosage group of Herba Selaginellae Involventis sheet and etamsylate all obviously shorten the bleeding time of rat docking, and with the contrast of blank group, difference has very obvious significance (P＜0.01), and has along with the corresponding enhanced trend of dosage increase effect.
2 pairs of hematoblastic influences of rabbit
Get 21 of new zealand rabbits, body weight is about 2.8KG, is divided into 4 groups at random, the Herba Selaginellae Involventis group, and respectively by 0.4,1.6g/kg.d * 8d administration (ig), the etamsylate group is pressed 0.08g/kg.d * 8d administration (ig), and the blank group is given normal saline.Respectively at before the administration and behind the administration 8d, heart extracting blood adopts the microscope direct counting method to calculate hematoblastic quantity in the whole blood, checks with t platelet between platelet counts before and after each group administration and each group is carried out statistical procedures.
Table 4 Herba Selaginellae Involventis is to the influence of rabbit platelet counts (X ± SD)
Relatively find that Herba Selaginellae Involventis is obvious platelet increasing number all before and after the medication, with before the administration and blank group comparing difference the meaning (P＜0.01) of highly significant is all arranged, and along with dosage increases, platelet counts has the trend that increases.
3 Herba Selaginellae Involventis sheets are to mice
60Hematoblastic protective effect after the Co total irradiation
Get 57 of NIH kind mices, body weight 18～22g, ♀ ♂ has concurrently, and blood is got in docking before the administration, and method is surveyed the platelet normal value routinely, is divided into 5 groups at random, and the adjacent doses ratio is 3.5.If three dosage groups of Herba Selaginellae Involventis sheet, in addition two groups is blank group and etamsylate positive controls, ig * 11d, in the 8th day with
60Co 800rad total irradiation.Drug withdrawal in the 11st day is measured and is respectively organized platelet count.The results are shown in Table 5:
The influence of platelet counts after table 5 Herba Selaginellae Involventis sheet shines mice 60Co (X ± SD)
Three dosage groups of Herba Selaginellae Involventis sheet and etamsylate all can be kept white mice
60Co irradiation back platelet is a higher level, and comparing difference with the blank group has the meaning of highly significant (P＜0.01)
The influence of the anti-CRBC antibody of 4 specificitys (IgM type hemolysin)
Hemolysin is a kind of dissolved toxin of red blood cell that makes, thereby the inhibition hemolysin is the key factor of treatment hemorrhage, here get 96 of mices, and with Herba Selaginellae Involventis preparation, cyclophosphamide and tragacanth gum it is carried out specific antibody CRBC experiment respectively.All JCR kind ip in mice 20% CRBC 0.2ml/ only, after the 8th heaven-made immunity second time, get 96 of mices, body weight 22-28g is divided into following 5 groups, ip7 days at random, in eye socket blood-letting in the 15th day, get serum, press the method for rabbit epidemic disease drug screening rules, and survey its IgM type hemolysin with spectrophotography.
Table 6 Herba Selaginellae Involventis is to specific antibody CRBC antibody (IgM type hemolysin)
Herba Selaginellae Involventis sheet and cyclophosphamide all can suppress the generation (P＜0.01) of CRBC sensitized mice IgM type hemolysin very significantly.
By above experiment as seen, the Herba Selaginellae Involventis sheet can obviously shorten the bleeding time of rat, significantly improve the platelet count of animal, promote hematoblastic aggregation capability, reduce hematoblastic destruction, and the humoral immunization that can suppress animal under the hypersensitive state, this is the pharmacological basis of its treatment thrombocytopenic purpura and other hemorrhage.The above-mentioned effect of Herba Selaginellae Involventis sheet and etamsylate, cyclophosphamide are suitable, and do not have the side effect of said medicine.
Claims (6)
1. treat the medicine of thrombocytopenic purpura, it is characterized in that: form by Herba Selaginellae Involventis dried cream powder and pharmaceutic adjuvant, wherein pharmaceutic adjuvant is selected from one or more in diluent, disintegrating agent, binding agent, the lubricant, the Herba Selaginellae Involventis dried cream powder is the 30-90 weight portion, and pharmaceutic adjuvant is the 10-70 weight portion;
2. the medicine of treatment thrombocytopenic purpura according to claim 1 is made up of Herba Selaginellae Involventis dried cream powder and pharmaceutic adjuvant, and its composition is expressed as follows by weight:
Herba Selaginellae Involventis dried cream powder 50-85
Diluent 2-30
Disintegrating agent 5-15
Binding agent 4-22
Lubricant 0.5-2
3. according to the medicine of claim 1,2 described treatment thrombocytopenic purpura, it is characterized in that: diluent is mannitol, Icing Sugar, lactose, starch, aluminium hydroxide or dextrin; Disintegrating agent is carboxymethylstach sodium, cross-linked carboxymethyl cellulose sodium, hyprolose, microcrystalline Cellulose, starch or polyvinylpolypyrrolidone; Binding agent is sucrose, arabic gum, pregelatinized Starch, soluble starch, dextrin, polyvidone, carmethose, methylcellulose, hypromellose or ethanol; Lubricant is Pulvis Talci, magnesium stearate, Stepanol MG, sodium lauryl sulphate or micropowder silica gel.
4. according to the medicine of claim 1,2 described treatment thrombocytopenic purpura, it is characterized in that: its composition is expressed as by weight, Herba Selaginellae Involventis dried cream powder 50-85 weight portion, aluminium hydroxide 2-8 weight portion, hyprolose 2-8 weight portion, starch 4-40 weight portion, carboxymethyl starch sodium 2-10 weight portion, magnesium stearate 0.5-2 weight portion.
5. the medicine of treatment thrombocytopenic purpura according to claim 1 is characterized in that: described medicine is tablet, capsule, granule or pill.
6. preparation method for the treatment of the thrombocytopenic purpura medicine, form by following steps successively:
(a) impurity is cleaned and removed to the Herba Selaginellae Involventis medical material;
(b) add 10-30 decocting doubly and boil 2-3 time, each 1-3 hour, collecting decoction, filtration also is concentrated into filtrate the cream of relative density 1.05-1.3;
(c) drying under reduced pressure is pulverized and is made the Herba Selaginellae Involventis dried cream powder;
(d) in the Herba Selaginellae Involventis dried cream powder, add adjuvant, mixing;
(e) prepare the Herba Selaginellae Involventis medicine by the pharmaceutical preparation conventional method.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104173563A (en) * | 2014-08-22 | 2014-12-03 | 上海中医药大学附属岳阳中西医结合医院 | Traditional Chinese medicine composition for treating idiopathic thrombocytopenic purpura |
| CN104546953A (en) * | 2015-01-08 | 2015-04-29 | 中国药科大学 | Application of moellendorf's spikemoss herb extract in preparation of medicines for treating thrombotic diseases |
| CN105878232A (en) * | 2015-12-31 | 2016-08-24 | 南京豪创药物科技有限责任公司 | Application of amentoflavone to preparation of medicine for treating thrombocytopenia |
-
2009
- 2009-04-17 CN CN200910038720A patent/CN101530438A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104173563A (en) * | 2014-08-22 | 2014-12-03 | 上海中医药大学附属岳阳中西医结合医院 | Traditional Chinese medicine composition for treating idiopathic thrombocytopenic purpura |
| CN104546953A (en) * | 2015-01-08 | 2015-04-29 | 中国药科大学 | Application of moellendorf's spikemoss herb extract in preparation of medicines for treating thrombotic diseases |
| CN105878232A (en) * | 2015-12-31 | 2016-08-24 | 南京豪创药物科技有限责任公司 | Application of amentoflavone to preparation of medicine for treating thrombocytopenia |
| CN105878232B (en) * | 2015-12-31 | 2018-04-13 | 南京豪创药物科技有限责任公司 | Amentoflavone is preparing the application for the treatment of platelet reducing disease medicine |
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Application publication date: 20090916 |