阅读说明：本技术 一种治疗原发免疫性血小板减少症的药物组合物及其制备方法 (Pharmaceutical composition for treating primary immune thrombocytopenia and preparation method thereof ) 是由 韩小霜 郁晨燕 李标有 于 2019-12-20 设计创作，主要内容包括：本发明提供了一种治疗原发免疫性血小板减少症的药物组合物及其制备方法,其特征在于,包括由如下重量份数的组分组成：吗替麦考酚酯1份～80份,三七0.5份～20份,黄芪1份～40份,鸡血藤0.5份～20份,茯苓0.5份～20份,白术0.5份～20份,阿胶1份～20份,党参1份～20份,炙甘草1份～10份,茜草1份～10份。本发明提供的治疗原发免疫性血小板减少症的药物组合物及其制备方法,采用中药联合吗替麦考酚酯的共同作用下,能治疗原发免疫性血小板减少症,提高了药物总疗效,且不良反应少、成本低,同时也能够有效降低吗替麦考酚酯对人体所造成的副作用,毒副作用小,疗效明显。(The invention provides a pharmaceutical composition for treating primary immune thrombocytopenia and a preparation method thereof, which is characterized by comprising the following components in parts by weight: 1 to 80 parts of mycophenolate mofetil, 0.5 to 20 parts of pseudo-ginseng, 1 to 40 parts of astragalus, 0.5 to 20 parts of suberect spatholobus stem, 0.5 to 20 parts of tuckahoe, 0.5 to 20 parts of largehead atractylodes rhizome, 1 to 20 parts of donkey-hide gelatin, 1 to 20 parts of radix codonopsitis, 1 to 10 parts of honey-fried licorice root and 1 to 10 parts of madder. The pharmaceutical composition for treating primary immune thrombocytopenia and the preparation method thereof provided by the invention have the advantages that the primary immune thrombocytopenia can be treated under the combined action of the traditional Chinese medicine and the mycophenolate mofetil, the total curative effect of the medicine is improved, the adverse reaction is less, the cost is low, the side effect of the mycophenolate mofetil on a human body can be effectively reduced, the toxic and side effects are small, and the curative effect is obvious.)

1. The pharmaceutical composition for treating primary immune thrombocytopenia is characterized by comprising the following components in parts by weight: 1 to 80 parts of mycophenolate mofetil, 0.5 to 20 parts of pseudo-ginseng, 1 to 40 parts of astragalus, 0.5 to 20 parts of suberect spatholobus stem, 0.5 to 20 parts of tuckahoe, 0.5 to 20 parts of largehead atractylodes rhizome, 1 to 20 parts of donkey-hide gelatin, 1 to 20 parts of radix codonopsitis, 1 to 10 parts of honey-fried licorice root and 1 to 10 parts of madder.

2. The pharmaceutical composition for treating primary immune thrombocytopenia as claimed in claim 1, wherein the pharmaceutical composition is in semi-solid form or in solid form.

3. The pharmaceutical composition for treating primary immune thrombocytopenia of claim 2, wherein said semisolid formulation comprises a paste or suspension or ointment.

4. The pharmaceutical composition for treating primary immune thrombocytopenia as claimed in claim 2, wherein said solid dosage form includes granule or powder or pill or tablet or capsule or dry suspension.

5. A method of preparing a pharmaceutical composition for the treatment of primary immune thrombocytopenia as claimed in any one of claims 1 to 4, comprising the steps of:

the method comprises the following steps: weighing Notoginseng radix, radix astragali, caulis Spatholobi, Poria, Atractylodis rhizoma, colla Corii Asini, radix Codonopsis, radix Glycyrrhizae Preparata, and radix Rubiae, cutting, soaking in water for a certain time, heating to boil, cooling, and separating the decoction;

step two: settling the decoction, filtering, concentrating at low temperature, adding ethanol, mixing, standing, collecting supernatant, washing precipitate with small amount of ethanol, mixing the washing solution and the supernatant, concentrating, standing to precipitate completely, and filtering to obtain filtrate.

6. The method for preparing a pharmaceutical composition for treating primary immune thrombocytopenia as claimed in claim 5, further comprising the steps of: evaporating the filtrate at low temperature to obtain soft extract, kneading the soft extract with mycophenolate mofetil, granulating into wet granules by a high-speed mixing granulator, adding an appropriate amount of wetting agent, grading, and drying to obtain dry granules.

7. The method for preparing a pharmaceutical composition for treating primary immune thrombocytopenia as claimed in claim 5, further comprising the steps of: adding mycophenolate mofetil into the filtrate, then spray drying to prepare extract powder, adding excipient and lubricant, and pressing into tablets.

8. The method for preparing a pharmaceutical composition for treating primary immune thrombocytopenia as claimed in claim 5, further comprising the steps of: evaporating the filtrate at low temperature to obtain soft extract, kneading the soft extract and mycophenolate mofetil, granulating into wet granules by using a high-speed mixing granulator, granulating, drying to obtain dry granules, adding the granulated materials into a mixing machine, adding a lubricant, uniformly mixing, and preparing the total mixed materials and the hollow gelatin capsules into capsules by using a No. 1 capsule mould on a capsule filling machine.

9. The method according to claim 5, wherein the first step is a step of separating the decoctions, decocting the residues 2-3 times, and collecting the decoctions.

10. The method for preparing a pharmaceutical composition for treating primary immune thrombocytopenia as claimed in claim 5, wherein in step one, the soaking time is 10-30 minutes.

Technical Field

The invention relates to the technical field of medical chemistry, in particular to a pharmaceutical composition for treating primary immune thrombocytopenia and a preparation method thereof.

Background

Platelets are small cytoplasm released from the cytoplasm of mature megakaryocytes in bone marrow, and are very important for the hemostasis function of the body. After the wound occurs, the platelets are quickly adhered to the wound and aggregated into a mass to form a softer hemostatic plug. Primary Immune Thrombocytopenia (ITP) is a symptom of immune syndrome and is a common hemorrhagic disease. Is characterized in that the platelet is damaged too much due to the existence of antiplatelet antibodies in blood circulation. The common symptoms are subcutaneous and mucous membrane bleeding, such as skin ecchymosis, purpura, bleeding of mouth, nose and gum and the like, and serious patients can cause massive gastrointestinal bleeding and bleeding in the central nervous system, thereby endangering life.

For ITP, glucocorticoid, gamma globulin, azathioprine, cyclosporin a, danazol, vinca alkaloid, cellcept, splenectomy therapy, and the like are used clinically. Hormone drugs can cause certain damage to human bone marrow, and gamma globulin is expensive and has short curative effect.

The mycophenolate mofetil is a common preparation for clinically treating primary immune thrombocytopenia due to the characteristics of no obvious liver and kidney toxicity, few adverse reactions and the like. Mycophenolate mofetil (MMF for short) is a 2-ethyl ester derivative of mycophenolic acid (MPA), and MPA is a high-efficiency, selective, noncompetitive and reversible hypoxanthine mononucleotide dehydrogenase (IMPDH) inhibitor and can inhibit the synthesis of guanine nucleotide, so that the synthesis of T, B lymphocyte is inhibited, the immune activity of an organism is reduced, and the damage of platelets is reduced.

Clinical data show that the simple use of mycophenolate mofetil for treating primary immune thrombocytopenia has certain limitation, opportunistic infection can occur, the chance of inducing malignant tumor is increased, and adverse reaction is increased. The traditional Chinese medicine has unique advantages in treating primary immune thrombocytopenia, and has the advantages of obvious curative effect, low toxic and side effects and low cost.

Disclosure of Invention

The invention aims to disclose a pharmaceutical composition for treating primary immune thrombocytopenia, which can treat primary immune thrombocytopenia and improve the total curative effect of the medicament under the combined action of traditional Chinese medicines and mycophenolate mofetil, has less adverse reaction and low cost, can effectively reduce the side effect of mycophenolate mofetil on human bodies, and has small toxic and side effects and obvious curative effect.

In order to achieve the aim, the invention provides a pharmaceutical composition for treating primary immune thrombocytopenia, which comprises the following components in parts by weight: 1 to 80 parts of mycophenolate mofetil, 0.5 to 20 parts of pseudo-ginseng, 1 to 40 parts of astragalus, 0.5 to 20 parts of suberect spatholobus stem, 0.5 to 20 parts of tuckahoe, 0.5 to 20 parts of largehead atractylodes rhizome, 1 to 20 parts of donkey-hide gelatin, 1 to 20 parts of radix codonopsitis, 1 to 10 parts of honey-fried licorice root and 1 to 10 parts of madder.

In some embodiments, the pharmaceutical composition is a semi-solid formulation or a solid formulation.

In some embodiments, the semi-solid formulation comprises a paste or suspension or an ointment.

In some embodiments, the solid formulation comprises a granule or powder or pill or tablet or capsule or dry suspension.

The second purpose of the invention is to disclose a preparation method of a pharmaceutical composition for treating primary immune thrombocytopenia, which can prepare a pharmaceutical composition capable of treating primary immune thrombocytopenia and effectively reducing the side effect of mycophenolate mofetil on human body.

In order to achieve the above object, the present invention provides a method for preparing a pharmaceutical composition for treating primary immune thrombocytopenia, comprising the following steps:

the method comprises the following steps: weighing Notoginseng radix, radix astragali, caulis Spatholobi, Poria, Atractylodis rhizoma, colla Corii Asini, radix Codonopsis, radix Glycyrrhizae Preparata, and radix Rubiae, cutting, soaking in water for a certain time, heating to boil, cooling, and separating the decoction;

step two: settling the decoction, filtering, concentrating at low temperature, adding ethanol, mixing, standing, collecting supernatant, washing precipitate with small amount of ethanol, mixing the washing solution and the supernatant, concentrating, standing to precipitate completely, and filtering to obtain filtrate.

In some embodiments, the method further comprises the following step three: evaporating the filtrate at low temperature to obtain soft extract, kneading the soft extract with mycophenolate mofetil, granulating into wet granules by a high-speed mixing granulator, adding an appropriate amount of wetting agent, grading, and drying to obtain dry granules.

In some embodiments, the method further comprises the following step three: adding mycophenolate mofetil into the filtrate, then spray drying to prepare extract powder, adding excipient and lubricant, and pressing into tablets.

In some embodiments, the method further comprises the following step three: evaporating the filtrate at low temperature to obtain soft extract, kneading the soft extract and mycophenolate mofetil, granulating into wet granules by using a high-speed mixing granulator, granulating, drying to obtain dry granules, adding the granulated materials into a mixing machine, adding a lubricant, uniformly mixing, and preparing the total mixed materials and the hollow gelatin capsules into capsules by using a No. 1 capsule mould on a capsule filling machine.

In some embodiments, in step one, the decoction is separated and then the residue is decocted 2-3 times by law, and each decoction is collected.

In some embodiments, in step one, the soaking time is 10 to 30 minutes.

Compared with the prior art, the invention has the beneficial effects that: the pharmaceutical composition for treating primary immune thrombocytopenia and the preparation method thereof provided by the invention have the advantages that the primary immune thrombocytopenia can be treated under the combined action of the traditional Chinese medicine and the mycophenolate mofetil, the total curative effect of the medicine is improved, the adverse reaction is less, the cost is low, the side effect of the mycophenolate mofetil on a human body can be effectively reduced, the toxic and side effects are small, and the curative effect is obvious.

Detailed Description

The present invention is described in detail below with reference to various embodiments, but it should be understood that these embodiments are not intended to limit the present invention, and those skilled in the art should be able to make modifications and substitutions on the functions, methods, or structures of these embodiments without departing from the scope of the present invention.