阅读说明：本技术 一种治疗器官移植后免疫排斥反应的复方制剂 (Compound preparation for treating immunological rejection after organ transplantation ) 是由 沈维丹 黄红红 李标有 于 2019-12-20 设计创作，主要内容包括：本发明公开了一种治疗器官移植后免疫排斥反应的复方制剂。该复方制剂包括由黄芪、当归、鸡血藤、甘草、半边旗组成的混合物,吗替麦考酚酯,填充剂,粘合剂,崩解剂,润滑剂。本发明具有与单独使用吗替麦考酚酯相比,能够有效减少副作用,缓解头痛,腹痛等症状,补气养血、补充人体能量,增加人体免疫功能的效果。(The invention discloses a compound preparation for treating immune rejection after organ transplantation. The compound preparation comprises a mixture consisting of astragalus, angelica, suberect spatholobus stem, liquorice and herba semilaginellae, mycophenolate mofetil, a filler, a binder, a disintegrating agent and a lubricant. Compared with the mycophenolate mofetil which is used alone, the mycophenolate mofetil has the effects of effectively reducing side effects, relieving symptoms such as headache, abdominal pain and the like, tonifying qi and nourishing blood, supplementing human body energy and increasing human body immunity.)

1. A compound preparation for treating immunological rejection after organ transplantation is characterized by comprising a mixture consisting of astragalus, angelica, suberect spatholobus stem, liquorice and herba laggerae semipinnatae, mycophenolate mofetil, a filler, an adhesive, a disintegrating agent and a lubricant.

2. The compound preparation for treating the immune rejection reaction after the organ transplantation according to claim 1, wherein the weight parts of the components are as follows: 20-50 parts of the mixture, 20-40 parts of mycophenolate mofetil, 20-50 parts of a filler, 2-6 parts of an adhesive, 2-6 parts of a disintegrating agent and 0.5-3 parts of a lubricant.

3. The compound preparation for treating immune rejection after organ transplantation according to claim 1, wherein the filler is one or more of starch, sucrose, dextrin, pregelatinized starch, microcrystalline cellulose and sorbitol.

4. The compound preparation for treating immune rejection after organ transplantation according to claim 1, wherein the binder is one or more of povidone, methylcellulose, hydroxymethylcellulose, hydroxypropylmethylcellulose and hydroxypropylcellulose.

5. The compound preparation for treating immune rejection after organ transplantation according to claim 1, wherein the disintegrant is one or more of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, crospovidone, croscarmellose sodium, pregelatinized starch, and sodium alginate.

6. The compound preparation for treating immune rejection after organ transplantation according to claim 1, wherein the lubricant is one or more of magnesium stearate, aerosil, talcum powder, hydrogenated vegetable oil, sodium dodecyl sulfate and polyethylene glycol.

7. The compound preparation for treating the immune rejection reaction after organ transplantation according to claim 1, wherein the compound preparation is an oral preparation.

8. The compound preparation for treating immune rejection after organ transplantation according to claim 7, wherein the oral preparation is a capsule.

9. The method for preparing a compound preparation for treating immune rejection after organ transplantation according to any one of claims 1 to 8, wherein the preparation method comprises the following steps:

s1, grinding the mixture of radix astragali, radix Angelicae sinensis, caulis Spatholobi, radix Glycyrrhizae and herba Pteridis Semipinnatae into superfine powder with a fine powder grinder;

s2, weighing the components according to the prescription amount, and sieving the components by a 60-mesh sieve for preparation;

s3, preparing the adhesive into 8% adhesive by using 70% ethanol as a solvent for later use;

s4, putting the sieved components and the mixture into a wet granulator, premixing, and spraying the prepared adhesive to prepare a soft material;

s5, carrying out wet granulation on the soft material by using a 20-mesh sieve;

s6, transferring the granulated wet soft material into a fluidized bed for blast drying, wherein the inlet air temperature is set to be 60 ℃, and the air volume is set to be 15m³H, taking out until the water content is less than 5%;

s7, taking out the dried particles, and sieving the particles with a 35-mesh sieve for dry granulation;

s8, adding the whole particles into a mixer, adding a lubricant, and uniformly mixing to prepare an intermediate;

and S9, preparing the total mixed material and the hollow gelatin capsule into a capsule by using a No. 1 capsule mould on a capsule filling machine.

Technical Field

The invention relates to the technical field of pharmaceutical preparations, in particular to a compound preparation for treating immune rejection after organ transplantation.

Background

With the improvement of medical technology level, organ transplantation is a way for treating various end-stage diseases, and brings certain hope for recovery of patients with end-stage liver diseases and patients with renal insufficiency, but most of organ transplantation are xenotransplantation, so adverse reactions such as postoperative immune rejection and the like are common, the survival rate of organs is low, and a series of postoperative syndromes of other diseases are caused, and postoperative drug therapy is particularly important.

Among the numerous immunosuppressive agents, Mycophenolate Mofetil (MMF) is a novel antimetabolite immunosuppressive agent, and its active ingredient in vivo, mycophenolic acid (MPA), inhibits the proliferation of lymph B, T cells by specifically inhibiting the activity of inosinic acid dehydrogenase (IMPDH), thus having a strong immunosuppressive effect. Compared with other immunosuppressive agents, MMF has lower toxicity to the liver, the kidney and the bone marrow, and does not cause side effects such as hypertension, diabetes, pancreatitis and osteoporosis, but the single use of mycophenolate mofetil may cause side effects such as headache and bellyache.

Disclosure of Invention

One aspect of the present invention is to provide a compound preparation for treating immune rejection after organ transplantation, comprising the following components: mycophenolate mofetil is a mixture consisting of astragalus root, angelica, suberect spatholobus stem, liquorice and semipinna in any proportion, a filler, a binder, a disintegrating agent and a lubricant.

In some embodiments, the composition comprises 20-40 parts of mycophenolate mofetil, 20-50 parts of a mixture, 20-50 parts of a filler, 2-6 parts of a binder, 2-6 parts of a disintegrating agent and 0.5-3 parts of a lubricant.

In some embodiments, the filler is one or a mixture of two or more of corn starch, sucrose, dextrin, pregelatinized starch, microcrystalline cellulose, and sorbitol in any ratio.

In some embodiments, the disintegrant is one or a mixture of two or more of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, crospovidone, croscarmellose sodium, sodium croscarmellose, pregelatinized starch, and sodium alginate in any ratio.

In some embodiments, the binder is one or a mixture of two or more of povidone, methylcellulose, hydroxymethylcellulose, hydroxypropylmethylcellulose and hydroxypropylcellulose in any proportion.

In some embodiments, the lubricant is one or a mixture of two or more of magnesium stearate, aerosil, talcum powder, hydrogenated vegetable oil, sodium dodecyl sulfate and polyethylene glycol in any proportion.

In some embodiments, the pharmaceutical composition is in the form of a capsule.

Compared with the single use of mycophenolate mofetil, the compound preparation of the invention has the advantages of effectively reducing side effects, relieving symptoms such as headache, abdominal pain and the like, effectively benefiting qi and nourishing blood, supplementing human body energy and increasing human body immunity.

Another aspect of the present invention provides a method for preparing a compound preparation for treating immune rejection after organ transplantation, comprising the steps of:

s1, grinding the mixture of radix astragali, radix Angelicae sinensis, caulis Spatholobi, radix Glycyrrhizae and herba Pteridis Semipinnatae into superfine powder with a fine powder grinder;

s2, weighing the components according to the prescription amount, and sieving the components by a 60-mesh sieve for preparation;

s3, preparing the adhesive into 8% adhesive by using 70% ethanol as a solvent for later use;

s4, putting the sieved components and the mixture into a wet granulator, premixing, and spraying the prepared adhesive to prepare a soft material;

s5, carrying out wet granulation on the soft material by using a 20-mesh sieve;

s6, transferring the granulated wet soft material into a fluidized bed for blast drying, wherein the inlet air temperature is set to be 60 ℃, and the air volume is set to be 15m³H, taking out until the water content is less than 5%;

s7, taking out the dried particles, and sieving the particles with a 35-mesh sieve for dry granulation;

s8, adding the whole particles into a mixer, adding a lubricant, and uniformly mixing to prepare an intermediate;

and S9, preparing the total mixed material and the hollow gelatin capsule into a capsule by using a No. 1 capsule mould on a capsule filling machine.

Compared with the single use of mycophenolate mofetil, the preparation method is used for preparing the blood fat reducing medicine compound preparation which has the advantages of effectively reducing side effects, relieving symptoms such as headache, bellyache and the like, effectively benefiting qi and nourishing blood, supplementing human body energy and increasing human body immunity.

Compared with the prior art, the invention has the beneficial effects that: compared with the single use of mycophenolate mofetil, the compound preparation for treating the immunological rejection after organ transplantation provided by the invention has the advantages of effectively reducing side effects, relieving symptoms such as headache, abdominal pain and the like, effectively benefiting qi and nourishing blood, supplementing human body energy and increasing human body immune function.

Detailed Description

The specific formulation and preparation method of the compound preparation for treating immune rejection after organ transplantation according to the present invention will be described in detail with reference to the following embodiments.