Immunodepressive medicine and its preparing process and application

A technology of inhibition and drugs, applied in drug combinations, pharmaceutical formulations, steroids, etc., can solve the problems of high price, high toxicity and side effects, loss of function of transplanted organs, etc.

Inactive Publication Date: 2005-07-13
中科生物医药集团有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although immunosuppressive therapy has experienced a century of development, it has made great progress from radiation and chemical drugs that indiscriminately destroy all differentiated cells to cyclosporine A and prograft that only inhibit cells participating in the immune response. However, rejection is still the main reason for the loss of function of transplanted organs. The lack of effective treatment methods for chronic rejection and the high toxicity and side effects of most immunosuppressants and high prices make organ transplantation unsatisfactory.

Method used

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  • Immunodepressive medicine and its preparing process and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Put the dried and pulverized medicinal materials in a reflux pot, add 1.5 times of ethyl acetate, heat and reflux for 3 hours, repeat twice to obtain an ethyl acetate extract, recover the solvent, and obtain a dry extract with a yield of 8.25%. Take 7.5 times the amount of the extract on silica gel for column chromatography, and use n-hexane / acetone gradient elution to obtain norzeramydal light yellow crystalline substance.

Embodiment 2

[0054] Embodiment 2. Preparation of norzeralin sustained-release capsules

[0055] Heat and melt stearyl alcohol on a water bath, add 5 mg of norzeratal, stir evenly, after cooling, grind, add hypromellose gel to make soft material, make wet granules with 18-mesh sieve, and dry at 60°C , the whole grain, and put into capsules to obtain a total of 250 capsules.

Embodiment 3

[0056] Example 3. Preparation of norzeralin soft capsules

[0057]First mix 5 mg of norzeratin with 25 g of vegetable oil, pulverize it with a colloid mill, and after the dispersion is uniform, add the rest of vegetable oil for miscibility to obtain 200 ml of liquid medicine. Prepare gelatin solution (100 parts of gelatin, 55 parts of glycerin, and 100 parts of water) for later use. Under the conditions of room temperature 23±2°C and relative humidity of 40%, the drug solution and gelatin solution are made into 500 capsules with an automatic rotary capsule rolling machine. Norzeratin soft capsules are obtained by drying the capsules for 20 hours at 28±2°C with a relative humidity of 40%.

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Abstract

The invention belongs to the field of pharmacy, and specifically relates to an immunosuppressive drug and a preparation method thereof, which extracts a monomer compound norzeramydal from Tripterygium wilfordii as an active ingredient. The monomer compound norzeramydal of the present invention can be used as a drug raw material to make oral sustained-release preparations, soft capsules, injections, ointments and the like. The immunosuppressive drug of the present invention has few toxic side effects, wide sources, low production cost, cheap price, and convenient application. The drug of the present invention has obvious anti-rejection effect after organ transplantation, and can also be used to treat other clinical autoimmune diseases such as lupus erythematosus Wait.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to an immunosuppressive drug with norzeramydal as an active ingredient, a preparation method thereof and the application of the preparation in anti-rejection after organ transplantation and in the treatment of certain autoimmune diseases. Background technique [0002] Organ transplantation is the most remarkable progress of surgery in the 20th century, from fantasy to reality. By the end of 1997, more than 610,000 patients around the world had received heart, lung, liver, kidney, pancreas, spleen, small intestine, testis, brain tissue, and almost all kinds of different types of organ transplants, and there were 30,000 in my country. More than 4,000 people are transplanted every year, and there is an increasing trend year by year. In addition, the survival rate and quality of life of kidney transplant patients have also been greatly improved. All of these great achievements in or...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/56A61P37/02C07J63/00
Inventor 杨春欣林宗明
Owner 中科生物医药集团有限公司
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