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Impurity removal method for traditional Chinese medicine injection

A technology for injections and traditional Chinese medicines, which is used in pharmaceutical formulations, drug delivery, and medical preparations containing active ingredients, and can solve problems such as irritation to the human body and unsatisfactory effects.

Inactive Publication Date: 2013-06-26
JIANGSU KANION PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In production practice, technicians found that only activated carbon and microporous membrane technology were used to remove impurities during the preparation of the injection, and the effect was not ideal. The passive skin allergy test of the finished injection was positive, indicating that there were still certain substances in the injection. A large amount of impurities are irritating to the human body

Method used

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  • Impurity removal method for traditional Chinese medicine injection
  • Impurity removal method for traditional Chinese medicine injection
  • Impurity removal method for traditional Chinese medicine injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0106] Embodiment 1 Chinese medicine injection intermediate liquid dosing preparation method

[0107] a. Preparation of Astragalus extract: Take Astragalus decoction pieces, add 8 times the amount of water to soak for 1 hour, heat and decoct for extraction for 3 hours, filter, and use the filtrate for later use; add 6 times of water to the dregs, decoct and extract twice, each time for 2 hours, filter. Combine the filtrates three times, concentrate to a relative density of 1.05-1.20 (50°C), cool to room temperature, add ethanol until the alcohol content reaches 80v / v, and refrigerate for 12h. The supernatant was poured out, and the dregs were centrifugally filtered. Combine the supernatant and filtrate, recover ethanol under reduced pressure and concentrate to a relative density of 1.05-1.20 (50°C). Inject the concentrated solution into the treated D101 macroporous adsorption resin, wash it with deionized water until it is colorless, and discard the water; then elute with 30...

Embodiment 2

[0110] Embodiment 2 intermediate impurity removal method

[0111] According to the method described in Example 1, the intermediate formulation was prepared.

[0112] Take the intermediate solution and refrigerate for 24 hours, filter, and take the supernatant I; centrifuge the supernatant I obtained in step 1 at a rate of 5000r / min for 15 minutes, and take the supernatant II; the supernatant obtained in step 2 Add 0.3% activated carbon by weight to II for adsorption, the adsorption time is 30min, and the adsorption temperature is 80°C. During the adsorption process, potassium hydroxide (KOH) is used to adjust the pH value to keep the supernatant pH value unchanged. After adsorption, filter and collect the filtrate.

Embodiment 3

[0113] Embodiment 3 intermediate impurity removal method

[0114] According to the method described in Example 1, the intermediate formulation was prepared.

[0115] Take the intermediate solution and refrigerate for 18 hours, filter, and take the supernatant I; centrifuge the supernatant I obtained in step 1 at a rate of 8000r / min for 10 minutes, and take the supernatant II; the supernatant obtained in step 2 Add 0.5% activated carbon by weight to II for adsorption, the adsorption time is 45min, and the adsorption temperature is 90°C. During the adsorption process, the pH value is adjusted with meglumine solution, so that the pH value of the supernatant remains unchanged. After adsorption, filter and collect the filtrate.

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Abstract

The invention relates to the traditional Chinese medicine injection impurity removal and purification technology, and in particular relates to an impurity removal method for a traditional Chinese medicine injection produced from astragalus mongholicus and red flower. The impurity removal method involves with the steps of cold storage, centrifuging, active carbon absorption and the like; after the intermediate of the injection is removed from impurities and purified through the previous steps, impurities such as resin and protein can be effectively removed; the impurity removal effect is obvious and the loss of the active ingredients is low; and besides, the impurity removal method is simple to implement, and economical and feasible, and further verifies necessity of the pretreatment technology of the liquid medicine, thereby providing reliable guarantee for the safety of the injection.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine, and relates to a technique for removing impurities from traditional Chinese medicine injections, in particular to a method for removing impurities from traditional Chinese medicine injections made from astragalus and safflower. Background technique [0002] The present invention is a technical improvement on the impurity removal link of the CN200410022665.9 patent technology. [0003] CN200410022665.9 Chinese patent, the title of the invention is "a pharmaceutical composition for the treatment of coronary heart disease and ischemic stroke and its preparation method", the patent was filed on May 31, 2004, and was filed on December 7, 2005 Open, the publication number is CN1704079, authorized on May 14, 2008. On October 2, 2009, the patentee of the invention was changed to Jiangsu Kangyuan Pharmaceutical Co., Ltd. [0004] In production practice, technicians found that only activated c...

Claims

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Application Information

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IPC IPC(8): A61K36/481A61K9/08
Inventor 萧伟王振中孙永成刘俊超王伟杨绪芳祝倩倩徐忠坤毕宇安徐丰果章晨峰于丹
Owner JIANGSU KANION PHARMA CO LTD
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