Preparation method of clindamycin hydrochloride freeze dried powder injection

A technology of clindamycin hydrochloride and freeze-dried powder injection, which is applied in the field of preparation of clindamycin hydrochloride freeze-dried powder injection, which can solve the problems of content reduction, high failure rate of clarity, and strong irritation of liquid medicine, etc.

Inactive Publication Date: 2006-09-13
巴里莫尔制药(通化)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the clindamycin hydrochloride freeze-dried powder injection in the domestic market is produced by many companies, all of which are prepared by traditional techniques. The existing products have poor quality stability, strong liquid irritation, poor solubility, and unqualified clarity. Problems such as high rate, decreased pH value, decreased content, deepened color, and unstable curative effect can never be solved
The main reason is that some impurities such as protein and tannin are not completely removed during the preparation process, and the instability of clindamycin hydrochloride itself causes

Method used

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  • Preparation method of clindamycin hydrochloride freeze dried powder injection

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Effect test

Embodiment 1

[0024] A) Take fresh water for injection with a preparation volume of 50%, lower the temperature to 40°C, and pass nitrogen gas for 30 minutes, then add the clindamycin hydrochloride in the prescription in the dark, stir and dissolve, and use an ultrafiltration membrane with a molecular weight cut-off of 30,000 ultrafiltration to obtain ultrafiltrate.

[0025] B) Preparation of mannitol filtrate: take 10% fresh water for injection, add mannitol in the prescription to dissolve, add 0.5% activated carbon, heat and boil for 15 minutes, circulate and cool the medicinal solution to 40°C, decarbonize and filter with a 0.45 μm filter membrane , and the filtrate is set aside.

[0026] C) Add the above-mentioned ultrafiltrate into the mannitol filtrate, mix evenly, constant volume, and adjust the pH value to 4.8. After the intermediate product is qualified, the liquid is sterilized and filtered through a terminal 0.22 μm filter membrane, and then filled with nitrogen under dark conditi...

Embodiment 2

[0028] A) Take fresh water for injection with a preparation volume of 80%, lower the temperature to 20° C., pass nitrogen gas for 10 minutes, and add clindamycin hydrochloride in the prescription in the dark, stir and dissolve thoroughly, and use an ultrafiltration membrane with a molecular weight cut-off of 20,000 ultrafiltration to obtain ultrafiltrate.

[0029] B) Preparation of mannitol filtrate: Take 30% fresh water for injection, add mannitol in the prescription to dissolve, add 0.1% activated carbon, heat and boil for 30 minutes, cool down the medicinal solution by 50°C in circulation, decarbonize and filter with a 0.45 μm filter membrane , and the filtrate is set aside.

[0030] C) Add the above-mentioned ultrafiltrate into the mannitol filtrate, mix evenly, constant volume, and adjust the pH value to 5.5. After the intermediate product is qualified, the liquid is sterilized and filtered through a terminal 0.22 μm filter membrane, and filled with nitrogen under dark co...

Embodiment 3

[0032] A) Take fresh water for injection with a preparation volume of 60%, cool it down to 35°C, pass nitrogen gas for 25 minutes, add clindamycin hydrochloride in the prescription in the dark, stir and dissolve, and use an ultrafiltration membrane with a molecular weight cut-off of 10,000 ultrafiltration to obtain ultrafiltrate.

[0033] B) Preparation of mannitol filtrate: take 15% fresh water for injection, add mannitol in the prescription to dissolve, add 0.4% activated carbon, heat and boil for 25 minutes, circulate and cool the medicinal solution to 46°C, decarbonize and filter with a 0.45 μm filter membrane , and the filtrate is set aside.

[0034]C) Add the above-mentioned ultrafiltrate into the mannitol filtrate, mix evenly, constant volume, and adjust the pH value to 5.2. After the intermediate product is qualified, the liquid is sterilized and filtered through a terminal 0.22 μm filter membrane, and filled with nitrogen under dark conditions. Filling in vials, free...

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Abstract

A freeze-dried powder injection of clindamycin hydrochloride for treating various infectious diseases, tonsillitis, tympanitis, acute bronchitis, pneumonia, etc is prepared from clindamycin hydrochloride through ultrafiltration, mixing with filtered mannitol in dark condition and N2 atmosphere, pouring in containers, freeze drying, and sealing.

Description

technical field [0001] The invention relates to a preparation method of clindamycin hydrochloride freeze-dried powder injection for antibiotic drug injection. Specifically, it relates to a freeze-dried powder injection with clindamycin hydrochloride as the main component. After clindamycin hydrochloride is processed by ultrafiltration technology, clindamycin hydrochloride ultrafiltrate is obtained, and mannitol filtrate is used to avoid It is prepared under light and nitrogen conditions, filled, freeze-dried, capped and packaged to make the finished product of clindamycin hydrochloride freeze-dried powder for injection. It has been proved by clinical experiments that it can be infused intravenously, and has high antibacterial activity against Gram-positive bacteria such as Staphylococcus (including penicillin-resistant strains), Streptococcus, Bacillus diphtheria, and Bacillus anthracis. It also has good antibacterial activity against Gram-negative anaerobic bacteria. Most of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7056A61K9/19A61P31/04
Inventor 郭智华
Owner 巴里莫尔制药(通化)有限公司
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