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Preparation method of lincomycin hydrochloride injection

A technology for the preparation of lincomycin hydrochloride and injection, which is applied in the fields of pharmaceutical formulations, heat exchange equipment, lighting and heating equipment, etc., can solve the problems of unfavorable environmental protection and increase of manufacturing cost, and achieve the reduction of content, avoiding high cost, The effect of improving quality

Inactive Publication Date: 2014-06-04
ANHUI HONGYE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method can effectively reduce the B component content in lincomycin, it requires a large amount of mixed alcohol, which not only increases the manufacturing cost, but also is not conducive to environmental protection

Method used

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  • Preparation method of lincomycin hydrochloride injection
  • Preparation method of lincomycin hydrochloride injection
  • Preparation method of lincomycin hydrochloride injection

Examples

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preparation example Construction

[0018] A kind of lincomycin hydrochloride injection preparation method of the present invention, the steps are as follows:

[0019] ①Take 20000ml of water for injection, 6kg of lincomycin hydrochloride original powder, 8g of EDTA-2Na, 172g of anhydrous sodium bicarbonate, appropriate amount of hydrochloric acid and anhydrous sodium bicarbonate for use;

[0020] ② Soak the reaction kettle, feed pipeline and constant temperature water supply system made of metal materials used in the preparation method with 0.02% concentration of disodium ethylenediaminetetraacetic acid for 25-35 minutes, rinse clean, and set aside;

[0021] ③ Connect the stored water for injection at 85°C-95°C to the water storage tank in the constant temperature water supply system, so that the water storage tanks are respectively connected to the constant temperature water for injection outlet pipes through pipes;

[0022] ④Inject constant temperature water for injection at 70°C into the reaction kettle throu...

Embodiment 1

[0031] Weigh 6kg of lincomycin hydrochloride original powder, 8g of EDTA-2Na, 172g of anhydrous sodium bicarbonate, and about 19000ml of water for injection.

[0032] Heat the water for injection to 70°C, dissolve the original powder of lincomycin hydrochloride, adjust the pH value of the liquid to 4.1-4.5 with hydrochloric acid, make the liquid acidic, stir well, and mix it with lincomycin hydrochloride Alcohol residual reaction, then add water for injection to 20000ml.

[0033] Use 5000 Dalton ultrafiltration equipment for ultrafiltration, add formula amount of anhydrous sodium bicarbonate to the solution after ultrafiltration to reduce irritation and pain during administration, add EDTA-2Na, stir well and use 0.02% activated carbon for needle depyrogenation, content measurement, pH value.

[0034] After the drug solution is qualified, it is filtered through a 0.2μm microporous membrane, and after being filled in a 100-grade environment, it is sterilized once by 100-105°C 1...

Embodiment 2

[0037] Weigh 3kg of lincomycin hydrochloride original powder, 6g of EDTA-2Na, appropriate amount of anhydrous sodium bicarbonate, and about 19000ml of water for injection.

[0038] Heat the water for injection to 70°C, dissolve the original powder of lincomycin hydrochloride, adjust the pH value of the liquid to 4.5-5.5 with hydrochloric acid, make the liquid acidic, stir well, and mix it with lincomycin hydrochloride Alcohol residual reaction, then add water for injection to 20000ml.

[0039] Use 5000 Dalton ultrafiltration equipment for ultrafiltration, add an appropriate amount of anhydrous sodium bicarbonate to the ultrafiltration solution to adjust the pH value to neutral, add EDTA-2Na, stir well and depyrogenate with 0.02% activated carbon for needles , measuring content, pH value;

[0040] After the drug solution is qualified, it is filtered through a 0.2μm microporous membrane, and after being filled in a 100-grade environment, it is sterilized once by 100-105°C 15mi ...

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Abstract

The invention provides a preparation method of lincomycin hydrochloride injection, which comprises the following steps: (1) fetching 20,000ml of injection water, 6kg of lincomycin hydrochloride raw powder, 8g of EDTA (ethylenediamine tetraacetic acid)-2Na, 172g of anhydrous sodium bicarbonate and appropriate hydrochloric acid and anhydrous sodium bicarbonate for later use; (2) soaking a reaction kettle, a conveying pipeline and a constant-temperature water supply system with EDTA, and flushing for later use; (3) leading the stored injection water into a water storage tank, and connecting the water storage tank with a water outlet pipe through a pipeline; (4) injecting the injection water into the reaction kettle through the water outlet pipe, adding the lincomycin hydrochloride raw powder, and dissolving; (5) adding the anhydrous sodium bicarbonate into the solution after ultrafiltration to adjust the pH value, adding EDTA-2Na, sufficiently stirring, and then measuring the content; (6) if the liquid medicine is qualified, filling in a hundred-class environment to obtain the lincomycin hydrochloride injection. According to the method provided by the invention, the content of a lincomycin component B is effectively reduced in order to improve the quality of the lincomycin hydrochloride injection and reduce the preparation cost.

Description

technical field [0001] The invention relates to a combination medicine, which is a preparation method of lincomycin hydrochloride injection. Background technique [0002] Lincomycin hydrochloride injection is a sterilized aqueous solution of lincomycin hydrochloride, which is a commonly used antibiotic drug in clinical practice. It is mainly used to treat sensitive Staphylococcus, Streptococcus, Streptococcus pneumoniae and anaerobic bacteria Respiratory tract infection, skin and soft tissue infection, female reproductive tract infection, pelvic cavity infection and abdominal cavity infection. Lincomycin contains two components, A and B, of which the main component is A component. The A and B components in lincomycin are quite different in pharmacology. Compared with the A component, the B component has lower antibacterial activity and higher toxicity. Therefore, the content of component B in the finished product is an important indicator to determine the quality of lincom...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7056A61P31/04A61J3/00F28F27/00
Inventor 刘飞飞
Owner ANHUI HONGYE PHARMA
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