Clindamycin phosphate injection preparation and preparation method thereof

A clindamycin phosphate and injection technology, which is applied in the fields of pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., can solve the problem of particles entering, and achieve the effect of stable quality and advanced preparation methods

Inactive Publication Date: 2010-07-21
双鹤药业(海南)有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Risk of particle ingress when opening ampoules

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Prescription: Clindamycin Phosphate 356.6g

[0028] Benzyl alcohol 20g

[0029] Edetate Disodium 1g

[0030] Add water for injection to 2000ml

[0031] Make 1000 pieces

[0032] Preparation:

[0033] ① Control the cleaning and sterilization of antibiotic glass bottles

[0034] Controlled antibiotic glass bottles are removed from the outer packaging, passed into the bottle washing and drying room, cleaned by a bottle washing machine, sterilized by hot air at 320°C for 6 minutes in a drying and sterilizing machine, and cooled.

[0035] ② Cleaning and sterilization of butyl rubber stoppers

[0036] The butyl rubber stoppers are removed from the outer packaging, cleaned by a stopper washing machine, sterilized by dry heat at 121°C for 120 minutes, cooled, and set aside.

[0037] ③Sterilization of aluminum-plastic composite lids

[0038] The aluminum-plastic cover is removed from the outer packaging, and it is sent to the ...

Embodiment 2

[0052] Prescription: Clindamycin Phosphate 1069.8g

[0053] Benzyl alcohol 100g

[0054] Edetate Disodium 5g

[0055] Add water for injection to 10000ml

[0056] Make 1000 pieces

[0057] Preparation:

[0058] ① Control the cleaning and sterilization of antibiotic glass bottles

[0059] Controlled antibiotic glass bottles are removed from the outer packaging, passed into the bottle washing and drying room, cleaned by a bottle washing machine, sterilized by hot air at 320°C for 6 minutes in a drying and sterilizing machine, and cooled.

[0060] ② Cleaning and sterilization of butyl rubber stoppers:

[0061] The butyl rubber stoppers are removed from the outer packaging, cleaned by a stopper washing machine, sterilized by dry heat at 121°C for 120 minutes, cooled, and set aside.

[0062] ③Sterilization of aluminum-plastic combined caps:

[0063] The aluminum-plastic cover is removed from the outer packaging, and it is sent to ...

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PUM

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Abstract

The invention provides a clindamycin phosphate injection preparation and a prescription thereof. According to the prescription, the clindamycin phosphate injection preparation comprises clindamycin phosphate, a cosolvent, a metal ion complexing agent, a solvent of raw materials and auxiliary materials and the like. The invention aims to provide a method for preparing the clindamycin phosphate injection preparation with more advanced technology and better product quality.

Description

technical field [0001] The invention belongs to pharmaceutical preparations, and relates to semi-synthetic clindamycin derivative preparations and preparation methods, in particular to clindamycin phosphate injection preparations and preparation methods. Background technique [0002] Clindamycin Phosphate is a semi-synthetic antibiotic belonging to the lincomycin class. Among similar products, clindamycin phosphate is better than clindamycin in fat solubility and permeability, especially overcoming the severe pain caused by clindamycin hydrochloride during intramuscular injection. The types of injections recorded in the Pharmacopoeia of China and the United Kingdom. [0003] Clindamycin Phosphate Injection currently has two inner packaging materials and two processes, namely ampoules and vials. At present, most manufacturers are ampoules, and the vials of clindamycin phosphate injection produced by our company are the only ones in China, and their characteristics are as fo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7056A61P31/04
Inventor 魏雪纹李强张美华申洁
Owner 双鹤药业(海南)有限责任公司
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