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Clindamycin phosphate injection and preparation method thereof

A technology for clindamycin phosphate and injection, which is applied in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. problem, to achieve the effect of control stability

Inactive Publication Date: 2020-06-26
SHANDONG WEIZHI BAIKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The technical problem to be solved by the present invention is to overcome the problem of easy decomposition brought by the method of high temperature sterilization and the problem of poor stability of clindamycin phosphate

Method used

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  • Clindamycin phosphate injection and preparation method thereof
  • Clindamycin phosphate injection and preparation method thereof
  • Clindamycin phosphate injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1: Clindamycin Phosphate Injection

[0030] formula:

[0031] Material name Dosage clindamycin phosphate 713mg Benzyl alcohol 37.8mg Edetate disodium 2mg 2mol / L sodium hydroxide solution About 0.57ml activated carbon Appropriate amount Add water for injection to 4ml

[0032] Preparation method: Dissolve 2 g of edetate disodium in a certain amount of water for injection under the condition that the air cleanliness is class 100 in the whole room until dissolved. Add a certain amount of 2mol / L sodium hydroxide solution, 713g of clindamycin phosphate (equivalent to 600g of clindamycin), and 37.8g of benzyl alcohol, and stir evenly. After adding a certain amount of activated carbon, stir, cool, filter and transport to the dilute tank. Add water for injection to the full amount (the total volume is 4000ml), adjust the pH value and measure the content of the main drug, fine filter, potting, light inspection, ...

Embodiment 2

[0034] Embodiment 2: Clindamycin Phosphate Injection

[0035] formula:

[0036] Material name Dosage clindamycin phosphate 713mg Benzyl alcohol 37.8mg Edetate disodium 4mg 2mol / L sodium hydroxide solution About 0.57ml activated carbon Appropriate amount Add water for injection to 4ml

[0037] Preparation method: Dissolve 4 g of edetate disodium in a certain amount of water for injection under the condition that the air cleanliness is class 100 in the whole room until dissolved. Add a certain amount of 2mol / L sodium hydroxide solution, 713g of clindamycin phosphate (equivalent to 600g of clindamycin), and 37.8g of benzyl alcohol, and stir evenly. After adding a certain amount of activated carbon, stir, cool, filter and transport to the dilute tank. Add water for injection to the full amount (the total volume is 4000ml), adjust the pH value and measure the content of the main drug, fine filter, potting, light inspection, ...

Embodiment 3

[0039] Embodiment 3: Clindamycin Phosphate Injection

[0040] formula:

[0041] Material name Dosage clindamycin phosphate 713mg Benzyl alcohol 37.8mg Edetate disodium 1mg 2mol / L sodium hydroxide solution About 0.57ml activated carbon Appropriate amount Add water for injection to 4ml

[0042] Preparation method: Dissolve 1 g of edetate disodium in a certain amount of water for injection under the condition that the air cleanliness is class 100 in the whole room until dissolved. Add a certain amount of 2mol / L sodium hydroxide solution, 713g of clindamycin phosphate (equivalent to 600g of clindamycin), and 37.8g of benzyl alcohol, and stir evenly. After adding a certain amount of activated carbon, stir, cool, filter and transport to the dilute tank. Add water for injection to the full amount (the total volume is 4000ml), adjust the pH value and measure the content of the main drug, fine filter, potting, light inspection, ...

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Abstract

The invention discloses a preparation method of a clindamycin phosphate injection. The clindamycin phosphate injection is prepared from components of raw materials as follows: clindamycin phosphate, sodium hydroxide, benzyl alcohol, edetate disodium and water for injection. The preparation method comprises steps as follows: (1) a certain amount of edetate disodium is dissolved in the water for injection under the condition that the air cleanliness is class 100 in a whole room and is stirred to be dissolved; (2) a sodium hydroxide solution, clindamycin phosphate and benzyl alcohol are added andstirred uniformly; (3) after activated carbon is added, the mixture is stirred, cooled and filtered, and then a substance obtained after filtering is conveyed to a dilution preparation tank; and (4)the water for injection is added to a full amount, the pH value is adjusted, the content of a main drug is tested, and refined filtration, filling and sealing are performed. The invention also discloses the clindamycin phosphate injection prepared with the method. By means of the method, high-temperature sterilization is not required finally, the defect that sterilization is performed with high-temperature sterilization adopted by a conventional method is overcome, and the stability of the clindamycin phosphate injection is effectively controlled.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a clindamycin phosphate injection and a preparation method thereof. Background technique [0002] Clindamycin Phosphate, the chemical name is (2S-trans)-6-(1-methyl-4-propyl-2-pyrrolidinecarbonamido)-1-thio-methyl -7-Chloro-6,7,8-trideoxy-L-threo-α-D-galactopyranoside-2-dihydrogen phosphate, molecular formula C 18 h 34 ClN 2 o 8 PS, molecular weight 504.97, its chemical structure is as follows: [0003] [0004] Clindamycin was synthesized in 1966, developed and patented by Upjohn Company of the United States, and successfully developed in my country in 1975 by North China Pharmaceutical Factory and Beijing Pharmaceutical Industry Research Institute. Clindamycin is an antibacterial drug with direct antibacterial activity and can produce antibacterial effects in vitro. [0005] Clindamycin phosphate is a semi-synthetic clindamycin derivative. It has no antibacte...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/10A61K47/18A61K47/02A61K31/7056A61P31/04
CPCA61K9/0019A61K9/08A61K31/7056A61K47/02A61K47/10A61K47/44A61P31/04
Inventor 徐青景邢艳平郭梦玲魏彦君
Owner SHANDONG WEIZHI BAIKE PHARM CO LTD
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