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Clindamycin hydrochloride injection and preparation method thereof

A technology for clindamycin hydrochloride and injection, which is used in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. To avoid problems such as poor performance, to achieve the effects of prolonged storage time, good bacteriostatic effect and stable content

Inactive Publication Date: 2021-08-27
苏州天马医药集团天吉生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the stability of its aqueous solution is slightly poor, and the sulfatide bond in the structure is easily hydrolyzed under the action of acid or metal, thus affecting the stability of the liquid medicine

Method used

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  • Clindamycin hydrochloride injection and preparation method thereof
  • Clindamycin hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] (1) Weigh 50 g of clindamycin hydrochloride, add water for injection to dissolve and dilute to 50 mL as stock solution, and set aside.

[0026] (2) Weigh 0.025 g of sodium edetate and dilute it with water for injection to obtain an aqueous solution of sodium edetate with a concentration of 0.1%.

[0027] (3) Accurately draw 25 mL of the stock solution, add 2.25 g of sodium chloride for injection, stir until dissolved, add 0.1% aqueous solution of sodium edetate to obtain a clindamycin hydrochloride mixed solution.

[0028] (4) Weigh 0.1 g of L-cysteine, dissolve it with water for injection, mix it with clindamycin hydrochloride mixed solution, and adjust the pH to 4.5 with pH 4.8 acetic acid-sodium acetate buffer solution.

[0029] (5) Heat the mixed solution to 115° C., and filter it with a 0.22 μm filter membrane under sterile conditions to obtain clindamycin hydrochloride injection.

Embodiment 2

[0031] (1) Weigh 50 g of clindamycin hydrochloride, add water for injection to dissolve and dilute to 50 mL as stock solution, and set aside.

[0032] (2) Weigh 0.01 g of sodium edetate and dilute it with water for injection to obtain an aqueous solution of sodium edetate with a concentration of 0.05%.

[0033] (3) Precisely draw 25 mL of the stock solution, add 1.5 g of sodium chloride for injection, stir until dissolved, add 0.05% aqueous solution of sodium edetate to obtain a clindamycin hydrochloride mixed solution.

[0034] (4) Weigh 0.05 g of L-cysteine, dissolve it with water for injection, mix it with clindamycin hydrochloride mixed solution, and adjust the pH to 4 with pH 4.8 acetic acid-sodium acetate buffer solution.

[0035] (5) Heat the mixed solution to 115° C., and filter it with a 0.22 μm filter membrane under sterile conditions to obtain clindamycin hydrochloride injection.

Embodiment 3

[0037] Take 2 mL of the clindamycin hydrochloride injection prepared in Example 1, add 1 g of sucrose, place the mixed solution in liquid nitrogen for 10 min, and freeze-dry for 24 h using a lyophilizer.

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Abstract

The invention relates to a clindamycin hydrochloride injection which contains clindamycin hydrochloride, sodium chloride for injection, L-cysteine and sodium edetate, the mass ratio of clindamycin hydrochloride to sodium chloride for injection to L-cysteine to sodium edetate is 50: (1-5): (0.04-0.2): (0.01-0.1), and the stability of the clindamycin hydrochloride injection is remarkably improved; meanwhile, a proper freeze-drying protective agent is selected so that the preservation time of the injection can be properly prolonged.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a clindamycin hydrochloride injection and a preparation method thereof. Background technique [0002] Clindamycin hydrochloride, also known as clindamycin, belongs to the lincomycin class of antibiotics and is a derivative of lincomycin. Clindamycin hydrochloride has strong antibacterial activity and broad antibacterial spectrum. It has antibacterial activity against Gram-positive aerobic bacteria, streptococcus and staphylococcus, and also has antibacterial activity against various anaerobic bacteria, chlamydia, mycoplasma and hookworm , It is often used clinically to treat tonsillitis and pharyngitis, lung infection, bone and joint infection, etc. At present, clindamycin has been included in the Chinese Pharmacopoeia, and it has also been included in the pharmacopoeias of the United States, Britain, Japan and other countries. [0003] The mechanism of acti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/19A61K31/7056A61K47/02A61K47/18A61K47/26A61P31/04
CPCA61K31/7056A61K9/08A61K9/19A61K9/0019A61K47/183A61K47/02A61K47/26A61P31/04
Inventor 沈云峰余婧岚杨振亚
Owner 苏州天马医药集团天吉生物制药有限公司
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