Clindamycin phosphate freeze-drying powder for injection, and preparation method thereof

A technology of clindamycin phosphate and freeze-dried powder, which is applied in the field of clindamycin phosphate freeze-dried powder and its preparation, and can solve the problems such as change in appearance of clindamycin phosphate freeze-dried powder, increase in substance content and the like , to achieve the effect of good resolubility, little muscle stimulation, and stability

Inactive Publication Date: 2018-12-18
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, after several years of production and inspection, it was found that the clindamycin phosphate freeze-dried powder prepared by this method occasionally changed in appearance after long-term storage, and the content of related substances increased significantly.

Method used

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  • Clindamycin phosphate freeze-drying powder for injection, and preparation method thereof
  • Clindamycin phosphate freeze-drying powder for injection, and preparation method thereof
  • Clindamycin phosphate freeze-drying powder for injection, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] A clindamycin phosphate freeze-dried powder for injection, wherein the main drug is clindamycin phosphate, the auxiliary solvent is sodium hydroxide, the auxiliary materials are sodium chloride and mannitol, and the solvent is water for injection. The quality of the clindamycin phosphate, sodium chloride, mannitol and sodium hydroxide is 300g, 30g, 12g and 54g respectively, which is supplemented to 2200g with water for injection. Use the above-mentioned materials to make 1000 finished products with a specification of 0.3g.

[0035] Its preparation process includes:

[0036] S1, material preparation: weigh clindamycin phosphate, sodium chloride, mannitol, sodium hydroxide according to the formula;

[0037] S2, preparation of medicinal solution: add 1100g water for injection to the liquid preparation tank, add 54g sodium hydroxide to fully dissolve, cool to room temperature; then add 300 grams of lindamycin phosphate, 30 g sodium chloride and 12 g Mannitol, stir to make...

Embodiment 2

[0048] The difference between this embodiment and embodiment 1 is:

[0049] During preparation,

[0050] S2, preparation of medicinal solution: add 1100g water for injection to the liquid preparation tank, add 54g sodium hydroxide to fully dissolve, cool to room temperature; then add 300 grams of lindamycin phosphate, 30 g sodium chloride and 12 g Mannitol, stir to make it dissolve completely; take a sample to test the pH value of the medicinal solution, adjust the pH value of the system to 6.0 with 1mol / L sodium hydroxide solution; then make up to 2200g with water for injection;

[0051] S5. Freeze-drying: put the subpackaged vials into a freeze-dryer, and freeze-dry to obtain a freeze-dried powder; the specific drying steps include:

[0052] S51. Pre-freezing: place the subpackaged clindamycin phosphate liquid on the partition layer in the lyophilizer, adjust the temperature of the partition, and reduce the clindamycin phosphate liquid to -20°C. Keep warm for 30 minutes; t...

Embodiment 3

[0058] The difference between this embodiment and embodiment 1 is:

[0059] A kind of freeze-dried powder of clindamycin phosphate for injection, the quality of described clindamycin phosphate, sodium chloride, mannitol, sodium hydroxide is respectively 300g, 33g, 10.5g, 60g, supplemented with water for injection to 2200g.

[0060] The difference in the preparation process is that,

[0061] S2, preparation of medicinal liquid: add 1100g water for injection in the liquid preparation tank, add 60g sodium hydroxide to fully dissolve, cool to room temperature; then add 300 grams of lindamycin phosphate, 33g sodium chloride and 10.5 g mannitol, stir to make it dissolve completely; take a sample to test the pH value of the medicinal solution, adjust the pH value of the system to 5.8 with 1mol / L sodium hydroxide solution; then make up to 2200g with water for injection;

[0062] S3. Filtration: add 4.4g of medicinal activated carbon to the liquid mixing tank, stir and absorb for 35m...

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Abstract

The invention relates to clindamycin phosphate freeze-drying powder for injection. The clindamycin phosphate freeze-drying powder for injection is prepared from the following components in parts by weight: 100 parts of clindamycin phosphate, 5 to 15 parts of sodium chloride, 2 to 6 parts of mannitol, and 10 to 30 parts of sodium hydroxide. A preparation method comprises the steps of preparing rawmaterials; preparing a medicine liquid; filtering; sub-packaging in a sterile way; vacuum freeze drying and packaging, wherein vacuum freeze drying comprises pre-freezing, one-stage drying, two-stagedrying, three-stage drying and four-stage drying. According to the clindamycin phosphate freeze-drying powder for injection provided by the invention, through adjusting and accurately controlling a product recipe, processing steps and control parameters, the stability performance of the product is further ensured; through the sufficient verification of a stability test, an acceleration test and along-term test, the clindamycin phosphate freeze-drying powder prepared by adopting the method provided by the invention is not changed in appearance, remarkably increased in related substances, and remarkably reduced in main content, so that the storage stability and the clinic application safety of the clindamycin phosphate freeze-drying powder are ensured maximally.

Description

technical field [0001] The invention relates to a medicine production method in the pharmaceutical field, in particular to a clindamycin phosphate freeze-dried powder and a preparation method thereof. Background technique [0002] Clindamycin Phosphate, whose 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, the molecular formula is C 18 h 34 C l N 2 o 8 PS, clindamycin phosphate is a derivative of clindamycin, which is inactive in vitro. After being injected into the body, it is quickly hydrolyzed into clindamycin to exert pharmacological effects and inhibit bacterial protein synthesis. It is mostly used clinically to treat Gram-positive It is also effective against bacteria resistant to penicillin, tetracycline, and erythromycin for infection by cocci and anaerobic bacteria, and has a prominent effect on various anaerobic bacteria. Abdominal cavity an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/7056A61K47/10A61P31/04
CPCA61K9/19A61K31/7056A61K47/10A61P31/04
Inventor 吴玉章杨杰钟海雄林小雪符永红王静
Owner HAINAN GENERAL & KANGLI PHARMA
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