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Clindamycin phosphate injection composition and preparation method thereof
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A technology of clindamycin phosphate and injection, which is applied in the direction of pharmaceutical formula, medical preparations containing active ingredients, freeze-dried delivery, etc., and can solve problems such as poor stability
Inactive Publication Date: 2014-02-12
江苏金丝利药业股份有限公司
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[0006] Aiming at the shortcoming of poor stability of the existing clindamycin phosphate injection, the present invention proposes a clindamycin phosphate injection composition and a preparation method thereof
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Embodiment 1
[0033] ClindamycinPhosphate Injection Composition 1 includes the following components:
[0039] The preparation of clindamycin phosphate injection composition is as follows:
[0040] (1) Dosing
[0041] Add water for injection into the liquid preparation tank, add the prescription amount of sodium hydroxide, make it into a concentration of 2%, stir and dissolve; add the prescription amount of clindamycin phosphate, measure the pH value of the solution after completely dissolving, the pH value is 6.0~ 7.0; Add 0.1% (w / w) medicinal activated carbon, dilute to the total volume with water for injection, stir for 30 minutes, and filter to remove carbon. Use a 0.22 micron microporous filter membrane to sterilize and filter, fill in 7ml vials with 2g and 4g per bottle ...
Embodiment 2
[0068] Clindamycin phosphate injection composition 2 includes the following components by weight:
[0073] The preparation of clindamycin phosphate injection composition is as follows:
[0074] (1) Dosing
[0075] Add water for injection into the liquid preparation tank, add the prescription amount of sodium hydroxide, make it into a concentration of 2%, stir and dissolve; add the prescription amount of clindamycin phosphate, measure the pH value of the solution after completely dissolving, the pH value is 6.0~ 7.0; Add 0.1% (w / w) medicinal activated carbon, dilute to the total volume with water for injection, stir for 30 minutes, and filter to remove carbon. Use a 0.22 micron microporous filter membrane to sterilize and filter, fill in 7ml vials with 2g and 4g per bottle respectively, add rubber stoppers halfway, put them in a freeze-dry...
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Abstract
The invention provides a clindamycinphosphate injection composition and a preparation method thereof. The clindamycinphosphate injection composition comprises the following components in parts by weight: 178-179 parts of clindamycinphosphate, 12-13 parts of sodiumhydroxide and 1000 parts of water for injection. The preparation method of the clindamycin phosphate injection composition comprises the following steps: adding water for injection; adding sodiumhydroxide into the water for injection; adding clindamycin phosphate into the solution added with sodiumhydroxide, so as to obtain a mixed solution, wherein pH of the mixed solution is 6.0-7.0; adding activated carbon into the mixed solution, realizing constant volume by adopting the water for injection, stirring, filtering, and decarbonizing; sterilizing and filtering the decarbonized mixed solution, and carrying out split charging and freeze drying, thus the clindamycin phosphate injection composition is obtained. The clindamycin phosphate injection composition has good stability, contains less impurities and is simple to prepare and applicable to industrial production.
Description
technical field [0001] The invention relates to the technical field of clindamycin phosphate, in particular to a clindamycin phosphate injection composition and a preparation method thereof. Background technique [0002] Clindamycin phosphate, chemical name: (2S-trans)-6-(1-methyl-4-propyl-2-pyrrolidinecarboxamido)-1-thio-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. Structural formula: [0003] [0004] ClindamycinPhosphate is white or off-white crystalline powder; odorless or almost odorless, bitter; hygroscopic. This product is easily soluble in water, slightly soluble in methanol, almost insoluble in ethanol, acetone or chloroform. But its stability is poor. A semi-synthetic derivative of clincomycin whose mechanism of action is the inhibition of bacterial protein synthesis. Gram-positive bacteria such as Staphylococcus aureus, Staphylococcus epidermidis,...
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