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Method for preparing clindamycin hydrochloride injection

A technology of clindamycin hydrochloride and injection, which is applied in the field of preparation of broad-spectrum antibiotic clindamycin hydrochloride injection, and can solve problems such as unstable pH value and large changes before and after sterilization

Inactive Publication Date: 2012-08-15
南阳普康药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the requirements for the related substances of the injection are relatively high, and many excipients have an influence on it, and its pH value is unstable, and changes greatly before and after sterilization. The determination of the related substances and the pH value of the injection has always been a difficult problem

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Prescription: active ingredient clindamycin hydrochloride 15g

[0018] Other components Sodium dihydrogen phosphate 1.17g

[0019] Disodium hydrogen phosphate 0.2g

[0020] Activated carbon for needles 0.02g

[0021] Water for injection 200mL

[0022] Preparation method: dissolve sodium dihydrogen phosphate and disodium hydrogen phosphate in 100mL water for injection, stir to dissolve into a phosphate buffer solution, add clindamycin hydrochloride to the phosphate buffer solution, stir to dissolve completely, and use water for injection Set the volume to 200mL, add needles to the drug solution and use activated carbon to absorb for 20min, then use a 0.45μm microporous membrane for coarse filtration, and then use a 0.22μm microporous membrane for fine filtration until the clarity meets the requirements, fill and seal with nitrogen, and circulate Steam sterilized at 100°C for 30 minutes to obtain 17 g of clindamycin ...

Embodiment 2

[0025] Prescription: Active ingredient Clindamycin Hydrochloride 825g

[0026] Other components Sodium dihydrogen phosphate 113.5g

[0027] Disodium hydrogen phosphate 8.3g

[0028] Activated carbon for needles 1.1g

[0029] Water for injection 11000mL

[0030] Preparation method: dissolve sodium dihydrogen phosphate and disodium hydrogen phosphate in 5500mL water for injection, stir to dissolve into a phosphate buffer solution, add clindamycin hydrochloride to the phosphate buffer solution, stir to dissolve completely, and use water for injection Set the volume to 11000mL, add activated carbon for needles to the drug solution and absorb for 20 minutes, then use a 0.45μm cartridge filter for coarse filtration, and then use a 0.22μm filter cartridge filter for fine filtration until the clarity meets the requirements, fill and seal with nitrogen , sterilized by circulating steam at 100°C for 30 minutes to obtain 946 g of cl...

Embodiment 3

[0033] Prescription: Active ingredient Clindamycin Hydrochloride 1125g

[0034] Other components Sodium dihydrogen phosphate 154.8g

[0035] Disodium hydrogen phosphate 11.2g

[0036] Activated carbon for needles 1.5g

[0037] Water for injection 15000mL

[0038] Preparation method: dissolve sodium dihydrogen phosphate and disodium hydrogen phosphate in 7500mL water for injection, stir to dissolve into a phosphate buffer solution, add clindamycin hydrochloride to the phosphate buffer solution, stir to dissolve completely, and use water for injection Set the volume to 15000mL, add needles to the drug solution and use activated carbon to absorb for 20min, then use a 0.45μm microporous membrane for coarse filtration, and then use a 0.22μm microporous membrane for fine filtration until the clarity meets the requirements, fill and seal with nitrogen, and circulate Steam sterilized at 100°C for 30 minutes to obtain 1290 g of cl...

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Abstract

The invention belongs to the technical field of pharmaceutical products and provides a method for preparing broad-spectrum antibiotic clindamycin hydrochloride injection. The method is mainly characterized by adopting the following steps: (1) weighing sodium dihydrogen phosphate and disodium hydrogen phosphate, putting sodium dihydrogen phosphate and disodium hydrogen phosphate into water for injection accounting for 50% of the total prepared solution and stirring and dissolving sodium dihydrogen phosphate and disodium hydrogen phosphate to prepare phosphate buffered solution; (2) adding clindamycin hydrochloride to the phosphate buffered solution and stirring and dissolving clindamycin hydrochloride; (3) using the water for injection to ensure the constant volume to reach the concentration of the injected liquid medicine and maintaining the pH value between 5.1 and 5.4; (4) adding activated carbon for injection, accounting for 0.1% of the total liquid medicine, to the liquid medicine for adsorption and then using a 0.45mu m microporous membrane or a cartridge filter with a 0.45mu m filter element for rough filtration; (5) then using a 0.22mu m microporous membrane or a cartridge filter with a 0.22mu m filter element for fine filtration until the clarity conforms to the specification; and (6) carrying out nitrogen filling, filling, sealing and sterilizing, thus obtaining the clindamycin hydrochloride injection. Lots of tests show that the single impurity content is lower than 0.5%, the total impurity content is lower than 4.5%, and the single and total impurity contents are higher than the international and national standards, so the injection has the advantages of safety and stability.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical product production, and relates to a preparation method of a broad-spectrum antibiotic clindamycin hydrochloride injection. Background technique [0002] Clindamycin is a semi-synthetic derivative of lincomycin. As early as 1966, Magerlein replaced the seventh hydroxyl in lincomycin molecule with chloride ion for the first time, thus improving lincomycin and becoming a new antibiotic-clindamycin, relative to lincomycin, clindamycin The antibacterial activity was increased by 4.8 times. The former U.S. General Pharmaceuticals (now Pharmacia) first launched the product in the United States in 1975. Clindamycin can act not only on many anaerobic bacteria such as Bacteroides, but also on Gram-positive aerobic bacteria. In the mid-1980s, clindamycin entered the Chinese market. After 1995, many pharmaceutical companies in China carried out imitation production, including clindamycin hydroc...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7056A61P31/04
Inventor 习羽夏汉卿简朝星袁旭耀张景林张小贝王珊珊周海晓杜旭举
Owner 南阳普康药业有限公司
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