A kind of preparation method and quality control method of compound injection
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A quality control method and injection technology, which are used in medical preparations containing active ingredients, pharmaceutical formulas, measuring devices, etc.
Active Publication Date: 2011-12-28
CHANGZHOU SIMM DRUG RES & DEV CENT
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[0004] One of the purposes of the invention is to provide a preparation method of compound injection, which effectively solves the problem of the raw material drug being adsorbed by activated carbon through the preparation method of separate preparation of concentrated compounding combined with dilute compounding and the use of methods such as replacing or removing titanium rods, and prepares the compound injection Injection
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[0074] (2) Preparation: Weigh 20.8 kg of levocarnitine raw material, stir and dissolve in 60,000 mL of water for injection at 60°C, after dissolving, add water for injection at 60°C to about 90,000 mL.
[0075] (3) pH adjustment: stir and add hydrochloric acid to the above-mentioned levocarnitine solution, and adjust the pH to 6.02.
[0076] (4) Decolorization: Weigh 401.21g of activated carbon (0.4% cast, w / v), add it into the pH-adjusted levocarnitine solution while it is hot, stir in a water bath at 60°C for 30 minutes, and the stirring speed is about 200r / min.
[0077] (5) Filtration: After the decolorization is completed, when the temperature of the solution drops be...
[0104] (1) Feeding (for the preparation of compound acetyl-levocarnitine injection 5000mL)
[0105]
[0106] (2) Preparation: Weigh 1.06kg of acetyl-levocarnitine raw material, stir and dissolve it in 3000mL of water for injection at 60°C and add 1.50g of EDTA. After dissolving, add to 4900mL with 60°C of water for injection.
[0107] (3) pH adjustment: Stir and drop hydrochloric acid into the above-mentioned acetyl-levocarnitine solution to adjust the pH to 5.6.
[0108] (4) Decolorization: Weigh 10.02g of activated carbon (0.2%, W / V), add it to the pH-adjusted acetyl-levocarnitine solution while it is hot, decolorize in a water bath at 60°C for 20min, and stir at a speed of about 250r / min.
[0109] (5) Filtration: After the decolorization is completed, when th...
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Abstract
The invention relates to a preparation method and a quality control method of a compound injection, belonging to the fields of preparation methods and quality control methods of injections. The compound injection is prepared from levocarnitine or derivatives/pharmaceutical salts thereof and trimetazidine or derivatives/pharmaceutical salts thereof as active pharmaceutical ingredients, and a pharmaceutically acceptable vector. By adopting a separate active pharmaceutical ingredient preparation process and a thick mixing/thin mixing technique, the preparation method maximally reduces the loss of the active pharmaceutical ingredients, ensures the product quality and implements the practicability of the technique; and in the quality control method, the contents of the two active pharmaceutical ingredients are simultaneously detected by high efficiency liquid chromatography, and dextrocarnitine is used as a related substance to carry out the detection. Thus, the quality control method is scientific and reasonable, and can be used for instructing production.
Description
technical field [0001] The invention relates to a preparation method and a quality control method of a compound injection. technical background [0002] There are no mature preparation methods and quality control methods for compound injections using the raw material levocarnitine or its derivatives or its pharmaceutically acceptable salts, the raw material trimetazidine or its derivatives or its pharmaceutically acceptable salts as raw materials , mainly related to the current situation of the existence of the two raw materials: ①The raw drug trimetazidine or its derivatives or its pharmaceutically acceptable salts are piperazine derivatives, the mother nucleus contains a piperazine ring, and the piperazine ring has photosensitivity Prone to ring-opening reaction (China Pharmaceutical Affairs 2000 14 (5) 322-325), and has a molecular structure similar to alkaloids, and such substances are easily adsorbed by porous substances such as activated carbon (Chinese patent medicine...
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