Coenzyme A medicament freeze-drying preparation and process for preparing same

Abstract

The invention discloses a coenzyme A medicament freeze-drying preparation, which adopts disodium hydrogen phosphate and sodium dishydrogen phosphate buffered salt liquor to protect a coenzyme A in the process of preparing the freeze-drying preparation. The freeze-drying preparation selects phosphate buffered salt liquor in the process of preparing medical liquor to enable the coenzyme A to be in the liquor with relatively constant pH values. Simultaneously, the phosphate buffered salt liquor is favorable for stabilizing a coenzyme A molecular structure containing phosphate groups, a coenzyme A potency (marked content) is lowered by no more than 2.5% from the process of preparing and filling to the beginning of freeze-drying.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a coenzyme A drug freeze-dried preparation and a preparation method thereof. Background technique [0002] Coenzyme A is a nucleotide coenzyme, composed of pantothenic acid, adenosine, phosphoric acid and aminoethanethiol, molecular formula: C 21 h 36 N 7 o 16 P 3 S; molecular weight: 767.54. The molecular structure is shown in the following formula: [0003] [0004] It is the coenzyme of acetylase in the body, plays the role of transferring acetyl group, and plays an important role in the metabolism of sugar, protein and lipid in the tricarboxylic acid cycle (tricarboxylic acid cycle) of human physiological metabolism. Its chemical structure was elucidated in the 1950s, introduced into clinical medical research from basic medicine in the 1960s, and began to be used clinically in the 1970s, and its safety has been extensively verified. [0005] Coenzyme A for injectio...

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Problems solved by technology

[0013] (2) The influence of pH changes on coenzyme A for injection: in the current production process, coenzyme A for injection is prepared, filled, freeze-dried, and then reconstituted for clinical use. For products with qualified pH value during preparation, when undergoing freeze-drying and reconstitution, the pH value changes greatly, reaching ±0.8, which is easy to exceed the internal control range

[0014] According to the existing production process, after a production cycle, the potency (marked content) of coenzyme A in coenzyme A for injection is generally 10-13% lower than the amount of feed, so when batching, the amount of feed is generally 110-113%. The degradation of A will inevitably increase other related impurities and affect product quality; at the same time, due to the increase in feeding amount, the production cost will increase by more than 10%.

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