Method for determining sodium bicarbonate content in compound preparation

Abstract

The invention provides a method for determining sodium bicarbonate content in compound preparation, which comprises steps of preparing sodium bicarbonate negative solution according to buffer base in a compound preparation prescription; determining sodium bicarbonate negative solution, determining a compound preparation sample, counting the sodium bicarbonate content and the like; according to the invention, the preparation of the sodium bicarbonate negative solution is increased; the sodium bicarbonate negative solution is corrected through a determined value; the interference of the buffer base such as sodium lactate and the like at an aspect of a content result is removed; in addition, novel color developing agent use technology is used; phenolphthalein-cresol red-thymol blue indicator is added based on original methyl red-bromocresol green indicator; the content of sodium carbonate and the sodum bicarbonate can be determined synchronously through the judgment of two ending points; simultaneously, color change is improved from the gradual change process of an original method into the sudden change process of a novel method. According to the invention, a content determining method is characterized by simple operation; and a determined result is precise, effective and stable.

Description

technical field [0001] The invention relates to the field of drug testing, in particular to a method for measuring the content of sodium bicarbonate in compound preparations. Background technique [0002] The sodium bicarbonate compound preparation (being peritoneal dialysis solution) in the prior art, its solvent is water, contains sodium chloride, calcium chloride, magnesium chloride, glucose, sodium lactate and sodium bicarbonate etc. in the prescription. According to relevant national regulations, the quality standard of the compound preparation should include the content determination experiments of various ionic components therein, but according to the 2010 version of "The People's Republic of China Pharmacopoeia", the content determination method of sodium bicarbonate in sodium bicarbonate injection is only as follows methods: [0003] Precisely measure an appropriate amount of this product (approximately equivalent to 0.5g of sodium bicarbonate), add water to make 5...

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Problems solved by technology

[0007] 2. The prescription contains sodium lactate and other buffer bases. Sodium lactate is a weak acid and strong base salt. It will consume a certain amount of hydrochloric acid during titration, resulting in high measured values.

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