Sodium carboxymethylstarch and preparation thereof

Abstract

The invention belongs to the pharmaceutical field, which relates to sodium carboxy methyl starch and a preparation method thereof. Products prepared by the existing preparation method of the sodium carboxy methyl starch are poor in clarification, have a plurality of white blocks, are extremely low in degree of substitution and are not in accordance with pharmaceutical standards; the technical problem solved by the invention is the improvement to the existing method, and the obtained products are colorless, transparent, uniform, exquisite and are in accordance with the pharmaceutical standards. The preparation method comprises the following steps: A. starch is hydrolyzed and gelatinized in a water solution with alcohol; B. carboxymethylation is carried out; and C pulpous products are settled, still stood overnight, filtered, alcohol precipitated, disssolved repeatedly, settled so as to obtain the sodium carboxy methyl starch; and the improvement lies in that a method of gradient heating is adopted to heat room temperature to 85 DEG C for carring out heating during the hydrolysis and gelatinization in the step A. The sodium carboxy methyl starch prepared by the preparation method is completely in accordance with requirements of the sodium carboxy methyl starch in ministry standards, which can satisfy the demands of the sodium carboxy methyl starch to be applied as immunity regulation medicines and is used for treating diseases, such as child repetitive respiratory infections and the induced bronchial asthma and the llike.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to an immunomodulator drug carboxymethyl starch sodium and a preparation method thereof. Background technique [0002] The immunomodulatory drug Carboxymethyl Starch Sodium (slurry) is recorded in Volume 6 of Part Two of the Ministry of Health of the People’s Republic of China’s Ministry of Health’s Drug Standards (Ministerial Standards for short), which is made from starch by partial hydrolysis. According to the calculation of the dry product, the sodium carboxymethyl starch content is more than 12.5%, the specific rotation of the sodium carboxymethyl starch is more than +175°, the intrinsic viscosity is 20-45, and the chloride must not exceed 5‰. [0003] Chinese patent CN85103760A, application number 85103760, the name of the invention is sodium carboxymethyl starch and the preparation method containing this material. It discloses a method for preparing sodium carboxymethyl s...

AI Technical Summary

Problems solved by technology

The contriver when applying this method to prepare carboxymethyl starch sodium, finds that can't prepare the carboxymethyl starch sodium that meets drug standard: its finished product clarification degree is poor, does not gelatinize hydrolyzed starch under certain temperature and make its molecular size as consistent as possible, according to The sodium carboxymethyl starch produced in its embodiment 1 has poor clarity, a large number of white lumps, and a very low degree of substitution, which is far from the requirements of the ministerial standards and does not meet the second part of the drug standards issued by the Ministry of Health of the People's Republic of China. According to the provisions of the booklet, it is necessary to improve the technology disclosed by the patent

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