Stable glucose oral solution for glucose tolerance test

Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a stable glucose oral solution for a glucose tolerance test as well as a preparation method and application thereof. The glucose oral solution comprises 75 g of anhydrous glucose and 0.5-5.0 g of a buffer pair, the volume of water is fixed to 150-350 ml, the ratio of acid and acid salt of the buffer pair is 0.40-3.30, and the pH value of the oral solution is 3.0-5.0. The glucose oral solution is convenient to take, good in taste, stable in property, especially beneficial to control of toxic impurity 5-hydroxymethylfurfural, basically free of impurities in 0 day, lower than 0.02% in impurity content in 30 days at high temperature, and controllable in quality.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a glucose oral solution for a glucose tolerance test and a preparation method and application thereof. Background technique [0002] With the rapid development of my country's economy and the continuous improvement of people's living standards, the number of diabetic patients has ranked first in the world, and the incidence of diabetes is showing a trend of increasing year by year and becoming younger. Oral glucose tolerance test (OGTT) is currently one of the important criteria for diagnosing type 2 diabetes and gestational diabetes. [0003] At present, there is no oral solution approved by the State Food and Drug Administration that can be produced by pharmaceutical companies and meets drug standards and is suitable for oral glucose tolerance tests for patients to use. At present, there are three main methods of clinical glucose tolerance test. The first...

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Problems solved by technology

The above methods of oral glucose tolerance test have the following disadvantages: first, high-concentration sugar water tastes bad, and has obvious sweet and greasy feeling, especially for pregnant women, it is easy to cause nausea and vomiting; second, the operability of the subjects is poor, For self-preparation, you need to bring a container and a stirring spoon, and the amount of water should not be controlled. It is very inconvenient to open multiple bottles of glucose injection for direct drinking; third, oral glucose tolerance beverages are food-grade beverages that implement general standards for beverages, and the quality requirements are low. , there is no control over the second type of genotoxic impurity 5-hydroxymethylfurfural; fourth, glucose injection generally adopts high-temperature sterilization process, and glucose is easily degraded under high temperature conditions to produce 5-hydroxymethylfurfural; while 5-hydroxymethylfurfural Furfural not only has neurotoxicity, can combine with human protein to produce accumulation poisoning, but also may polymerize and cause the color of the solution to turn yellow

[0004] Regarding 5-hydroxymethylfurfural, the prior art (IN299712B) discloses that the pH of the solution is adjusted to 6-8 by alkali, especially when the pH value is adjusted to 7, the production of the impurity can be significantly reduced; good or astringent

Regarding the taste problem, the prior art (CN110314243A, CN109568603A) adjusts the taste by adding vitamin C or sour agent, essence, etc. Although it can cover the taste to a certain extent or have a sour taste, it cannot solve the problem of oral solution stability

In addition, with regard to sterility, most of the glucose oral solutions reported in the prior art (CN109044966B, US7566463B2, CN113425675A) use bacteriostatic agents, but the composition is complex and the bacteriostatic effect is not ideal, and the complex additives also have the risk of toxicity to the human body

In addition, the oral glucose solution of the prior art has complex components, low glucose content, and no control of 5-hydroxymethylfurfural impurities and microorganisms, resulting in unstable quality

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