Method for inhibiting precipitation of oral liquid

Abstract

The invention discloses a method for inhibiting precipitation of an oral liquid. The method adopts the manners of adding 0.01-3% of EDTA-2Na or EDTA-4Na in the liquid preparation process to complex metal ions in a solution and block the formation pathway of tannin red precipitate, and using low-temperature storage of -5 DEG C to 10 DEG C in the storage process to block or inhibit the formation pathway of ellagic acid precipitate. The combination of the two manners can significantly improve the clarity of the oral liquid, so that the amount of precipitate formed after 6 months of storage is only 1 / 10 of that of an original solution stored at normal temperature, the visible precipitate is reduced, and the quality of the product is greatly improved.

Description

technical field [0001] The invention relates to a method for inhibiting the generation of oral liquid precipitation. Background technique [0002] Oral liquid is based on traditional Chinese medicine decoction, extracting the active ingredients in the medicine, adding additives such as flavoring agents and antibacterial agents, and making a sterile or semi-sterile product according to the injection ampoule filling and sealing process. Oral liquid formulation, therefore also known as oral ampoules. [0003] The prescription of Sanlejiang oral liquid (SOL) is derived from Indian Ayurvedic medicine and Tibetan medicine famous prescription Sanguo Decoction (Zhebusong), which is extracted and purified from emblica, chebula and emblical fresh juice It is prepared through the processes of removing impurities, preparing liquid, filling, and sterilizing. It is an important health-care medicine for students and mental workers in my country to refresh their minds, enhance immunity, and...

AI Technical Summary

Problems solved by technology

During the storage process, as short as half a month and as long as 1-2 months, a certain amount of black or dark brown precipitates will be produced, and the amount of precipitates will continue to increase with the prolongation of the storage time. The reduction of ingredient content will affect the effectiveness and stability of the oral liquid. On the other hand, it will make consumers mistakenly think that the product has deteriorated, which will affect the patient's psychology.

[0005] Taking Sanlejiang Anti-fatigue Oral Liquid as an example, since it came out in the early 1990s, the problem of clarity has always existed, and it is difficult to store it stably for more than 3 months, which seriously affects the shelf life of the product

Although continuous process improvement research has been carried out, the early alcohol precipitation has been changed to gelatin and chitosan for multiple adsorption clarification, and measures such as filter paper pulp and PT membrane pressure filtration have been added. The chemical nature and formation mechanism of the drug are not clearly understood, and it is impossible to form a targeted regulation technology, and it is always difficult to achieve the technical goal of stable storage for more than 3 months

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