A method for inhibiting the generation of oral liquid precipitation

Abstract

The invention discloses a method for inhibiting the formation of oral liquid precipitation, which is to add 0.01 to 3% of EDTA-2Na or EDTA-4Na in the liquid preparation link, so as to complex the metal ions in the solution and block the precipitation of tanning red The formation pathway of ellagic acid precipitation is blocked or inhibited by low temperature storage at -5-10°C during storage. Through the combination of the two methods, the clarity of the oral liquid can be significantly improved, so that the amount of precipitate formed after 6 months of storage is only 1 / 10 of that of the original liquid stored at room temperature, and the visible precipitation is reduced, which greatly improves the quality of the product.

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) originated from Indian Ayurvedic medicine and Tibetan medicine famous prescription Sanguo Decoction (Zhebu Songsan), which is extracted and purified from emblica, chebula and emblical 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 prepare...

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] Take Sanlejiang Anti-fatigue Oral Liquid as an example. Since it came out in the early 1990s, the problem of clarity has always existed. 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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