Composition capable of eliminating poloxamer clouding phenomenon and application of composition to pharmaceutical preparation

Abstract

The invention discloses a composition capable of eliminating poloxamer clouding phenomenon. The composition is characterized by comprising the following components in percentage by weight: 0.0001%-10% of difficulty soluble medicine, 0.7%-30% of poloxamer, 10%-60% of a polyhydroxylated compound and the balance of water. When the composition is applied to preparation of difficulty soluble medicine injection, the clouding phenomenon is not caused after the preparation is sterilized at 115 DEG C for 30 minutes and sterilized at 121 DEG C for 10 minutes; the controllability of the whole preparation process is ensured; all the negative results caused by the clouding phenomenon during the sterilization of the preparation can be avoided. By virtue of the composition, the poloxamer clouding phenomenon is eliminated; the serious problems in application of poloxamer to the industrial mass production are solved.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a composition capable of eliminating poloxamer epilepsy and its application in pharmaceutical preparations. Background technique: [0002] Poloxamer is a class of PEO-PPO-PEO nonionic triblock copolymers composed of polyoxyethylene (PEO) and polyoxypropylene (PPO), trade names are pluronic, lutrol F (BASF, Germany) and poloxamer (ICI), the Chinese name is Poloxamer or Pluronic. The Poloxamer series contains more than 30 kinds of polymers with different PPO and PEO block ratios, all of which have surface activity. Among them, the PEO chain is relatively hydrophilic, and the polyoxypropylene chain is relatively lipophilic. The structural formula is as follows: [0003] [0004] There are many types of poloxamers, and as the degree of polymerization increases, the state of matter varies from liquid, semi-solid to waxy solid, from insoluble liquid to water-soluble solid....

AI Technical Summary

Problems solved by technology

[0006] Although poloxamer has the above-mentioned advantages and is so widely used in pharmacy, it also has disadvantages that cannot be ignored: a very serious problem determined by its own structural characteristics - epilepsy

[0010] If it is in large-scale industrial production, the serious consequences that may be caused by the poloxamer phenomenon are: when a batch or even several batches of liquid preparations of insoluble drugs that use poloxamers as solubilizers are sterilized, due to It leads to the scrapping of the preparation, especially the large-dose solution with poloxamer as the solubilizer, which not only causes multiple unnecessary losses in manpower, material resources, and financial resources of the enterprise, but also leads to poloxamer-related sterilization. The uncontrollability of the process and the randomness of qualified preparations in the preparation process

[0011] In addition, the serious consequences of poloxamer epidemiology may also lead to a greatly reduced application prospect

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