Acidic biological adhesion heat-variable gelling agent, its preparing method and uses

Abstract

The invention discloses acidic biologic adhesion heat-variable gelling agent, which includes (a) 12-20 wt percent of polyoxy ethylene polyoxy propylene polymer, (b) 0.5-10wt percent of polydimethyl siloxane and (c) 1.0-2.5 wt percent of acidity buffering agent. The invention is characterized in that a pH value is 3.0 to 4.5, the gelling agent is under a liquid state at the temperature less than and equal to 28 DEG C, and is under a gel state at the temperature more than and equal to 32 DEG C. The acidic biologic adhesion heat-variable gelling agent is used to prepare liquid preparation with the function of both contraception and preventative spread disease (STDs / HIV). The acidic biologic adhesion heat-variable gelling agent provides reformation and convenience for a production process, the loading and filling operation of the liquid medicine is convenient, the filling amount is accurate, and the invention particularly is suitable for GMP scale production and becomes an optimal substitute of a contraceptive sheath or lubricating additive.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a pharmaceutical excipient gel and its preparation method and application. Background technique [0002] Gels have been used clinically for several years. At first, they were mostly prepared in small quantities for hospital preparations. Due to the continuous expansion of the application range and the continuous improvement of industrial production levels in recent years, more varieties of gels have been mass-produced. The requirement for commercially available gels is to keep the gel shape at room temperature without drying or liquefying. [0003] For example, there is a gel on the market to control vaginal pH, Aci-Jel TM (Ortho-McNeil Pharmaceutical Corp., Raitan, NJ), which is a water-dispersible buffered gel with a pH of 3.9-4.1, is used to restore and maintain normal vaginal acidity. It becomes a gel no matter in the normal temperature outside the body or in the temperature environ...

AI Technical Summary

Problems solved by technology

However, these preparations are not bioadhesive enough to truly form a barrier on the vaginal mucosal surface and thus do not adequately capture STD-causing microorganisms and / or spermatozoa, nor prevent sperm from entering

[0005] At present, all gels remain gelatinous and viscous at room temperature, so it is difficult to accurately fill the amount in production, and GMP large-scale production is extremely difficult

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