Study on process and rheological parameters of Kucha gynaecological gel / 中草药

ABSTRACT

Objective To investigate the preparation process of Kucha gynecological gel and prepare a temperature-sensitive in situ gel capable of rapid phase change in vagina. Methods Poloxamer P188 and Poloxamer P407 were used as gel matrix, Lactic acid and sodium lactate were used as the acid buffer solution. The central composite design was performed to optimize the prescription and technology, and the gelation temperature (GT), gelation time, and the effects of different acid buffer solutions on GT, gel stability, and related rheological properties were determined. Results Within a certain concentration range, the gelation temperature was gradually increased with the increase of poloxamer 188 concentration, and the gelation temperature was gradually decreased with the increase of poloxamer 407 concentration, and the optimized prescription by central composite design was poloxamer P188 with a concentration of 3.51% and poloxamer P407 with a concentration of 17.16%. The addition of different buffers has a deviation of 5% of the gelation temperature of the gel in vitro, but the variation in the vaginal fluid is large. The gelation temperatures of the citric acid-sodium citrate buffer and the lactic acid-sodium lactate buffer solution in the vaginal fluid were 68.5 ℃ and 35.8 ℃, respectively, and the rheological data showed that the gel retained better in vivo. Conclusion The Kucha gynecological gel preparation corresponded with the model employed by central composite design, and the screened process can prepare situ gels with good retention and stable properties.