Studies On The Preparation Of Shuang Huang Lian (SHL) In Situ Gel

The purpose of this paper was to develop a thermosensitive in situ gel including Shuang Huang Lian (SHL) for rectal administration. This dosage form can make itself liquid state at room temperature and a semisolid gel at rectal temperature with the advantage of safe and sure effect, stable property, controllable quality, simple preparation, convenient administration and good compliance of patient.According to The gelation properties of the thermosensitive materials, the formulation screening was performed by taking appearance, viscosity at 25℃(room temperature), gelation temperature, pharmaceutical stability as indices and the two available formulations were obtained. With the study of gelation temperature, dynamic rheological properties and the in vitro release mechanisms of the the three components, chlorogenic acid、baicalin and phillyrin, the better choice for the two available formulations was made.The method for the determination of chlorogenic acid、baicalin and phillyrin at the same time in SHL in situ gel was established by gradient elution of HPLC. The rusults of the technology consideration indicated that it was suitable for the quality control of Shuanghuanglian in-situ gel with the advantage of rapid and convenient analysis, good sensitiveness and specificity, accurate quantitation and reliable results. The stability of the preparation was carried out. The influencing factors tests indicated that this preparation was a little unstable to heat and light, therefore, it should be stored at low temperature without light. The accelerating tests and room temperature tests for three months indicated the initial stability of SHL in situ gel was nice.