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To establish the analytical method for the release kinetic (RK) of Aconitum Brachypodum gel based on the nonlinear mixed effect model (NLMEM), in order to rationally evaluate the drug release process and explain the release mechanism.The zero-order kinetic model containing for non-corroded drug system with the random effect was taken as the base model. The fixed effect and random effect factors impacting the drug release were analyzed by PROC NLMIXED of SAS to establish the final typical model. Subsequently, 10 training subsets were randomly extracted from the primary data to respectively their RK models, calculate the corresponding predicted root-mean-square error and average relative error, and evaluate the model stability and prediction accuracy.The burst effect F0 had a very significant effect on the RK model. Among the component factors, carbopol 940 showed an obvious effect on the inherence release speed constant k0 and the concentration gradient change constant a, with different variations on the basis of dosage range. The random effect factors of k0 and a had a significant impact. The final RK model was proved to be stable, effective and reliable in the cross validation.The drug release kinetic analysis method could be used to rationally evaluate the drug release process and explain the release mechanisms.

For anti-inflammation, relieving pain and decreasing acute toxicity, the best condition for extracting procedure of Psammosilene tunicoides was chosen. And the relationships between several solvent extracts and pharmacodynamic index were studied.Uniform design with multi-targets was used in the optimization process, and the evaluate index were the results of anti-inflammation, relieving pain and LD50 were employed as the evaluating indexes. At the same time, the contents of the extracts, water extract, acetic ester extract and ether extract were determined.The best condition is that the medicinal material is optimized with 8 times of water (pH 6-7) and 2 h of each time. The best condition is satisfactory by test verification. And the pharmacodynamic actions of anti-inflammation, relieving pain and LD, were not obviously related to the dry extracts, water extract, acetic ester extract and ether extract.Uniform design method with pharmacodynamic index has the merit of being relaated to the function and symptom directly. The extracted twice technology condition optimized is stable, feasible and suitable for industry production. And it is not suitable to take the solvent extracts as quality control index related to the function and symptom.

To establish the optimized preparation procedure and study the method to determine the content for soybean isoflavone(SIF) Dropping Pills.The preparation conditions, such as the proportion between SIF and PEGs, the temperature of mixture of SIF and PEGs, dropping distance, etc., were studied with Uniform Design and One-way ANOVA. SIF was identified by TLC and the content of SIF was determined by UV spectrometry at 262 nm detection wavelength.Three batches of the prepared products meet the standards of the Chinese pharmacopoeia on dropping pills. SIF can be identified by TLC. Using UV spectrometry, the linear range of SIF was 0. 407 2 to 4. 072 g x mL(-1) and the correlation coefficient was 0. 999 8. In high, middle and low concentration, average recovery were 96. 54%, 97.27% and 97.21%, respectively (RSD were 1.3%, 0.78% and 0.71%).The preparation procedure is feasible, simple and suitable, the method established in this paper can be adopted for the quality control of SIF dropping pills, and the determination method is simple, relatively fast and accurate.

To optimize the different components proportions of the Realgar floating tablets for gastric retention by uniform design and correlation analysis.With the different dosage of hydroxypropyl methyl cellulose (HPMC) as the tablets frame matrix, uniform design and correlation analysis were used to optimize the best component proportions of formula, and to measure the dissolution of the tablets in vitro.Dissolution of the tablets in vitro was conformed to the expectation of experiment. The drug-release mechanism was by diffusion and corrosion at the same time.The Realgar floating tablets for gastric retention achieved the goal of design, which demand sustained release and safety.

To study the transdermal osmosis process of Aconitum brachypodum's liniment, gel and patcher to provide basis for selecting dosage form and controlling the quality.Taking the cumulate rate of transdermal as index, a imitated Fick's diffusion device was used for the investigating the transdermal osmosis course of the three preparations. The best transdermal mathematics models are obtained and the relations between the transdermal course and the release course are analysed.The three preparations have different characteristics of transdermal osmosis course. The liniment meets dynamics 0 order process, the gel and the patcher meet dynamic 0 order process of non-corroded drug system. And the relation is good cubic equation between their transdermal course and release course.The transdermal osmosis experiment in vitro for three preparations can provide basis for selecting dosage form and the quality control in future studies.