Comparative Diagnosis Test Accuracy of Five Weighting Methods for Type 2 Diabetes Mellitus with Dampness-heat Syndrome / 中医杂志

ObjectiveTo compare the diagnostic accuracy of five different weighting methods of Chinese medicine syndrome and then analyze their diagnostic efficacy and characteristics， by taking Diagnostic Standard for Type 2 Diabetes Mellitus （T2DM） with Dampeness-heat Syndrome （abbreviated as diagnostic standard） as an example. MethodsData from expert questionnaire on the diagnostic standard and a cross-sectional survey of 1021 patients were collected. The comparative diagnostic test accuracy （CDTA） method was used to calculate the area under the ROC curve （AUC）， area under the PR curve （AUPR）， accuracy （ACC）， sensitivity， and specificity of five commonly used weighting methods in two categories， including knowledge-driven weighting methods （expert scoring synthesis method， analytic hierarchy process， and precedence chart method） and data-driven weighting methods （logistic regression contribution method and entropy weighting method）. ResultsAmong 1021 patients with T2DM， 389 cases were diagnosed as dampness-heat syndrome. The expert scoring synthesis method， analytic hierarchy process method， and precedence chart method were basically consistent in the weight scores of each item. The expert scoring comprehensive method， analytic hierarchy process method， and entropy weighting method have a smaller difference in the weight scores of each item， while there was larger difference in the weight scores of each item of the precedence chart method and the logistic regression contribution method. The AUC （95% CI）， AUPR， ACC， sensitivity， and specifi-city of the expert scoring synthesis method were 0.913 （0.893， 0.932）， 0.851， 0.870， 0.868 and 0.875， respectively； while those of the analytic hierarchy process method were 0.910 （0.890， 0.930）， 0.838， 0.879， 0.848 and 0.896； of the precedence chart method were 0.919 （0.900， 0.937）， 0.858， 0.875， 0.871 and 0.875； of the logistic regression contribution method were 0.867 （0.842， 0.891）， 0.792， 0.853， 0.769 and 0.898； and of the entropy weighting method were 0.895 （0.873， 0.916）， 0.820， 0.869， 0.802 and 0.908. ConclusionThe knowledge-driven weighting methods are better than the data-driven weighting methods in terms of diagnostic efficacy and reflecting expert experience.

The in vitro and in vivo evaluation of fenofibrate with a self- microemulsifying formulation.

Fenofibrate is virtually insoluble in water and is highly lipophilic, which leads to poor oral bioavailability. The purpose of this approach is to develop self-microemulsifying drug delivery system (SMEDDS) for oral bioavailability enhancement of fenofibrate. The in vitro dissolution test and pharmacokinetic behavior in beagle dogs were conducted to assess the formulation of fenofibrate in selfmicroemulsifying systems. The concentrations of fenofibrate were determined by HPLC. A crossover fashion study was performed in six fasted beagle dogs with SMEDDS formulation and commercial capsules. The results showed that SMEDDS formulation provides a good drug release with more than 90% of fenofibrate dissoluted from self-emulsifying formulations while less than 10% from the commercial capsules was released within 20min. The mean particle size of SMEDDS formulation after dispersion was about 33.7nm In pharmacokinetic parameters of SMEDDS formulation, the area under the plasma concentration-time curve (AUC) was significantly higher and was approximately 7-fold greater than that obtained when commercial capsule of the same dose of fenofibrate was administered. Also, the maximum absorption was advanced (2h to 1.25h) with SMEDDS formulation. The self-microemulsifying drug delivery systems can significantly increase fenofibrate dissolution in vitro and absorption in vivo.

The In vitro and In vivo Evaluation of Fenofibrate with a Self-microemulsifying Formulation.

Fenofibrate is virtually insoluble in water and is highly lipophilic, which leads to poor oral bioavailability. The purpose of this approach is to develop self-microemulsifying drug delivery system (SMEDDS) for oral bioavailability enhancement of fenofibrate. The in vitro dissolution test and pharmacokinetic behavior in beagle dogs were conducted to assess the formulation of fenofibrate in self-microemulsifying systems. The concentrations of fenofibrate were determined by HPLC. A crossover fashion study was performed in six fasted beagle dogs with SMEDDS formulation and commercial capsules. The results showed that SMEDDS formulation provide a good drug release with more than 90% of fenofibrate dissoluted from self-emulsifying formulations while less than 10% from the commercial capsules was released within 20min. The mean particle size of SMEDDS formulation after dispersion was about 33.7nm In pharmacokinetic parameters of SMEDDS formulation, the area under the plasma concentration-time curve (AUC) was significantly higher and was approximately 7-fold greater than that obtained when commercial capsule of the same dose of fenofibrate was administered. Also, the maximum absorption was advanced (2h to 1.25h) with SMEDDS formulation. The self-microemulsifying drug delivery systems can significantly increase fenofibrate dissolution in vitro and absorption in vivo.

Study on Formation Technics of Xuesaitong Drop Pills / 中国药房

OBJECTIVE:To study the optimum formation technics of Xuesaitong drop pill.METHODS:Parallel tests were conducted on the dosage of different base materials and the main drug with the forming percentage and the rate of qualified weight as the index of evaluation,the orthogonal test was conducted on the4factors,including the temperature of drops and the liquor condensate,the drug height in the drug storage tank and the dropping distance.RESULTS:The ratio of base materials and the main drug was2.5∶1.The optimum forming technics could be seen as follows,the height of the drug storage tank was3cm,the temperature of drops was90℃,the dropping distance was5cm and the temperature of the liquor condensate was12.5℃.CONCLUSION:There was a high rate of end product of dropping pill prepared with this optimum process,which was in conformity with the standard stated in the Chinese Pharmacopoeia.

Empirical Study on the Extraction of Volatile Rose Oil by Supercritical Fluid Extraction / 中国药房

OBJECTIVE:To extract volatile rose oil by the supercritical fluid extraction technology.METHODS:The optimum extraction technology condition was investigated by orthogonal experiment with extraction rate as the evaluation in?dex,and with the pressure,temperature of extraction and the flow of CO 2 as investigation factors(3levels of each were cho?sen).RESULTS:The optimum technology condition was the following:the extraction pressure was25MPa,the temperature was50℃and the flux of CO 2 was600L/h.CONCLUSION:The established method has the following merits:high extraction rate,fast speed,simple technics,pollution-free,pure extraction etc.

Preparation Methods of Dripping Core Pills / 中国药房

OBJECTIVE: To develop a new form named dropping core pills which contain both water soluble and liposoluble constituents of the traditional Chinese medicine compounds. METHODS: Volatile, liposoluble and water-soluble constituents were extracted with supercritical fluid extraction-CO2,ethanol extraction, water decoction and membrane separation and other methods respectively. The dropping core pills were prepared with liposoluble and volatile constituents before being coated with water-soluble constituent. RESULTS: As compared with watered pills and dropping pills, dropping core pills had the advantages of both but overcome their shortages in that the dosage form was optimized, the amount of the reagent less and the resolving time was shorter. CONCLUSION: Dropping core pill was a new dosage form suitable for traditional Chinese Medicine compounds in which liposoluble and water-soluble components were both active compounds.