Critical quality attribute assessment of big brand traditional Chinese medicine: quality control method of ginkgo leaves extract material based on powder physical properties / 中国中药杂志

The physical properties of ginkgo leaves extract(GLE) are the critical quality attributes for the control of the manufacturing process of ginkgo leaves preparations. In this study, 53 batches of GLE with different sources from the real world were used as the objects to carry out the research from 3 levels. First, based on micromeritics evaluation method, a total of 29 physical attribute quality parameters in five dimensions were comprehensively characterized, with a total of 1 537 data points. Further, with use of physical fingerprinting technology combined with similarity evaluation, the powder physical properties of 53 batches of GLE showed obvious differences from an overall perspective, and the similarity of the physical fingerprints was 0.876 to 1.000. Secondly, hierarchical clustering analysis(HCA) and principal component analysis(PCA) models were constructed to realize the reliable identification and differentiation of real-world materials produced by GLE from different sources. Multivariate statistical process control(MSPC) model was used to create GLE material Hotelling T~2 and squared prediction error(SPE) control charts. It was found that the SPE score of B_(21) powder exceeded the 99% confidence control limit by 22.495 9, and the SPE scores of A_1 and C_(10) powder exceeded the 95% confidence control limit by 16.099 2, realizing the determination of abnormal samples in the materials of GLE from the production in real world. Finally, the physical quality control method of GLE in the production process of ginkgo leaves preparations was established in this study, providing a reference for the quality control methods of ginkgo leaves preparations in their manufacturing process.

Criticalquality attribute assessment of big brand traditional Chinese medicine: visualization method for quality control of Ginkgo Leaves Tablets based on spatial distribution uniformity / 中国中药杂志

Spatial distribution uniformity is the critical quality attribute(CQA) of Ginkgo Leaves Tablets, a variety of big brand traditional Chinese medicine. The evaluation of the spatial distribution uniformity of active pharmaceutical ingredients(APIs) in Ginkgo Leaves Tablets is important in ensuring their stable and controllable quality. In this study, hyperspectral imaging technology was used to construct the spatial distribution map of API concentration based on three prediction models, further to realize the visualization research on the spatial distribution uniformity of Ginkgo Leaves Tablets. The region of interest(ROI) was selected from each Ginkgo Leaves Tablet, with length and width of 50 pixels, and a total of 2 500 pixels. Each pixel had 288 spectral channels, and the number of content prediction data could reach 1×10~5 for a single sample. The results of the three models showed that the Partial Least Squares(PLS) model had the highest prediction accuracy, with calibration set determination coefficient R_(pre)~2 of 0.987, prediction set determination coefficient R_(pre)~2 of 0.942, root mean square error of calibration(RMSEC) of 0.160%, and root mean square error of prediction(RMSEP) of 0.588%. The classical least-squares(CLS) model had a greater prediction error, with the RMSEP of 0.867%. Multivariate Curve Resolution-Alternating Least Square(MCR-ALS) model showed the worst predictive ability among the three models, and it couldn't realize content prediction. Based on the prediction results of PLS and CLS models, the spatial distribution map of APIs concentration was obtained through three-dimensional data reconstruction. Furthermore, histogram method was used to evaluate the spatial distribution uniformity of API. The data showed that the spatial distribution of APIs in Ginkgo Leaves Tablets was relatively uniform. The study explored the feasibility of visualization of spatial distribution of Ginkgo Leaves Tablets based on three models. The results showed that PLS model had the highest prediction accuracy, and MCR-ALS model had the lowest prediction accuracy. The research results could provide a new strategy for the visualization method of quality control of Ginkgo Leaves Tablets.

Orthogonal Experiment Study on Extraction Process of Ginkgo Leaves / 中国中医药信息杂志

Objective To determine the best extraction process of ginkgo leaves with the total transfer rate of total flavonol glycosides and terpene lactones as the index.Methods The effects of ethanol concentration, solid-liquid ratio and extraction time on extraction process were investigated by orthogonal design method, and the contents of total flavonol glycosides and terpene lactones were detected by HPLC to calculate transfer rate.Results The optimum extraction conditions were as follows:85% ethanol refluxing and extracting for three times;the first time extracting with five-fold amount of solvent (V/W) for 3 hours;the last two times with three-fold solvent (V/W) for 2 hours.Conclusion This extraction process has the advantages of simplicity of operator, reason, energy conservation, high efficiency, and is suitable for industrial production.

GINKGO LEAVES ASSOCIATED WITH PERENAN TREATING VASCULAR DEMENTIA / 现代医院

Objective To evaluate the effect and security of ginkgo leaves associated with Perenan in the treatment of vascular dementia.Methods Eighty two cases of vascular dementia were randomly divided into ginkgo leaves associated with Perenan treatment group (observation group) and Piracetam treatment group (control group) by case-control study.Intelligence and the social function of all patients were evaluated separately by Mini Mental State Examination(MMSE)and Functional Assessment Questionnaire(FAQ)before medication and 6 months after medication.Results MMSE and FAQ score of the observation group was significantly higher than the control group(p<0.05),the efficiency rate was significantly improved (73.81% vs 47.50%).Conclusion Ginkgo praeparatum associated with Perenan can effectively improve the cognition and social function of vascular dementia patients.Moreover, it can postpone the development of Alzheimer's disease without obviously side effect.It's an effective and safe therapy method to select.

Optimization of the Formula of Compound Ginkgo Leaves Tablets by Orthogonal Experiment / 中国药房

OBJECTIVE:To optimize the formula of the compound ginkgo leaves tablets.METHODS:The formula(dosage of low-substituted hydroxypropyl cellulose;the ratio between crude drug and loading agent and the dosage of micro-crystalline cellulose)was optimized using orthogonal design and multi-index(tablet weight variation and disintegration de-gree)comprehensive score method.RESULTS:The optimized formula was the following:the dosage of low-substituted hy-droxypropyl cellulose was5%;the ratio between crude drug and loading agent was1∶1and the dosage of microcrystalline cellulose was10%.CONCLUSION:The tablets are reasonable in formula and the forming quality of which is also good.

Effects of Extracts of Ginkgo Leaves on the Experiment Myocardial Ischemia and Blood Hemorheology / 中药新药与临床药理

Objective To observe the effects of extracts of ginkgo leaves (EGL) on acute myocardial infarction, acute myocardial ischemia and blood hemorheology.Methods The effects of EGL on acute myocardial infarction were observed in dogs model induced by the ligation of anterior descending branch of left coronary artery; effects on acute myocardial ischemia were observed on rats model caused by intravenous injection of pituitrin and effects on blood hemorheology were observed in rabbits. Results EGL significantly reduced the myocardial infarction area, decreased the activities of lactate dehydrogenase and creatine phosphokinase in dogs, reduced the elevation of ST segment of electrocardiogram in rats with myocardial ischemia and decreased whole blood viscosity and plasma viscosity in rabbits. Conclusion EGL has protective effect against myocardial ischemic injury and can improve the parameters of blood hemorheology in rabbits. Its mechanism may be concerned with the reduction of the myocardial infarction area and infarction degree and the relief of acute myocardial ischemia.