Objective To establish a quality standard for Biqing Suppository. Methods Rhizoma Dioscoreae Septemlobae, Rhizoma Acori Tatarinowii, Radix Et Rhizoma Salviae Miltiorrhizae and Cortex Phellodendri Chinensis were qualitatively identified by TLC method. The content of berberine hydrochloride in Biqing Suppository was determined by HPLC method. The chromatographic column was Waters C18 (250 mm×4.6 mm, 5 μm);the mobile phase was acetonitrile∶water (0.2%phosphoric acid-0.02%three triethylamine)=25∶75;the flow rate was 1 mL/min;the detection wavelength was 265 nm. Results The spots of qualitative identification method were clear without interference. Berberine hydrochloride had good linear relationship in the range of 0.235-9.40 μg;the regression equation was Y=40 033 998.176 3X-85 021.2, r=0.999 7;the average recovery rate was 99.16%, RSD=3.45%. Conclusion The method is simple, flexible and reproducible, which can be used as the quality control standard for Biqing Suppository.

OBJECTIVE:To optimize the purification process of the extract from Yiqi guben granules. METHODS:The purifi-cation effect of the process was investigated with transfer rate of polysaccharide,calycosin glucoside and dry paste as evaluation in-dexes,using ZTC1+1 type Ⅱ,and shell poly sugar and 95% ethanol as clarifying agents. The purification process of the extract from Yiqi guben granules was optimized by orthogonal test using the ratio of material to liquid,the amount of clarifying agent and standing time as factor. The validation test was conducted. RESULTS:Selecting ZTC1+1 type Ⅱ as a clarifying agent,the best trans-fer rate of effective component had been obtained;optimal purification process was as follows as the ratio of material to liquid 1:2, the ratio of ZTC1+1 type Ⅱ A liquid 5%,the ratio of B liquid 10%,standing time of 5 h. The results of verification test showed transfer rates of dry paste in 3 tests were 71.54%,70.98%,69.21%,respectively;those of polysaccharide were 82.55%, 81.78%,82.15%,respectively;those of calycosin glucoside were 91.92%,92.34%,91.58%,respectively (all RSD≤1.72%, n=3). CONCLUSIONS:The optimized purification process is effective,stable and practical,and can be used for the purification of the extract from Yiqi guben granules.

Objective To optimize the prescription of flaxseed lignans sustained release tables by central composite design-response surface methodology.MethodsWith HPMC, EC and starch dosage as factors, and flaxseed lignans in 2, 6 and 12 h of cumulative release as evaluation indexes, central composite design-response surface optimization method was used to conduct prescription optimization experiments, and optimized prescription analysis was carried out.Results The optimal prescription of flaxseed lignans sustained release tables was as following: HPMC dosage was 43%; EC was 26%; starch content was 17%. Optimized index forecast values were very close to the observed values. In vitro release test of three selected optimal formulations indicated that there existed high approximation between the observed and estimated values.Conclusion It shows that the established model is suitable for flaxseed lignans sustained release tables, which can be used in the optimization of the prescription of flaxseed lignans sustained release tables.

Objective To investigate the effect of chronotherapy (chemotherapy plus timely medication) on neutrophils in breast cancer patients with neoadjuvant chemotherapy.Methods Fifty breast cancer patients with neoadjuvant chemotherapy were selected from 2011 to 2014 and divided into chronotherapy group and conventional treatment group (conventional group) by random number table method with 25 cases each.Conventional group received conventional neoadjuvant chemotherapy and conventional drug treatment.Chronotherapy group received neoadjuvant chemotherapy combined with chronochemotherapy and timely medication treatment,and applied clinical nursing care pathway.Both groups were conducted three cycles of chemotherapy,three weeks after the first and the second chemotherapy,the results of routine blood and liver function were compared in patients between two groups.The number of readmission and fever because of agranulocytosis were calculated.Results The two groups of patients were successfully completed three cycles of chemotherapy,after the first cycle of chemotherapy,the neutrophil was (4.40 ± 2.20)x109/L in chronotherapy group,and (3.18 ± 1.35) × 109/L in conventional group;after the second cycle of chemotherapy,the neutrophil was (3.95 ± 1.58) × 109/L,and (2.83 ± 1.49) x 109/L in conventional group,the two groups were statistically significant,t=2.375,2.563,P ＜0.05.Two cases needed readmission in chronotherapy group during chemotherapy,accounting for 8％(2/25),much lower than conventional group of 8 cases accounting for 32％(8/25).Conclusions The use of chronotherapy in breast cancer chemotherapy has less neutropenia,mild side effects of bone marrow suppression.It is an effective and safe viable option.

An approach was proposed to evaluate preparation technology by means of fingerprint-peak matching technology of high performance liquid chromatography with diode array detector (HPLC-DAD).Similarity and hierarchical clustering analysis (HCA) were applied to identify the 15 batches of Xiaochaihu granules from different manufacturers and our laboratory,and peak pattern matching between the composite formulae and Radix Bupleuri Chinensis,which was one of the main ingredients of Xiaochaihu granules,was utilized to evaluate the preparation technology of Xiaochaihu granules via the indexes of the relative deviation of retention time (RT) and UV spectrum feature similarity of their corresponding peaks.Eleven matching peaks were found between Xiaochalhu granules and Radix Bupleuri Chinensis.However,the saikosaponin A and saikosaponin D,which are the important active components in Radix Bupleuri Chinensis,were not found in Xiaochaihu granules from any manufacturers.The peak areas of 11 characteristic peaks of Xiaochaihu granules samples formed a matrix of 11 × 15.The result of HCA showed that Xiaochaihu granules samples were divided into four kinds of category.Xiaochaihu granules samples from the same manufacturer were basically clustered of the same category.The results suggested that the saikosaponin A and saikosaponin D are prone to structural transformation under the condition of decoction and in the presence of the organic acidic components.These active components,existing in raw herb,might transform to a series of non-active secondary saikosaponin due to unfavourable preparation technology.So the conventional decoction-based preparation technology of Xiaochaihu granules might greatly affect its quality and therapeutic effectiveness. This study demonstrates that fingerprint-peak matching technology can not only be used for quality control of this composite formulae,but also provide some guidance for preparation technology of Xiaochaihu granules.

A simple and accurate high-performance liquid chromatography (HPLC) coupled with diode array detector (DAD) and evaporative light scattering detector (ELSD) was established for the determination of six bioactive compounds in Zhenqi Fuzheng preparation (ZFP).The monitoring wavelengths were 254,275 and 328 nm.Under the optimum conditions,good separation was achieved,and the assay was fully validated in respect of precision,repeatability and accuracy.The proposed method was successfully applied to quantify the six ingredients in 31 batches of ZFP samples and evaluate the variation by hierarchical cluster analysis (HCA),which demonstrated significant variations on the content of these compounds in the samples from different manufacturers with different preparation procedures.The developed HPLC method can be used as a valid analytical method to evaluate the intrinsic quality of this preparation.

A simple and accurate high-performance liquid chromatography（HPLC）coupled with diode array detector（DAD）and evaporative light scattering detector（ELSD）was established for the determination of six bioactive compounds in Zhenqi Fuzheng preparation（ZFP）.The monitoring wavelengths were 254,275 and 328 nm.Under the optimum conditions,good separation was achieved,and the assay was fully validated in respect of precision,repeatability and accuracy.The proposed method was successfully applied to quantify the six ingredients in 31 batches of ZFP samples and evaluate the variation by hierarchical cluster analysis（HCA）,which demonstrated significant variations on the content of these compounds in the samples from different manufacturers with different preparation procedures.The developed HPLC method can be used as a valid analytical method to evaluate the intrinsic quality of this preparation.

OBJECTIVETo develop a HPLC method for determination of matrine, oxymatrine; ferulic acid, L-shikonin and beta, beta-dimethylacrylshikonin in compound preparatioti of Dangguishuan.

METHODThe chromatogtaphic separation was performed on a Kromasil ODS C18 column (4.6 mm x 250 mm, 5 microm) maintaining at 30 degrees C during the whole process. The mobile phase consisted of methanol and 0.1% triethylamine aqueous solution (adjusted with phosphoric acid, pH 3) at a flow rate of 1.0 mL x min(-1). The detection wavelength was set at 220 nm for matririne and oxymatrine, 316 nm for ferulic acid, 516 nm for L-shikonin and beta, beta-dimethylacrylshikonin, respectively.

RESULTAll the compounds showed good linearity (r > 0.9996) in the range of the test concentrations, and the average recoveries of the method is betwuen 96.92% and 102.22%, RSD < 3.1%.

CONCLUSIONThe method is proved to be credible, sensitive, accurate and repeatable. It can be applied to determine of matrine, oxymatrine, ferulic acid, L-shikonin and beta, beta-dimethylacrylshikonin in compound preparation of Dangguishuan simultaneously, and provide a basal method of quality control to this preparation and other relative preparations.

Alkaloids ; analysis ; Chromatography, High Pressure Liquid ; methods ; Coumaric Acids ; analysis ; Drugs, Chinese Herbal ; analysis ; Naphthoquinones ; analysis ; Quinolizines ; analysis

OBJECTIVETo determine bergapten's concentration in plasma and observe its pharmacokinetics in rats using a combined LC-MS/MS analytical method.

METHODBlood samples were separated on a Hypersil ODS column (4.6 mm x 250 mm, 5 mm) at a temperature of 30 degrees C, and mobile phase consisted of water and methanol (22.5: 77.5) at a flow rate of 0.8 mL x min(-1).

RESULTThe methodological study showed a good linear relationship of 8.12-162.4 g x L(-1) (r = 0.9999). The inner and inter-days relative standard deviations were both less than 10% , indicating legitimate precise and accuracy to the requirement of biological sample analysis.

CONCLUSIONThe method is suitable for in vivo quantitative analysis for bergapten due to its accuracy, sensitivity and specificity. The pharmacokinetic process in rats forms a two-compartment model with first-order absorption.

Animals ; Chromatography, Liquid ; Male ; Methoxsalen ; analogs & derivatives ; blood ; pharmacokinetics ; Rats ; Rats, Sprague-Dawley ; Reference Values ; Reproducibility of Results ; Sensitivity and Specificity ; Tandem Mass Spectrometry ; Time Factors

Objective:To optimize the alcohol precipitation process of Quhan Zhufeng Granules.Methods:Taking the volume fraction of ethanol, the relative density of the concentrated solution and the standing time as the investigation factors, the Z value of the total evaluation of gentiopicrin content, oleanolic acid content and dry paste yield of gentiana macrophylla as the evaluation indexes, the star-point design-response surface method was used to optimize the alcohol precipitation process.Results:The optimal the alcohol precipitation process of Quhan Zhufeng Granules: concentration relative density 1.08 g/ml (90-95 ℃), alcohol precipitation at the end of volume fraction of 62% ethanol, standing for 16 h.Conclusion:The alcohol precipitation process using overall desirability and central composite design is stable and feasible, and has good predictability, which can provide experimental basis for further scale production.