[Objectives]To establish a HPLC characteristic spectrum of honeysuckle stem formula granules,and to evaluate the quality consistency based on the standard decoction.[Methods]Using Agilent ZORBAX SB-C_(18)(5μm,250 mm&...[Objectives]To establish a HPLC characteristic spectrum of honeysuckle stem formula granules,and to evaluate the quality consistency based on the standard decoction.[Methods]Using Agilent ZORBAX SB-C_(18)(5μm,250 mm×4.6 mm)chromatographic column;gradient elution with acetonitrile-0.4%phosphoric acid solution(0.2:99.8,V/V),column temperature at 25℃;detection wavelength at 236 nm;flow rate 1.0 mL/min;using"Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine",to evaluate the similarity of the characteristic chromatogram of crude drug,standard decoction and formula granules of honeysuckle stem.[Results]The similarity of characteristic chromatogram was higher than 0.94,and 6 components were identified from 10 characteristic peaks.[Conclusions]The established method can more comprehensively reflect the overall appearance of the chemical substances in the honeysuckle stem and the transmission law,and can provide an experimental basis for the consistency of the quality of the honeysuckle stem formula granules.展开更多
Guided by the theory of traditional Chinese medicine(TCM),TCM formula granules are made through the optimal process of extraction,concentration,drying,and granulation by combining modern new preparation technologies a...Guided by the theory of traditional Chinese medicine(TCM),TCM formula granules are made through the optimal process of extraction,concentration,drying,and granulation by combining modern new preparation technologies and pharmaceutical technologies.TCM formula granules are stable,safe,convenient,and effective.Compared with TCM decoction pieces,TCM formula granules can achieve the full process control of its industry chain from field to workshop and standardize the management of the origin of medicinal materials,processing of decoction pieces,processing technology,quality inspection,sales,and products distribution.TCM formula granules can partially replace Chinese patent medicines.Only available for around 800 common varieties of TCM,TCM formula granules cannot replace decoction pieces for many types which are not commonly used in clinical practice.A large number of formula granules are used in clinical and animal studies so that investigators no longer need to extract and control the quality of TCM decoction pieces.How to improve the production process,establish the quality standard,perfect the regulatory system,and expand the clinical application are the problems we need to solve as soon as possible for the better development of formula granules.展开更多
[Objectives]This study aimed to establish a QAMS(quantitative analysis of multi-components by single-marker)method for simultaneous determination of four phenolic acids,salvianolic acid B,tanshinol,lithospermic acid a...[Objectives]This study aimed to establish a QAMS(quantitative analysis of multi-components by single-marker)method for simultaneous determination of four phenolic acids,salvianolic acid B,tanshinol,lithospermic acid and rosmarinic acid in Radix Salviae Miltiorrhizae by HPLC and conduct methodological investigation.[Methods]Salvianolic acid B,with moderate retention time,good resolution,great response value and easy availability was selected as the internal standard,and the relative retention values and relative correction factors between tanshinol,rosmarinic acid,lithospermic acid and salvianolic acid B were established.The results of QAMS were compared with those of external standard method to verify the accuracy and applicability of QAMS.[Results]There were no significant differences between the calculated values of QAMS and the measured values of external standard method.The relative deviation was less than 3%,and the relative correction factors obtained from the experiment were credible.[Conclusions]QAMS can be used to determine the contents of phenolic acids in Radix Salviae Miltiorrhizae formula granules.展开更多
[Objectives]This study aimed to establish HPLC chromatograms of decoction pieces,standard decoction and formula granules of Spica Prunellae.[Methods]The chromatographic conditions were as follows:column,SHISEIDO CAPCE...[Objectives]This study aimed to establish HPLC chromatograms of decoction pieces,standard decoction and formula granules of Spica Prunellae.[Methods]The chromatographic conditions were as follows:column,SHISEIDO CAPCELL PAK C18 MGII column(4.6 mm×250 mm,5μm);mobile phase,acetonitrile-0.1%phosphoric acid;gradient elution;detection wavelength,280 nm;flow rate,1.0 mL/min;and column temperature,30℃.The correlation between the decoction pieces,standard decoction and formula granules of Spica Prunellae was analyzed by specific chromatograms.[Results]The fingerprint chromatograms of decoction pieces,standard decoction and formula granules of Spica Prunellae showed five common peaks,with good correlation.Among the five common peaks,four of them were tanshinol,protocatechuic acid,caffeic acid and rosmarinic acid.[Conclusions]The main chemical constituents of decoction pieces,standard decoction and formula granules of Spica Prunellae are basically the same.The HPLC specific chromatogram established can be used for the quality control of Spica Prunellae formula granules.展开更多
OBJECTIVE:To evaluate the efficacy and safety of Zhumian Tang formula granules(助眠汤配方颗粒)combined with eszopiclone for treating poor sleep quality.METHODS:This multi-center,dynamic blockrandomized,parallel-group ...OBJECTIVE:To evaluate the efficacy and safety of Zhumian Tang formula granules(助眠汤配方颗粒)combined with eszopiclone for treating poor sleep quality.METHODS:This multi-center,dynamic blockrandomized,parallel-group superiority clinical trial included 130 patients.The combined treatment group received Zhumian Tang formula granules combined with eszopiclone treatment,and the control group received eszopiclone treatment only.The group allocation ratio was 1∶1.The duration of treatment was 2 weeks.Participants were asked to complete questionnaires before treatment,after 1 week of the intervention,after 2 weeks of the intervention,and at the follow-up on week 3.The primary outcomes were the Pittsburgh Sleep Quality Index(PSQI)score and the total effective rate of treatment.The secondary outcome was the rate of adverse effects.RESULTS:Compared with the eszopiclone treatment group,the PSQI score of the combined treatment group was significantly lower after 2 weeks of the intervention(6.98 vs 8.26,P<0.05).However,there was no significant difference in the mean PSQI score after 1 week of the intervention(9.89 vs 9.15,P=0.124).After the follow-up on week 3,the PSQI score of the combined treatment group remained significantly lower than that of the eszopiclone treatment group(6.12 vs 8.31,P<0.001).The total effective rates of treatment of the combined group and the eszopiclone group were 36.92%vs 35.38%(Z=0.033,P=0.855)after 1 week of the intervention,83.08%vs 58.46%(Z=9.519,P<0.05)after 2 weeks of the intervention,and 83.08%vs 61.54%(Z=7.530,P<0.05)and after the follow-up on week 3,respectively.There was no significant difference in the overall rate of adverse reactions between the combined and eszopiclone treatment groups(21.53%vs 31.8%,P=0.318).CONCLUSION:The combination of Zhumian Tang formula granules with eszopiclone was found to be safe and more effective in improving sleep quality than eszopiclone alone.Traditional Chinese medicine can enhance the effectiveness of Western medicine in the treatment of insomnia.展开更多
基金Supported by Major Project of Nanning Scientific Research and Technology Development Plan in 2020(20201048)。
文摘[Objectives]To establish a HPLC characteristic spectrum of honeysuckle stem formula granules,and to evaluate the quality consistency based on the standard decoction.[Methods]Using Agilent ZORBAX SB-C_(18)(5μm,250 mm×4.6 mm)chromatographic column;gradient elution with acetonitrile-0.4%phosphoric acid solution(0.2:99.8,V/V),column temperature at 25℃;detection wavelength at 236 nm;flow rate 1.0 mL/min;using"Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine",to evaluate the similarity of the characteristic chromatogram of crude drug,standard decoction and formula granules of honeysuckle stem.[Results]The similarity of characteristic chromatogram was higher than 0.94,and 6 components were identified from 10 characteristic peaks.[Conclusions]The established method can more comprehensively reflect the overall appearance of the chemical substances in the honeysuckle stem and the transmission law,and can provide an experimental basis for the consistency of the quality of the honeysuckle stem formula granules.
文摘Guided by the theory of traditional Chinese medicine(TCM),TCM formula granules are made through the optimal process of extraction,concentration,drying,and granulation by combining modern new preparation technologies and pharmaceutical technologies.TCM formula granules are stable,safe,convenient,and effective.Compared with TCM decoction pieces,TCM formula granules can achieve the full process control of its industry chain from field to workshop and standardize the management of the origin of medicinal materials,processing of decoction pieces,processing technology,quality inspection,sales,and products distribution.TCM formula granules can partially replace Chinese patent medicines.Only available for around 800 common varieties of TCM,TCM formula granules cannot replace decoction pieces for many types which are not commonly used in clinical practice.A large number of formula granules are used in clinical and animal studies so that investigators no longer need to extract and control the quality of TCM decoction pieces.How to improve the production process,establish the quality standard,perfect the regulatory system,and expand the clinical application are the problems we need to solve as soon as possible for the better development of formula granules.
基金Supported by High-level Entrepreneurial and Innovative Talent(Team)Project 2015.
文摘[Objectives]This study aimed to establish a QAMS(quantitative analysis of multi-components by single-marker)method for simultaneous determination of four phenolic acids,salvianolic acid B,tanshinol,lithospermic acid and rosmarinic acid in Radix Salviae Miltiorrhizae by HPLC and conduct methodological investigation.[Methods]Salvianolic acid B,with moderate retention time,good resolution,great response value and easy availability was selected as the internal standard,and the relative retention values and relative correction factors between tanshinol,rosmarinic acid,lithospermic acid and salvianolic acid B were established.The results of QAMS were compared with those of external standard method to verify the accuracy and applicability of QAMS.[Results]There were no significant differences between the calculated values of QAMS and the measured values of external standard method.The relative deviation was less than 3%,and the relative correction factors obtained from the experiment were credible.[Conclusions]QAMS can be used to determine the contents of phenolic acids in Radix Salviae Miltiorrhizae formula granules.
基金Supported by Scientific Research and Technology Development Project of Nanning City(20173158-5).
文摘[Objectives]This study aimed to establish HPLC chromatograms of decoction pieces,standard decoction and formula granules of Spica Prunellae.[Methods]The chromatographic conditions were as follows:column,SHISEIDO CAPCELL PAK C18 MGII column(4.6 mm×250 mm,5μm);mobile phase,acetonitrile-0.1%phosphoric acid;gradient elution;detection wavelength,280 nm;flow rate,1.0 mL/min;and column temperature,30℃.The correlation between the decoction pieces,standard decoction and formula granules of Spica Prunellae was analyzed by specific chromatograms.[Results]The fingerprint chromatograms of decoction pieces,standard decoction and formula granules of Spica Prunellae showed five common peaks,with good correlation.Among the five common peaks,four of them were tanshinol,protocatechuic acid,caffeic acid and rosmarinic acid.[Conclusions]The main chemical constituents of decoction pieces,standard decoction and formula granules of Spica Prunellae are basically the same.The HPLC specific chromatogram established can be used for the quality control of Spica Prunellae formula granules.
基金Supported by Sichuan Province Central Guided Local Science and Technology Development Special Project:a Study of the Chinese and Western Medicine Clinical Consensus Program for People with Poor Sleep Quality(No.2021ZYD0109)Natural Science Foundation of Sichuan Province:Study on the Efficacy and Mechanism of Acupuncture in Treating Drug-dependent Insomnia from the Liver based on Multi-modal f MRI Technology(No.2022NSFSC0858)。
文摘OBJECTIVE:To evaluate the efficacy and safety of Zhumian Tang formula granules(助眠汤配方颗粒)combined with eszopiclone for treating poor sleep quality.METHODS:This multi-center,dynamic blockrandomized,parallel-group superiority clinical trial included 130 patients.The combined treatment group received Zhumian Tang formula granules combined with eszopiclone treatment,and the control group received eszopiclone treatment only.The group allocation ratio was 1∶1.The duration of treatment was 2 weeks.Participants were asked to complete questionnaires before treatment,after 1 week of the intervention,after 2 weeks of the intervention,and at the follow-up on week 3.The primary outcomes were the Pittsburgh Sleep Quality Index(PSQI)score and the total effective rate of treatment.The secondary outcome was the rate of adverse effects.RESULTS:Compared with the eszopiclone treatment group,the PSQI score of the combined treatment group was significantly lower after 2 weeks of the intervention(6.98 vs 8.26,P<0.05).However,there was no significant difference in the mean PSQI score after 1 week of the intervention(9.89 vs 9.15,P=0.124).After the follow-up on week 3,the PSQI score of the combined treatment group remained significantly lower than that of the eszopiclone treatment group(6.12 vs 8.31,P<0.001).The total effective rates of treatment of the combined group and the eszopiclone group were 36.92%vs 35.38%(Z=0.033,P=0.855)after 1 week of the intervention,83.08%vs 58.46%(Z=9.519,P<0.05)after 2 weeks of the intervention,and 83.08%vs 61.54%(Z=7.530,P<0.05)and after the follow-up on week 3,respectively.There was no significant difference in the overall rate of adverse reactions between the combined and eszopiclone treatment groups(21.53%vs 31.8%,P=0.318).CONCLUSION:The combination of Zhumian Tang formula granules with eszopiclone was found to be safe and more effective in improving sleep quality than eszopiclone alone.Traditional Chinese medicine can enhance the effectiveness of Western medicine in the treatment of insomnia.
