The rhizome of Alpinia officinarum Hance is a well-known traditional Chinese medicine(TCM)and has been widely used for the remedy of gastrointestinal diseases.In the present study,a simple and rapid HPLC-DAD was devel...The rhizome of Alpinia officinarum Hance is a well-known traditional Chinese medicine(TCM)and has been widely used for the remedy of gastrointestinal diseases.In the present study,a simple and rapid HPLC-DAD was developed for the quality control of the rhizomes of A.officinarum.Its chemical fingerprint was established using raw material of 15 different origins in China.Similarity analysis(SA)and hierarchical clusting analysis(HCA)were applied to select the qualitative markers.Principal components analysis(PCA)was conducted to select the quantitative markers of the rhizomes of A.officinarum samples from different origins.The constituents were confirmed by(+)electrospray ionization LC-MS.12 constituents were selected as common peaks and 10 of them were confirmed by(+)electrospray ionization LC-MS.Six bioactive constituents including DPHA,galangin flavanone,galangin,galangin 3-methylether,DPHB and DPHC were simultaneous determination by using the HPLC-DAD analysis.The developed method was able to determine the bioactive components with excellent resolution,precision and recovery.The results indicated that chromatographic fingerprint combination with multi-components determination method is suitable for quality assessment of the rhizomes of A.officinarum.展开更多
Drug product internationalization(DPI) can be affected by multiple firm-level factors. However, existing studies mainly focus on a single or several factors and the deviation generated by the factors' effects on ea...Drug product internationalization(DPI) can be affected by multiple firm-level factors. However, existing studies mainly focus on a single or several factors and the deviation generated by the factors' effects on each other has been neglected. We aimed to study the comprehensive influences of firm-level factors on Chinese pharmaceutical firms that chose the DPI mode. Student's t tests and Chi Square tests were used to explore the differences between firms with or without DPI modes. Then, logistic regression analysis was used to explore the comprehensive impacts of these 16 variables. Through empirical research, we found the factors influencing the DPI mode of Chinese pharmaceutical enterprises and the firm-level factors that influenced DPI mode selection. This study showed that the capacity of enterprise's innovation and knowledge absorption were related to the mode selection. Moreover, the education of the top management team significantly contributed to the DPI mode selection of pharmaceutical firms. This study also provided theoretical and empirical evidence for pharmaceutical enterprises when choosing their DPI mode. The internationalization of Chinese pharmaceutical firms remained at the early stage. However, the internationalization of drug products from China would affect the international pharmaceutical supply in the long term.展开更多
Chinese patent medicines(CPMs) are widely used across China, and they are differently administrated from chemical drugs. For traditional reasons, CPMs may contain opium-derived compounds, such as morphine, which may...Chinese patent medicines(CPMs) are widely used across China, and they are differently administrated from chemical drugs. For traditional reasons, CPMs may contain opium-derived compounds, such as morphine, which may pose the issues of drug abuse and addiction. In the present study, we aimed to evaluate the present risk of morphine-containing CPMs in causing drug abuse and addiction, based on a questionnaire-based approach and from a medicinal administrative perspective. We chose 76 CPMs containing morphine from government document and set them as the study group, and 10 chemical drugs containing morphine were set as the control group. Because there is no ready-made method, we created an evaluation sheet consisting of five questions to evaluate each drug and generate a risk-value score. Crosstabs analysis using SPSS 15.0 was conducted to obtain the influencing factors. We found that the study group obtained a mean score of 2.04 for the risk value, which was five times of that of the control group. Specifically, no maximum limit of morphine or codeine was set in product quality standards for more than four-fifth of the drugs. Moreover, 46.0% of package inserts failed to show any warning about addiction or prohibition over the long-term use of the drugs. The number of ingredients, as well as the functions of the drugs, was found to correlate with the risk value. Our findings suggested that CPMs were more risky in causing drug abuse and addiction than chemical drugs. Approaches, such as i) controlling the number of ingredients, ii) setting up maximum limit of morphine or codeine in quality standard, iii) providing more information on the package insert of drugs and iv) monitoring the drug containing both morphine and ephedrine, will be effective in reducing the risk of drug abuse and addiction.展开更多
To alleviate problems with access and affordability,six targeted anticancer medications(TAMs)were listed in the Provincial Reimbursement Drug List(PRDL)for the first time in Zhejiang,China in February 2015.In the pres...To alleviate problems with access and affordability,six targeted anticancer medications(TAMs)were listed in the Provincial Reimbursement Drug List(PRDL)for the first time in Zhejiang,China in February 2015.In the present study,we aimed to evaluate the implementation of the PRDL policy on TAMs use.Using the pharmaceutical procurement data of these six listed TAMs(study group)and four unlisted TAMs(control group)from 22 tertiary hospitals in Zhejiang,China dated between January 2014 and February 2017,interrupted time-series analysis was adopted to examine differences in the average hospital purchasing volume(HPV)and the average hospital purchasing spending(HPS)between the two groups.The average daily cost of listed TAMs in the study group was decreased after April 2015.After enlistment,the average HPV per month was significantly increased by 34.6 defined daily doses(DDDs)(P<0.001),and the average HPS per month was significantly increased by USD 6614.9(P<0.001)for the listed TAMs in the study group(n=6).Neither the average HPV nor the average HPS changed significantly for the unlisted TAMs in the control group(n=4).The PRDL policy showed positive effects on improving patients’affordability and promoting access to TAMs in Zhejiang.The government should conduct further price negotiations and include more TAMs with clinical benefits into reimbursement schemes to relieve patients’financial burden and promote access.展开更多
基金The National Natural Science Foundation of China(Grant No.81503210)the Medical Scientific Research Foundation of Guangdong Province(Grant No.B2017049)the Natural Science Foundation of Guangdong Food and Drug Vocational College(Grant No.2016YZ003)
文摘The rhizome of Alpinia officinarum Hance is a well-known traditional Chinese medicine(TCM)and has been widely used for the remedy of gastrointestinal diseases.In the present study,a simple and rapid HPLC-DAD was developed for the quality control of the rhizomes of A.officinarum.Its chemical fingerprint was established using raw material of 15 different origins in China.Similarity analysis(SA)and hierarchical clusting analysis(HCA)were applied to select the qualitative markers.Principal components analysis(PCA)was conducted to select the quantitative markers of the rhizomes of A.officinarum samples from different origins.The constituents were confirmed by(+)electrospray ionization LC-MS.12 constituents were selected as common peaks and 10 of them were confirmed by(+)electrospray ionization LC-MS.Six bioactive constituents including DPHA,galangin flavanone,galangin,galangin 3-methylether,DPHB and DPHC were simultaneous determination by using the HPLC-DAD analysis.The developed method was able to determine the bioactive components with excellent resolution,precision and recovery.The results indicated that chromatographic fingerprint combination with multi-components determination method is suitable for quality assessment of the rhizomes of A.officinarum.
文摘Drug product internationalization(DPI) can be affected by multiple firm-level factors. However, existing studies mainly focus on a single or several factors and the deviation generated by the factors' effects on each other has been neglected. We aimed to study the comprehensive influences of firm-level factors on Chinese pharmaceutical firms that chose the DPI mode. Student's t tests and Chi Square tests were used to explore the differences between firms with or without DPI modes. Then, logistic regression analysis was used to explore the comprehensive impacts of these 16 variables. Through empirical research, we found the factors influencing the DPI mode of Chinese pharmaceutical enterprises and the firm-level factors that influenced DPI mode selection. This study showed that the capacity of enterprise's innovation and knowledge absorption were related to the mode selection. Moreover, the education of the top management team significantly contributed to the DPI mode selection of pharmaceutical firms. This study also provided theoretical and empirical evidence for pharmaceutical enterprises when choosing their DPI mode. The internationalization of Chinese pharmaceutical firms remained at the early stage. However, the internationalization of drug products from China would affect the international pharmaceutical supply in the long term.
基金Funding Grants from University of Macao Research Grants(MYRG2015-00160-ICMS-QRCM and MYRG2014-00069-ICMS-QRCM)
文摘Chinese patent medicines(CPMs) are widely used across China, and they are differently administrated from chemical drugs. For traditional reasons, CPMs may contain opium-derived compounds, such as morphine, which may pose the issues of drug abuse and addiction. In the present study, we aimed to evaluate the present risk of morphine-containing CPMs in causing drug abuse and addiction, based on a questionnaire-based approach and from a medicinal administrative perspective. We chose 76 CPMs containing morphine from government document and set them as the study group, and 10 chemical drugs containing morphine were set as the control group. Because there is no ready-made method, we created an evaluation sheet consisting of five questions to evaluate each drug and generate a risk-value score. Crosstabs analysis using SPSS 15.0 was conducted to obtain the influencing factors. We found that the study group obtained a mean score of 2.04 for the risk value, which was five times of that of the control group. Specifically, no maximum limit of morphine or codeine was set in product quality standards for more than four-fifth of the drugs. Moreover, 46.0% of package inserts failed to show any warning about addiction or prohibition over the long-term use of the drugs. The number of ingredients, as well as the functions of the drugs, was found to correlate with the risk value. Our findings suggested that CPMs were more risky in causing drug abuse and addiction than chemical drugs. Approaches, such as i) controlling the number of ingredients, ii) setting up maximum limit of morphine or codeine in quality standard, iii) providing more information on the package insert of drugs and iv) monitoring the drug containing both morphine and ephedrine, will be effective in reducing the risk of drug abuse and addiction.
文摘To alleviate problems with access and affordability,six targeted anticancer medications(TAMs)were listed in the Provincial Reimbursement Drug List(PRDL)for the first time in Zhejiang,China in February 2015.In the present study,we aimed to evaluate the implementation of the PRDL policy on TAMs use.Using the pharmaceutical procurement data of these six listed TAMs(study group)and four unlisted TAMs(control group)from 22 tertiary hospitals in Zhejiang,China dated between January 2014 and February 2017,interrupted time-series analysis was adopted to examine differences in the average hospital purchasing volume(HPV)and the average hospital purchasing spending(HPS)between the two groups.The average daily cost of listed TAMs in the study group was decreased after April 2015.After enlistment,the average HPV per month was significantly increased by 34.6 defined daily doses(DDDs)(P<0.001),and the average HPS per month was significantly increased by USD 6614.9(P<0.001)for the listed TAMs in the study group(n=6).Neither the average HPV nor the average HPS changed significantly for the unlisted TAMs in the control group(n=4).The PRDL policy showed positive effects on improving patients’affordability and promoting access to TAMs in Zhejiang.The government should conduct further price negotiations and include more TAMs with clinical benefits into reimbursement schemes to relieve patients’financial burden and promote access.