[Objectives]To optimize the drying technology and formation process of Naomai Xingshen Capsules.[Methods]The yield of paste powder and moisture content as evaluation indicators were taken as indicators,the relative de...[Objectives]To optimize the drying technology and formation process of Naomai Xingshen Capsules.[Methods]The yield of paste powder and moisture content as evaluation indicators were taken as indicators,the relative density of feed liquid,inlet air temperature and dosage of excipients were selected as investigation factors,the orthogonal experiment method was used to optimize the spray drying process.The moisture absorption rate and angle of repose were taken as evaluation indicators,the types of forming excipient were screened,and the critical relative humidity was determined.[Results]The optimum spray drying process was that the relative density of liquid medicine was 1.05(60℃),the air inlet temperature was 200℃,and the dosage of excipients was 2%.The effect of using dextrin as a forming excipient was better,and the relative humidity of the production environment should be controlled below 65%.[Conclusions]The optimized process is stable,feasible,scientific and reasonable,and can be used for large-scale industrial production.展开更多
[Objectives]To explore the stability of Naomai Xingshen Capsules.[Methods]Accelerated test and long-term test were carried out to investigate the changes in properties,identification,moisture,disintegration time and m...[Objectives]To explore the stability of Naomai Xingshen Capsules.[Methods]Accelerated test and long-term test were carried out to investigate the changes in properties,identification,moisture,disintegration time and microbial limit of Naomai Xingshen Capsules.[Results]There were basically no changes in all indicators for the three batches of samples(after 6-month accelerated test and 24-month long-term test),and they all met the requirements of quality standards.[Conclusions]The preparation of Naomai Xingshen Capsules is stable and reliable,and the stability test provides a reliable basis for its expiration date.展开更多
基金Medical Research Project of Zhongshan City Health and Family Planning Bureau,Guangdong Province(2015J050).
文摘[Objectives]To optimize the drying technology and formation process of Naomai Xingshen Capsules.[Methods]The yield of paste powder and moisture content as evaluation indicators were taken as indicators,the relative density of feed liquid,inlet air temperature and dosage of excipients were selected as investigation factors,the orthogonal experiment method was used to optimize the spray drying process.The moisture absorption rate and angle of repose were taken as evaluation indicators,the types of forming excipient were screened,and the critical relative humidity was determined.[Results]The optimum spray drying process was that the relative density of liquid medicine was 1.05(60℃),the air inlet temperature was 200℃,and the dosage of excipients was 2%.The effect of using dextrin as a forming excipient was better,and the relative humidity of the production environment should be controlled below 65%.[Conclusions]The optimized process is stable,feasible,scientific and reasonable,and can be used for large-scale industrial production.
基金Supported by Medical Research Project of Zhongshan City Health and Family Planning Bureau,Guangdong Province(2015J050)。
文摘[Objectives]To explore the stability of Naomai Xingshen Capsules.[Methods]Accelerated test and long-term test were carried out to investigate the changes in properties,identification,moisture,disintegration time and microbial limit of Naomai Xingshen Capsules.[Results]There were basically no changes in all indicators for the three batches of samples(after 6-month accelerated test and 24-month long-term test),and they all met the requirements of quality standards.[Conclusions]The preparation of Naomai Xingshen Capsules is stable and reliable,and the stability test provides a reliable basis for its expiration date.
