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Objective@#To evaluate the efficacy and safety of Qili Qiangxin Capsule (QLQXC) combined with western medicine in patients with ischemic cardiomyopathy (ICM) comorbid with heart failure (HF) for clinical application.@*Methods@#We searched relevant references in Chinese databases including China National Knowledge Infrastructure (CNKI), China Scientific Journal Database (VIP), Wanfang Database, and China Biology Medicine (CBM), as well as English databases including PubMed and Embase, from the foundation of the database to January 8, 2023, without language restrictions. All statistical analyses, including subgroup and sensitivity analyses, were performed using the Review Manager (version 5.4) and Stata (version 15.0).@*Results@#QLQXC combined with western medicine significantly increased the endpoints of overall response rate (ORR) (P< 0.000 01), left ventricular ejection fraction (LVEF) (P< 0.000 01), the score of Minnesota Living with Heart Failure Questionnaire (MLHFQ) (P = 0.000 2), and 6-minute walking distance (6MWD) (P < 0.000 01), decreased left ventricular end-diastolic diameter (LVEDD) (P < 0.000 01), left ventricular end-systolic diameter (LVESD) (P = 0.03), and pro-brain natriuretic peptide (pro-BNP) (P < 0.000 01), and reduced the incidence of rehospitalization (P = 0.000 3) and adverse events (AEs) (P = 0.000 6) compared with those under the conventional western therapy alone. Nonetheless, no significant difference was observed in reducing the mortality between the QLQXC combined with western medicine group and the western medicine group (P = 0.30).@*Conclusion@#The combination therapy of QLQXC with western medicine can potentiate cardiac function and raise the quality of life in patients with ICM comorbid with HF.
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@#Objective This study aimed to design and optimize the water extraction process for Chuantieling (喘贴灵, CTL) based on the concept of quality by design (QbD). Methods The single-factor experiments were used to select the best experimental points of CTL water extraction. On this basis, the transfer rate of ephedrine hydrochloride and sinapine thiocyanate, and the yield of the extract were evaluated as the evaluation indicators. The liquid-solid ratio, extraction time, and pH value were selected as the main factors to carry out the Box-Behnken design (BBD). A mathematical model of the critical process parameters (CPPs) and critical quality attributes (CQAs) was established, the interaction between CQAs and CPPs was examined, and the CTL extraction process design space was established and optimized, which guaranteed the stability of the process. The high performance liquid chromatography (HPLC) was used to analyze the main active compounds in the CTL extract. Results Through single-factor experiments, the best experimental parameters were found to be a liquid-solid ratio of 8∶1, extraction time of 90 min, pH value of 4, and extraction times of three. The experimental variance analysis results of the BBD showed that the P value of the regression model was less than 0.05, and the lack-of-fit value was greater than 0.01, indicating that the constructed model had good predictive ability. The operating space of the CPPs of the CTL water extraction process was combined with the actual production situation. In the production situation, the best extraction process was nine times of water addition, 72 min of extraction time, and 4.5 of pH value. The HPLC results showed that the peak areas of ephedrine hydrochloride, sinapine thiocyanate, tetrahydropalmatine, methyl eugenol, cinnamaldehyde, and 6-gingerol in the CTL extract accounted for 0.94%, 14.32%, 0.78%, 31.23%, 0.34%, and 0.44% of the total peak area, respectively. Conclusion The water extraction process design space of CTL based on QbD was conducive to actual production operations, ensuring the stability of the process.