Study on Optimization of spray Drying Process of Banlangen Formula Granules / 世界科学技术-中医药现代化

Objective To optimize the spray drying process of Banlangen(Isatidis Radix)formula granules based on quality by design(QbD)concept.Methods Using powder yield and the contents of uridine,adenosine,guanosine,and(R,S)-goitron as the critical quality attributes(CQAs),Plackett-Burman design was used to screen out critical process parameters(CPPs)for inlet temperature,spray pressure,liquid temperature,pump speed,and liquid relative density.The central-composite design(CCD)test was used to optimize the CPPs,which were screened.Based on the quadratic polynomial regression model,the design space of spray drying process of Banlangen(Isatidis Radix)formula granules was established,and further validated by experiments.Results Plackett-burman test results show that liquid relative density and inlet velocity are the key parameters for the study.The variance analysis results of CCD test showed that the constructed model in a good prediction ability,since the P-values of model was less than 0.01 and P-values of items lack of fit was more than 0.05.The optimized design space of CPPs was the liquid relative density 1.05-1.08,and pump speed 30%-40%.Conclusion Based on the QbD concept,the design space for the spray drying process of Banlangen(Isatidis Radix)formula granules can improve the stability of its process and help ensure the consistency of product quality.

Study on Rolling Granulation of Valsartan Tablets / 中国药师

Objective: To prepare valsartan tablets and optimize the parameters of rolling granulation process. Methods: The par-ticle size (D50, Y1/μm), tablet hardness (Y2/N), and 30-min drug dissolution (Y3/%) as the evaluation indices, the critical process variables were studied by Plackett-Burman experiment design firstly, and then Box-Behnken response surface method was used to optimize the parameters of rolling granulation process. Results: Plackett-Burman experimental design showed that the rolling pressure and mesh size had significant effect on the granule size (P<0. 05). The rolling pressure, rolling nip and mesh size had significant effect on the tablet hardness (P<0. 05). The optimum rolling parameters based on Box-Behnken response surface method were as fol-lows: the rolling pressure was 30 bar, the rolling nip was 3. 0 mm and the mesh size was 2. 0 mm. Valsartan tablets had good compres-sibility and high drug dissolution, which was similar to the in vitro dissolution profile of commercial reference preparations. Conclu-sion: The experimental designs to optimize the rolling granulation process of valsartan tablets can improve the controllability of the prod-uct quality.

Optimization of preparation process and dissolution test of tetrandrine dropping pills / 中草药

Objective: To optimize the preparation process of tetrandrine dropping pills (TDP) and investigate the in vitro dissolution rate. Methods: Plackett-Burman experimental design was used to screen the critical factors in the preparation process of TDP from the ratio of matrix, ratio of matrix to drug, dropping temperature, dropping rate, dropping distance, and condensate temperature. The forming rate and weight variation of TDP were used as the evaluation index, the parameters in the preparation process of TDP were optimized by using the Box-Behnken response surface method. Moreover, the in vitro dissolution rate of TDP was compared with tetrandrine tablets by rotating basket method. Results: The Plackett-Burman experimental design results showed that the ratio of matrix, dropping temperature and condensate temperature had a significant effect on the forming rate of TDP. The optimum preparation parameters by Box-Behnken response surface method were as follows: the ratio of matrix was 2.6∶1, dropping temperature was 82.4 ℃ and condensation temperature was 7.5 ℃ with high forming rate, good roundness, stable weight, and fast drug dissolution rate of TDP. Conclusion: The quality of TDP by experimental design method can meet the requirements and can be further amplified.

Optimization of extraction technology for Fufang-Fuqing-Xiji by orthogonal test combined with Plackett-Burman experimental design / 国际中医中药杂志

Objective To optimize extraction technology of Fufang-Fuqing-Xiji.Methods Orthogonal test combined with Plackett-Burman experimental design was adopted to study the influence factors of water extraction in Fufang-Fuqing-Xiji. The contents of chlorogenic acid, paeoniflorin and caffeic acid in Fufang-Fuqing-Xiji were determined by HPLC gradient elution method at the same time. A multi-index comprehensive score method was applied to analyze the data and to screen the optimum extraction technology. Results The best extraction conditions of Fufang-Fuqing-Xiji were as following: threaded 80 mesh sieve, soaked 2 h, decocted 3 times with 12 times the amount of water for 1h each time.Conclusions This optimized extraction technology was rational and stable, which could be used for the extraction ofFufang-Fuqing-Xiji.