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OBJECTIVE To optimize the molding process of Shuangye pipa granules based on the concept of quality by design （QbD） and analyze its physical fingerprint. METHODS The dry extract of Shuangye pipa granules was used as the main drug. The retention rate of total flavonoid， moisture absorption rate， dissolution rate， angle of repose and molding rate of the granules were selected as evaluation indexes. The single-factor test combined with the entropy weight method and Box-Behnken response surface design was used to optimize the molding process， and validation test was conducted. The physical fingerprints of 10 batches of Shuangye pipa granules prepared by the optimal process were comprehensively analyzed by eight secondary physical indexes （relative homogeneity， moisture， moisture absorption rate， Hausner ratio， angle of repose， bulk density， tap density and porosity）. RESULTS The optimal molding process of Shuangye pipa granules was as follows： soluble starch-maltodextrin-mannitol was 1∶1∶1 （m/m/m）， 95% ethanol was as wetting agent and the amount of it was 37%， the drug-assisted ratio was 1∶0.8 （m/m）， the drying temperature was 59 ℃， drying time was 28 min. The results of 3 validation tests showed that the average comprehensive score was 0.879 6， the RSD of which with prediction value （0.881 9 score） was 1.97%. The similarity between the physical fingerprints of 10 batches of Shuangye pipa granules and the control physical fingerprint was higher than 0.99. CONCLUSIONS The optimized molding process of Shuangye pipa granules is stable and feasible， and the physical property of Shuangye pipa granules is stable and controllable.
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Objective:To optimize the best molding process of Jinpuju Qingrelishi Granules.Methods:Based on the single factor test, the relative density of clear ointment and the amount of diluent (dextrin∶lactose=2∶1) are used as investigating factors, and the overall evaluation of the molding rate and angle of repose overall desirability (OD) is used as the evaluation index. The effect surface method is used to optimize the best molding process of Jinpuju Qingrelishi Granules.Results:The best molding process conditions: the relative density of the clear paste is 1.20 (60 ℃) and the amount of diluent is 3 times that of the clear paste. After mixing the clear paste and diluent, make soft material, pass through a 14-mesh sieve to granulate, dry in an oven (55 ℃) for 1 hour, and sizing to obtain. The molding rates of the three batches of verification test granules were 93.73%, 93.03%, 95.59%, respectively, the predicted OD value was 0.928, the verification value was 0.936, and the deviation from the predicted value was -0.86%.Conclusion:The molding process of this experiment is stable and reliable, with good repeatability, which can provide a reference for the follow-up research of Jinpuju Qingrelishi Granules.
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OBJECTIVE: To develop vegetable enteric hollow capsules with sodium alginate (Alg-Na), starch and excipients by one-line molding process and investigate their properties. METHODS: The influence of the ratio of raw materials on capsule shape index was analyzed by multiple factors trials. The light transmittance and mechanical properties were evaluated, and DSC, FT-IR, and SEM analysis were conducted. RESULTS: The optimal formula composed of medium viscosity Alg-Na 0.6%, ultralow viscosity Alg-Na 2.5%, starch 10%, gellan gum 0.6%, and glycerin 2% could produce vegetable enteric hollow capsules with good performance. The main property indexes were as follows: liquid viscosity 434 mPa·s, capsule thickness 0.11-0.12 mm, water content 10.09%, disintegration time 8-15 min in simulated intestinal fluid (not disintegrated within 2 h in simulated gastric fluid), light transmittance of capsule film 85.5%, tensile strength 27.97 MPa, and elongation at break 2.0%. CONCLUSION: This study lays theoretical foundation for replacing gelatin capsules with vegetable enteric hollow capsules.
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Objective To optimize the molding process of Erzhi pill. Methods Using the external properties of pill, the pill weight, disintegration time as the comprehensive evaluation index, the L9(34) orthogonal test was used to test the effects of three factors:the relative density of thick paste(A), the powder fineness(B), and the proportion of powder and honey(C). Results The best molding process was as follows: the relative density of thick paste was 1.25, the powder fineness was 100 meshes, and the proportion of powder and honey was 1: 0.6. Conclusion This optimized molding process proved to be repeatable, simple and feasible. The Erzhi pill made by this preparation technology are round, the color and luster are uniform and the dissolving time is short. It provides the basis for studying the molding process of Erzhi pill .
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Objective To optimize the molding process of Erzhi pill. Methods Using the external properties of pill the pill weight, disintegration time as the comprehensive evaluation index, the L9(34) orthogonal test was used to test the effects of three factors: the relative density of thick paste(A), the powder fineness(B), and the proportion of powder and honey (C). Results The best molding process was as follows: the relative density of thick paste was 1.25, the powder fineness was 100 meshes, and the proportion of powder and honey was 1: 0.6. Conclusion This optimized molding process proved to be repeatable simple and feasible. The Erzhi pill made by this preparation technology are round, the color and luster are uniform and the dissolving time is short. It provides the basis for studying the molding process of Erzhi pill.