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Objective To study the optimum molding process condition of dry granulating of Shenqi Fukang Granules (SFG). Methods Using primary formation rate and hygroscopicity rate as evaluation indicators; The optimal excipient ratio was optimized by L9(34) orthogonal test method. Results The ratio of dry extract-micro silica gel-soluble starch-maltodextrin 77.5:2.5:5:15 was the optimal ratio of excipients; Dry granulating conditions parameters: workshop temperature of 20 oC, relative humidity of 50%, extrusion pressure of 12 kg/cm3, side seal pressure of 14 kg/cm3, extrusion frequency of 22 Hz, granulation frequency of 52 Hz, and feeding frequency of 19 Hz. Conclusion The optimized SFG dry granulating molding process is stable and feasible. The finished product showed a fine liquidity, good dissolubility and little hygroscopicity, which provides a reliable experimental basis for large-scale production.
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Objective: To study the prescription and process of Fritillariae Thunbergii Bulbus (FTB) formula granules. Methods: FTB was extracted by decocting method. FTB extract powder was prepared by spray drying method. Wet-extruding granulating, extruded-rolling granulating, and one-step granulating were adopted for preparing the formula granules. A comprehensive evaluation method was based on the powder fluidity parameters such as the rest angle, the final volume reduction degree (a), the filling velocity constant (b, k), and the yield of the particles, to optimize the optimum preparation process, prescription excipients and their proportion. An HPLC method was used to determine the contents of peimine and peiminine. The chromatographic column was the Agilent Zorbax Eclipse XDB-C18 column (150 mm × 4.6 mm, 5 μm), and the flow phase was Acetonitrile-water-diethylamine (70:30:0.03); The volume flow was 1.0 mL/min; The column temperature was 30 ℃. Results: The synthesis score of the FTB formula granules prepared by one-step granulating method was the highest. The best prescription was the extract powder-dextrin- 95% ethanol solution (100:100:160). The particle yield was 91.3%, the rest angle was 30.73°, the value of a was 0.109 1, the value of b was 0.025 5 and the value of k was 0.030 1, the fluidity of the granules was good and the yield was high. The content of peimine was 0.305% and the content of peiminine was 0.098% in the particles by HPLC. Conclusion: In this experiment, the formulation and process of FTB formula granules were designed to met the design requirements, which could be used in the production of the technology.
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Objective: The optimum technological conditions of granule dry granulation of Wenshen Zhuanggu Granule (WZG) were optimized to improve production efficiency and ensure product quality and curative effect. Methods: The difficulty degree of granulation was studied by orthogonal test. The molding rate and the dissolved property of the granule determined the type and dosage of excipients for the evaluation index. Through single factor investigation test and combined with Box-behnken response surface method, the feed speed, rolling speed and rolling pressure were the independent variables, and the particle forming rate was dependent variable, in order to optimize process parameters of dry granulation. Results: The optimum proportion of excipients was the dextrin with 1:3 of the dosage of dry paste powder, 1:15 carboxymethy starch sodium, 1:90 of the micro-powder silica gel, the best granulation process for rolling wheel pressure 9.5 MPa, rolling speed 14.0 Hz, and feed speed 13.2 Hz. Through the amplification process validation of three batches, it showed that the WZG prepared by the optimized excipients and process parameters have the advantages of high molding rate, good melting and low moisture absorption rate. Conclusion: The selected process is reasonable and feasible, and it provides technical reference and basis for the industrial application of the product.
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This study was aimed to introduce the key link in the process of granulating of small-dose methyl can-tharis amine tablets. Combined with practical experiences in daily jobs, related literatures in recent years from the fineness of raw materials, choice of main materials mixing, selection of adhesive, drying methods and grain quality were analyzed. The results showed that in order to ensure the content uniformity of small-dose tablets and conform to requirements of the Chinese Pharmacopoeia, the fineness of raw materials should be appropriate; the main supple-mentary material must be evenly mixed with enough time; the choice of adhesive should be scientific and reasonable;the drying method should be practical; and the grain quality should meet the technological requirements.
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OBJECTIVE:To study the dry granulating technology in the preparation of cefuroxime axetil tablets so as to establish the preparative method.METHODS:With granule size,fluidity and yield as indexes to optimize the dry granulating technology for cefuroxime axetil tablets,and a comparative study was conducted on quality and stability of the samples prepared by wet process.RESULTS:The optimum conditions for the dry granulating technique were as follows:hydraulic pressure = 2.5～3 MPa,extrusion rate = 15～20 r?min-1,powder feed rate=200～300 g?min-1.The extrusion thickness was controlled at 1～2 mm.By circular dry granulating method,the proportion of qualified granules(16～30 meshes) was as high as above 90%,with an angle of repose of 30? and good mobility,and the yield was about 94%,with all indexes in line with the standards specified in Chinese Pharmacopoeia(2005 edition) in the accelerated test and permanent stability test.CONCLUSION:The optimized technological parameters and the mildly readjusted formulation can meet the requirements for the dry granulation method,with the stability of the product superior to that by wet method,and this method has a good reproducibility and shorter production cycle.