ABSTRACT
Objective: To study the effect of ultrafine grinding on the micromeritic properties of Zhengfupian (steamed pieces of Aconiti Lateralis Radix Praeparata) and provide the basis for its preparation and quality control. Methods: Three kinds of Zhengfupian powders were prepared by ultrafine grinding mill. Their micromeritic properties, including size distribution, surface area and porosity, flowability, scanning electronic microscope, infrared spectrum, moisture absorption and dissolution rate were detected. Then the effects were comprehensively analyzed. Results: With the increasing of grinding time, the powder's particle size decreased, morphology and structure tended to be uniform, the specific surface area and porosity increased, the particles assembled easily, the compressibility and the angle of repose increased, the dissolution rate increased dramatically, and there were no significant changes in the infrared spectrum and moisture absorption. Conclusion: As the micromeritic properties and dissolution rate of Zhengfupian are considered, Zhengfupian's ultrafine grinding time should be controlled at about 25 min, particle size d0.9 should be around 100.46 μm.
ABSTRACT
Objective: To investigate the correlations between micromeritic primary properties and compactibility of granules produced by wet granulation of Sarcandrae Herba with soluble starch and microcrystalline cellulose (MCC). Methods: Micromeritic primary properties and compactibility of granules produced by wet granulation which was obtained by different prescriptions and processes were determined. Particle size (D90), specific surface area (SSA), pore volume (PV), moisture content (MC), bulk density (BD), tap density (TD), tap index (TI), angle of repose (AOR), and Kawakita equation parameters a and b were used as evaluation indexs to study the micromeritic primary properties of granulation. The tensile strengths of granules at 5, 10, 15, 20, 25, and 30 kN pressure were used as the indexs to evaluate the compactibility of granules produced. Multivariate analysis was applied to evaluating the correlations between micromeritic primary properties and compactibility of granules produced. Results: The micromeritic primary properties of granules could be extracted as two principal components, morphology parameter and compressibility parameter. The significant effects on the tablet compactibility are the compressibility, moisture, and surface morphology of granules produced. Conclusion: Multivariate data analysis could make the quick and easy classification of Sarcandrae Herba Granule. The correlation between granules micromeritic primary properties and tablet compactibility is given. By controlling compressibility, moisture, and surface morphology of granules produced, the tablets with good compactibility can be obtained.
ABSTRACT
O controle de qualidade de matérias-primas é imprescindível, pois visa assegurar a qualidade do produto acabado. O objetivo do trabalho foi avaliar a qualidade físico-química e farmacotécnica de matérias-primas de alopurinol, fármaco utilizado para a prevenção e o tratamento de crises de gota, amplamente prescrito e produzido por indústrias e farmácias magistrais. As amostras (A, B, C e D) de alopurinol oriundas de diferentes fornecedores foram submetidas a ensaios farmacopeicos (características organolépticas; solubilidade; ensaios de identificação: teste de precipitação e varredura no UV; ensaios de pureza: limpidez de solução, perda por dessecação, cinzas sulfatadas; doseamento), análise térmica (DSC, TG), análise granulométrica e determinação das propriedades de fluxo (ângulo de repouso, densidade bruta e de compactação, fator de Hausner, índice de compressibilidade e compactabilidade). As amostras foram aprovadas em todos os ensaios farmacopeicos. Nas curvas de DSC, o ponto de fusão foi de cerca de 380 °C para todas as amostras e, após a fusão houve a degradação, confirmada pelas curvas TG, com uma perda de massa de aproximadamente 100 %. A partir da distribuição granulométrica as amostras A e B foram classificadas como pós finos e as C e D como finíssimos. Os valores de ângulo de repouso caracterizaram as amostras A, B, C e D como de fluxo fraco e, o fator de Hausner e índice de compressibilidade caracterizaram as amostras como amostras de fluxo bastante deficiente. Os ensaios demonstraram-se úteis para avaliar a qualidade das amostras. A adição de adjuvantes apropriados durante o preparo das formulações de alopurinol é essencial para melhoramento do fluxo.
The quality control of raw materials is intended to ensure the quality of the finished product. The objective of this study was to carry out physicochemical and pharmacotechnical assessments of allopurinol raw materials. This drug is widely prescribed for the prevention and treatment of gout and is produced both by drug manufacturers and compounding pharmacies. Samples (A, B, C and D) from 4 different suppliers were subjected to pharmacopoeial testing (organoleptic characteristics; solubility; identification tests: precipitation and scanning UV; purity tests: clarity of solution, loss on drying, sulphated ash; assay), thermal analysis (DSC, TG), particle size analysis and flow property tests (angle of repose, bulk density and tapped density, Hausner ratio, compressibility and compactibility). The samples were approved in all the pharmacopoeial tests. In the DSC curves, the melting point was about 380 °C for all samples and after fusion there was degradation, confirmed by TG, with a weight loss of approximately 100%. From the particle size distributions, samples A and B were classified as fine powders and C and D as very fine powders. The angles of repose characterized the samples A, B, C and D as having weak flow, while the Hausner ratio and compressibility index indicated that they had very, very poor flow. The tests proved useful for assessing the quality of the samples and showed that appropriate adjuvants need to be added to the allopurinol formulations to improve the flow.
Subject(s)
Allopurinol/pharmacokinetics , Quality ControlABSTRACT
AIM: To prepare traditional Chinese medicine formula Danggui Buxue Pellets by extrusion-spheronization and to study the optimal process and formulation. METHODS: Danggui Buxue Pellets were prepared by a new style extrusion-spheronization equipment;The optimal process and formulation were obtained on the studies of influenitial factors and L_9(3~4) orthogonal design,The micromeritic properties and reception percentage of pellets were determined. RESULTS: The prepared Danggui Buxue Pellets by extrusion-spheronization were all spheral with smooth surface;The percent of reception was not less than 85%. CONCLUSIONS: Extrusion-spheronization is suitable to produce herbal medicine pellets.The preparation process is simple and feasible;The quality of the prepared pellets is excellent and the percent of reception is high.