RÉSUMÉ
Objective Three kinds of pretreatment methods were studied to compare and select the suitable pretreatment methods for Lycii Fructus (LF) reference standards to improve its crushing and packaging efficiency. Methods LF was treated by three pretreatment methods of decompression drying, liquid nitrogen freeze-drying, and freeze-drying. The difference of characteristic values before and after treatment was determined and compared with LF without pretreatment. The determination of characteristic values included the determination of moisture, content, etc. Results The water content of raw material of directly crushed LF was 6.4%, and the water content of the other three pretreated LF was 4.6%, 5.0%, and 5.2%, respectively. The content of polysaccharide and betaine in the raw material of directly crushed LF was 2.5% and 0.98%. The polysaccharide content of the other three pretreated LF was 2.6%, 2.8%, and 2.6%, respectively. The content of betaine was 0.94%, 1.00%, and 0.87% by the other three pretreatment methods. The results showed that there was no significant difference in the quality of LF obtained by the three pretreatment methods. Therefore, from an economic point of view, this paper recommended to use more affordable pretreatment method of decompression drying for LF. In addition, the pretreated raw materials of LF should be crushed and subpackaged as soon as possible, and the crushing and the dividing environment humidity should be strictly controlled at 20% to 30%, in order to improve the efficiency of crushing and dividing. Conclusion Based on the cost consideration, the decompression drying method is the most economical and effective of the three pretreatment methods. Therefore, the decompression drying method is recommended in actual work.
RÉSUMÉ
OBJECTIVE: To study influence of humidity on granule flowability, explore relationship between flowability and quality of guaifenesin sustained tablet, give a basis for industrialization. METHODS: By hygroscopicity study, CRH was measured. After 10 days in RH 33%, 60%, 75%, 84%, 92.5%, flowability of granule and quality index of tablet, such as appearance, extremum of weighty friability was measured and compared with result of 0 d. Functional relationship between micromeritics parameter and quality index of tablet was fitted. RESULTS: CRH of granule is between RH 67%-68%. When relative humidity is above RH 60%, flow-ability and quality of tablet is changed obviously. Used compressbiliity as X1, repose angle as X2, extremum of tablet weight as Y1, friability as Y2, linear relationship of them is Y1 = 0.192X1+ 0.092X2- 7.398 (r = 0.9921), Y2= 0.069X1 + 0.087X2 - 3.505 (r = 0.9881), when P < 0.001, the equations had statistical significance in the range of observation. CONCLUSION: Relative humidity of production and storage of granule should less than RH 60%. Functional relationship between micromeritics parameter of granule (compressbiliity and repose angle) and quality index of tablet (extremum of weighty friability) had statistical significance in the range of observation. Copyright 2012 by the Chinese Pharmaceutical Association.