干燥方式对熊胆粉物理特性、紫外及抑菌作用的影响

Effects of drying methods on physical properties,ultraviolet spectrum,and antibacterial activity of bear bile powder

目的考察干燥方式对熊胆粉物理特性、紫外及抑菌作用的影响。方法采用常压、减压及冷冻干燥对熊胆汁进行干燥,对熊胆粉各项物理质量属性指标进行综合表征,建立由8个指标:颗粒间空隙率(Ie)、卡尔指数(IC)、松密度(Da)、振实密度(Dc)、干燥失重(%HR)、吸湿性(%H)、豪纳斯比(IH)、休止角(α)构成的物理指纹图谱,以雷达图定量直观展示并比较其物理特性差异。以相似度分析,聚类分析(CA),主成分分析(PCA)等多元统计分析方法对不同干燥方式生产的9批熊胆粉进行质量评价,找出样品批间差异性指标。采用紫外可见分光光度计分别扫描9批熊胆粉溶液全波长图谱,建立对照紫外可见图谱,用相关系数法计算样品指纹图谱与对照指纹图谱的相似度。采用牛津杯抑菌法测定3种干燥方式(常压干燥、减压干燥、冷冻干燥)熊胆粉对大肠埃希菌、金黄色葡萄球菌及枯草芽胞杆菌的体外抑菌值;结果相同干燥方式所得熊胆粉物理及紫外指纹谱间相似度较大,不同干燥方式所得熊胆粉物理指纹图谱间相似度为57.1%~92.9%,其紫外指纹图谱间相似度不低于91.3%。干燥方式导致物理属性指标有一定差异,其主要差异性指标分别为颗粒间空隙率、干燥失重、卡尔指数、休止角、吸湿性。3种干燥方式熊胆粉均对大肠埃希菌、金黄色葡萄球菌、枯草芽胞杆菌有抑菌作用,其中冷冻干燥熊胆粉抑菌作用最弱,与常压干燥、减压干燥组比较,有显著性差异(P<0.05,P<0.01);结论干燥方式对熊胆粉物理特性有一定影响,对其紫外指纹图谱无较大影响,但对熊胆粉抑菌作用有较大影响。该方法从物理状态层面评价熊胆粉批间的质量一致性,可反映生产工艺对熊胆粉物理性质的影响,为后续制剂的质量控制研究提供新思路。

Abstruct Objective To investigate the effects of drying methods on the physical properties,UV spectrum,and bacteriostatic effects of bear bile powder.Methods Bear bile was dried by atmospheric pressure,decompression,and freeze drying,and the physical quality properties of bear bile powder were characterized comprehensively.A physical fingerprint was established,which was composed of eight indexes:Intergranular voidage(Ie),Karl index(IC),loose density(Da),vibrating density(Dc),drying weight loss(%HR),hygroscopicity(%H),Honas ratio(IH),and repose angle(α).The differences of physical characteristics were quantitatively and intuitively displayed by radar map and compared.The quality of nine batches of bear bile powder produced by different drying methods was evaluated by multivariate statistical analysis methods such as similarity analysis,cluster analysis(CA)and principal component analysis(PCA),and the difference indexes between batches of samples were found.The full-wavelength spectra of nine batches of bear bile powder solution were scanned by UV-vis spectrophotometer,and the control UV-vis spectra were established.The similarity between sample fingerprints and control fingerprints was calculated by the correlation coefficient method.The in vitro bacteriostatic value of bear bile powder against Escherichia coli,Staphylococcus aureus,and Bacillus subtilis was determined by the Oxford cup bacteriostatic method.Results The physical and UV fingerprints of bear bile powder obtained by the same drying method had great similarity.The similarity between physical fingerprints of bear bile powder obtained by different drying methods was 57.1%to 92.9%,and the similarity between UV fingerprints was not less than 91.3%.Drying methods led to some differences in physical properties,and the main differences were inter-particle voidage,drying weight loss,Carr index,rest angle,and hygroscopicity.Bear bile powder of three drying methods had bacteriostatic effect on Escherichia coli,Staphylococcus aureus,and Bacillus subtilis,among which freeze-dried bear bile powder had the weakest bacteriostatic effect.Compared with normal pressure drying and vacuum drying group,there was significant difference(P<0.05,P<0.01).Conclusion The drying method has a certain effect on the physical properties of bear bile powder,but has no significant effect on its UV fingerprint,but has a great influence on the bacteriostatic effect of bear bile powder.This method can evaluate the quality consistency between batches of bear bile powder from the level of physical state,which can reflect the effect of production process on the physical properties of bear bile powder,and provide a new idea for the quality control of follow-up preparations.