基于酒醋盐炙法探讨赤芍不同炮制品饮片-丸剂物性参数与化学成分的相关性

Correlation Between Physical Parameters and Chemical Components of Prepared Slices and Pills of Different Processed Products of Paeoniae Radix Rubra Based on the Method of Baking with Wine, Vinegar or Salt

关键词:  赤芍  炮制品  丸剂  物性参数  化学成分  溶出  回归模型

Key words:  Paeoniae Radix Rubra  processed products  pills  physical parameters  chemical composition  dissolution  regression model

摘要:

目的 探讨赤芍不同炮制品饮片-丸剂物性参数与化学成分的相关性。方法 通过泛制法制备赤芍不同炮制品丸剂，测定赤芍不同炮制品饮片及丸剂物性参数（相对密度、pH值、氧化值），HPLC测定芍药苷含量；紫外分光光度法测定淀粉含量；测定丸剂体外溶出度，Weibull拟合丸剂溶出方程；运用SPSS 20.0结合MATLAB及Graphad prims 6.0进行物性参数与化学成分间相关性分析，建立回归模型。结果 赤芍不同炮制品饮片及丸剂物性参数pH值、芍药苷、淀粉含量具有显著相关性；依据相关性拟合回归模型，均与物性参数pH值相关，拟合程度较好，所得R²均>0.9，因此可选用pH值作为丸剂酒醋盐炮制质量控制的指标；溶出度结果表明酒醋盐炙法炮制对丸剂溶出具有一定的促进作用。结论 该研究选取物性参数、大分子（淀粉）、小分子（芍药苷）三者进行综合考察，揭示了物性参数与化学成分的变化规律，物性参数pH值与化学成分含量之间的回归模型，诠释了饮片制备成丸剂物性参数与化学成分含量之间的动态变化过程，可用于分析预测赤芍不同炮制品饮片制备所得丸剂的质量，为其丸剂的质量控制提供一定参考。

Abstract:

OBJECTIVE To investigate the correlation between physical parameters and chemical components of prepared slices and pills of different processed products of Paeoniae Radix Rubra. METHODS Pills of different processed products of Paeoniae Radix Rubra were prepared by general method. Physical parameters(relative density, pH value and oxidation value) of different processed products and pills were determined. The content of paeoniflorin and starch was determined by HPLC and UV, respectively. In vitro dissolution of pills was fitted used Weibull equation. SPSS20.0 combined with Matlab and Graphad prims 6.0 was used to analyze the correlation between physical parameters and chemical components, and the regression model was established. RESULTS The physical parameters, pH value, the content of paeoniflorin and starch had significant correlation between different processed products of Paeoniae Radix Rubra and their pills. According to the correlation fitting regression model, all of them were related to the pH value. The fitting degree was good, and the R² was >0.9. Therefore, the pH value could be selected as index for the quality control of the different processed products of Paeoniae Radix Rubra and their pills. The results of dissolution experiment showed that the processed products prepared by wine, vinegar or salt had certain promoting effect on the dissolution of pills. CONCLUSION The study selects physical parameters, macromolecules(starch), and small molecules(paeoniflorin) to conduct a comprehensive investigation, revealing the changing laws of physical parameters and chemical components. The regression model between physical parameters(pH value) and chemical components explaines the dynamic change process from processed products to pills, analyze and predict the quality of pills prepared from different processed products of Paeoniae Radix Rubra, and provide reference for the quality control of their pills.