Maxinshigan Soup, Quality Control Methods Compatible Regularity

Some researches on extraction process optimization, quality control methods and compatibility rule of Maxingshigan recipe were carried out. Ephedrine, pseudephedrine, Ca²⁺, amygdaloside and glycyrrhizic acid were selected as mark ingredients to find out the best extraction process and to establish quality control methods for the recipe. The stopping cough and relieving asthma capabilities were also selected to research the compatibility rule of the recipe.In the optimization experiment of extraction process, the best extraction dissolvent was found out firstly and the best extraction process was found out secondly. The results showed that both Herba Ephedrae and Gysum Fibrosum were well extracted when water was used to prepare the recipe but all the four Chinese traditional medicines were well extracted when 55% alcohol was used to prepare the recipe. As a result 55% alcohol was chosen as the dissolvent to prepare the recipe. The optimization experiment for extraction process was performed according to the L₉ (3⁴) orthogonal table. The results showed that extraction times influenced the extraction of all the four Chinese medicine; the extraction time effects the extraction of Herba Ephedrae, Semen Ameiacae Amarum and Radix Glycytthizae; the quantity of solvent influenced the extraction of gypsum only. So, A₂B₂C₂ (to extract for 2 times with 8 times of 55% ethanol, 45 minutes per time) was selected as the best extraction process for Maxingshigan recipe.TLC methods were developed for the identification of Herba Ephedrae, Semen Ameiacae Amarum and Radix Glycytthizae in consult of ChP (2005). The sample was alkalified with ammonia water and extracted with ether for the identification of ephedrine. In the identification of Semen Ameiacae Amarum, liposoluble ingredients were extracted by ether.HPLC methods were developed for the determination of mark ingredients in Maxingshigan recipe. In the determination of ephedrine and pseudephedrine, methanol-5 mmol·mL^-1 solution of sodium dodecylsulfate (38:62, v/v, modified pH to 3.3 with H₃PO₄) was used as mobile phase. The assay was carried out at 210 nm and the linearity range was 5.0-40μg·mL^-1 (r = 0.999 8) for ephedrine and 2.5-20μg·mL^-1 (r = 0.999 5) for pseudephedrine. In the determination of amygdaloside, methanol-water (22:78, v/v) was used as mobile phase. The assay was carried out at 215 nm and the linearity range was 0.10～3.0 mg.mL^-1 (r=0.999 8) for amygdaloside. In the determination of glycyrrhizic acid, methanol-0.2 mol·L^-1 ammonium acetate-acetic acid (67:33:1, v/v/v,) was used as mobile phase. The assay was carried out at 250 nm and the linearity range was 1.2～6.0 mg.mL^-1 (r=0.999 5) for glycyrrhizic acid. CBG was used as the indicator and EDTA as the titrant for the assay of Ca²⁺, whose linearity range was 9.3～46.5 mg (r=0.999 9).Some researches on pharmacodynamic actions of Maxingshigan recipe were carried out. Tests of stopping cough and asthma abilities were performed on mice and guinea pigs respectively. Chemical reference solution (CR in short), the blank and the test preparation (TP, three different dosages) were given to mice and guinea pigs. It was found that CR and TP have remarkable pharmacodynamic effects on both mice and guinea pigs compared with the blank. The intensity of these effects increased in responding to the increase of the dosage. The difference showed between stopping cough and relieving asthma was that the highest dosage was the best dosage for relieving asthma while the moderate dosage was the best for stopping cough. The orthogonal method was used to split the formula and the pharmacodynamic abilities of relieving cough and asthma were selected to appraise the effects of each group. Three Chinese traditional medicines, including ephdra (A), gypsum(B) and almond(C), were selected as influencing factors and three levels, that is 0, 1 and 2 times of medical substance to the original proportion of Maxingshigan recipe, were selected for each Chinese traditional medicine. The experiments were carried out according to the L₉ (3⁴) orthogonal table. It was showed in stopping cough and relieving asthma tests showed that, A had remarkable influence in both the two tests, B had remarkable influence in relieving asthma tests and C had remarkable influence on stopping cough tests among A, B and C.