ABSTRACT
OBJECTIVE: To establish the method for simultaneous determination of pim-O-glucosylcimifugin, liquiritin, 5-0-methylvisammioside and amonium glycyrrhizinate in Xinyi byan pills.METHODS: HPLC-switching wavelength method was used for content determination of 52 batches of Xinyi byan pills sample from enterprises A, B, C. The determination was performed on Kromasil C18 column with mobile phase consisted of acetonitrile-0. 1 ％ phosphoric acid at the flow rate of 1. 0 mL/min. The detection wavelengths were set at 220 nm (pim-O-glucosylcimifugin, liquiritin, 5-O-methylvisammioside) and 250 nm (amonium glycyrrhizinate). The column temperature was 30℃, and sample size was 10 μ L. RESULTS: The linear ranges of prim-O-glucosylcimifugin, liquiritin, 5-O-methylvisammioside and amonium glycyrrhizinate were 6. 138-122. 77 μg/mL (r=0. 999 9), 2. 502-50. 03 μg/mL (r=0. 999 9), 5. 988-119. 75 μg/mL (r=0. 999 9) and 12. 788-255. 76 μg/mL (r=0. 999 9), respectively. RSDs of precision, stability and reproducibility tests were all lower than 2. 0％ (n=6). The recovery rate were 100. 32％ (RSD=0. 58％, n=6), 100. 24％ (RSD=0. 56％, n=6), 101. 28％ (RSD=0. 91％, n=6) and 101. 48％ (RSD=0. 79％, n=6), respectively. Total contents of 4 components in enterprise A were generally higher than enterprises B, C, among which the difference of liquiritin was significant; the content of prim-O-glucosylcimifugin in enterprise B was higher than enterprises A, C, while the content of 5-O-methylvisammioside was lower than enterprises A, C. The content of liquiritin in enterprise B was outlier. CONCLUSIONS: This method is simple, reproducible and can provide reference for quality control of Xinyi biyan pills.
ABSTRACT
OBJECTIVE:To observe therapeutic efficacy of Xinyi biyan pills combined with budilaide in the treatment of aller-gic rhinitis and its effects on related inflammatory factors. METHODS:A total od 120 patients with allergic rhinitis were randomly divided into observation group and control group,with 60 cases in each group. Control group was treated with Budesonide nasal spray,spraying once each nostril(64 μg/spray),2 times a day. Observation group was additionally treated with Xinyi biyan pills 3 g,3 times a day. Treatment course lasted for 4 weeks. Clinical efficacies of 2 groups were observed and compared. The changes of total score of clinical symptoms and signs were observed before and after treatment. The contents of IgE and LTE4 were deter-mined,and the occurrence of ADR was recorded. RESULTS:Three patients of observation group and 4 patients of control group fell of the study. Total response rate of observation group was significantly higher than that of control group,with statistical signifi-cance (84.21% vs. 73.21%,P0.05). After 2 and 4 weeks of treatment,total score of clinical symptoms and signs,IgE and LTE4 levels in 2 groups were significantly lower than before treatment,and the observation group was signifi-cantly lower than control group,with statistical significance (P<0.05). No obvious ADR was found in 2 groups. CONCLU-SIONS:Xinyi biyan pills combined with budesonide show good therapeutic efficacy for allergic rhinitis,improve clinical symp-toms and signs significantly and reduce inflammatory factors levels with good safety.