小儿肺炎口服液的质量标准研究

目的：建立小儿肺炎口服液主要成分的含量测定方法，为该制剂的质量控制提供参考。方法：采用高效液相色谱．二极管阵列检测器（HPLC—DAD）法分别对小儿肺炎口服液中的主要成分盐酸麻黄碱、盐酸伪麻黄碱、盐酸小檗碱、黄芩苷、大黄素、大黄酚、紫菀酮进行定量分析。结果：所测定的主要成分在其最大吸收波长下均达到基线分离，线性范围较宽，盐酸麻黄碱在0．1013—0．5065mg／mL（r=0．9998）、盐酸伪麻黄碱在0．1040～0．5200mg／mL（r=0，9999）、盐酸小檗碱在O．1852—0．9260m/mL（r=0．9999）、黄芩苷在1．0500～5．2500mg／mL（r=0．9999）、大黄素在0．0028～0．0142mg／mL（r=0．9997）、大黄酚在0．0023—0．0114mg／mL（r=0．9996）、紫菀酮在0．0392—0．3136mg／mL（r=0．9996）范围内与峰面积线性关系良好，平均回收率在95．0％以上。结论：HPLC—DAD法测定小儿肺炎口服液主要成分含量方法简便、准确、重复性好，可用于小儿肺炎口服液的质量控制。

小儿肺炎口服液中主要成分的鉴别方法探析

目的 :分析对小儿肺炎口服液中主要成分进行鉴别的方法。方法 :采用高效液相色谱法(HPLC)对小儿肺炎口服液中的麻黄、紫菀进行鉴别,采用薄层色谱法(TLC)对小儿肺炎口服液中的黄连、黄芩和大黄进行鉴别,并分析其鉴别结果。结果 :在相应的TLC色谱中,黄连、黄芩和大黄分别在与其对照药材色谱相同的位置上出现相同的颜色斑点。在采用HPLC-DAD法对麻黄、紫菀进行检测时,可在不同的波长处检出盐酸麻黄碱、盐酸伪麻黄碱及紫菀酮。结论 :本文建立了小儿肺炎口服液中黄连、大黄和黄芩的TLC鉴别法及麻黄和紫菀的HPLC鉴别法,其操作简便快速、重现性好,可用于该制剂的质量控制。

Effect of xiaoer feire kechuan oral solution on extrapulmonary injury induced by mycoplasma pneumoniae in infant wistar rats

Objective To observe the effect of Xiaoer Feire Kechuan oral solution on the extrapulmonary injury induced by Mycoplasma pneumoniae in infant Wistar rats. Methods Infant Wistar rats were infected intranasally with M. pneumoniae once a day for four days. In the treatment groups, Xiaoer Feire Kechuan oral solution was administered daily for four days beginning from the day of infection. On day 5, blood of the rats was collected, and blood routine and biochemistry indexes were measured. All rats were sacrificed, and the weight of brain, heart, liver, and kidney was measured to calculate the organ indexes. The GM1 and GALC-Ab content in brain tissue was determined by ELISA. Pathological changes in the brain, heart, liver, kidney, and cerebellum were observed by HE staining. Results Blood routine indexes fluctuated within the normal range in the infection control group and in three of the Xiaoer Feire Kechuan oral solution groups. The serum LDH, CK, and CRE in all three Xiaoer Feire Kechuan oral solution groups were distinctly lower than those in the infection control group (P < 0.01, P < 0.05). Rat brain index and GALC-Ab content in the brain tissue showed an increase in infection control group. In the Xiaoer Feire Kechuan oral solution groups, the GALC-Ab content in brain tissue was decreased significantly. The heart, liver, and kidney tissues showed mild pathological changes in the infection group, which were reversed by Xiaoer Feire Kechuan oral solution treatment. Conclusions The extrapulmonary injury induced by M. pneumoniae in infant Wistar rats was significantly inhibited by Xiaoer Feire Kechuan oral solution.