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OBJECTIVE：To optimize the inclusion technology of volatile oil from Ganmao qingre granules. METHODS ： Guided by the concept of “quality by design ”，taking volatile oil inclusion rate and inclusion complex yield as key quality attribute，comprehensive score of above two indexes after weighting as response value ，inclusion temperature ，inclusion time ，the ratio of β-CD to volatile oil as key technology parameters ，Box-Burman response surface design was adopted to establish the design space of key technology parameters and key quality attributes. The design space was optimized and verified by 95％ confidence interval. The stability of inclusion complex was investigated preliminarily. RESULTS ：The optimal design space ，i. e. the optimal technology parameters rang ，included inclusion temperature 35-40 ℃，inclusion time 1.8-2.0 h，the ratio of β-CD to volatile oil 9.5∶1- 10∶1（g/mL）. The results of 3 validation tests showed that the volatile oil inclusion rates were all over 62％，the yields of inclusion complex were all over 75％，and the comprehensive scores were all over 80 point. The results of preliminary stability showed that the inclusion rate of volatile oil ，the yield of inclusion complex and the comprehensive score did not change significantly. The difference in evaluation indicators within 7 days was within 5％. CONCLUSIONS ：The optimized inclusion technology is feasible ， and the obtained inclusion complex is stable.
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To systematically evaluate the efficacy and safety of Ganmao Qingre Granules in treatment of children with wind-cold syndrome. The study systematically retrieved CNKI, WanFang, VIP, CBM, PubMed, EMbase and Cochrane Library for children cases with wind-cold syndrome treated with RCT. The literature inclusion criteria provided by Cochrane was used to evaluate the litera-ture quality, and Meta-analysis was conducted by RevMan 5.3 software. A total of 6 literatures were included, with a total sample size of 492 cases, including 246 cases in the experimental group and 246 cases in the control group. According to the results of Meta-analysis, the experimental group recorded the hypothermia time(MD=-0.38, 95%CI[-0.53,-0.23], P<0.01), the total clinical effective rate(RR=1.25, 95%CI[1.15, 1.36], P<0.01), the cough relief time(MD=-2.75, 95%CI[-3.05,-2.46], P<0.01), the decrease nasal congestion relief time(MD=-1.45, 95%CI[-1.69,-1.22], P<0.01), traditional Chinese medicine syndrome score(MD=-8.35, 95%CI[-9.35,-7.36], P<0.01), all of them were superior to those of the control group(Aminophenol Huangnamin Granules), with statistically significant differences. Only 2 literatures mentioned no obvious adverse reaction, and the other 4 literatures did not mention any adverse reactions. Based on the results of this study, it was indicated that Ganmao Qingre Granules were effective in the treatment of children with wind-cold syndrome, but with unclear adverse reactions. Due to the insufficient quantity and low quality of included literatures, the efficacy and safety need to be further confirmed by more high-quality clinical studies.
Subject(s)
Child , Humans , Cough , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Syndrome , WindABSTRACT
OBJECTIVE:To establish a method for simultaneous determination of the content of 14 common metal elements (Mg,Ca,Cr,Mn,Fe,Ni,Cu,Zn,As,Se,Cd,Sb,Ba and Pb)in Ganmao qingre granules. METHODS:Microwave diges-tion-inductively coupled plasma mass spectrometry(ICP-MS)method was conducted. The samples were digested with concentrated nitric acid-hydrogen peroxide(2∶1,V/V),and then ICP-MS was used to determine the mass concentration of 14 metal elements. Li, Sc,Ge,Y,In,Bi and Tb were used as internal standards,and branches and leaves of bush were used as standard substances. RE-SULTS:The correlation coefficient of the standard curves of 14 elements was larger than 0.999 6,detection limits were in the range of 0.002-0.035 μg/L,recoveries were in the range of 80.57%-104.2% and RSDs were in the range of 0.34%-2.71%. CON-CLUSIONS:The method is specific,accurate and sensitive,and suitable for the content determination of 14 common metal ele-ments in Ganmao qingre granules. The total mass concentrations of 6 batches of heavy metals are all meet the requirements of Green Trade Standards of Importing&Exporting Medicinal Plants&Preparations.
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OBJECTIVE:To establish the ion chromatography for the mass fractions of 9 inorganic anions (fluoride ion,for-mate radical,chloride ion,nitrite radical,bromide ion,nitrate radical,sulfate radical,oxalate radical and phosphate radical) in Ganmao qingre granules. METHODS:Ion chromatograph was used. The column was Ion Pac AS11-HC with the mobile phase of po-tassium hydroxide solution by gradient elution(concentration:30 mmol/L,time:15 min),the column temperature was room tem-perature,the volume was 25 μl. RESULTS:The 9 inorganic anions were basically achieved separation and had good linear relation-ship with r of 0.999 2-0.999 9,respectively;RSDs of precision,stability and reproducibility tests were less than 3.50%. Average re-covery was 92.47%-103.51%(RSD=0.42%-3.41%,n=6),respectively. CONCLUSIONS:The established method is fast,accu-rate,sensitive and repeatable and can be used for the determination of 9 inorganic anions in Ganmao qingre granules.
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AIM: To study the quality standard for Ganmao Qingre Granules(Herba Schizonepetae,Radix Saposhnikoviae,Radix Puerariae,etc). METHODS: Radix Saposhnikoviae,Spica Schizonepetae,Radix Bupleuri,Herba Platycodonis in Ganmao Qingre Granules were identified by TLC,and the content of puerarin was determined by HPLC. RESULTS: Radix Saposhnikoviae,Herba Schizonepetae,Radix Bupleuri,Herba Platycodonis could be identified by TLC.The concentration curve of hesperdin showed linearity over the range of 0.086 8-8.680 ?g(r=0.999 9).The average recovery was 99.09%,RSD was 1.12%(n=9). CONCLUSION: The method is simple,specific and accurate and can be used effectively for the quality control of Ganmao Qingre Granules.