Study On Quality Standard Of Niuhuangshuangbanlian Oral Liquid

Harbin 242 Hospital Pharmacy Niuhuangshuangbanlian oral liquid,hospital preparation room which is a self-made compound,that is composed of Lonicerae Japionicae Flos,Scutellariae Radix,Fructus Forsythiae,Buball Cornu,Isatidis Radix of Chinese medicine.Niuhuangshuangbanlian oral liquid even attending the efficacy of oral solution detoxify,cool scattered wind heat,reducing swelling.For the common cold,Hyperactivity cough,febrile disease fever,pharyngitis embolism,has been one of the focus areas of the treatment of respiratory tract infections.In this study,the other by thin-layer chromatography in the qualitative identification of Chinese Traditional Medicines,which Niuhuangshuangbianlan oral liquid even in the prescription oral forsythia amount is twice the rest of the four,is the minister drugs.Mean while Forsythin is one of the most active antibacterial ingredient found so far from Forsythia plants,the experiment by HPLC to determine the content of Forsythin.In this paper,the quality standards of its research done qualitative and quantitative research.In qualitative terms,the use of thin-layer chromatography flavors of traditional Chinese medicine for identification.In the quantitative analysis,the use of high performance liquid chromatography,density checks done,pH value test,the determination forsythin linear range investigated,precision test,repeatability,stability test,test specificity,and recovery test negative control test,determine the appropriate quality standards and control targets.The experimental results are as follows:(1)Preparation of drugs:Lonicerae Japionicae Flos 250g,Scutellariae Radix 250g,Fructus Forsythiae 500g,Buball Cornu 250g,Isatidis Radix 250g,Buball Cornu boiling water for 1 hour,add the remaining four flavor such as Lonicerae Japionicae Flos,Fructus Forsythiae,Scutellariae Radix,Isatidis Radix,continue boiling twice every 1.5 hours merger fried liquid filtration,the filtrate was concentrated to a relative concentration of 1.20?1.25(80?)of clear paste and let cool to 40?,slowly adding ethanol containing alcohol amounted to 60%,stir and let stand overnight,filtration,the amount of the residue in 60%ethanol,stir well and let stand 12 hours,filtration,combined filtrate recovery of ethanol to no alcohol taste,add water to adjust to 1000ml,stir,filtration,filling,sterilization,vested.check the connection density Niuhuangshuangbanlian oral liquid,according to the requirements for preparing the test,the test results for the sample density is 1.136,not less than 1.04,in line with the standard;inspection Niuhuangshuangbianlan oral liquid pH value,the result of six copies of the test were within the pH range of 4.0 to 6.0?(2)Qualitative identification:using thin layer chromatography,for the flavors of traditional Chinese medicine for qualitative identification.First,in accordance with the test requirements for the preparation of the test solution,the negative control solution,the reference solution,according to the Chinese Pharmacopoeia 2010 edition flavors of traditional Chinese medicine for the identification and get chromatogram.(3)Quantitative analysis:Using high performance liquid chromatography,according to the corresponding chromatographic conditions:filler is octadecylsilane bonded silica,reference to Forsythin,not less than the number of theoretical plates 4000;mobile phase of acetonitrile-water(25:75);detection wavelength was 278nm,column temperature:30?,Injection volume:10?L,flow rate:1.5mL/min,the preparation of the corresponding test,the reference solution,the measured content forsythin then methodological study visits,including linear range,precision test,test repeatability,stability test,test specificity,negative controls,recovery tests,etc.,to give the corresponding chromatogram,the test results not only proved the product a good degree of precision and repeatability,and other test results are in line Pharmacopoeia.Final conclusion:the qualitative identification in strict accordance with the provisions of the new pharmacopoeia of Chinese flavors in this product were identified by thin layer chromatography,chromatograms prove the product contains the flavors of traditional Chinese medicine.Content was determined by high performance liquid chromatography,the results were more than 0.30mg/ml,in line with national pharmacopoeia.Methodological study in forsythin within 0.3?g?1.8?g concentration range,the sample volume and the peak area was linearly correlated linearly related by observing the chromatogram can be seen in the negative sample forsythin reference peaks corresponding position without interfering peaks,indicating specificity of the method is good.We passed system suitability test,the number of theoretical plates measured Forsythin reference solution for 9409.According to the basic requirements for stability,the stability of the Niuhuangshuangbianlan oral liquid were investigated,after 0,2,4,8,12,16,24 hours were investigated,and some related substances increased slightly,while the content of slightly There are lower,other indicators did not change significantly,the results also demonstrated compliance test stability within 24 hours,indicating a good stability.In the precision and reproducibility of the test,the test results show that the precision of the Niuhuangshuangbianlan oral liquid and good repeatability.In the negative control experiments,the negative control solution in the test solution and reference solution retention time forsythin no absorption peaks corresponding position,indicating a negative control without interference.Test each of the indicators are in line with Pharmacopoeia requirements.Initially established quality standards,can effectively control the product quality.By studying this subject,even for the quality control of Niuhuangshuangbianlan oral liquid of the foundation.