Methodological Study On The Control Of Macromolecular Impurities In Qingkailing Injection(QKLI)from The Extraction Stage

Objective:In order to select the best extraction temperature,this experiment studied the effects of different extraction temperature on the endogenous compounds and active ingredients of three plant medicinal materials in Qingkailing injection(QKLI).Methods:(1)Extracting these three herbal medicines with five different temperatures,QKLI was prepared according to the Pharmacopoeia of the People's Republic of China.(2)Using the molecular sieve,the macromolecular substances in the three plant medicinal materials with five different temperatures was detected by the 10 K ultrafiltration tubes.(3)According to the operation specifications of the Pharmacopoeia of the People's Republic of China,the endotoxin in the three herbal drugs with five different extraction temperatures and the self-mad QKLI were detected.(4)Using the HPLC fingerprint,we compared the material peaks of the final extracts of three herbal drugs.(5)Histological microscopic images were used to observe the histological differences of the radix isatidis and honeysuckle which were extracted at five different temperatures.(6)Obtaining the best washing time,the washing solutions of the three herbal drugs were detected.Results: (1)Among the extracts of radix isatidis with five different temperatures,the macromolecule get from boiling temperature is least while the micro-molecule get from 80? is the most.Considering the ratio of micro-molecule and macromolecular,the boiling extraction is better.(2)Among the extracts of honeysuckle with five different temperatures,the macromolecule get from 90? is least while the micro-molecule get from 80? is the most.Considering the ratio of micro-molecule and macromolecular,the 90 ? extraction is better.(3)Among the extracts of gardenia with five different temperatures,the macromolecule get from boiling temperature is the least while the micro-molecule get from 70? is the most.Considering the ratio of micro-molecule and macromolecule,the boiling extraction is better.(4)Among the self-made QKLIs with five different temperatures,the macromolecules get from the 90? is the least while the micro-molecule get from 80? is the most.Considering the ratio of micro-molecule and macromolecule,the 90? extraction is the best,followed by the boiling extraction.(5)The endotoxin test showed that the content of lipopolysaccharides in the first extraction from the three plants was relatively high,but most of the lipopolysaccharides had been removed after the alcohol precipitation.The content of lipopolysaccharides was very low in the self-made QKLIs.(6)The HPLC fingerprint showed that the peak area of the temperature which is get the more micro-molecules was larger.(7)After washing the three herbal drugs,it was found that the best washing time of radix isatidis was 6 minutes;the best washing time of honeysuckle is 15 minutes;the best washing time of gardenia is 20 minutes.Conclusion:Considering the content of macromolecules and micro-molecules in the process of the extraction,the 90? is the best extraction temperature which is followed by the boiling temperature.For each herb,the boiling temperature is best for extracting radix isatidis and gardenia and 90? is best for extracting honeysuckle.