Study On The Preparation Process And Quality Standard Of Changma Xifeng Oral Liquid

Changma Xifeng tablets mainly treat children with multiple twitching,and sputum in the chest;the main performance is abnormal pronunciation in the larynx,irritability,many dreams and so on.Tablets are easy to carry but the drug is mainly aimed at children,because of children esophagus is narrow,deglutition medicaments is difficult,at the same time this disease comes on urgently,process is fast,so it needs medicaments to take effect quickly.However,tablets with excipient and compressed into form,compared with oral solution,the dissolution rate is slow and the bioavailability is low.In this study,the oral liquid dosage form was developed by applying modern pharmaceutical technology based on the secondary development of Changma Xifeng tablets.Compared with tablet,liquid preparation has the advantages of high concentration,small dosage,good taste,fast action and dosing.In terms of technology,the extraction process of Acori Tatarinowii rhizoma volatile oil was investigated by orthogonal experiment with the extraction rate of volatile oil as an index.Finally,the optimal extraction process was 40 g of Acori Tatarinowii rhizoma powder,10 times of 4% 1-butyl-3-methylimidazole chloride salt was added,30 min of ultrasound,2h of soaking,and 8h of distillation by water vapor.The volatile oil was collected and added into the separating funnel.5ml of petroleum ether was added into the separating funnel.After extraction and static stratification,anhydrous sodium sulfate was filtered and petroleum ether was removed by a rotary evaporator in a 40℃ water bath.Volatile oil was added to 10 ml of 2%glycerol and into the solution after water sinking.According to the comprehensive index of paeoniflorin,gastrodin and extract rate,the extraction process of traditional Chinese medicine was obtained as follows: the residue of the liquid after distillation of Acorus tatarinowii was added with 60 g of Paeoniae radix alba medicinal material fine powder,30 g of Gastrodiae rhizoma fine powder and 30 g of Polygala radix fine powder,and 15 times of 80% ethanol solution was added to soak for 2 h,heated and refluxed for 90 min,and filtered with a Buchner funnel.Evaporate ethanol in a water bath,continue to concentrate to a relative density of 1.20,add water to 50% of the total,refrigerate for 24 h,and filter.Margaritifera concha was crushed and heated with 8 times amount of 6mol/L sulfuric acid for 10 h.The filtrate was filtered and adjusted to neutral by adding 4mol/L barium hydroxide.The filtrate was added to the liquid after water sinking.In the clarification process study,2% ZTC1+1 natural clarifier was added and stirred at 60℃ for 30 min,placed for 24 h,and the clarity was good after filtration.For the added excipients,2g/L aspartame was added with the best taste and 0.15% sodium sorbate preservative.When adjusted at Ph4.5,the clarity was good,sterilized at 105℃ for 45 min,and the quality was stable.All the medicinal herbs in oral liquid have been purified,which not only ensures the effectiveness,but also improves the drug safety and compliance.The inspection was carried out with reference to the provisions of the General Principles of Preparations of the Chinese Pharmacopoeia（2015 edition）under Oral Solution,and the results met the requirements.In terms of quality standards,TLC identification method was established for Paeoniae radix alba,Gastrodiae rhizoma and Polygala radix in Changma Xifeng oral liquid,and HPLC detection method for paeoniflorin and this product tentatively contains no less than 0.31mg/ml of paeoniflorin and no less than 0.25mg/ml of gastrodin.The different chromatographic conditions and extraction conditions were investigated to determine the detection method.Ten batches of samples of Changma Xifeng Oral Liquid were determined,and the HPLC fingerprint was established.The similarity comparison was carried out with the help of the“Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System”2004A version software.The results showed that there were 10 common peaks with similarity between 0.989 and 0.999.Peak 2,6 and 7 were identified as gastrodin,paeoniflorin and paeoniflorin by comparison with the control.In the stability study of this product,accelerated and long-term stability investigation was carried out,the identification of microbial limit content of residual solvent of the sample was investigated,and the stability of the drug was investigated.In summary,the preparation process of Changma Xifeng oral liquid is reasonable,which meets the requirements of liquid preparation in Chinese Pharmacopoeia,and the quality standard is improved,and the fingerprint of oral liquid is added;On this basis,preliminary stability study is carried out,which shows that the quality of oral liquid is stable and controllable,providing a scientific basis for the next product declaration and clinical practice.