| Objective: To develop the optimal preparation process of Qinqi oral liquid,establish the quality standard of Qinqi oral liquid,and investigate the stability of Qinqi oral liquid.Methods: In this experiment,the water addition amount,extraction time and extraction times of Qinqi oral liquid were investigated by orthogonal experiment.The content of baicalin was used as the detection index to optimize the extraction process of Qinqi oral liquid..The concentration of crude drug,alcohol concentration and resting time in oral liquid purification were optimized to optimize the purification process of Qinqi oral liquid.The antiseptic process of Qinqi oral liquid was determined by microbial limit experiment.Through the identification of traits,Radix Isatidis,Radix Astragali,Radix Scutellariae,Forsythia,Salvia miltiorrhiza,relative density,p H,loading and content of baicalin,the quality standard of Qinqi oral liquid was established.The expiration date of the sputum oral liquid was determined by an accelerated stability test and a long-term stability test.Results: The results of the process optimization and the establishment of quality standards of Qinqi oral liquid are as follows:1.The best preparation process of Qinqi oral liquid was immersed in 10 times water for 1.5 h,then decocted twice,1.5 h each time,the liquid was concentrated to 1.5 g·m L-1,and ethanol was added until the alcohol content was 60%,4 °C was allowed to stand for 12 h,filtered,ethanol was recovered,water was added until the concentration of crude drug was 1 g·m L-1,and it was allowed to stand at 4 ° C for 48 h,filtered,and 3‰sodium benzoate was added and potted.2.According to the observation of the color and state of the Qinqi oral liquid,it is determined that the properties of the Qinqi oral liquid are dark reddish brown liquid and the gas is fragrant,tastes sweet and slightly bitter.The preparation test of Qinqi oral liquid showed that the relative density was not less than1.01,the p H was about 4.6,and the loading was not less than 97% of the labeled capacity(250 m L).3.The results of content determination showed that the chromatogram of the Qinqi oral liquid sample showed the same color spots at the corresponding positions of the reference medicinal materials of RadixIsatidis,Radix Astragali,Radix Scutellariae,Forsythia,Salvia miltiorrhiza,and there was no interference at the position of the negative control.The results were in accordance with the requirements of TLC in the Chinese Veterinary Pharmacopoeia(Part 2,2015),indicating that this method is suitable for TLC of Qinqi oral liquid.4.The results of HPLC showed that the content of baicalin was in a good linear relationship with the peak area in the range of 0.1531 μg~1.225 μg(r=0.9999).The average recovery was 98.96% and the RSD was1.29%(n=6).The precision,repeatability and stability was no more than 2%.The results were in accordance with the HPLC items in the Chinese Veterinary Pharmacopoeia(Part 2,2015),indicating that this method is suitable for the determination of the content of Qinqi oral liquid.5.Under the conditions of accelerated stability test and long-term stability test,the results of the test are stable,and the shelf life can be tentatively set at two years.Conclusion: The laboratory successfully prepared the Qinqi oral liquid.The optimized process is simple,stable,feasible,and low in cost,and can be used as a preparation process for industrial production of Qinqi oral liquid.The quality standard of Qinqi oral liquid was successfully established.The TLC identification method and the HPLC method are simple,reproducible and specific,and can be used to control the quality of the Qinqi oral liquid.This experiment laid the foundation for the subsequent pharmacology,toxicology,clinical and expanded clinical research of Qinqi oral liquid. |
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