The Preparation Technology And Quality Standard Of Tianlongjie Capsule And Its Effect On The Expression Of CTGF Factor In Pulmonary Fibrosis Rats

Objective:To develop"Tianlongjie"prescription as a traditional Chinese medicine compound capsule that is convenient to carry,has good patient compliance,and is more suitable for clinical application.The preparation process and quality standards of Tianlongjie capsules and its effect on the expression of CTGF factors in pulmonary fibrosis rats The research provides theoretical and experimental basis for the party’s declaration of preparations in medical institutions and expansion of clinical applications.Methods:Taking the yield of dry paste and the transfer rate of salidroside as evaluation indexes,the optimum extraction process was optimized by orthogonal test on the basis of single factor test.Taking the transfer rate of salidroside as the evaluation index,the effects of atmospheric pressure concentration and vacuum concentration on the extract were investigated by single factor experiment,and the transfer rates of salidroside and Panax notoginseng saponins R1 were used as the evaluation index.single factor experiments were conducted to investigate the effects of atmospheric drying and vacuum drying on salidroside and Panax notoginseng at different temperatures.According to the angle of rest,bulk density and hygroscopicity,the properties of filling powder were investigated and the type of capsule was determined.Rhodiola,Panax notoginseng and Draconis Draconis in the capsule were identified by TLC,the contents of salidroside and Loureirin An in the capsule were determined by HPLC,the fingerprint of Tianlongjie capsule was established by HPLC,and the stability test was carried out.The rat model of pulmonary fibrosis was used to observe the effect of Tianlongji capsule on the expression of CTGF factor in rats with pulmonary fibrosis by using the expression of CTGF factor and histopathological sections as indicators.Results:The optimum extraction conditions of Tianlongji capsule were as follows:10 times amount of water,1.5 hours and 3 times,the extract concentrated to 1.3-1.4（50℃60℃）had no significant effect on salidroside,and the vacuum drying extract at60℃had no significant effect on salidroside and notoginsenoside R₁,the resting angle of filling powder was 37.63°,the bulk density was 0.832g/ml,and the hygroscopicity was small.The TLC qualitative identification of Rhodiola,Panax notoginseng and Draconis Draconis in Tianlongjie capsule was clear and negative without interference.The determination conditions of salidroside in Tianlongji capsule were as follows:C₁₈column;mobile phase:acetonitrile-0.1%phosphoric acid solution（10:90）;column temperature:30℃;detection wavelength:275 nm;flow rate:1ml·min-1;injection volume 10μl,the limit was not less than 4.62mg/particles,the determination condition of Loureirin A was C18 column,acetonitrile-0.1%phosphoric acid solution（50:50）was used as mobile phase.The detection wavelength is 270 nm,the flow rate is 1ml·min-1,the column temperature is 30℃,the injection volume is 10μl,and the limit is not less than 0.77mg/particles.In the fingerprint study,32 chromatographic peaks were identified,and peak 3 was identified as salidroside,14 as notoginsenoside R1,17 as ginsenoside Rg1,30 as Loureirin A,31 as Loureirin B.in the similarity analysis,the similarity between the fingerprint of 14 batches of Tianlongyu capsule and the control was more than 0.9.After 6 months of accelerated test and long-term test,the quality of Tianlongyu capsule was stable,all the identification,detection and content were qualified,and Tianlongyu capsule could significantly reduce the content of CTGF factor in model rats.Conclusion:The study shows that the technological route of Tianlongyu capsule is reasonable,stable and feasible,the quality standard and content determination method is simple,the specificity is good,the preparation is stable,and it has a certain therapeutic effect on pulmonary fibrosis.