Study On The Preparation Technology And Quality Evaluation Of Yinchenhao Decoction Dripping Pills

Yinchenhao Decoction（YCHD）is a classic prescription in Treatise on Febrile Diseases,comprising Yinchen（Artemisiae Scopariae Herba）,Zhizi（Gardeniae Fructus）and Dahuang（Rhei Radix Et Rhizoma）.It treats symptoms of hot and humid jaundice,and also has the effect of reducing gallbladder and yellowing,resisting liver damage,etc.It has been widely used in clinical treatment of hepatobiliary system diseases,hyperlipidemia,etc.YCHD is still widely used today due to its irreplaceable clinical efficacy.The traditional pharmaceutical preparation is decoction,but the inconvenience of the decoction in preparation,carrying,and taking limits the clinical promotion and use.Therefore,it’s an urgent need to explore a new dosage form of YCHD with important modern clinical application value.In this study,it is expected that the active ingredients in medicinal materials will be extracted by modern technology and made into a solid Dripping Pill preparation with a suitable matrix.With the advantages of portability,effective fast,good curative effect,low toxic and side effects,good drug stability,etc.,Dripping pills make up for the shortcomings of YCHD traditional decoction in terms of the dosage form.Therefore,the following four aspects of YCHD Dripping Pills were studied.First part of this thesis,research on the extraction process of YCHD Dripping Pills.Firstly,the medicinal materials were identified,and then the water extraction and alcohol precipitation method were used to extract the effective components.The orthogonal experimental design method was used to optimize the process parameters.After multiple experiments,the optimal extraction process was determined as follows:10 times water,1h of decoction,and one extraction time;The best alcohol precipitation process was:70%ethanol solution,concentration ratio 1:1,alcohol precipitation time 8h.Three batches of verification tests proved that the extraction process was stable and feasible.Second part of this thesis,research on the preparation process of YCHD Dripping Pills.The single-factor experiment and orthogonal design test method were used to optimize the preparation conditions of YCHD Dripping Pills.Finally,the optimal preparation process was determined as follows:the ratio of matrix PEG4000 and PEG6000 was 1:1.5,the condensate was dimethyl silicone oil,the dropping temperature was 70°C,the ratio of the main drug and the matrix was 1:2,the dropping speed was 30 d·min^-1,the dropping distance was 10cm,the temperature of the condensate was 8°C.According to the preparation process,three consecutive batches of verification tests confirmed the stability and feasibility of the process.Third part of this thesis,the quality evaluation study of YCHD Dripping Pills.First of all,according to the relevant requirements under the Pills items of the fourth section of the Pharmacopoeia of the People’s Republic of China（Ch P,2015 edition）,the formed preparations were inspected for traits,weight difference,dissolution time limit,and microbial limit.the results met the requirements.Secondly,the thin layer identification methods of YCHD Dripping Pills were established,including the identification of Artemisiae Scopariae Herba,Gardeniae Fructus,and Rhei Radix Et Rhizoma.The results showed that the thin layer identification methods were stable and feasible.In addition,the content determination method was established,and the methodological investigation results showed that the method was applicable and feasible.Chlorogenic acid content was not less than 3.2 mg/g,Geniposide content was not less than 9.3 mg/g,Emodin content was not less than 0.2 mg/g,Chrysophanol content was not less than 0.28 mg/g,Aloe Emodin content was not less than 0.18 mg/g,and the content of Rhein was not less than 0.18 mg/g.At the same time,the HPLC fingerprint of YCHD Dripping Pills was established.Finally,the comprehensive quality evaluation system of YCHD Dripping Pills was determined.Fourth part of this thesis,preliminary study on the stability of YCHD Dripping Pills.Accelerated and long-term stability studies have confirmed that the quality of YCHD Dripping Pills was stable.In summary,the best extraction and preparation technology was determined through the research on the preparation technology and quality evaluation of YCHD Dripping Pills.The process was stable and feasible with good reproducibility.And further control the quality of YCHD Dripping Pills from multiple levels.It is expected to transform the research results in the future and lay a foundation for modern clinical applications.