Study On Technology And Quality Standard Of Zhilian Jieyu Capsules

Zhilian Jieyu Capsule, consist of gardenia, forsythia suspensa, magnolia officinalis, rhizome pinelliae preparata, poria cocos, caulis perillae and liquorice, is the sixth category of national TCM drug classification. The prescription of Zhilian Jieyu Capsule, bases on Capejasmine and Magnolia Decoction and Pinelliae and Magnoliae Officinalis Decoction, is made by Professor Huanghuang, doctoral tutor of Nanjing University of Chinese Medicine, according to Zhongjing Zhang’s academic thinking of emotional disease treating. Many years of clinical observation has proved that Zhilian Jieyu Capsule can significantly alleviate the patients’ chest, bloating, constipation, loss of appetite and other symptoms, relieve the patients’ anxiety, insomnia, restlessness, inattention, inefficiency, forgetfulness and other psychiatric symptoms, improve the patients’ quality of life. The elimination of physical symptoms and improvement of sleep quality first appears during the treatment. Then the patient’s mood changed for the better and were less depressed and anxious. No obvious adverse reactions shows the good drug safety of Zhilian Jieyu Capsule.This topic is mainly on the study of the preparation technology and the quality standard of the Zhilian Jieyu Capsule. guided by the traditional Chinese medicine theory.The study of the preparation process:1. The screening of extraction solvent:According to the physicchemical charac-teristics and reported in the literature, the extraction solvent of traditional Chinese medicines in the prescription were selected. Gardenia, Magnolia officinalis and Forsythia were extracted with ethanol; Poria cocos, Perilla stem,Licorice were extracted with water,the powders of Rhizome Pinelliae were used.2. The process optimization:the influencing factors of extraction process, such as extraction times, the concentration and amount of ethanol, extraction time of Gardenia, Magnolia officinalis and Forsythia were investigated by orthogonal test. And the optimum extraction conditions were ascertained as follows:adding 8 times amount of 60% ethanol,extracting for two times,two hours of every time;The Poria cocos, Perilla stem,Licorice,medicinal water extraction process of extraction time,solvent dosage,extraction time was examined,and the extraction process with water extraction was determined as follows:water extraction for three times,each time for 2 hours,adding 9 times amount for the first time,the second and third time with 7 times amount of water.3. The molding process:the preparation of molding process was studied,and the molding process was determined as follows: merging with concentrated liquid of Alcohol extract and water extract, Spray granulate with fine powder of Rhizome Pinelliae, frequency conversion:6~12Hz,tempreture of main fan: 70~80℃,the total pressure of compressed air:0.4Mpa, angle of repose:36.74°,filling with No.0 capsules,0.4g each capsules.After the 3 batch of pilot test,the results showed that the process is stable and feasible.The quality standard study: the TLC method was established for the gardenia, forsythia suspensa, magnolia officinalis, rhizome pinelliae preparata, poria cocos, caulis perillae and liquorice. The content of geniposide and forsythin in gardenia and forsythia suspensa was determined using HPLC.