Study On Improving Quality Standard Of Xiangshaliujun Preparations

Xiangshaliujun prescription is elaborately made of traditional Chinese medicinal materials such as Radix Aucklandiae, Fructus Amomi, Codonopsis Pilosula, Atractylodes Macrocephala, Poria Cocos, Glycyrrhiza Uralensis, Pericarpium Citri Reticulatae, Pinellia Ternata, etc. With good effects of invigorating spleen, replenishing qi and harmonizing stomach, it has curative effect on spleen deficiency and qi stagnation, indigestion, eructation and poor appetite, gastric and abdominal distention, and sloppy diarrhea. The former water pill standard mainly includes microscopic identification, thin-layer chromatography identification, content determination, etc. During the quality recheck of concentrated pills in accordance with the water pill standard, it is found that:(1) In the microscopic identification item, qualitative identification of Poria Cocos and Pinellia Ternata in the prescription can be carried out. Therefore the method for this identification item is retained.(2) In the thin-layer chromatography identification item, qualitative identification of components cannot be carried out smoothly because of too many components to be identified, tedious preparation process of sample solutions and unsatisfactory extraction effect of components.(3) Chromatographic column with octadecylsilane chemically bonded silica gel as its filler is adopted in the high-efficiency liquid phase chromatography. Although good separation of hesperidin is realized, the content determination item in the quality standard of the preparation only determines the content of hesperidin and cannot effectively control inherent quality of medicines. The paper makes the following explorations and studies on the above issues.I. Study of thin-layer chromatography identification.1. The study of qualitative identification of Pericarpium Citri Reticulatae, Glycyrrhiza Uralensis, Radix Aucklandiae and Fructus Amomi is carried out, and the preparation process of sample solutions is improved.2. Through optimizing the chromatogram development system and reducing the use of precursor chemicals such as methylbenzene, acetone and chloroform, a thin-layer chromatography identification method that is effective and practicable with strong specificity and no negative interference is finally achieved.II. Study of the content determination method. Through the study on the improved quality standard, quantitative determination of effective components such as costunolide and dehydrocostus lactone of Radix Aucklandiae (sovereign drug) is enhanced so as to better control the quality of drugs. III. Quality inspection of Xiangshaliujun tablets and pills is carried out by adopting the method after the quality standard is improved, thin-layer chromatography identification results of Pericarpium Citri Reticulatae, Glycyrrhiza Uralensis, Radix Aucklandiae and Fructus Amomi indicate that the samples, comparison medical materials and reference substances show spots of the same colors at the corresponding positions and there is no negative interference. Results indicate that with strong specificity and good repeatability, the method after improvement can be used as the method for controlling the quality of Xiangshaliujun preparation. The content results of samples determined by adopting the method after improvement have greater improvement than those determined by following the former standard, and the contents have met the requirements for limit. Therefore, a simple and accurate method with good repeatability is offered for content determination of costunolide and dehydrocostus lactone.After verified by methodology, this method is simple and accurate with good repeatability, and benefits better quality evaluation and supervision of Xiangshaliujun preparation.