Study On The Preparation Technology And Quality Standard Of Luomai Granules

Luomai Granules is a health care medicinal granule, which can replenish vital essence to nourish the lung and clear the throat. It is composed of mangosteen, ophiopogon, platycodon, liquorice and chrysanthemu m that all can be used as medicinal and edible. The formula is the folk experience prescription and curative effect. The original prescription is a traditional decoction. This paper is based on the theory of traditional Chinese medicine, according to the active component of th e Chinese traditional medicines in the party and its physicochemical properties, the use of modern pharmaceutical technology, the effective components extraction system of all the traditional Chinese medicines prepared extracts, and improve its dosage form, made modern healthcare compound granule.This thesis studies the extract process of five medicines, include mangosteen, ophiopogon, platycodon, liquorice and chrysanthemum. This topic this paper mixed herbs, radix ophiopogonis, radix platycodi, chrysanthemu m and licorice respectively studied the extraction technology. Using the orthogonal experimental design, respectively in siraitia grosvenorii total saponins, dwarf lilyturf, total polysaccharides and total saponins, platycodon and licorice flavonoids and total saponins of flavonoid extraction rate as index, the above five tastes of Chinese medicine extraction process of the system. The verification test was carried out after determined the best extraction process of each single herb medicine. Experimental results show that, the extract preparation process is simple, stable and feasible, suitable for industrial production.In the molding process, through the variety of the excipients screening experiment, determine the powdered sugar and maltodextrin as excipient particles.Through the investigation of the granulation effect, the best mixing ratio of sugar and maltodextrin was 3:1. The central composite experimental design, with qualified particle solubility, hygroscopicity, yield, sensory evaluation score "normalized value" as the evaluation index, the material ratio, ethanol concentration, dosage of citric acid three factors were investigated. Combining the range of each factor with the actual situation, the best molding process was determined. Molding process for particle rolmex excipients was 5 times the amount of extract, citric acid content was 0.3%, 85% ethanol as wetting agent.In order to ensure the quality, the paper studied the quality standard of Luomai Granules. The TLC condition of Siraitia grosvenorii, Platycodon root, chrysanthemu m in the Luomai Granules was founded. The results show that the method is simple, rapid, reproducible, and reliable. Studied on the content of effective components in granules was determined by HPLC, the method for determination of Mogroside V, liquiritin and glycyrrhizic acid content was developed. The test results show that, the method has high accuracy, good reproducibility. Experimental study on stability is one of the important content in the research of quality control of health products, so this topic has carried on the preliminary stability tests on Luomai Granules. With the accelerated stability test, characters, identification, moisture content, particle size, etc. are regularly test. The results of stability test showed that, the index is basically stable, and meets the quality standard.In this dissertation, a systemic research on preparation and quality standard of the Luomai Granules was made. It laid the foundation for the product development and industrial production of Luomai Granules.