Study On Preparation Technology And Quality Standard Of Tangxiao Capsule

Sugar Xiao particles of composed is radix rehmanniae Preparata yellow,and dogwood,and Yam,and Peony skin,and medlar,and smallpox powder,and days winter,and Ophiopogon japonicus,and North littoralis,and oyster,and cinnamon,and Astragalus 12 flavor TCM,this drug has yin,and solid kidney role,General should for due to diabetes led to of kidney virtual,and urine frequency,and volume more,and accompanied by thirsty upset,waist acid weak,tongue red easy dry,pulse sank fine number,symptoms.Previously in removing particles of sugar for the sugar-free formulations,as both drugs during transportation and storage of moisture surges,which can lead to drug projects such as the appearance,properties,moisture test results do not meet the requirements of the 2010 edition of the Chinese Pharmacopoeia standards,in order to radically improve the problems of over,so the original prescription granule formulations on the basis of dosage forms capsules instead.Sugar capsule advanced extraction technology,science,and extraction process of extraction of effective components of a complete,quality controllability,and high quality standards.Due to drug fills in capsule in the yihou,and after aluminum plastic packaging machine for aluminum plastic packaging,seal collection is closely,full of makes drug and outside of various effects factors mutual isolation,such as external of storage environment,air in the of moisture,and external air,and Sun irradiation,factors,makes they cannot effects to drug of quality,such on greatly of improve has drug of stability,thoroughly of settlement has original sugar Xiao particles agent easy suck water deliquescence,and store time short,and not convenient storage transport,disadvantages and insufficient.Capsule agent of raw materials drug is to powder or fine particles state exists Yu capsule shell in the of,through capsule fills machine directly fills to capsule in the,in fills process almost not needs by outside forcing on can fills to capsule shell in the,due to drug raw materials comparison loose,so capsule in gastrointestinal road in the of collapse solutions speed soon,such drug will quickly dissolved bulk and was human by absorption.This topic is the sugar extraction process of capsule technology,manufacturing technology,pilot procedures,quality standards,the stability of the preparation was studied,provides sufficient pharmaceutical preparations for approval for listing in the future basic research data.This project identified the best sugar capsule forming,drying methods,as well as preparation of the extraction and process route,developed a draft quality standard,also for six months and long-term stability study of three batches of product.ResLilts of this study indicate that study identifying the technological parameters of preparationof sugar capsule accurate,stable process deviations are small;Experimentally established quality standards,the checking method for the examination,through methodological validation proves good reproducibility and high stability,can be used to control sugar capsule quality;After sugar anxiao capsules for six months of stability,examining preliminary results validate the quality of sugar capsule is stable.