Research On Liuwei Dihuang Preparations Quality Differences

Liuwei Dihuang, which compound as a TCM of "Nourishing Yin and Tonifying Kidney ", is composed of a certain percentage of 6 kinds of medicine prescription drugs, such as liquor Cornus, Rhizoma alismatis, prepared rhizome of rehmannia, Chinese yam, Poria cocos and paeonol.Studies have shown that the compound has immunomodulatory, antioxidant, lower blood sugar, anti-tumor and other pharmacological effects, for the treatment of kidney Yin deficiency type, weak waist, sweating, tinnitus and hearing loss, nocturnal emission and so on. Liuwei dihuang (LWDH) as a traditional compound preparation, There is no unified approach for quality evaluation of the preparation because of the diversity of dosage forms, complicated composition, uneven quality. In this study, concentrated pills and soft capsules as the main research objects, with feature chromatogram, multiple index component content determination and dissolution as observation indexes, through the establishment of the general detection method of LWDH preparations and unified evaluation method to evaluate the different qualities in dosage forms, manufacturer, and the batch of LWDH. This research mainly divided into the following two parts:The first part:the HPLC method was used to LWDH soft capsule and concentrated pill these two common preparations as the main research object, using the single factor experiments, choose the content of gallic acid and other seven elements as testing indexes, set up covering LWDH preparations feature chromatogram, multiple index component content determination and dissolution of three aspects of the general test methods.The second part:using statistical analysis method, with multiple component content, specific chromatogram and dissolution as evaluation index, to complete the analysis and evaluation of 45 batches of different batches of LWDH concentrated pill, 22 batches of different batches of samples of soft capsule and four other types LWDH preparations. The experimental results show that, with the same dosage form with the same manufacturer the difference in detection component content is small, the same dosage form detection component content varied with different manufacturer, significant difference was found in different dosage forms to detect the contents of indicators.Feature chromatogram experiments respectively analyze 15 batches of concentrated pill and 12 batches of soft capsule, using the similarity analysis, clustering analysis of the two comprehensive methods. For concentrated pill, similarity values range between 0.944 to 0.988, clustering analysis can significantly distinguish between samples from different sources; For soft capsules, similarity values range were greater than 0.92, shows that the 12 batches of samples similarity degree is higher, different batches of the sample quality is consistent, and similarity analysis and cluster analysis showed no significant difference between batches. There was diference among six formulations characteristic spectrum, and no obvious difference between soft capsule and LWDH concentrated pill, the difference between honeyed pills was small.Dissolution test comprehensively survey the dissolution media, rotate speed and volume of dissolution media, ultimately determine to choose 900 ml 0.1 mol/L HCL to 100 rpm/min dissolution, and Loganin dissolution limits no less than 80% in 90 min, application to establish dissolution conditions, based on the variation in content of three components in the sample index is investigated 21 batches of the cumulative percentage dissolution of LWDH concentrated pill samples, and draw the dissolution curve, and through the similarity factor method to evaluate dissolution differences, the results show that different manufacturer concentrated pill were significantly differences sample dissolution. The experimental results showed that the same manufacturer dissolution condition of differences between different batches are relatively small, reminder each manufacturer needs to ensure that products meet the requirements of the standard, at the same time, to improve product quality from the perspective of the stability of the formulation.This study established a universal detection method for LWDH preparation, presentation and application of the same prescription, the main function is the same, different evaluation method of preparation technology and dosage form, the methed could fit the demand of determination. Also confirmed that among the different forms, there are differences in the same dosage form different manufacturers and different batches of the same manufacturer LWDH quality of preparation, may be source of medicinal raw materials, different control and process related. The study provide a reference for the quality control of Liuwei Dihuang.