Improvement Of Mixing Uniformity Of Xiaojin Pills By Partical Design Technology

Xiaojin pills as a classical prescription in the Qing Dynasty, has been included in the national basic medical insurance directory, which is classified as B surgery medicine of TCM preparation of warming maneger, regulating qi and activating blood circulation. However, the Xiaojin pills have prominent adverse reaction, widespread uneven color, odor differencesand severe allergic reactions. So far. there was no predictable pattern in how these allergic reaction happens. most scholars believe that it is the process of mixing uniformity that was the main factors which caused Xiaojin pills uneven color, odor differences and allergic reactions.In this paper, content uniformity of commercially available xiaojin pills were determinated by two indicators, the two of which are the main component of single ester type alkaloids of Radix Aconiti kusnezoffii ferulic acid of Angelica. Through the content determination of commercially available Xiaojin pills, the results show that the highest value of the 8 batches of single ester type alkaloids was 11 times as much as the lowest content value. Eight batches of Xiaojin pill monoester type alkaloid content value of RSD was up to 61.44%, and the three batches of monoester alkaloid content value of RSD from B factory was 63.90%. The highest value of the ferulic acid content among the 8 batches of Xiaojin pills was 5.3 times the lowest content values.8 batches of Xiaojin pills ferulic acid RSD value was as high as 60.89%. There exists great difference in the different batches of the same company. The content value of RSD of three batches from B factory was 42.62%. Similarly, the value of RSD from C factory was 20.19%.Both of the results indicated that under the same conditions of raw materials, production equipment and process parameter complexity of Xiaojin pill raw material texture does not meet the mixing process, so that Xiaojin pill powder is distributed randomly and unevenly after mixing, leading to the problem of uneven material distribution.Based on the thorough analysis of powder characteristics and Chinese medicine pill process characteristics, traditional Chinese medicine particle design technology was embedded in the pill crushing and mixing process. To study the Crushing rule of Kusnezoffii, earthworm, wine Angelica, Fragrant ink and other drugs from Xiaojin pill, to establish the quadratic polynomial regression equations by the particle size- grinding time and to calculate crushing the minimum size and grinding time of each drug. According to the laws of the different material crushing and powder properties, the material is divided into two broad categories:easily crushed material and the viscous material, respectively as the shell particles and nuclear particles of particle design. Controlling feeding sequence and status of the different nature of the materialto form a core-shell structure, uniform dispersion of the composite particles. Using size, color, adhesion, scanning electron microscope to evaluation composite particles, the results showed that easily crushed material acted as shell particles, and the viscous material played as nuclear particle to form core-shell particles.Comparative study of the particle design powder, artificial mixing powder and control samples(Pharmacopoeia method), xiaojin pill particle design powder of particle size and color RSD value were significantly lower than those of artificial mixing powder and control samples. The RSD contents of ferulic acid and ester alkaloids of particle design powder were significant lower than artificial mixing powder and control samples, the mixing uniformity of particle design sample powder was improved a lot.Traditional Chinese medicine particle design technology can realize the mixing of materials and fundamentally solve the materials with different properties, especially the great difference of properties materials mixing uniformity.