Application Of Particle Design Technology To Improve The Quality Of Zhuhuang Chuihou Pulvis

Objective In this study,the modern preparation Zhuhuang Chuihou Pulvis was taken as the object of research,which aiming at the formulation problems,such as uneven mixing,poor patient compliance,weak wettability,poor fluidity and many other pharmacological problems.Based on the formulation theory of "combination of medicine and excipients",the introduction of particle design technology to improve the quality of preparations,which provides reference value and scientific basis for the research on the adaptability of particle design and even powder modification technology in the field of traditional Chinese medicine preparations.Methods 1.Studying on the powder properties of compound prepared slices and extraction of pharmacological defects: Systematically investigate the changes and comminution rule of powder properties of compound prepared slices of Zhuhuang Chuihou Pulvis during the crushing process,extract the main influencing factors leading to preparation defects,and identify the object of particle design technology.2.Research on preparation technology of particle design and evaluation of pharmaceutics properties: Based on the concept of "quality comes from design",the composite particles of realgar-calcined borax-Coptidis Rhizoma PhellodendriChinensis Cortex were prepared and the main causes of pharmaceutical defects of Zhuhuang Chuihou Pulvis were extracted in this study.Furthermore,by comparing the powder properties of composite particles before and after the introduction of particle design technology,such as wettability,particle surface micro-morphology,characteristics of surface composition and so on,we can clarify the advantages of particle design technology to improve the quality of traditional Chinese medicine pulvis.3.The influence of particle design technology on the pharmaceutical properties of Zhuhuang Chuihou Pulvis: In order to clarify the impact of particle design technology on the pharmaceutical properties of Zhuhuang Chuihou Pulvis,the composite particles with shell-core coating structure of realgar-calcined borax-Coptidis Rhizoma Phellodendri-Chinensis Cortex were completely returned to the whole prescription,and the pharmaceutical characteristics were evaluated respectively such as content uniformity,appearance uniformity,oral compliance and so on.In addition,the dissolution rate of berberine hydrochloride before and after particle design was investigated by in vitro dissolution test,so as to clarify the potential influence of particle design technology on the dissolution characteristics of Zhuhuang Chuihou Pulvis in vitro.Results 1.Studying on the powder properties of compound prepared slices and extraction of pharmacological defects: There is a good correlation between the crushing particle size and the crushing time of Zhuhuang Chuihou Pulvis,and the characterization results of material powder show that the main reason for the preparation problems such as poor uniformity and poor taste of Zhuhuang Chuihou Pulvis is that realgar and calcined borax in the prescription are easy to be separated,which can easily lead to uneven content.At the same time,Coptidis Rhizoma and Phellodendri Chinensis Cortex are difficult to take,which affects the compliance of the patients.According to the requirements of the preparation of composite particles and combined with the main causes of the defects of Zhuhuang Chuihou Pulvis,the composite particles with shell-core coating structure were prepared with Coptidis Rhizoma and Phellodendri Chinensis Cortex as core particles,realgar and calcined borax as shell particles.2.Research on preparation technology of particle design and evaluation of pharmaceutics properties: In this study,through the study of the powder properties of compound prepared slices,the obvious pharmaceutical defects were clearly extracted,and the feeding sequence and crushing time of the materials were controlled to prepare composite particles.What’s more,the feasibility of the preparation process was evaluated by wettability,morphology and surface composition analysis.Finally,appropriate amount of realgar and calcined borax were put into the ultra-fine pulverizer according to the prescription ratio,and the fine powder of Coptis Rhizoma and Phellodendri Chinensis Cortex were crushed at-5 ℃ for 18 min and 50 min,and then the composite particles were crushed for 4 min as the preparation process of composite particles.3.The influence of particle design technology on the pharmaceutical properties of Zhuhuang Chuihou Pulvis: The designed particle size is about 120 μm,and many tiny particles are attached on the surface of particle design pulvis.The wettability behavior,appearance characteristics and surface composition of particle design pulvis are different from those of physical mixture and superfine dispersion,and the hygroscopicity of particle design powder is not significantly different from that of physical mixture.The content uniformity RSD of berberine hydrochloride and arsenic disulfide were significantly lower than those of ordinary particles and ultrafine pulvis.The RSD values of chromaticity difference and density difference of particle design pulvis decreased significantly,and the taste sensory evaluation result of particle design pulvis was the best one.The results of in vitro dissolution test show that the cumulative dissolution rate of particle design pulvis increases gradually,but its dissolution trend is similar to that of ordinary pulvis,which once again shows that the particle design technology has not changed the material basis of the preparation.The above research results show that the uniformity of appearance and content,and patient compliance of Zhuhuang Chuihou Pulvis were improved after powder modification and particle design,so as to ensure the stability and safety of the preparation.Conclusion With the introduction of traditional Chinese medicine particle design technology,Zhuhuang Chuihou Pulvis was optimized from uneven texture and disorderly mixing to a stable and orderly structural unit,so as to improve the quality of the original preparation.it provides a scientific basis for the optimization and quality control of Chinese medicine preparations.