Chinese Medicine(Guanxinsuhe Pill) Powder Mixing Uniformity Of Process Validation

Traditional Chinese medicine is our precious wealth that has been for thousands of years. Pill of guanxinsuhe come from pill of suhexiang which come into being the Song Dynasty..Pill of guanxinsuhe is an effective medicine for treatment of coronary heart disease angina pectoris. Composition by storax, civil incense, frankincense, sandalwood and borneol. Harbin Pharmaceutical Group of shiyitang in 1988 to begin production of the varieties. There has always been a good reputation and credibility. But now we find the semi-finished products hybrid inhomogeneity. This not only affects the quality, efficacy, but also detrimental to the reputation of our plan. So, we take this as the subject, Study and research, To achieve uniform and stable quality of products.First, according to Pharmacopeia determine semi-finished powder's study indicators. One is the RSD of borneol content value, the other is a civil lactone content of RSD value. Then determine a method for measuring the two substances, Use gas chromatography?Sample 1?to determine the content. Borneol content is calculated by the correction factor. Alantolactone content is calculated by peak area.Then do methodological study. Respectively to investigate whether the two methods for determining the rationality and superiority.Secondly, according to read the literature and experience in peacetime production, to determine the factors influencing the mixing uniformity of sheet. They are mixer coefficients loaded, the fineness of the powder, the water content of the powder, the total mixing time and mixing method. Select EYH300 dimensional mixer, to determine the content, the RSD values were calculated, To determine the indexes of the province. By single factor test,we found that load factor mixer, the total mixing time and mixing way to have a greater impact on semi-finished powder mixing uniformity. Then, for the three influential factors, carries on the L9 (33) orthogonal test. Identified at the time of the mixer for mixing the best mixing process.Again, through the above experimental data and rules to guide the production. But always used in the production equipment more than ten times larger than previously test, so the total mixing time there will be different. Namely, the large-scale production of the total mixing time of single factor, other mixing parameters reference optimum orthogonal experiment obtained. Through the single factor investigation, found that total mixing time of 50 min,60 min and 70 min, the RSD values of the two inspection indexes are less than 2%. Considering total mixing time selected 60 min, under the condition of other parameters constant, powder process validation. Through continuous three batch powder, determine the process to produce powder content uniformity of semi-finished products. Then, do the study of the product content uniformity.Finally, the best production process is:Load coefficient of the mixer is 1/2, powder moisture content is 5%?8%, powder fineness of 100 mesh, the mixing time is 60 min, Mixed mode is before the crushing spices, borneol single powder and powder with research group through a 40 mesh sieve, frankincense single powder and powder with research group through a 40 mesh sieve, sifting process in proportion to the group into powder.