Study On The Preparation In Medical Institutions Of FengCang Granules

Based on summarizing the experience of Professor Shao Zhaodi for many years of clinical use of drugs, to carry on the reform to the experience formulation, developed a traditional Chinese medicine preparation for treating syndrome of deficiency of both Qi and Yin of chronic kidney disease. This study established the preparation technology of Feng Cang granule, main component encapsulation particle identification by TLC, and the quality standard research, stability test and acute toxicity test of Feng Cang granule, Clinical study provide Feng Cang granule prescription in treating Qi and Yin deficiency of chronic kidney disease. For the clinical treatment of chronic kidney disease in patients with Qi-Yin deficiency provides a reliable curative effect, convenient carrying, economic security traditional Chinese medicine preparation.1.Research of preparation processAccording to the needs of nature and the clinical medication prescription medicines, preliminary determine the extraction process for the water decocting method, dosage form for the granule, To determine the preparation process by orthogonal test and forming technology research.2.Research of quality standardsWith astragaloside control products, loganin control products as the control, Astragalus and Cornus in Feng Cang granular preparation were respectively identified by TLC. The results showed clear fingerprints, the separation effect is good. At the same time, check the size, moisture, solubility, load difference, microbial limits, the results met the pharmacopoeia requirements.3.Research of stabilityFeng Cang granular with aluminum-plastic composite membrane seal, and outsourcing box at room temperature storage for 12 months and 37 to 40℃, RH 75% under conditions of continuous 6 months of storage, the detection of indicators are in line with the quality standards, it shows the stability of product quality.4.Research of acute toxicity(1.62g· ml-1), the maximum volume(40ml·kg-1) for 1 day by gavage for 2 times(equivalent to 58 times the clinical dose), continuous observation for 14 days, there was no animal toxicity. Indicating that Feng Cang granular has low toxicity, taking orally is safe and reliable, with widely safe range.5.Clinical research1.The total effective rate of treatment group 86.21%, control group, the total efficiency of 66.07%, the total had significant difference compared to efficiency(P<0.05), the treatment group was better than that of the control group. 2.The total score of symptoms in two groups after treatment than before treatment was decreased, the treatment group had very significant difference(P<0.01),the control group had significant difference(P<0.05), there was significant difference between groups(P<0.01), the treatment groupwas significantly better than the control group. 3.The treatment group after treatment in improving the symptoms were significant difference(P<0.05), while the control group only in improving fatigue and edema symptoms had significant difference(P<0.05), the remaining symptoms had no significant difference(P>0.05).The comparison between two groups in the improvement of the symptoms of lassitude, soreness and weakness of waist and knees, there was a significant difference(P<0.01), dry mouth and throat, swollen in improving symptoms, there was significant difference(P<0.05). 4.24 hupq of two groups after treatment were decreased, there was significant difference compared with before treatment(P<0.05), there was statistical significance compared with groups(P<0.05), the treatment group was better than that of the control group; The two groups after treatment in treatment group only urine red blood cell count decreased, there was significant difference compared with before treatment(P<0.05), the control group of urine red blood cell count before and after treatment no significant change(P>0.05). 5.BUN, Scr of two groups after treatment were not significantly decreased,compared with before treatment had no significant difference(P>0.05). After treatment there had no significant difference between the two groups(P>0.05).6.e GFR of two groups after treatment were slightly increased than before treatment, but there was no significant difference(P>0.05), comparison between groups also had no significant difference(P>0.05).