| This study is in view of the clinical disease of high incidence rate, the recurrence rate of chronic uropoiesis infection,selects the Hubei Province Chinese Medicine Hospital-- Badao Dihuang mixtura the proven prescription to take the object of study.The drug dispersion degree of mixtura is large, and does not need to break up and dissolve the process,the rate of absorption is quick,can display the drug efficacy rapidly, the biological exploitability is high, takes merits and convenience so on; "Medical establishment Preparation Registration Policing method"(bureau command 20th) requests according to 2005, to Badao Dihuang mixtura preparation craft, the quality specification, the preparation stability test and the acute toxicity test conducts the research, and provides Badao Dihuang mixtura prescription treatmentrate of chronic uropoiesis infection clinical curative effection of the research material, provides the research material for the development treatment of chronic uropoiesis infection of medical establishment preparation. 1,Research of preparation technology According mainly treats, in the compound prescription,the function of prescription drug 〠medicines physics and chemistry nature is various.for example: The soap glucoside class, the polysaccharide, the alkaloid and so on are the inspection targets, takes the multi-factor orthogonal experiment design, to withdrew the time, the watering quantity, the extraction number of times three factors have carried on the optimization,through the research of preparation craft, had setted the suitable p H value scope and the relative density, simultaneously have carried on screening to the microorganism limit and the anticorrosion method,had deter--mined the best craft parameter, and through the craft duplication experiment, has confirmed the preparation craft feasibility. 2, Research ofquality criteria In order to ensure the quality of drug is controled,so Badao Dihuang mixtura quality standard were studied.TLC method was carried out on the prescription of dogwood, radix rehmanniae, cortex phellodendri, respectively the thin layer identification;the cornus map of dogwood is clear, spotseparation effection is good, negative control without interference.Radix rehmanniae, cortex phellodendri, negative control interference.Set up the content determination method for preparation of dogwood, this product can be used as a control index of inner quality.According to the results of several sample, made the product. 3, Research ofthe stability of the preparat Badao Dihuang mixtura by using glass bottle sealed packaging, natural storage at room temperature for 12 months and 37~40℃, RH75 % placed consecutively six months, under the condition of various detection indexes conforms to the product quality standard, indicates that the product quality is stable. 4, Research of acute toxicity Badao Dihuang mixtura on acute toxicity test in mice, at the highest concentration of crude drugs(2.05g·ml-1), the maximum volume(40 ml·kg-1) 2 times filling in one day(equivalent to 103 times clinical dosage), continuous observation for 14 days, without toxic reaction, so this product lavage in mice maximum tolerance dose greater than 164g·kg-1 [1]. 5, Summary of the clinical research In the treatment group, totally disease efficiency was 76.7%, in the control group, the efficiency was 51.7%.Total effective rate was significantly difference(P<0.05).The experimental group was better than the control group in the effect of disease. In the treatment group,the total effective rate was significantly difference(P<0.05).The treatment group was better than the control group in the effect of syndromes of TCM. Comparison of individual symptom scores:After treatment,the individual symptom scores between the two groups in waist and knee pain symptoms of improvement, there was a very significant difference(P<0.01).In frequency of urinatior,urgent urination,odynuria,urethral and glowing symptom improvement,there was a significant difference(P<0.05),the experimental group was better than the control group. The count of urine leukocyte,the treatment group and control group before treatment in urine leukocyte count was no significant difference(P =0.41), comparable; In the two groups compared during the treatment, the urine leucocyte count was significant difference(P<0.01); there was no significant difference between the two groups after treatment(P=0.46).In the two groups during the overcast rate in the midway of urine bacteria develop, the treatment group was 76.9%, control group was 69.2%, there was no significant difference(P=O.74). The results showed that the decrease in leukocyte count and overcast rate in the midway of urine bacteria develop,is both in the treatment group and the control group is better than that of before treatment after treatment; Comparison between the two groups after treatment.no significant differences. At the end of the course of six weeks to review the urine bacterial count, the treatment group and control group 6 weeks after treatment,there were 14 cases recurrence in the treatment, 28 cases of recurrentthe in the control group,two sets of data statistics, chisquare, X2=4.5933, P=0.0321<0.05, the difference was statistically significant, the recurrence of treatment group were superior to the control group. Said Badao Dihuang mixtura in chronic urinary infection recurrence rate is better than control group. |