Objective To establish the preparation method of Xiao' er Jiere hollow type suppository and determination method of the dissolubility.Methods Xiao' er Jiere hollow type suppository and ordinary suppository were prepared.With bacalin and chlorogenic acid as the standards,the in-vitro dissolution test and HPLC method were applied to determine the accumulated dissolution rate of bacalin and chlorogenic acid in two different types of suppository.Results The linearity of bacalin was in the range of 0.040 ? g～ 0.320 ? g(r=0.999 7)and that of chlorogenic acid was in the range of 0.064～ 0.512 ? g(r=0.999 8).The accumulated dissolution rate of the hollow type suppository was over 97 % in 30min.Conclusion Drug release rate of hollow type suppository is higher than the ordinary suppository.The method is stable and accurate.

Objective To explore the comprehensive therapy of infants with urinary calculus induced by melamine.Methods Clinical data of 228 infants(aged from 4 months to 3 years,mean age 11 months)with urinary calculus induced by melamine were analyzed. Bilateral renal calculi were found in 144 cases and one-side renal calculus in 54 cases,of which the diameter ranged from 0.5-2.5 cm.Ureteral calculi with moderate to severe hydronephrosis were found in 15 cases,of which the diameter ranged from 0.4-1.1 cm. Bladder calculi with urinary retention were found in 5 cases and urethral calculi with urinary retention in 10 cases,of which the diameter ranged from 0.5-1.3 cm. All the urinary calculi were confirmed by B-uhrasound examination and CT. Group 1 : Of the 15 cases with acute renal failure, 13 underwent shattering and dissolving renal and ureternal calculus by pelvis clysis with alkalinity drug, detaining double J tubes through ureteroscope. After operation, these patients were treated with alkalinity drugs. Two cases were treated by percutaneous nephrostomy guided by B ultrasound and underwent shattering and dissolving renal calculus by intermittent pelvis clysis with alkinity drug. Group 2:15 cases of ureteral calculus with serious nephrohydrops underwent shattering and detaining double J tubes through ureteroscope, then treated with alkalinity drug. Group 3:15 cases of infant bladder and urethral caleus with acute urinary retention were treated by EMS through ureterscope per urethra. Group 4: The rest 183 cases without urinary obstruction received 1-8 week'surine alkalization therapy. Among them, 113 cases received sodium bicarbonate 0.15 g twice per day,23 cases received potassium sodium hydrogen citrate 2.4g/d, and 47 cases received 10% potassium citrate solution 5 ml 3 times per day. Sixty-one cases who were of no effect with alkalinity drug were treated by extracorporeal shock wave lithotripsy (ESWL) and dissolving calculus with sodium bicarbonate. During treatment with alkalinity drug, urine Ph was observed by urine analysis once per day.When it exceeded 7.5, alkalinity drug. Was withdrawn. All the patients were followed up for 1 to 3 months. Statistical analysis was done with the SPSS 13.0 software. ResultsHyperdiuresis emerged 12-24 h after operation in group 1. The duration of hyperdiuresis was 24-72 h with the urine volume of 800-2500 ml/24h. Urine volume revived gradually 48--96h after operation while serum BUN and Cr revived 1-5 d after operation. Four cases with renal and ureteral calculus became almost stone-free in 1-2 weeks and 14 cases became completely stone-free in 2-4 weeks after operation. Patients of group 2 became completely stone-free in 1-2 weeks. Patients of group 3 were cured by one EMS session through ureterscope per urethra and smooth urination was seen immediately after operation. No retained calculus in the bladder and urethra was found by B ultrasound 3 days later. In the sodium bicarbonate group, 4 cases became completely stone-free in 2 weeks, 18 cases in 4 weeks, 15cases in 13 weeks. The stones lessened and faded in 34 cases and had no changes in 42 cases. In the potassiun sodium hydrogen citrate group, 4 cases became completely stone-free in 1 weeks, 7 cases in 2 weeks, 10 cases in 4 weeks, 2 cases in 6 weeks. In the potassium citrate group, 3 cases became completely stone-free in 1 weeks, 5 cases in 2 weeks, 16 cases in 4 weeks, 11 cases in 8 weeks. The stones lessened and faded in 8 cases in 8 weeks and had no changes in 4 cases. The efficacy of the sodium bicarbonate group was significantly different with the efficacy of the citrate group (P=0. 001). No significant difference was found between the potassium sodium hydrogen citrate group and the potassium citrate solution group(P=0. 372). ConclusionsConservative treatment should be employed mainly in the earlier stage for the infant urinary calculus induced by melamine . When the diagnosis of acute renal failure, moderate to severe hydronephrosis and acute lower urinary tract obstruction are established, surgical intervention should be the main method to relieve obstruction, protect renal function and resume normal rnicturition. With the development of the characteristics of the stones later,the oral dissolution therapy with alkalirtity drug could not dissolve the calculi and ESWL should be employed.

Objective:To systematically identify and summarizes the weaknesses of the key aspects of Investigator-Initiated Clinical Trial (IIT) quality management in China, and quantitatively assess these weaknesses with a synthesis of relevant evidence, thereby providing references for the subsequent establishment of a complete IIT quality management system in China.Methods:According to the Scoping review report checklist (PRISMA-ScR statement), we conducted a systematic literature retrieval and screening, data extraction, and result synthesis of IIT quality management issues after defining the research questions.Results:73 eligible studies were eventually included. It was found that the most frequently explored issues were a lack of guidance and support from methodological and statistical experts at the project initiation stage (60.9%), a lack of research funding or improper funding management at the project implementation stage (49.3%), mismanagement of archival materials at the project completion stage (70.0%). Meta-analysis results showed that after evidence synthesis, the incidence of irregular informed consent signing, untraceable raw data, delayed study progress, and protocol violation were all above 40%, but there was heterogeneity in the results.Conclusion:Some outstanding issues in IIT quality management need to be addressed. Future studies should conduct more practical research to obtain quantitative data, undertake demonstrative application of management protocols, further carry out pioneering exploration and research in the field of IIT quality management, and propose effective solutions and strategies to improve IIT quality.