1.Study on in Vitro Dissolution Rate of Niaosaitong Sugar-coated Tablets and Film-coated Tablets
Chinese Traditional Patent Medicine 1992;0(05):-
Objective:To investigate the quality of Naosaitong Tablets by determing of the dissolution rates of different batches of tablets. Methods: The rotatory-basket method was used. The cumulative dissolution percentage was determined by UV. The dissolution parameters were got and their correlation was studied. Results: Statistics indicated there was a significant difference in dissolution parameter (T 50) between film-coated tablets and sugar-coated tablets. The dissolution percentage of film-coated tablets in 45 minutes was over 90%, whereas sugar-coated tablets was only 49-78%. Conclusion: Niaosaitong Film-coated Tablets in superior to its sugar-coated tablets in dissolution rate. It is necessary to improve the quality of Niaosationg Sugar-coated Tablets.
2.Phase Ⅱ clinical trial of Shixinyatong buccal tablets in the treatment of gastropyretic toothache(pericoronitis)
Junzheng WU ; Yuancong LI ; Kaijin HU ; Xianchun BO ; Desheng WEN ; Sumin GUAN
Journal of Practical Stomatology 2009;25(6):865-871
Objective: To study the effects and safety of Shixinyatong buccal tablets in the treatment of gastropyretic toothache (perico-ronitis). Methods: Randemized, double-blinded, double-imitated, parallel-controlled and multi-center clinical study was employed. 120 cases of gastropyretic toothache (pericoronitis) was enrolled in the experimental group( SBT group) and another 120 in control group(CBD group). Pericoronal pocket rinsing was performed for each case at the first visit, then the patients in SBT group were treated by Shixin buccal tablets(SBT) , 0. 6 g×2, 4/d and oral adiministration of the vehicle of cow-bezoare detoxicating tablets,0.3 g×3, 3/ d. The patients in CBD group were treated by oral adiministration of cow-bezoare detoxicating tablets ( SBD), 0. 3 g×3, 3/d and the vehicle of SBT, 0.6 g ×2, 4/d respectively. Pain, gingiva contagious tumefaction, pyorrhea of periocoronal pocket and limitation of mouth opening were scored by 0, 2, 4 and 6 as the major physical signs and symptoms(MAS); periocoronal flap and pocket, facial swelling, hot and foul breath, costipation, lymphadenectasis, thirsty and desire of cold drinks, fever by 0, 1,2 and 3 as the minor (MIS). Treatment was continued for 5 days and data were statistically analysed with SAS6. 12 software. Significant effectiveness was i-dentified by the decrease of total score of all the physical signs and symptoms(TS) ≥70% .effectiveness 30%~69% and ineffectiveness ≤29%. Routine examinations of blood, urine and stool, function of liver and kidney and electrocardiogram were conducted before and after treatment. Adverse events(AE) were observed. Results: 3 cases divorced from SBT group and 2 from CBD group. The demographic data and all the scores before treatment were not statistically different between groups (P>0.05). 3 and 5 days after treatment theTS, TSMA and TSMI were decreased(P= 0.000) in both groups, in SBT group decreased more than in CBD(P<0.001). Significant effectiveness ratio of SBT group was higher than that of CBD (P=0. 000). 5 days after treatment TS of MASs and the scores of each MAS in SBT group decreased more than in CBD( P<0.05). Vital signs were in normal range and not statisticaly different between groups(P>0.05). The clinical lab examinations showed no abnormal changes. Drug-related AE were observed in 3 cases, 1 with moderate AE in SBT group recovered after drug withdrawal, 2 with mild AE in CBD group recovered without aditional treatment. Conclusion; Shixinyatong buccal tablet is more effective in the treatment of gastropyretic toothache (pericoronitis) than cow-bezoare detoxicating tablets and with similar safety.