Studies On Preparation And Application Of Povidone Iodine Vagina Effervescent Tablet And Compound Gel

Povidone-idine (PVP-I) is a kind of microbicide which is broad-spectrum, highly effective, and without toxic-effect, side-effect and resistance. There were many kinds of dosage-forms of this drug developed in Domestic and foreign and in the humanity or animal clinical disease treatment, such as solid, semi-solid and the liquid. But have not yet seen report about dosage-form of the effervesce tablets and the gel of PVP-I used in treating the cow genital tract disease. This research was aimed firstly to prepared the effervesce tablets and the compound gel of PVP-I and analyzed their physics and chemistry characteristic and the security; Secondly, analyzed the clinical practice effect of this two new kinds of medicine. Finally, was aimed to provide the experimental basis for the registration.This research was carried out in three parts: The First part was prescription design: Firstly, act PVP-I as the main commponent, selected out the feasible excipients such as disintegration agent, examine the compatibility of main medicine with excipients, designed different kinds of prescription, prepared into different kinds of prescription of Povidone-idine effervescent tablet by adopted dry-grained and appended the disintegration agent inside and outsideand then determined the best one. Secondly, examined the compatibility of PVP-I with oxytocin in method of sample stay under room temperature, then added quantum satis of excipient and prepared into the Povidone-idine compound gel. The Second part was quality examination: Firstly, Masured key items of the Povidone-idine effervescent tablets according correlative stipulation of the pharmacopoeia,then, examined the stability of this preparation in the method of sae stay under room temperature; Secondly, Masured key items of the Povidone-idine compound gel according correlative stipulation of the pharmacopoeia, then examined the stability in the method of sample stay under room temperature and appraised the security to the skin and mucous membrane through skin irritant experiment;Thirdly, adopt the micro dilution method to appraise the vitro bacteriostasis effect of the effervesce tablets and the gel to the standard strain and the clinical separation strain of golden yellow staphylococcus, escherichia coli and streptococcus. The third part was clinical application: Firstly, take the Povidone-idine effervesce tablets as the treatment group, the terramycin, the aureomycin was the control group, carries on the curative effect observation to 98 cows wich infected vaginitises;Secondly, take the Povidone-idine compound gel as the treatment group, carries on the preventing and controlling experiment over 88 cows which infected endometritis and 10 cows that just parturition, simultaneously set up control groups of Aureomycin, Terramycin and Gong De Kang.Result and conclution: In the prescription design part, Firstly, selected out PVPP as disintegration agent, there was not obvious incompatibility in the compatible experiment between the PVP-Ⅰand the excipient, erery performance of the prescription J conforms to correlation stipulation of the pharmacopoeia, so determined the prescription J as the right prescription; Secondly, the compatibility test showed that, there have not seen the obvious incompatibility of PVP-Ⅰwith oxytocin under the room temperature condition; The preparation of the Povidone-idine compound gel was simple. In the part of quality examination,Firstly, the key items of the Povidone-idine effervesce tablets such as characteristics, effective iodine content, disintegration time limited and dissolution conformed to correlation stipulation of the pharmacopoeia: the result of the test of stability showed that, after 3monthes under the condition of room temperature, hibernation and airproof, the key items of the effervesce tablets such as characteristics, disintegration time limited and dissolution kept stable, but compared with the value of pre-stay, the effective idodine content of two batches of sample decreased respectively, there were 1.98% and 1.58%, and the differernce was remarkable (P＜0.05), indicated that the effective iodine content of the effervesce tablets was not stable under this condition for 3monthes; Secondly, erery performance of the Povidone-idine compound gel such as character, pH, effective idodine content, titer of oxytocin conforms to correlation stipulation of the pharmacopoeia; The result of the test of stability showed that, the character, pH and the titer of oxytocin of the gel kept stable after 2monthes under the condition of room temperature, hibernation, but compared with the value of pre-stay, the effective idodine content of three batches of sample decreased 1.98%, the differernce was remarkable (P＜0.05), indicated that the effective iodine content of the Povidone-idine compound gel was not stable under this condition for 2mouthes; The skin irritant experiment demonstration does not have the skin mucous membrane irritating quality. Thirdly, the vitro antibiosis test result indicated that, the MBC of the Povidone-idine effervesce tablets to the standard strain and clinical seperated strain of staphylococcus aureus, escherichia coli and streptococcus was 12.5mg/mL -25mg/mL, and it was 16 times of PVP-Ⅰstuff drug; the MBC of the Povidone-idine compound gel to standard strain and clinical seperated strain of the staphylococcus aureus was 25mg/mL, and the MBC to standard strain and clinical seperated strain of the staphylococcus aureus and streptococcus was 12.5mg/mL, so according the vitro antibiosis result we could make sure the clinical dosage of this two preparations; In the part of clinical application,firstly, in the test of treating cows infected with vaginitises, the cure rate of the Povidone-idine effervesce tablets treatment group (81.58%) was higher than the Terramycin control group the cure rate (60%), the differernce was not remarkable (P＞0.05), the total effective rate was higher than the Terramycin control group, and the difference was remarkable (P＜0.01); the cure rate of the treatment group was remarkably higher than cure rate of the Aureomycin control group (50%) (P＜0.05), the total effective rate of the treatment group was also higher than the total effectiveness of the Aureomycin control group (60%), the difference was remarkable (P＜0.05); The average treatment times of the treatment group (7.7) was obviously less than the terramycin control group (25.8) and the aureomycin control group (34.8), the difference was extremely remarkable (P＜0.01); So,we could drive to a conclusion that Povidone-idine effervesce tablet was effective when treating cows that infected with vaginitises; Secondly, in the test of cows that infected with endometritis, the cure rate of the Povidone-idine compound gel treatment group (86.27%) and the total effective rate(98.04%) were obviously higher than the Aureomycin control group (44.67%,66.67%) and also the Terramycin control group (33.33%,73.33%), the differences were remarkable (P＜0.01); The average treatment times of the treatment group (6.1) was obviously less than the terramycin control group (18.1) and the aureomycin control group (26.8), the difference was extremely remarkable (P＜0.01); The cure rate of the treatment group was remarkably higher than the Gong De Kang control group (P＜0.05), the average treatment times of the treatment group's was obviously less than the Gong De Kang control group (12.0) (P＜0.05); There was no one infected with retention of placenta when using the Povidone-idine compound gel after parturition, while the rate of the control group infected with retention of placenta was 17.7%. So we could conclude that the Povidone-idine compound gel was effective on treating endometritis and retention of placenta of cows.