| In order to alleviate the mental stress and physical pain during maternal delivery,proper acceleration of labor is necessary.The rate of cervical dilation is decisive for the progress of labor.The commonly used drugs are diazepam,pethidine,atropine,,but most of these drugs have adverse reactions to maternal and neonatal,such as improper medication can cause serious consequences.Resorcinol is a pro-muscle smooth muscle antispasmodic drug that accelerates cervical dilatation and shortens the first stage of labor during the active period of uterine cervix expansion,which can promote the progress of labor,increase the rate of vaginal delivery,and reduce the rate of cesarean section.Therefore,this paper prepared a pyrogallol-containing in situ gel for promoting labor-assisted delivery,conducted in vitro studies and established relevant quality standards,providing a basis for subsequent research.The specific research contents are as follows:.1.Preparation: Poloxamer P407 and poloxamer P188 as gel materials to prepare in-suit gel of Phloroglucinol.Using the phase transition temperature as an indicator,the central design-response surface method is used to determine the proportion of each component in the prescription,and investigate the phase transition temperature and rheological properties of the gel.2.According to the relevant provisions of the Chinese Pharmacopoeia and the literature,different in vitro release methods were investigated to study the effect of gel dissolution on drug release,and the release curve was fitted to the release curve.The results showed that the release of pyrogallol gel was stable,and the cumulative release rate of the drug within 8 hours reached more than 95%.Model fitting is performed,and the drug release mechanism is a synergistic drug release mechanism for diffusion mechanism and dissolution.3.The method for verifying and optimizing HPLC to determine the content of phloroglucin and related substances was carried out,and the method was verified to establish the quality standard of the gel preparation.The stability of the gelling agent was examined by influencing factor tests and long-term tests.The results showed that both light and high temperature had a great influence on the gel content.After 10 days in 4500±500 Lx light,the drug content decreasedfrom 98.12% to 93.43%.After 10 days at 60 °C,the content was from 99.34%.Reduced to87.12%,the gel becomes thinner and can not be gelled at body temperature;the preparation should be stored at low temperature and protected from light;the centrifugation test shows that the content of the drug is basically unchanged before and after centrifugation,and the preparation will not cause the drug content due to long-term placement.Evenly.The long-term stability test showed that the drug content changed little within 3 months,and the stability for a longer period of time remains to be investigated.4.Using phloroglucinol as a protective agent,silver nanoparticles was prepared by chemical reduction method,and a phloroglucinol gel was prepared.The prepared silver nanoparticals are spherical,and the average particle diameter is about 13.44 nm,the distribution are relatively uniform,and have good dispersion.The results of bacteriostatic test showed that the inhibition zone diameter of phloroglucinol gel containing silver nanoparticles to Escherichia coli and Staphylococcus aureus was 10.78±0.37 nm and 9.82±0.57 nm respectively,the MIC is 4.0 mg/L which had good antibacterial effect.The auxiliary delivery gel containing phloroglucinol was prepared by prescription screening and optimization,and related in vitro studies were carried out.All the indicators met the established quality standards.The antibacterial agent nano silver is added,and the pathogenic microorganisms in the birth canal are inhibited after administration.The pyrogallol-assisted delivery thermosensitive gel studied in this paper provides a new preparation for promoting labor. |
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