CN1743004A - Compound preparation for anti-pregnancy by killing sperm and sterilizing, preparation method thereof - Google Patents
Compound preparation for anti-pregnancy by killing sperm and sterilizing, preparation method thereof Download PDFInfo
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Abstract
本发明涉及一种用用于杀菌消毒和杀精抗孕阴道给药复方制剂及其制备方法,包括广谱抗菌剂、抗孕杀精剂、水及医学上可接受的量的辅料,其制备方法包括在常温条件下将水、单体载体、表面活性剂、分散剂混合搅拌均匀,加入广谱抗菌剂、抗孕杀精剂搅拌均匀,分装。本发明的杀菌消毒和杀精抗孕阴道给药复方制剂安全有效、具有避孕,抗菌、润滑的作用,使用方便、毒副作用小。The invention relates to a compound preparation for vaginal administration of sterilization and spermicide and anti-pregnancy and a preparation method thereof, including broad-spectrum antibacterial agent, anti-pregnancy spermicide, water and a medically acceptable amount of auxiliary materials, and its preparation The method comprises mixing and stirring water, monomer carrier, surface active agent and dispersant under normal temperature condition, adding broad-spectrum antibacterial agent and anti-pregnancy spermicide, stirring evenly, and subpackaging. The sterilizing and spermicidal anti-pregnancy compound preparation for vaginal administration of the invention is safe and effective, has the functions of contraception, antibacterial and lubricating, is convenient to use, and has little toxic and side effects.
Description
技术领域technical field
本发明涉及一种用于杀精抗孕和杀菌消毒的复方制剂,具体讲涉及一种用于杀精抗孕和杀菌消毒的凝胶剂及其制备方法。The invention relates to a compound preparation for spermicide, anti-pregnancy and sterilization, in particular to a gel for spermicide, anti-pregnancy and sterilization and a preparation method thereof.
背景技术Background technique
计生事业是国家的基本国策,对计划生育用具和器械的改进和推广应用则是对实现这一国策的重要技术支持,开发安全、有效、简便、副作用少、有利于生殖健康、群众乐于接受的计划生育用具和器械是计生产品的发展趋势。Family planning is the basic national policy of the country, and the improvement and popularization of family planning appliances and equipment is an important technical support for the realization of this national policy. The development of safe, effective, simple, less side effects, beneficial to reproductive health, and the masses are willing to accept Family planning appliances and devices are the development trend of family planning products.
目前常用的避孕方法为口服避孕药、外用屏障避孕,安全套、阴道隔膜、宫颈帽、避孕海棉、节育术在使用上都存在一定的不足之处,口服避孕药常有干扰内分泌作用,引起恶心、呕吐、甚至阴道不规则流血等副反应,限制了其使用范围;安全套是目前使用较多的男用避孕工具,但部分人可出现过敏反应或不适感,破裂率报道在1%-12%不等,性交中滑脱率为6%;阴道隔膜是一种房事前放入阴道内覆盖于宫颈和后穹窿的柔软橡胶帽,但因隔膜边缘与阴道壁不能严密封闭,失败率在1.6% ̄9.8%不等;宫颈帽是一种与隔膜相类似的橡胶屏障避孕工具,应用时须医生选配尺寸并指导应用方法,失败率为5%-18%;避孕海棉是一种含杀精剂的由聚胺酯材料的圆形弹性物块,其有吸取精液,制动精子和屏障避孕的作用,但有因阴道海绵碎片残留在阴道引起中毒休克综合征的报道。Currently commonly used contraceptive methods are oral contraceptives and external barrier contraception. Condoms, vaginal diaphragms, cervical caps, contraceptive sponges, and birth control all have certain deficiencies in use. Oral contraceptives often have endocrine-interfering effects and cause nausea. , vomiting, and even irregular vaginal bleeding and other side effects limit its scope of use; condoms are currently the most widely used male contraceptive tool, but some people may experience allergic reactions or discomfort, and the rupture rate is reported at 1%-12% The rate of slippage during sexual intercourse is 6%. The vaginal diaphragm is a soft rubber cap that is put into the vagina before intercourse and covers the cervix and posterior fornix. However, because the edge of the diaphragm cannot be tightly sealed with the vaginal wall, the failure rate is 1.6%. It varies from 9.8%; the cervical cap is a rubber barrier contraceptive tool similar to the diaphragm, and the doctor must choose the size and guide the application method during application, and the failure rate is 5%-18%; the contraceptive sponge is a spermicide It is a circular elastic block made of polyurethane material, which has the functions of absorbing semen, immobilizing sperm and barrier contraception, but there are reports of toxic shock syndrome caused by vaginal sponge fragments remaining in the vagina.
发明内容Contents of the invention
本发明的目的在于提供一种避孕效果显著、使用方便、毒副作用小的用于杀精抗孕和杀菌消毒的复方制剂。The object of the present invention is to provide a compound preparation for spermicide, anti-pregnancy and sterilization, which has remarkable contraceptive effect, is convenient to use and has little toxic and side effects.
本发明的另一目的是提供一种用于杀精抗孕和杀菌消毒的复方制剂及其制备方法的制备方法。Another object of the present invention is to provide a compound preparation for spermicide, anti-pregnancy and sterilization and its preparation method.
为实现上述目的,本发明提供的用于杀精抗孕和杀菌消毒的复方制剂包括述重量份的组分:In order to achieve the above object, the compound preparation for spermicide, anti-pregnancy and sterilization provided by the present invention includes the components of the following parts by weight:
广谱抗菌剂0.01-50、抗孕杀精剂2-20。Broad-spectrum antibacterial agent 0.01-50, anti-pregnancy spermicide 2-20.
优选地,包括下述重量份的组分:Preferably, the following components by weight are included:
广谱抗菌剂15-50、抗孕杀精剂2-20。Broad-spectrum antibacterial agent 15-50, anti-pregnancy spermicide 2-20.
优选地,包括下述重量份的组分:Preferably, the following components by weight are included:
广谱抗菌剂0.01-0.1、抗孕杀精剂2-20。Broad-spectrum antibacterial agent 0.01-0.1, anti-pregnancy spermicide 2-20.
最优选地,所述的复方制剂还包括下述重量份的组分:Most preferably, the compound preparation also includes the following components in parts by weight:
水90-750及医学上可接受的量的辅料。Water 90-750 and medically acceptable amount of auxiliary materials.
所述的广谱抗菌剂为纳米银、苯扎氯铵、苯扎溴铵、醋酸氯己定、三氯生的一种或其中几种的混合物。The broad-spectrum antibacterial agent is one or a mixture of nanometer silver, benzalkonium chloride, benzalkonium bromide, chlorhexidine acetate, and triclosan.
所述的纳米银粒径为1-100纳米。The particle diameter of the nano-silver is 1-100 nanometers.
所述的抗孕杀精剂为辛苯聚醇、壬苯醇醚、烷苯醇醚、孟苯醇醚、氯化苄烷铵中的一种或其中几种的混合物。The anti-pregnancy spermicide is one of octoxynol, nonoxynol ether, alkanol ether, menthoxynol ether and benzalkonium chloride or a mixture of several of them.
所述的辅料为单体载体、表面活性剂及分散剂中的一种或其中几种的混合物。The auxiliary material is one or a mixture of monomer carriers, surfactants and dispersants.
所述的辅料的重量份比:The weight ratio of described auxiliary material:
单体载体15-815 表面活性剂50-140 分散剂45-350;Monomer carrier 15-815 Surfactant 50-140 Dispersant 45-350;
所述的单体载体为卡波姆、羧甲基纤维素钠(CMC-Na)、聚乙烯吡咯烷酮(PVP)、聚乙烯醇(PVA)、聚乙二醇-400、聚乙二醇-3350中的一种或其中几种的混合物。Described monomer carrier is carbomer, sodium carboxymethylcellulose (CMC-Na), polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA), polyethylene glycol-400, polyethylene glycol-3350 one or a mixture of several of them.
所述的表面活性剂为月桂醇硫酸钠、硬酯酸、硬酯醇、十二烷基磺酸钠(AS)、十二烷基硫酸钠(SDS)、十六烷基三甲基溴化铵(CTAB)、α-单烷基甘油醚(GE)、聚氧乙烯聚氧丙烯共聚醚、聚甘油-聚亚丁基脂肪醇醚(PGT烷基醚)、果糖苷、硬脂酸丁酯、异硬脂酸异丙醇酯、聚乙烯吡咯烷酮、十二烷基二甲基乙酸钠(BS-12)、烷基酰胺丙基甜菜碱、烷基咪唑啉中的一种或其中几种的混合物。Described tensio-active agent is sodium lauryl sulfate, stearic acid, stearyl alcohol, sodium dodecyl sulfate (AS), sodium dodecyl sulfate (SDS), cetyl trimethyl bromide Ammonium (CTAB), α-monoalkyl glyceryl ether (GE), polyoxyethylene polyoxypropylene copolyether, polyglycerol-polybutylene fatty alcohol ether (PGT alkyl ether), fructoside, butyl stearate, One or a mixture of isopropanol isostearate, polyvinylpyrrolidone, sodium lauryl dimethyl acetate (BS-12), alkyl amidopropyl betaine, and alkyl imidazoline .
所述的分散剂为丙三醇、丙二醇、月桂醇硫酸钠、三乙醇胺中的一种或其中几种的混合物。The dispersant is one or a mixture of glycerol, propylene glycol, sodium lauryl sulfate and triethanolamine.
所述的复方制剂为凝胶剂。The compound preparation is a gel.
一种制备杀菌消毒和杀精抗孕阴道给药复方制剂的方法,包括:在常温条件下将水、单体载体、表面活性剂、分散剂混合搅拌均匀,加入广谱抗菌剂、抗孕杀精剂搅拌均匀,分装。A method for preparing a compound preparation for sterilizing, disinfecting and spermicidal anti-pregnancy vaginal administration, comprising: mixing and stirring water, a monomer carrier, a surfactant, and a dispersant evenly under normal temperature conditions, adding broad-spectrum antibacterial agents, anti-pregnancy Stir the essence evenly and divide into packages.
制备杀菌消毒和杀精抗孕阴道给药复方制剂的又一方法,包括:在常温条件下将水、单体载体、表面活性剂、分散剂混合搅拌均匀,加入广谱抗菌剂、抗孕杀精剂搅拌均匀,在60-90℃加热和搅拌的条件下加入硬酯酸和/或硬酯醇,混合均匀,搅拌下冷却至凝固,分装。Another method for preparing a sterilizing and spermicidal anti-pregnancy compound preparation for vaginal administration includes: mixing and stirring water, monomer carriers, surfactants, and dispersants evenly at room temperature, adding broad-spectrum antibacterial agents, anti-pregnancy Stir the essence evenly, add stearic acid and/or stearyl alcohol under the condition of heating and stirring at 60-90°C, mix evenly, cool to solidify under stirring, and pack separately.
制备杀菌消毒和杀精抗孕阴道给药复方制剂的再一方法,包括:Yet another method for preparing the compound preparation for vaginal administration of sterilization, sterilization and spermicide and anti-pregnancy, including:
在常温条件下将广谱抗菌剂、抗孕杀精剂溶解于水中;将卡波姆加入丙三醇中研磨使湿润并部分溶胀,卡波姆溶胀度为40-60%,加入水使之吸收水分充分溶胀直至为半透明状凝胶,再将分散剂溶于水中加入上述凝胶,研匀成稠厚透明的凝胶基质,加入上述广谱抗菌剂、抗孕杀精剂溶液,研匀,分装即可。Dissolve the broad-spectrum antibacterial agent and anti-pregnancy spermicide in water under normal temperature conditions; add carbomer to glycerol and grind to make it wet and partially swell, the swelling degree of carbomer is 40-60%, add water to make it Absorb water and swell until it becomes a translucent gel, then dissolve the dispersant in water and add the above gel, grind it into a thick and transparent gel matrix, add the above broad-spectrum antibacterial agent, anti-pregnancy spermicide solution, and grind Evenly, divide into packs.
用法与用量:Usage and Dosage:
房事前使用一支。Use one before intercourse.
使用前撕开包装,取出载有纳米银避孕凝胶的阴道给药器;Tear open the package before use, and take out the vaginal applicator loaded with nano-silver contraceptive gel;
将阴道给药器前端的前盖取下,插入阴道给药后端作为助推杆;采用仰卧位,膝盖弯曲,尽量打开双腿,将阴道给药器缓环插入阴道深处,用食指推动助杆,将纳米银避孕凝胶全量推入深处,然后缓缓抽出。Remove the front cover of the vaginal applicator, and insert it into the rear end of the vaginal applicator as a booster rod; adopt the supine position, bend the knees, open the legs as much as possible, insert the vaginal applicator slow ring into the deep vagina, and push it with the index finger With the aid of the rod, push the nano-silver contraceptive gel fully into the depth, and then slowly pull it out.
本发明的杀菌消毒和杀精抗孕阴道给药复方制剂安全有效、具有避孕,抗菌、润滑的作用,使用方便、毒副作用小。临床资料显示,复方杀菌避孕凝胶剂在试验条件下作用2min、20min,对大肠杆菌的抑菌率分别为93.8%、98.3%;;对金黄色葡萄球菌的抑菌率分别为97.9%、99.3%;对白色链珠菌的抗菌率均分别为95.0%、97.2%,表明有较强的抗菌作用。复方杀菌避孕凝胶剂在1∶6的稀释度下,1分钟内精子失活率达100%;在1∶30的稀释度下,1分钟内精子失活率达100%;在1∶60的稀释度下,1分钟内精子失活率达79.00±3.92%;5分钟内精子失活率达100%。阻隔精子试验表明在5秒钟内精子灭活率平均98.2%,1分钟内精子灭活率平均100%。The sterilizing and spermicidal anti-pregnancy compound preparation for vaginal administration of the invention is safe and effective, has the functions of contraception, antibacterial and lubricating, is convenient to use, and has little toxic and side effects. Clinical data show that the compound bactericidal contraceptive gel acts for 2 minutes and 20 minutes under the test conditions, and the bacteriostatic rates against Escherichia coli are 93.8% and 98.3% respectively; the bacteriostatic rates against Staphylococcus aureus are 97.9% and 99.3% respectively. %; the antibacterial rates against Streptococcus albicans were 95.0% and 97.2%, respectively, indicating a strong antibacterial effect. At a dilution of 1:6, the sperm inactivation rate of the compound bactericidal contraceptive gel reaches 100% within 1 minute; at a dilution of 1:30, the sperm inactivation rate reaches 100% within 1 minute; at 1:60 At a certain dilution, the sperm inactivation rate reaches 79.00±3.92% within 1 minute; the sperm inactivation rate reaches 100% within 5 minutes. The barrier sperm test showed an average sperm inactivation rate of 98.2% within 5 seconds and an average sperm inactivation rate of 100% within 1 minute.
另有说明除外,下述试验中复方杀菌抗孕凝胶剂的配方为:Unless otherwise specified, the formula of the compound bactericidal anti-pregnancy gel in the following tests is:
纳米银 0.1kg 辛苯聚醇 20kgNano silver 0.1kg octoxynol 20kg
聚乙二醇-400 90kg 丙三醇 200kgPolyethylene Glycol-400 90kg Glycerol 200kg
卡波姆940 15g 三乙醇胺 150gCarbomer 940 15g Triethanolamine 150g
月桂醇硫酸钠 3.0kg 聚乙二醇-3350 50kgSodium Lauryl Sulfate 3.0kg Macrogol-3350 50kg
纯化水 471.9kg Purified water 471.9kg
制成 1000kgMade 1000kg
抗菌性试验
抗菌试验由广州市疾病预防控制中心检测:依据GB15979-2002《(一次性使用卫生用品卫生标准》附录C规定进行,试验结果表明:复方杀菌抗孕凝胶剂在试验条件下作用2min、20min,对大肠杆菌的抑菌率分别为93.8%、98.3%;对金黄色葡萄球菌的抑菌率分别为97.9%、99.3%;对白色链珠菌的抗菌率均分别为95.0%、97.2%;有较强的抗菌作用。见表1。The antibacterial test was tested by the Guangzhou Center for Disease Control and Prevention: it was carried out according to the provisions of Appendix C of GB15979-2002 "(Sanitary Standards for Disposable Sanitary Products"). The antibacterial rates to Escherichia coli were 93.8%, 98.3%; the antibacterial rates to Staphylococcus aureus were 97.9%, 99.3%; the antibacterial rates to Streptococcus albicans were 95.0%, 97.2%; Strong antibacterial effect. See Table 1.
试验组所用试剂:复方杀菌抗孕凝胶剂(见说明书第3页20-29行);Reagents used in the test group: compound bactericidal anti-pregnancy gel (see lines 20-29 on page 3 of the instruction manual);
对照组所用试剂:The reagents used in the control group:
大肠杆菌:无菌氯化钠-蛋白胨缓冲液+大肠杆菌(8099);Escherichia coli: sterile sodium chloride-peptone buffer + Escherichia coli (8099);
金黄色葡萄球菌:无菌氯化钠-蛋白胨缓冲液+金黄色葡萄球菌(ATCC6538);Staphylococcus aureus: sterile sodium chloride-peptone buffer + Staphylococcus aureus (ATCC6538);
白色念珠菌:无菌氯化钠-蛋白胨缓冲液+白色念珠菌(ATCC10231)。Candida albicans: sterile sodium chloride-peptone buffer + Candida albicans (ATCC10231).
表1:抗菌试验结果
杀精作用试验Spermicidal effect test
体外杀精子试验由国家计划生育委员会科学技术研究所检测:依据《WHO人类精液及精子—宫颈粘液相互作用试验手册》中方法进行,实验结果表明:复方杀菌抗孕凝胶剂在1∶6的稀释度下,1分钟内精子失活率达100%;在1∶30的稀释度下,1分钟内精子失活率达100%;在1∶60的稀释度下,1分钟内精子失活率达79.00±3.92%;5分钟内精子失活率达100%。见表2。The in vitro spermicidal test was tested by the Institute of Science and Technology of the National Family Planning Commission: it was carried out according to the method in the "WHO Human Semen and Sperm-Cervical Mucus Interaction Test Manual". Under the dilution, the sperm inactivation rate reaches 100% within 1 minute; at the 1:30 dilution, the sperm inactivation rate reaches 100% within 1 minute; at the 1:60 dilution, the sperm inactivation rate reaches 1 minute The rate reached 79.00±3.92%; the sperm inactivation rate reached 100% within 5 minutes. See Table 2.
表2:复方杀菌抗孕凝胶剂原液稀释对人精子作用能力的检测
注:复方杀菌抗孕凝胶剂(见说明书第3页20-29行)Note: compound bactericidal anti-pregnancy gel (see lines 20-29 on page 3 of the instruction manual)
阻隔精子试验Barrier sperm test
体外阻隔人精子试验(由中山医科大学附属三院进行):参照WHO推荐的Sander-Ceamer氏法,试验结果显示:实验组与空白组比较在5秒钟内精子失活率有明显提高,有显著统计学意义P<0.001,1分钟后至30分钟精子存活率有明显下降;试验组2通过0.1%伊红染色液精子染色判断在5秒钟内精子灭活率平均98.2%,1分钟内精子灭活率平均100%,与空白对比显著提高,有统计学差异P<0.001。见表3。In vitro barrier human sperm test (conducted by the Third Affiliated Hospital of Zhongshan Medical University): with reference to the Sander-Ceamer method recommended by WHO, the test results show that the sperm inactivation rate in the experimental group is significantly improved within 5 seconds compared with the blank group, and there is Significant statistical significance P<0.001, the sperm survival rate decreased significantly after 1 minute to 30 minutes; the sperm inactivation rate in test group 2 was judged by 0.1% eosin staining solution sperm staining within 5 seconds on average 98.2%, within 1 minute The sperm inactivation rate was 100% on average, which was significantly improved compared with the blank, with a statistical difference P<0.001. See Table 3.
试验组所用试剂:纳米银水溶液,浓度为20ppm;Reagents used in the test group: nano-silver aqueous solution, the concentration is 20ppm;
试验组2所用试剂:复方杀菌抗孕凝胶剂(见说明书第3页20-29行);Reagent used in test group 2: compound bactericidal anti-pregnancy gel (see lines 20-29 on page 3 of the instruction manual);
空白组所用试剂:液化精液Reagent used in blank group: liquefied semen
表3:体外阻隔人精子试验结果
杀伤精子的可靠性与实用性的临床研究A clinical study on the reliability and practicability of killer sperm
临床试验:复方杀菌抗孕凝胶剂杀伤精子的可靠性与实用性的临床研究(上海第二医科大学附属仁济医院)表明:本组受试者32对均完成本试验,无一脱落。手淫取精液后检测发现,精液量2.1±0.3ml,精子密度74.54±10.25×106/ml,精子平均活率70.64±15.1%。通过显微镜高倍视野下观察精子和伊红染色发现:使用30min-1h,30对夫妇中女方后穹隆均无活精子,31例宫颈粘液中无活动精子,精子失活率为97.0%。有1例使用后30min、2h时,宫颈黍液中仍有活动精子,出现活精子的百分率为3%。调查其使用方法发现,为使用剂量过小,产品注入未达到阴道所需要深度。试验过程中,所有组夫妇在性交过程中和性交后无阴茎、阴道水肿或糜烂等严重不良反应,2例使用后女方阴道有轻度灼热感,但可以耐受,约10min内灼热感消失。用复方杀菌抗孕凝胶剂30min-1h内与男方手淫取精液时活精子百分率比较,高倍视野下出现活精子百分率差异非常显著,统计学处理P<0.01。阴道标本涂片、白带常规、阴道pH和阴道杆菌培养,入组查体与使用复方杀菌抗孕凝胶剂24h后比较,统计学处理无显著性差异,P>0.05。24h后无凝胶残留,32对夫妇中30对夫妇对本产品避孕与阴道润滑疗效满意,满意率为93.8%。Clinical trial: The clinical research on the reliability and practicability of the compound bactericidal anti-pregnancy gel in killing sperm (Renji Hospital Affiliated to Shanghai Second Medical University) showed that all 32 pairs of subjects in this group completed the test, and none fell out. After masturbation to collect semen, it was found that the semen volume was 2.1±0.3ml, the sperm density was 74.54±10.25×10 6 /ml, and the average motility rate of sperm was 70.64±15.1%. Observing the sperm and eosin staining under the high power field of the microscope found that: after using for 30min-1h, there was no viable sperm in the posterior fornix of the woman in 30 couples, no motile sperm in the cervical mucus of 31 cases, and the sperm inactivation rate was 97.0%. In one case, 30 minutes and 2 hours after use, there were still motile sperm in the cervical millet fluid, and the percentage of viable sperm was 3%. Investigating its method of use found that the dosage was too small, and the product was not injected into the vagina to the required depth. During the test, all the couples in all groups had no serious adverse reactions such as penis, vaginal edema or erosion during and after sexual intercourse. Two cases of women had mild vaginal burning sensation after using it, but it was tolerable, and the burning sensation disappeared within about 10 minutes. Comparing the percentage of live sperm when taking the compound bactericidal anti-pregnancy gel within 30min-1h with the man's masturbation, the difference in the percentage of live sperm under the high-power field of view is very significant, and the statistical processing is P<0.01. Vaginal specimen smear, leucorrhea routine, vaginal pH and vaginal bacilli culture, compared with those after 24 hours of using the compound anti-pregnancy gel, there was no statistically significant difference, P>0.05. There was no gel residue after 24 hours Among the 32 couples, 30 couples were satisfied with the contraceptive and vaginal lubrication effects of this product, and the satisfaction rate was 93.8%.
纳米银避孕凝胶临床试用试验总结(华中科技大学同济医学院计划生育研究所)临床试验表明:25例受试者在整个试验时间内下阴道均未发现有活动精子。其余5例受试者,活动精子主要集中在同房后1min,精子分级为b级与c级,未见a级精子。5min后,仅两例受试者发现活动精子,10min后,活动精子全部制动。The summary of the clinical trials of nano-silver contraceptive gel (Family Planning Research Institute of Tongji Medical College, Huazhong University of Science and Technology) showed that no motile sperm was found in the lower vagina of 25 subjects during the entire test period. In the remaining 5 subjects, the motile sperm were mainly concentrated 1 minute after intercourse, and the sperm were graded as b and c grades, and no a grade sperm was seen. After 5 minutes, only two subjects found motile sperm, and after 10 minutes, all motile sperm were immobilized.
复方杀菌抗孕凝胶剂(见说明书第3页20-29行)Compound bactericidal anti-pregnancy gel (see lines 20-29 on page 3 of the instruction manual)
复方纳米银辛苯聚醇凝胶剂抗菌试验效果的比较Comparison of antibacterial test effects of compound nano-silver octoxynyl polyol gel
纳米银组;辛苯聚醇组;复方杀菌抗孕凝胶剂(由广州市疾病预防控制中心检测):依据GB15979-2002《一次性使用卫生用品卫生标准》附录C规定进行,试验结果表明:复方杀菌抗孕凝胶剂在试验条件下作用2min、20min,对大肠杆菌的抑菌率分别为94.7%、98.0%;纳米银组在试验条件下作用2min、20min,对大肠杆菌的抑菌率分别为92.5%、96.0%;辛苯聚醇组在试验条件下作用2min、20min,对大肠杆菌的抑菌率分别为85.3%、90.2%;三组比较,以复方杀菌抗孕凝胶剂和纳米银组抗菌作用较好,辛苯聚醇组次之。见表4。Nanosilver group; Octoxynol group; compound bactericidal anti-pregnancy gel (detected by Guangzhou Center for Disease Control and Prevention): according to the provisions of Appendix C of GB15979-2002 "Hygienic Standards for Disposable Sanitary Products", the test results show that: The compound bactericidal and anti-pregnancy gel acted for 2 minutes and 20 minutes under the test conditions, and the bacteriostatic rates against Escherichia coli were 94.7% and 98.0% respectively; were 92.5%, 96.0% respectively; the octoxynol group acted under test conditions for 2min, 20min, and the bacteriostatic rates to Escherichia coli were respectively 85.3%, 90.2%; The antibacterial effect of the nano-silver group was better, followed by that of the octoxynol group. See Table 4.
复方杀菌抗孕凝胶剂组使用的是复方杀菌抗孕凝胶剂(见说明书第3页20-29行);The compound bactericidal anti-pregnancy gel group used compound bactericidal anti-pregnancy gel (see lines 20-29 on page 3 of the instruction manual);
纳米银组使用的是纳米银水溶液,浓度为20ppm;The nano-silver group uses a nano-silver aqueous solution with a concentration of 20ppm;
辛苯聚醇使用的是辛苯聚醇,重量百分比浓度为2%;What octoxynyl alcohol used is octoxynyl alcohol, and the weight percent concentration is 2%;
表4:三组对大肠杆菌体外抗菌试验结果
纳米银组、复方杀菌抗孕凝胶剂、辛苯聚醇组体外杀精效果的比较Comparison of in vitro spermicidal effects among nano silver group, compound bactericidal anti-pregnancy gel and octoxynol group
纳米银组、复方杀菌抗孕凝胶剂组;辛苯聚醇组体外杀精效果的比较(由中山医科大学附属三院进行):参照WHO推荐的Sander-Ceamer氏法,试验结果显示:用Ridit分析法,复方杀菌抗孕凝胶剂组的R值为0.620,辛苯聚醇组R值为0.495,纳米银组R值为0.3210,在95%的可信区间中,纳米银隐形避孕套组可信区间为0.531-0.693,辛苯聚醇组可信区间为0.380-0.595,纳米银组可信区间0.228-0.44z6,三组有不同的杀精效果。复方纳米银辛苯聚醇凝胶组的R值>辛苯聚醇组R值>纳米银组R值,三者比较,复方纳米银辛苯聚醇凝胶组杀精效果较好,辛苯聚醇组次之,纳米银组又次之。见表5。Nano-silver group, compound bactericidal anti-pregnancy gel group; the comparison of the in vitro spermicidal effect of the octoxynol group (by the Third Affiliated Hospital of Zhongshan Medical University): with reference to the Sander-Ceamer method recommended by WHO, the test results show that: Ridit analysis shows that the R value of the compound bactericidal anti-pregnancy gel group is 0.620, the R value of the octoxynol group is 0.495, and the R value of the nano-silver group is 0.3210. In the 95% credible interval, the nano-silver invisible condom The credible interval of the octoxynol group is 0.531-0.693, the credible interval of the octoxynol group is 0.380-0.595, and the credible interval of the nano-silver group is 0.228-0.44z6. The three groups have different spermicidal effects. The R value of the compound nano-silver octoxynyl polyol gel group > the R value of the octoxynyl polyol group > the R value of the nano-silver group. Compared among the three, the spermicidal effect of the compound nano-silver octoxynyl polyol gel group was better, and the octoxynyl polyol gel group had a better spermicidal effect. The polyalcohol group is next, followed by the nano-silver group. See Table 5.
复方杀菌抗孕凝胶剂组使用的是复方杀菌抗孕凝胶剂(见说明书第3页20-29行);The compound bactericidal anti-pregnancy gel group used compound bactericidal anti-pregnancy gel (see lines 20-29 on page 3 of the instruction manual);
纳米银组使用的是纳米银水溶液,浓度为20ppm;The nano-silver group uses a nano-silver aqueous solution with a concentration of 20ppm;
辛苯聚醇使用的是辛苯聚醇水溶液,重量百分比浓度为2%;What octoxynyl alcohol used is an aqueous solution of octoxynyl alcohol, and the weight percent concentration is 2%;
表5:三组体外杀人精子试验结果
具体实施方式Detailed ways
实施例1Example 1
纳米银 0.07kg 辛苯聚醇 15kg 卡波姆 15kgNano Silver 0.07kg Octoxynol 15kg Carbomer 15kg
聚乙二醇-3350 30kg 聚乙二醇-400 50kg 月桂醇硫酸钠 0.5kgPolyethylene glycol-3350 30kg Polyethylene glycol-400 50kg Sodium lauryl sulfate 0.5kg
丙三醇 200kg 三乙醇胺 150kg 蒸馏水 550kgGlycerol 200kg Triethanolamine 150kg Distilled water 550kg
纳米银的粒径为50纳米;The particle size of nano silver is 50 nanometers;
制备方法:在常温条件下将纳米银、辛苯聚醇、月桂醇硫酸钠、聚乙二醇-400、聚乙二醇-3350溶解于150kg蒸馏水中;将卡波姆加入丙三醇中研磨使湿润并部分溶胀,卡波姆溶胀度为60%,加入350kg蒸馏水使之吸收水分充分溶胀直至为半透明状凝胶,再将三乙醇胺溶于50kg蒸馏水中加入上述凝胶,研匀成稠厚透明的凝胶基质,加入上述纳米银、辛苯聚醇溶液,研匀,分装即可。Preparation method: Dissolve nano-silver, octoxynyl alcohol, sodium lauryl sulfate, polyethylene glycol-400, polyethylene glycol-3350 in 150kg of distilled water at room temperature; add carbomer to glycerol and grind Make it wet and partially swell, the swelling degree of carbomer is 60%, add 350kg distilled water to make it absorb water and swell fully until it becomes a translucent gel, then dissolve triethanolamine in 50kg distilled water and add the above gel, grind until it becomes thick Thick and transparent gel matrix, add the above-mentioned nano-silver and octoxynyl polyalcohol solution, grind it evenly, and pack it separately.
实施例2Example 2
纳米银 0.01kg 壬苯醇醚 13kg 羧甲基纤维素钠 10kgNano Silver 0.01kg Nonoxynol 13kg Sodium Carboxymethyl Cellulose 10kg
聚乙二醇-400 300kg 聚乙二醇-3350 400kg 硬酯酸 50kgPolyethylene glycol-400 300kg Polyethylene glycol-3350 400kg Stearic acid 50kg
十二烷基磺酸钠 0.5kg 三乙醇胺 15kg 丙二醇 65kgSodium dodecyl sulfonate 0.5kg Triethanolamine 15kg Propylene glycol 65kg
去离子水 146.42kgDeionized water 146.42kg
纳米银的粒径为1纳米;The particle size of nano silver is 1 nanometer;
制备方法:常温条件下按处方量将去离子水、羧甲基纤维素钠、十二烷基磺酸钠、三乙醇胺、丙二醇、聚乙二醇-400、聚乙二醇-3350混合搅拌均匀,加入纳米银、壬苯醇醚搅拌均匀,在60℃条件下加入硬酯酸置于均质机内使其混合均匀,搅拌下冷却至凝固,分装即可。Preparation method: Mix and stir deionized water, sodium carboxymethylcellulose, sodium dodecylsulfonate, triethanolamine, propylene glycol, polyethylene glycol-400, and polyethylene glycol-3350 according to the prescription amount at room temperature , add nano-silver and nonoxynol ether and stir evenly, add stearic acid under the condition of 60°C and put it in a homogenizer to mix evenly, cool to solidify under stirring, and pack it separately.
实施例3Example 3
纳米银 0.1kg 孟苯醇醚 17kg 聚乙二醇-3350 200kgNanosilver 0.1kg Menthoxylin Ether 17kg Polyethylene Glycol-3350 200kg
聚乙二醇-400 400kg 聚乙烯吡咯烷酮 15kg 硬脂酸 14.5kgPolyethylene glycol-400 400kg Polyvinylpyrrolidone 15kg Stearic acid 14.5kg
硬酯醇 35kg 十二烷基硫酸钠 0.5kg 三乙醇胺 20kgStearyl Alcohol 35kg Sodium Lauryl Sulfate 0.5kg Triethanolamine 20kg
丙三醇 45kg 蒸馏水 300kgGlycerol 45kg Distilled water 300kg
纳米银的粒径为100纳米;The particle size of nano silver is 100 nanometers;
制备方法:常温条件下按处方量将蒸馏水、聚乙烯吡咯烷酮、十二烷基硫酸钠、三乙醇胺、丙三醇、聚乙二醇-400、聚乙二醇-3350混合搅拌均匀,加入纳米银、辛苯聚醇搅拌均匀,在75℃加热和搅拌的条件下加入硬脂酸和硬酯醇最后置于均质机内使其混合均匀,搅拌下冷却至凝固,分装即可。Preparation method: Mix distilled water, polyvinylpyrrolidone, sodium lauryl sulfate, triethanolamine, glycerol, polyethylene glycol-400, polyethylene glycol-3350 according to the prescription amount at room temperature and stir evenly, add nano-silver , octoxynyl alcohol, stir evenly, add stearic acid and stearyl alcohol under the condition of heating and stirring at 75°C, and finally put it in a homogenizer to mix evenly, cool to solidify under stirring, and pack it separately.
实施例4Example 4
苯扎氯铵 15kg 氯化苄烷铵 20kg 聚乙烯醇 50kgBenzalkonium Chloride 15kg Benzalkonium Chloride 20kg Polyvinyl Alcohol 50kg
十六烷基三甲基溴化铵 50kg α-单烷基甘油醚 60kgCetyltrimethylammonium Bromide 50kg α-Monoalkylglycerol Ether 60kg
丙三醇 55kg 去离子水 750kgGlycerol 55kg Deionized water 750kg
制备方法:常温条件下按处方量将去离子水、聚乙烯醇、十六烷基三甲基溴化铵、α-单烷基甘油醚、丙三醇、混合搅拌均匀,加入苯扎氯铵、氯化苄烷铵搅拌均匀,分装即可。Preparation method: Mix and stir deionized water, polyvinyl alcohol, cetyltrimethylammonium bromide, α-monoalkyl glycerol ether, glycerin according to the prescription amount at room temperature, and add benzalkonium chloride , Benzalkonium chloride, stir evenly, and pack it separately.
实施例5Example 5
苯扎溴铵 50kg 孟苯醇醚 20kg 卡波姆 10kgBenzalkonium Bromide 50kg Menthoxylin Ether 20kg Carbomer 10kg
聚乙二醇-400 100kg 聚乙二醇-3350 100kg 羧甲基纤维素钠 20kgPolyethylene glycol-400 100kg Polyethylene glycol-3350 100kg Sodium carboxymethyl cellulose 20kg
聚氧乙烯聚氧丙烯共聚醚 60kg 聚甘油-聚亚丁基脂肪醇醚 50kgPolyoxyethylene polyoxypropylene copolyether 60kg Polyglycerol-polybutylene fatty alcohol ether 50kg
硬脂酸丁酯 30kg 蒸馏水 560kgButyl stearate 30kg Distilled water 560kg
制备方法:常温条件下按处方量将蒸馏水、卡波姆、羧甲基纤维素钠、聚氧乙烯聚氧丙烯共聚醚、聚甘油-聚亚丁基脂肪醇醚、硬脂酸丁酯、聚乙二醇-400、聚乙二醇-3350混合搅拌均匀,加入苯扎溴铵、孟苯醇醚搅拌均匀,分装即可。Preparation method: Distilled water, carbomer, sodium carboxymethyl cellulose, polyoxyethylene polyoxypropylene copolyether, polyglycerol-polybutylene fatty alcohol ether, butyl stearate, polyethylene glycol Glycol-400 and Polyethylene Glycol-3350 are mixed and stirred evenly, add benzalkonium bromide and menthenyl ether, stir evenly, and pack them separately.
实施例6Example 6
三氯生 30kg 烷苯醇醚 10kg 聚乙烯吡咯烷酮 30kgTriclosan 30kg Alkylphenol ether 10kg Polyvinylpyrrolidone 30kg
聚乙二醇-400 400kg 聚乙烯醇 20kg 异硬脂酸异丙醇酯 30kgPolyethylene glycol-400 400kg Polyvinyl alcohol 20kg Isopropyl isostearate 30kg
十二烷基二甲基乙酸钠 50kg 丙三醇 45kg 去离子水 385kgSodium Lauryl Dimethyl Acetate 50kg Glycerol 45kg Deionized Water 385kg
制备方法:常温条件下按处方量将去离子水、聚乙烯吡咯烷酮、聚乙烯醇、异硬脂酸异丙醇酯、聚乙烯吡咯烷酮、十二烷基二甲基乙酸钠、丙三醇、聚乙二醇-400混合搅拌均匀,加入三氯生、烷苯醇醚搅拌均匀,分装即可。Preparation method: deionized water, polyvinylpyrrolidone, polyvinyl alcohol, isopropyl isostearate, polyvinylpyrrolidone, sodium dodecyldimethylacetate, glycerol, polyvinyl Ethylene Glycol-400 is mixed and stirred evenly, add triclosan and alkanol ether, stir evenly, and pack it separately.
实施例7Example 7
醋酸氯己定 30kg 苯醇醚 10kg 羧甲基纤维素钠 30kgChlorhexidine acetate 30kg Phenyl alcohol ether 10kg Sodium carboxymethyl cellulose 30kg
聚乙烯醇 50kg 烷基酰胺丙基甜菜碱 20kgPolyvinyl alcohol 50kg Alkyl amidopropyl betaine 20kg
烷基咪唑啉 30kg 丙二醇 200kg 去离子水 630kgAlkyl imidazoline 30kg propylene glycol 200kg deionized water 630kg
制备方法:常温条件下按处方量将去离子水、羧甲基纤维素钠、聚乙烯醇、烷基酰胺丙基甜菜碱、烷基咪唑啉、丙二醇、三乙醇胺混合搅拌均匀,加入醋酸氯己定、壬苯醇醚搅拌均匀,分装即可。Preparation method: Mix and stir deionized water, sodium carboxymethylcellulose, polyvinyl alcohol, alkyl amidopropyl betaine, alkyl imidazoline, propylene glycol, and triethanolamine according to the prescription amount at room temperature, and add chlorohexyl acetate Ding and nonoxynol are stirred evenly, and then packed separately.
实施例8Example 8
纳米银 0.1g 辛苯聚醇 20gNano silver 0.1g octoxynol 20g
卡波姆940 15g 三乙醇胺 150gCarbomer 940 15g Triethanolamine 150g
丙三醇 200g 去离子水 550gGlycerol 200g Deionized water 550g
制备方法:在常温条件下将纳米银、辛苯聚醇溶解于150kg去离子水中;将卡波姆940加入丙三醇中研磨使湿润并部分溶胀,卡波姆溶胀度为50%,加入350kg蒸馏水使之吸收水分充分溶胀直至为半透明状凝胶,再将三乙醇胺溶于50kg去离子水中加入上述凝胶,研匀成稠厚透明的凝胶基质,加入上述纳米银、辛苯聚醇溶液,研匀,分装即可。Preparation method: Dissolve nano-silver and octoxynol in 150kg of deionized water at room temperature; add carbomer 940 to glycerol and grind to make it wet and partially swell, the swelling degree of carbomer is 50%, add 350kg Distilled water to absorb water and swell fully until it becomes a translucent gel, then dissolve triethanolamine in 50kg deionized water and add the above gel, grind it into a thick and transparent gel matrix, add the above nano-silver, octoxynol Solution, grind well, then pack.
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| WO2008027950A1 (en) * | 2006-08-30 | 2008-03-06 | Alllen Thomas K | Antimicrobial composition |
| CN102266283A (en) * | 2011-07-29 | 2011-12-07 | 石家庄诺利达医疗器械有限公司 | Acidic buffering sterilization gel for vagina gynaecologically |
| CN102335161A (en) * | 2011-07-15 | 2012-02-01 | 成都顺发消洗科技有限公司 | Spermicide for disinfecting skin and mucous membrane, preparation method thereof |
| CN101991858B (en) * | 2009-08-18 | 2012-06-27 | 天津京英透皮材料科技开发有限公司 | Novel externally applied auxiliary material and preparation method thereof |
| CN105168676A (en) * | 2015-09-25 | 2015-12-23 | 湖北穆兰同大科技有限公司 | Female safety antimicrobial gel and preparation method thereof |
| CN109260529A (en) * | 2018-10-15 | 2019-01-25 | 海氏海诺乳胶(青岛)有限公司 | A kind of antibacterial body lotion and preparation method thereof |
| CN111345288A (en) * | 2020-03-12 | 2020-06-30 | 优仕康生(天津)科技发展有限公司 | A colloidal carrier capable of forming antibacterial and antiviral coating on the surface of respiratory protector, colloidal tincture and application thereof |
| CN113230204A (en) * | 2021-05-21 | 2021-08-10 | 河南依维意实业有限公司 | Contraceptive gel with barrier and spermicidal double protection functions and preparation method thereof |
-
2005
- 2005-10-13 CN CNB2005101083553A patent/CN100518825C/en not_active Expired - Lifetime
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008027950A1 (en) * | 2006-08-30 | 2008-03-06 | Alllen Thomas K | Antimicrobial composition |
| CN101991858B (en) * | 2009-08-18 | 2012-06-27 | 天津京英透皮材料科技开发有限公司 | Novel externally applied auxiliary material and preparation method thereof |
| CN102335161A (en) * | 2011-07-15 | 2012-02-01 | 成都顺发消洗科技有限公司 | Spermicide for disinfecting skin and mucous membrane, preparation method thereof |
| CN102266283A (en) * | 2011-07-29 | 2011-12-07 | 石家庄诺利达医疗器械有限公司 | Acidic buffering sterilization gel for vagina gynaecologically |
| CN102266283B (en) * | 2011-07-29 | 2012-09-05 | 石家庄诺利达医疗器械有限公司 | Acidic buffering sterilization gel for vagina gynaecologically |
| CN105168676A (en) * | 2015-09-25 | 2015-12-23 | 湖北穆兰同大科技有限公司 | Female safety antimicrobial gel and preparation method thereof |
| CN105168676B (en) * | 2015-09-25 | 2019-12-03 | 湖北穆兰同大科技有限公司 | Safe bacteriostatic gel of Ms and preparation method thereof |
| CN109260529A (en) * | 2018-10-15 | 2019-01-25 | 海氏海诺乳胶(青岛)有限公司 | A kind of antibacterial body lotion and preparation method thereof |
| CN111345288A (en) * | 2020-03-12 | 2020-06-30 | 优仕康生(天津)科技发展有限公司 | A colloidal carrier capable of forming antibacterial and antiviral coating on the surface of respiratory protector, colloidal tincture and application thereof |
| CN113230204A (en) * | 2021-05-21 | 2021-08-10 | 河南依维意实业有限公司 | Contraceptive gel with barrier and spermicidal double protection functions and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100518825C (en) | 2009-07-29 |
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