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CN101066409A - A pharmaceutical composition for killing sperm and treating vaginitis - Google Patents

A pharmaceutical composition for killing sperm and treating vaginitis Download PDF

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Publication number
CN101066409A
CN101066409A CNA2007100281791A CN200710028179A CN101066409A CN 101066409 A CN101066409 A CN 101066409A CN A2007100281791 A CNA2007100281791 A CN A2007100281791A CN 200710028179 A CN200710028179 A CN 200710028179A CN 101066409 A CN101066409 A CN 101066409A
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pharmaceutical composition
sperm
treating vaginitis
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acid
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苏子仁
赖小平
陈建南
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Guangzhou University of Chinese Medicine
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Guangzhou University of Chinese Medicine
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Abstract

The present invention provides one kind of medicine composition for killing sperm and treating vaginitis simultaneously. The medicine composition consists of active components comprising zedoary oil 0.5-20 wt% and hyodeoxycholic acid 0.5-20 wt% and pharmaceutically acceptable supplementary material. The medicine composition can kill sperm, change the physical and chemical properties of sperm and cervical mucus to prevent conception and kill microbes causing vaginal infection, so as to contracept and prevent and treat microbe caused viginitis.

Description

一种杀精和治疗阴道炎的药物组合物A pharmaceutical composition for killing sperm and treating vaginitis

技术领域technical field

本发明涉及中药领域,具体涉中药组合物。The invention relates to the field of traditional Chinese medicines, in particular to traditional Chinese medicine compositions.

背景技术Background technique

当今社会,计划外怀孕、泌尿生殖道感染等现象已经严重影响了广大妇女的日常生活,成为医学界急需解决的问题之一。目前,避孕的方法有多种,避孕套是目前全球最普遍的避孕方式,但在发展中国家的使用率很低。此外,由于避孕套会引起人体过敏反应以及影响快感,因此使用受到了相当一部分男性的抵制。避孕药应用很广,主要为口服或注射避孕药物及阴道内用药,现在世界上有数千万的人在使用女用口服避孕药,但是有严重心血管疾病,肝肾炎,内分泌疾病,肿瘤或血液病患者均不宜服用,容易引起头晕,恶心,呕吐,月经周期紊乱等不良反应,中国妇女口服避孕药的现用率呈下降趋势。女性外用避孕药有阴道栓剂、阴道隔膜等剂型,但由于操作复杂而不被许多女性接受。In today's society, phenomena such as unplanned pregnancy and genitourinary tract infection have seriously affected the daily life of women and become one of the urgent problems in the medical field. At present, there are many methods of contraception. Condoms are currently the most common contraceptive method in the world, but their usage rate in developing countries is very low. In addition, because condoms can cause allergic reactions in the human body and affect pleasure, a considerable number of men resist their use. Contraceptives are widely used, mainly oral or injectable contraceptives and intravaginal drugs. Now tens of millions of people in the world are using oral contraceptives for women, but they have serious cardiovascular diseases, liver nephritis, endocrine diseases, tumors or Patients with blood diseases should not take it, as it may easily cause dizziness, nausea, vomiting, menstrual cycle disorders and other adverse reactions. The current use rate of Chinese women's oral contraceptives is on a downward trend. Female external contraceptives have dosage forms such as vaginal suppositories and vaginal diaphragms, but they are not accepted by many women because of complicated operations.

90年代起,节育技术的研究已从以往单独注重避孕效果趋向于避孕与防病治病。作为屏障避孕方法之一的杀精剂,具有避孕和预防性传播疾病的双重功能且能为女性自主选择使用的优点。而目前常用的表面活性剂类避孕药如NP-9,对女性的阴道上皮组织有一定的损坏作用,有些还会影响阴道内的的正常菌群。因此,开发一种既可避孕,又可抗菌消炎,且粘膜刺激性小的复方中药避孕药有广阔的应用前景。Since the 1990s, research on birth control technology has shifted from focusing solely on contraceptive effects to contraception, disease prevention and treatment. Spermicide, as one of the barrier contraceptive methods, has the dual functions of contraception and prevention of sexually transmitted diseases, and has the advantage that women can choose to use it independently. The currently commonly used surfactant contraceptives such as NP-9 have a certain damage effect on the vaginal epithelial tissue of women, and some will also affect the normal flora in the vagina. Therefore, the development of a compound Chinese medicine contraceptive that can not only prevent pregnancy, but also antibacterial and anti-inflammatory, and has little mucosal irritation has broad application prospects.

莪术油是莪术根茎部的提取物,具有破血行气止痛,消积散结,破血祛瘀的功效,用于治疗妇女闭经,痰湿淤血凝结而成的症瘕癖块和疼痛。莪术油在医药领域的应用十分广泛,如:复方莪术油栓,每枚复方莪术油栓含硝酸益康唑50mg、莪术油0.21ml和冰片3mg,用于治疗各种阴道感染;莪术油注射液,含1%莪术油,用于早期宫颈癌的治疗;复方莪术油软胶囊,主要活性成分为莪术油和陈皮油,用于治疗由于消化不良引起的胃疾。单独用莪术油治疗阴道炎的效果并不是很理想,因此一般都和抗真菌剂搭配使用以增强其抗菌消炎的作用。Zedoary oil is the extract of the rhizome of Zedoary. It has the effects of breaking blood, promoting qi and relieving pain, eliminating stagnation, breaking blood and removing stasis. Zedoary oil is widely used in the field of medicine, such as: compound zedoary oil suppository, each compound zedoary oil suppository contains 50mg of econazole nitrate, 0.21ml of zedoary oil and 3mg of borneol, used to treat various vaginal infections; zedoary oil injection , containing 1% zedoary oil, used for the treatment of early cervical cancer; compound zedoary oil soft capsule, the main active ingredients are zedoary oil and tangerine peel oil, used to treat stomach problems caused by indigestion. The effect of treating vaginitis with curcuma oil alone is not very satisfactory, so it is generally used in combination with antifungal agents to enhance its antibacterial and anti-inflammatory effects.

猪去氧胆酸是从猪胆汁中提取的一种胆烷酸单体化合物,能抑制胆酸的形成及溶解脂肪,降低血中胆固醇和甘油三酯;对百日咳杆菌、白喉杆菌、金黄色葡萄球菌等有一定的抑菌作用,可用作消炎药;有研究表明猪去氧胆酸还对体外培养的人阴道毛滴虫有碎解作用(詹志曾,新医学,1979,10(2):66)和较强的杀精子作用(胡卿发等,陕西新医药,1986,15(8):3)。Hyodeoxycholic acid is a cholic acid monomer compound extracted from pig bile, which can inhibit the formation of cholic acid and dissolve fat, reduce blood cholesterol and triglyceride; etc. have a certain antibacterial effect and can be used as anti-inflammatory drugs; studies have shown that hyodeoxycholic acid also has a disintegrating effect on Trichomonas vaginalis cultured in vitro (Zhan Zhizeng, New Medicine, 1979, 10(2): 66) And strong spermicidal effect (Hu Qingfa et al., Shaanxi New Medicine, 1986, 15(8): 3).

发明内容Contents of the invention

本发明要解决的技术问题是提供一种杀精和治疗阴道炎的药物组合物,以进一步提高莪术油和猪去氧胆酸的抗菌消炎和杀精的作用。The technical problem to be solved by the present invention is to provide a pharmaceutical composition for killing sperm and treating vaginitis, so as to further improve the antibacterial, anti-inflammatory and spermicidal effects of zedoary oil and hyodeoxycholic acid.

本发明实现上述目的的技术方案是:The technical scheme that the present invention realizes above-mentioned purpose is:

一种杀精和治疗阴道炎的药物组合物,该组合物由活性成份和医学上可接受的辅料组成,其特征是含有以下重量百分比的活性成份:莪术油0.5~20%、猪去氧胆酸0.5~20%;优选莪术油4%、猪去氧胆酸2%。A pharmaceutical composition for killing sperm and treating vaginitis, the composition is composed of active ingredients and medically acceptable auxiliary materials, and is characterized in that it contains the following active ingredients in weight percent: zedoary oil 0.5-20%, hyodeoxycholic acid 0.5-20%; preferably turmeric oil 4%, hyodeoxycholic acid 2%.

本发明所述的莪术油为姜科植物蓬莪术(Curcuma phaeocaulis Valeton)、温郁金(Curcumawenyujin Y.H.Chen et C.Ling)或广西莪术(Curcuma kwangsiensis S.G.Lee etC.F.Liang)等的干燥根茎经水蒸汽蒸馏或应用超临界二氧化碳萃取技术提取的脂溶性部分;猪去氧胆酸是健康猪胆汁提取的3α,6α-二羟基5β-胆烷酸,按干燥品计算,C20H40O4含量不得少于98.0%。Zedoary oil of the present invention is the dry rhizome of Zingiberaceae plant Curcuma phaeocaulis Valeton (Curcuma phaeocaulis Valeton), Wen Yujin (Curcumawenyujin YHChen et C.Ling) or Guangxi Zedoary (Curcuma kwangsiensis SGLee et C.F.Liang) etc. through steam distillation or The fat-soluble part extracted by supercritical carbon dioxide extraction technology; hyodeoxycholic acid is 3α, 6α-dihydroxy 5β-cholanic acid extracted from healthy pig bile, and the content of C 20 H 40 O 4 should not be less than 98.0 %.

本发明药物组合物是临床可接受的剂型,如洗剂、软膏剂、凝胶剂、泡沫剂、栓剂、气雾剂或阴道泡腾片。所述洗剂的辅料是乳化剂和水,其中乳化剂选用吐温-80;所述软膏剂的辅料是软膏基质、保湿剂和乳化剂,其中,软膏基质选用卡波姆,保湿剂选用甘油,乳化剂选用吐温-80;所述凝胶剂的辅料是凝胶基、表面活性剂、保湿剂和乳化剂,其中,凝胶基质选用Poloxamer 407,表面活性剂选用甲基纤维素,保湿剂选用甘油,乳化剂选用吐温-80;所述泡沫剂的辅料是乳化剂、保湿剂、防腐剂、酸碱中和剂、增塑剂和表面活性剂,其中,乳化剂选用吐温-80,保湿剂选用甘油,防腐剂选用苯甲醇,酸碱中和剂选用三乙醇胺,增塑剂选用硬脂酸,表面活性剂选用平平加O;所述栓剂的的辅料是栓剂基质,如可可豆脂;所述气雾剂的辅料是乳化剂、保湿剂、防腐剂、酸碱中和剂、增塑剂、抛射剂和表面活性剂,其中,乳化剂选用吐温-80,保湿剂选用甘油,防腐剂选用苯甲醇,酸碱中和剂选用三乙醇胺,增塑剂选用硬脂酸,表面活性剂选用平平加O,抛射剂选用二甲醚;所述阴道泡腾片的辅料是包合剂和CO2发生剂,其中,包合剂选用环糊精,CO2发生剂选用硼酸、酒石酸和碳酸氢钠。The pharmaceutical composition of the present invention is a clinically acceptable dosage form, such as lotion, ointment, gel, foam, suppository, aerosol or vaginal effervescent tablet. The adjuvant of described lotion is emulsifier and water, and wherein emulsifier selects Tween-80 for use; The adjuvant of described ointment is ointment base, humectant and emulsifier, wherein, ointment base selects carbomer for use, and moisturizer selects glycerol for use , emulsifier selects Tween-80 for use; The adjuvant of described gel is gel base, surfactant, humectant and emulsifier, wherein, gel base selects Poloxamer 407 for use, and surfactant selects methyl cellulose for use, moisturizing Glycerol is selected as the agent, and Tween-80 is selected as the emulsifier; the auxiliary materials of the foaming agent are emulsifier, humectant, preservative, acid-base neutralizer, plasticizer and surfactant, wherein the emulsifier is selected from Tween-80. 80. Glycerin is selected as the moisturizing agent, benzyl alcohol is selected as the preservative, triethanolamine is selected as the acid-base neutralizer, stearic acid is selected as the plasticizer, and flat plus O is selected as the surfactant; the auxiliary material of the suppository is the suppository base, such as cocoa soybean fat; the adjuvants of the aerosol are emulsifier, humectant, antiseptic, acid-base neutralizer, plasticizer, propellant and surfactant, wherein, emulsifier selects Tween-80 for use, and moisturizer selects Glycerin, antiseptic selects benzyl alcohol for use, acid-base neutralizer selects triethanolamine for use, plasticizer selects stearic acid for use, surfactant selects Pingping and O for use, and propellant selects dimethyl ether for use; Compounding agent and CO Generating agent, wherein, inclusion agent selects cyclodextrin for use, CO Generator selects boric acid, tartaric acid and sodium bicarbonate for use.

本发明药物组合物的活性成分由莪术油、猪去氧胆酸两味中药组成,以莪术油为君药,其作用是:一、现代研究表明其具有抗菌消炎功能,可以抑制“阴痒之虫”;二、在阴道内可抑制精子成活率,减少受孕机率,达到避孕作用。以猪去氧胆酸为臣药,猪去氧胆酸主归肝经,善清肝胆之湿热以除邪实。二药同用共凑“清热抗菌,止痛避孕”之功,配伍后抗菌消炎作用增强,杀精有效浓度比单独使用猪去氧胆酸降低。“阴痒之虫”得灭,则阴部瘙痒之症得除;肝胆实热得清,则白带量多,色黄,质稠,臭秽;阴部红肿疼痛及其伴随症状亦平;阴道润滑,则性交疼痛可缓。The active ingredient of the pharmaceutical composition of the present invention is composed of two traditional Chinese medicines, zedoary oil and hyodeoxycholic acid, and the zedoary oil is used as the king drug. "; 2. In the vagina, it can inhibit the survival rate of sperm, reduce the chance of conception, and achieve the contraceptive effect. With hyodeoxycholic acid as the ministerial drug, hyodeoxycholic acid mainly returns to the liver meridian, and is good at clearing damp-heat in the liver and gallbladder to eliminate pathogenic factors. The two medicines are used together to achieve the function of "clearing away heat and antibacterial, relieving pain and contraception". After compatibility, the antibacterial and anti-inflammatory effects are enhanced, and the effective spermicidal concentration is lower than that of hyodeoxycholic acid alone. If the "pruritus of vulvae" is exterminated, the symptoms of genital itching will be eliminated; if the excess heat in the liver and gallbladder is cleared, the amount of leucorrhea will be large, yellow in color, thick in quality, and smelly; Then sexual intercourse pain can be relieved.

综上所述,本发明药物组合物具有两大优点:首先,作为阴道给药的制剂,不仅具有治疗阴道炎的作用,同时由于药味精当,作用缓和,不具有刺激性和腐蚀性,因此同时具有治疗性和实用性;其次,本制剂还可以减少阴道内精子的成活率达到避孕的目的。In summary, the pharmaceutical composition of the present invention has two major advantages: first, as a preparation for vaginal administration, it not only has the effect of treating vaginitis, but also because the medicine monosodium glutamate is suitable, the effect is moderate, and it does not have irritation and corrosion. Simultaneously, it has therapeutic properties and practicality; secondly, the preparation can also reduce the survival rate of sperm in the vagina to achieve the purpose of contraception.

下面将通过实验进一步说明本发明所具有的优点和所能达到的的技术效果。The advantages and attainable technical effects of the present invention will be further illustrated through experiments below.

1、本发明药物组合物的杀精作用和避孕效果实验1. Experiments on the spermicidal effect and contraceptive effect of the pharmaceutical composition of the present invention

(1)受试药物:(1) Test drug:

本发明药物组合物乳液:取本发明药物组合物,用0.9%氯化钠溶液配制成含莪术油4%、猪去氧胆酸2%和吐温-80 2%的乳液;Pharmaceutical composition emulsion of the present invention: get pharmaceutical composition of the present invention, be mixed with turmeric oil 4%, hyodeoxycholic acid 2% and Tween-80 2% emulsion with 0.9% sodium chloride solution;

(2)实验材料:(2) Experimental materials:

精子:取自成年健康男子(年龄25~38岁),禁欲3~7d,手淫法取精液于洁净试管内,37℃0.5h内液化后,光镜下常规检查,精子密度50×109~80×109L-1,活动率70%以上,活动力为IV,畸形精子<30%,无精子凝集现象。Sperm: collected from adult healthy men (age 25-38 years old), abstinence for 3-7 days, masturbation method to collect semen in a clean test tube, liquefied within 0.5 hours at 37°C, routine inspection under light microscope, sperm density 50×10 9 ~ 80×10 9 L -1 , motility rate over 70%, motility IV, deformed sperm <30%, no sperm agglutination.

宫颈粘液:取自健康成年排卵期妇女,有拉丝度,涂片晾干后镜下可见羊齿状结晶。Cervical mucus: taken from a healthy adult ovulating woman, it has a stringiness, and fern-like crystals can be seen under the microscope after the smear is dried.

(3)实验方法:(3) Experimental method:

a.本发明组合物对精液的作用:在清洁的3个试管中各加入精液0.5ml,在一定间隔时间内分别向该3管加入本发明药物组合物乳液0.01ml、0.02ml、0.03ml,同时用不加本发明药物组合物乳液的精液平行对照。分别计时并摇匀或用吸管吹打,并用肉眼观察,分别于加药液后20S、1min、15min、30min、60min吸取试管混匀液20μl于载玻片上,加盖玻片后显微镜观察。分别记录精子活力、活率、密度等。a. the effect of the composition of the present invention on seminal fluid: respectively add seminal fluid 0.5ml in 3 clean test tubes, add pharmaceutical composition emulsion 0.01ml, 0.02ml, 0.03ml of the present invention to these 3 tubes respectively in a certain interval time, Simultaneously, parallel control was performed with the semen that did not add the emulsion of the pharmaceutical composition of the present invention. Timing and shaking or blowing with a straw, and observed with the naked eye, pipette 20 μl of the mixed liquid in the test tube at 20 seconds, 1 minute, 15 minutes, 30 minutes, and 60 minutes after adding the drug solution, respectively, and put it on a glass slide, and observe under the microscope after adding a cover glass. Sperm motility, motility, density, etc. were recorded respectively.

b.本发明组合物对宫颈粘液的作用:在清洁的3个试管中各加入宫颈粘液0.15ml,分别加入药液0.01ml、0.02ml、0.03ml,摇匀或用吸管吹打数次。肉眼观察,看拉丝度,涂片晾干,光镜下看羊齿状结晶。b. The effect of the composition of the present invention on cervical mucus: add 0.15ml of cervical mucus to three clean test tubes, add 0.01ml, 0.02ml, and 0.03ml of liquid medicine respectively, shake well or blow several times with a straw. Observe with the naked eye to see the degree of stringiness, dry the smear, and see fern-shaped crystals under a light microscope.

c.本发明组合物对精液与宫颈粘液混合液的作用:取精液0.1ml与宫颈粘液0.1ml混匀,加入本发明药物组合物乳液0.02ml混匀后取混合液一滴于载玻片上,加盖玻片后显微镜下观察,记录精子活率、活力、密度等。c. The effect of the composition of the present invention on the mixed liquid of semen and cervical mucus: get 0.1ml of semen and 0.1ml of cervical mucus and mix well, add 0.02ml of the pharmaceutical composition emulsion of the present invention and mix well, get a drop of the mixed solution on a glass slide, add Observe under the microscope after covering the glass, and record the sperm motility, vitality, density, etc.

d.玻片穿透试验:分别取3所述3个试管中本发明药物组合物乳液和宫颈粘液混合液20μl于载波片上,取等量精液相距4mm置于同一张载玻片上,压上盖玻片后用相差显微镜观察。d. Glass slide penetration test: take 20 μl of the emulsion of the pharmaceutical composition of the present invention and cervical mucus mixture in the three test tubes described in 3 respectively on the slide, take an equal amount of semen and put it on the same slide at a distance of 4mm, press the cover The slides were observed with a phase-contrast microscope.

e.毛细管爬高试验:取b中的第1管精液于专用塑料贮精池内,将毛细管充满宫颈粘液,顶端用橡皮泥封闭,另一端插入贮精池,浸入精液深度约2mm.确保毛细管中宫颈粘液柱长5cm以上。放入37℃环境,计时并分别在30min、60min、120min把毛细管平放在倒置相差显微镜下观察。第2管、第3管精液试验方法同上,同时用不加本发明药物组合物乳液的精液平行对照。e. Capillary climbing test: Take the first tube of semen in b in a special plastic semen storage tank, fill the capillary with cervical mucus, seal the top with plasticine, insert the other end into the semen storage tank, and immerse the semen at a depth of about 2mm. The cervical mucus column is more than 5cm long. Put it into a 37°C environment, time it, and place the capillary flat on an inverted phase-contrast microscope at 30 minutes, 60 minutes, and 120 minutes respectively for observation. The semen test method of the 2nd tube and the 3rd tube is the same as above, and the semen that does not add the pharmaceutical composition emulsion of the present invention is used as a parallel control simultaneously.

(4)实验结果:(4) Experimental results:

a.本发明组合物对精液的作用,如表3所示,本发明药物组合物乳液用药1小时后各组精液中精子的活力和活率均降为0,密度降为20-40;本发明药物组合物乳液用药3ml在20s后精子的活力和活率均为0,密度为20×109~40×109L-1。在0.024%浓度时可瞬间使精子失活,0.008%浓度时,1h内可使全部精子失活,杀精子效果较单独使用要好,可见本发明组合物有很好的杀精作用。a. the composition of the present invention is to the effect of seminal fluid, as shown in table 3, the motility and viability of sperm in each group's seminal fluid are all reduced to 0, and density is reduced to 20-40 after pharmaceutical composition emulsion medication of the present invention 1 hour; After taking 3ml of the inventive pharmaceutical composition emulsion, the motility and motility rate of the sperm are both 0 after 20s, and the density is 20×10 9 -40×10 9 L -1 . When the concentration is 0.024%, sperm can be inactivated instantly, and when the concentration is 0.008%, all sperm can be inactivated within 1 hour, and the spermicidal effect is better than that used alone. It can be seen that the composition of the present invention has a good spermicidal effect.

                                  表3  药液对精液作用的结果   时间   空白对照   本发明组合物/0.02ml   本发明组合物/0.02ml   本发明组合物/0.03ml   活力   活率%   密度×109L-1 活力 活率%   密度×109L-1 活力 活率%   密度×109L-1 活力 活率%   密度×109L-1   20S   IV   70   >50   IV   70   >50   II   40   >50   0   0   20-40   1min   IV   70   >50   III   60   >50   I   20   >50   0   0   20-40   15min   IV   70   >50   II   40   >50   0   0   20-40   0   0   20-40   30min   IV   70   >50   I   20   >50   0   0   20-40   0   0   20-40   60min   III   60   >50   0   0   20-40   0   0   20-40   0   0   20-40 Table 3 The results of the effect of medicinal liquid on semen time blank control Composition of the present invention/0.02ml Composition of the present invention/0.02ml Composition of the present invention/0.03ml vitality Survival rate% Density×10 9 L -1 vitality Survival rate% Density×10 9 L -1 vitality Survival rate% Density×10 9 L -1 vitality Survival rate% Density×10 9 L -1 20S IV 70 >50 IV 70 >50 II 40 >50 0 0 20-40 1min IV 70 >50 III 60 >50 I 20 >50 0 0 20-40 15min IV 70 >50 II 40 >50 0 0 20-40 0 0 20-40 30min IV 70 >50 I 20 >50 0 0 20-40 0 0 20-40 60min III 60 >50 0 0 20-40 0 0 20-40 0 0 20-40

b.本发明组合物对宫颈粘液的作用:加入本发明组合物乳液后立即出现白色絮状物,用吸管吹打时可见乳白色凝固团,凝固程度与所加药液量成正比,用镊子检查拉丝度消失。将混合物涂片烘干后,光镜下见凝固团部位无羊齿状结晶,析出液部位可见羊齿状结晶,说明本发明组合物能改变宫颈粘液的理化性质。b. The effect of the composition of the present invention on cervical mucus: immediately after adding the emulsion of the composition of the present invention, white flocs appear, and milky white solidified masses can be seen when blowing with a straw. degrees disappear. After drying the smear of the mixture, no fern-shaped crystals can be seen in the coagulated mass under the light microscope, and fern-shaped crystals can be seen in the eluate, indicating that the composition of the present invention can change the physical and chemical properties of cervical mucus.

c.本发明组合物对精液与宫颈粘液混合液的作用:加本发明药物组合物乳液0.02ml混匀后镜下。可见精子全部制动。密度下降,并且丝状物增多。c. The effect of the composition of the present invention on the mixed liquid of semen and cervical mucus: add 0.02 ml of the emulsion of the pharmaceutical composition of the present invention and mix well, then observe under the microscope. It can be seen that all the spermatozoa are immobilized. Density decreases and filaments increase.

d.玻片穿透试验结果:加入本发明药物组合物乳液后.无一使精子穿透。镜下见精液与之接触处有指样突出,但每一突出的交界面精子也被制动。并且随着乳液的流入,与乳液接触的活动精子也被制动。d. Result of slide penetration test: After adding the emulsion of the pharmaceutical composition of the present invention, none of them made the sperm penetrate. Under the microscope, it can be seen that there are finger-like protrusions at the contact part of the semen, but the sperm at each protruding interface is also braked. And as the emulsion flows in, the motile sperm that come into contact with the emulsion are also braked.

e.毛细管爬高试验结果,结果见表4。e. The results of the capillary climbing test, the results are shown in Table 4.

                           表4  毛细管爬高试验结果   时间/min   本发明组合物/0.02ml   本发明组合物/0.02ml   本发明组合物/0.03ml 正常对照组 30 无穿透 无穿透 无穿透   1.5cm可见大量活动精子 60   0.5cm处见几个活动精子 无穿透 无穿透   3cm可见大量活动精子 120   0.5cm处见几个活动精子   0.5cm处见几个活动精子 无穿透   5cm可见大量活动精子 Table 4 Capillary climb test results time/min Composition of the present invention/0.02ml Composition of the present invention/0.02ml Composition of the present invention/0.03ml normal control group 30 no penetration no penetration no penetration A large number of motile sperm can be seen at 1.5cm 60 Several motile spermatozoa were seen at 0.5cm no penetration no penetration A large number of motile sperm can be seen at 3cm 120 Several motile spermatozoa were seen at 0.5cm Several motile spermatozoa were seen at 0.5cm no penetration A large number of motile sperm can be seen at 5cm

结论:莪术油、猪去氧胆酸组合物不但有较强的杀精作用,而且可改变精液、宫颈粘液的理化性质,阻止受孕。Conclusion: The combination of zedoary oil and hyodeoxycholic acid not only has a strong spermicidal effect, but also can change the physical and chemical properties of semen and cervical mucus to prevent conception.

2、抗阴道感染实验2. Anti-vaginal infection experiment

(1)受试药物:(1) Test drug:

本发明药物组合物:A.莪术油4%、猪去氧胆酸2%、吐温-80 2%和0.9%氯化钠的乳液,Pharmaceutical composition of the present invention: A. the emulsion of turmeric oil 4%, hyodeoxycholic acid 2%, Tween-80 2% and 0.9% sodium chloride,

                  B.莪术油2%、猪去氧胆酸1%、吐温-80 2%和0.9%氯化钠的乳液;B. Emulsion of turmeric oil 2%, hyodeoxycholic acid 1%, Tween-80 2% and 0.9% sodium chloride;

聚维酮碘软膏(批号06060305,广东众生药业股份有限公司生产):用生理盐水配制成含聚维酮碘10%的溶液。Povidone-iodine ointment (batch number 06060305, produced by Guangdong Zhongsheng Pharmaceutical Co., Ltd.): use physiological saline to prepare a solution containing 10% povidone-iodine.

(2)实验材料:(2) Experimental materials:

新西兰白兔,购自广州中医药大学实验动物中心。New Zealand white rabbits were purchased from the Experimental Animal Center of Guangzhou University of Traditional Chinese Medicine.

金黄色葡萄球菌、大肠杆菌、乙型链球菌、白色念珠菌。标准菌株由中国药品生物制品检定所提供。Staphylococcus aureus, Escherichia coli, B streptococcus, Candida albicans. Standard strains were provided by China National Institute for the Control of Pharmaceutical and Biological Products.

(3)实验方法:(3) Experimental method:

a.体外抑菌实验a. Antibacterial test in vitro

取本发明药物组合物A做2倍比稀释(平皿法),多点定量接种加入标准菌液,37℃恒温箱中培养7d,同时对照和菌种对照同样培养7d,观察各浓度的抑菌效果。Get the pharmaceutical composition A of the present invention and do 2 times ratio dilution (petri dish method), multi-point quantitative inoculation adds standard bacterial liquid, cultivates 7d in 37 ℃ of incubators, simultaneously controls and bacterial classification control same cultivation 7d, observes the bacteriostasis of each concentration Effect.

b.实验性家兔阴道炎的治疗作用b. The therapeutic effect of experimental rabbit vaginitis

取体重3kg左右雌性家兔36只,其中4只作为正常对照组,其余32只分别给予按1∶1∶1混合的乙型链球菌、金黄色葡萄球菌、白色念珠菌培养菌液,按照0.4ml/只,将混合菌液注人家兔阴道内。注入菌液后自由活动,8h后再用相同方法重复感染一次。3d后取其阴道分泌物做镜检及培养,阴道分泌物3种菌检都为阳性者为合格受试动物。将检验阳性的合格动物随机分为4组,模型组、原浓度莪术油、猪去氧胆酸组合物组、50%浓度莪术油、猪去氧胆酸组合物组和10%聚维酮碘软膏对照组。每只于每日8:00Am和8:00Pm各给药一次,连续给药10d,对照组给与等容量生理盐水。给药方法是动物仰卧位,用乳胶管冲洗阴道,给药容积都是每只2mL,每次给药后动物立即自由活动任由药液流出,不进行清洁冲洗。末次给药后2h,处死所有动物,解剖各家兔阴道,沿阴道纵轴剖开,肉眼观察阴道和子宫颈处粘膜有无充血红肿、水肿、脓肿,然后用10%甲醛固定做病理组织学检查。Take 36 female rabbits with a body weight of about 3kg, 4 of which are used as the normal control group, and the remaining 32 are respectively given the culture solution of Streptococcus beta, Staphylococcus aureus, and Candida albicans mixed at a ratio of 1:1:1, and the ratio of 0.4 ml/only, inject the mixed bacterial solution into the vagina of rabbits. After injecting the bacterial solution, move freely, and repeat the infection again in the same way after 8 hours. After 3 days, the vaginal secretions were taken for microscopic examination and culture, and those whose vaginal secretions were all positive for the three bacterial tests were qualified as test animals. Qualified animals with positive test results were randomly divided into 4 groups, model group, original concentration zedoary oil, hyodeoxycholic acid composition group, 50% concentration zedoary oil, hyodeoxycholic acid composition group and 10% povidone-iodine ointment control group Group. Each rat was administered once a day at 8:00Am and 8:00Pm for 10 consecutive days, and the control group was given equal volume of normal saline. The administration method is that the animal is placed in the supine position, and the vagina is rinsed with a latex tube. The volume of administration is 2mL per animal. After each administration, the animal moves freely immediately and allows the liquid to flow out without cleaning and washing. 2 hours after the last administration, all animals were killed, and the vaginas of each rabbit were dissected, cut open along the longitudinal axis of the vaginas, and observed with the naked eye for redness, swelling, edema, and abscesses in the mucous membranes of the vaginas and cervix, and then fixed with 10% formaldehyde for histopathological examination .

(4)结果(4) Results

a.体外抑菌实验:具体结果见表1和表2。a. Antibacterial test in vitro: See Table 1 and Table 2 for specific results.

                       表1.本发明药物组合物体外抑菌实验结果   稀释倍数菌种   1∶2   1∶4   1∶8   1∶16   1∶32   1∶64   菌种对照 E   J   E   J   E   J   E   J   E   J   E   J   金黄色葡萄球菌 -   -   -   -   -   -   -   -   +   +   +   +   +   +   大肠杆菌 -   -   -   -   -   -   ±   ±   +   +   +   +   +   +   乙型链球菌 -   -   -   -   -   -   ±   ±   +   +   +   +   +   +   白色念珠菌 -  -  -  -  -  -  -  -  +  +  +  +  +  + Table 1. In vitro antibacterial test results of the pharmaceutical composition of the present invention Dilution times 1:2 1:4 1:8 1:16 1:32 1:64 Strain control E. J E. J E. J E. J E. J E. J Staphylococcus aureus - - - - - - - - + + + + + + Escherichia coli - - - - - - ± ± + + + + + + B Streptococcus - - - - - - ± ± + + + + + + Candida albicans - - - - - - - - + + + + + +

注:E表示莪术油、猪去氧胆酸组合物,J表示聚维酮碘软膏;-表示无相应菌生长,+表示有相应菌生长,±表示有微弱相应菌生长。Note: E indicates the composition of turmeric oil and hyodeoxycholic acid, J indicates povidone-iodine ointment; - indicates no growth of corresponding bacteria, + indicates growth of corresponding bacteria, ± indicates weak growth of corresponding bacteria.

结果显示,莪术油、猪去氧胆酸组合物与聚维酮碘软膏均能抑制多种细菌的生长。The results showed that zedoary oil, hyodeoxycholic acid composition and povidone-iodine ointment could all inhibit the growth of various bacteria.

表2 本发明组合物与莪术油、猪去氧胆酸的对各种致病菌的MIC(g/ml)   菌种   莪术油   猪去氧胆酸   本发明组合物   金黄色葡萄球菌   0.005   >0.01   0.001   乙型溶血性链球菌   0.005   0.01   0.01   大肠埃希氏菌   0.01   0.05   0.01   绿脓假单胞菌   >0.05   0.01   >0.01   白色念珠菌   0.005   0.05   0.005   阴道加特纳菌   0.005   0.01   0.001   奈瑟淋球菌   0.001   0.01   0.001   平均MIC   >0.011   >0.021   >0.005 Table 2 The MIC (g/ml) of the composition of the present invention, zedoary oil and hyodeoxycholic acid to various pathogenic bacteria bacteria Curcuma Oil hyodeoxycholic acid Composition of the invention Staphylococcus aureus 0.005 >0.01 0.001 Beta-hemolytic Streptococcus 0.005 0.01 0.01 Escherichia coli 0.01 0.05 0.01 Pseudomonas aeruginosa >0.05 0.01 >0.01 Candida albicans 0.005 0.05 0.005 Gardnerella vaginalis 0.005 0.01 0.001 Neisseria gonorrhoeae 0.001 0.01 0.001 Average MIC >0.011 >0.021 >0.005

注:MIC是指完全抑制试验菌种生长所含的最小药物浓度。Note: MIC refers to the minimum drug concentration that completely inhibits the growth of the test bacteria.

结果表明本发明组合物对各种阴道炎致病菌的MIC比莪术油和猪去氧胆酸的都有所降低,且有的降幅高达10倍,可见本发明组合物有很强的抗菌作用。The results show that the MIC of the composition of the present invention to various vaginitis pathogenic bacteria is lower than that of zedoary oil and hyodeoxycholic acid, and some of the reductions are as high as 10 times. It can be seen that the composition of the present invention has a strong antibacterial effect.

b.实验性家兔阴道炎实验b. Experimental Rabbit Vaginitis Experiment

以阴道壁的炎性浸润、粘膜增生和间质水肿为主要组织学指标,进行半定量分级,以模型对照组为参照系(等级指数M=0),等级指数法进行组间差异的显著性检验,结果见表2。The inflammatory infiltration of the vaginal wall, mucosal hyperplasia and interstitial edema were used as the main histological indicators, and the semi-quantitative grading was carried out, and the model control group was used as the reference system (grade index M=0), and the significance of the difference between groups was carried out by the grade index method The test results are shown in Table 2.

                  表2 对感染性阴道炎病理形态学的影响结果            Table 2 Effects on the Pathomorphology of Infectious Vaginitis

                                  表2-1   组别   N(只)                         炎性浸润   #(只)   +++(只)   ++(只)   +(只) M T   正常组   4                          不明显   模型组   8   5   3   0   0   0   本发明组合物A组   8   0   0   3   5   5.83   2.71   本发明组合物B组   8   0   0   5   3   4.94   2.28   聚维酮碘组   8   0   0   4   4   5.43   2.38 table 2-1 group N (only) Inflammatory infiltration #(Only) +++(only) ++(only) +(only) m T normal group 4 not obvious model group 8 5 3 0 0 0 Composition A group of the present invention 8 0 0 3 5 5.83 2.71 Composition B group of the present invention 8 0 0 5 3 4.94 2.28 povidone iodine group 8 0 0 4 4 5.43 2.38

                                  表2-2   组别   N(只)                        黏膜增生   #(只)   +++(只)   ++(只)   +(只)   M   T   正常组   4                         不明显   模型组   8   6   2   0   0   0  本发明组合物A组   8   0   0   4   4   5.43   2.38  本发明组合物B组   8   0   0   6   2   4.47   2.43  聚维酮碘组   8   0   0   3   5   5.83   2.71 Table 2-2 group N (only) mucosal hyperplasia #(Only) +++(only) ++(only) +(only) m T normal group 4 not obvious model group 8 6 2 0 0 0 Composition A group of the present invention 8 0 0 4 4 5.43 2.38 Composition B group of the present invention 8 0 0 6 2 4.47 2.43 povidone iodine group 8 0 0 3 5 5.83 2.71

                                    表2-3   组别   N(只)                           水肿   #(只)   +++(只)   ++(只)   +(只) M T   正常组   4                          不明显   模型组   8   4   4   0   0   0   本发明组合物A组   8   0   0   3   5   5.83   2.71   本发明组合物B组   8   0   0   4   4   5.43   2.38   聚维酮碘组   8   0   0   4   4   5.43   2.38 Table 2-3 group N (only) edema #(Only) +++(only) ++(only) +(only) m T normal group 4 not obvious model group 8 4 4 0 0 0 Composition A group of the present invention 8 0 0 3 5 5.83 2.71 Composition B group of the present invention 8 0 0 4 4 5.43 2.38 povidone iodine group 8 0 0 4 4 5.43 2.38

注:M为等级指数,正值说明形态学指示好于模型组,数值越大,形态学越好。T为与模型组进行t检验的值,T0.05=1.98。+表示偶见少量白细胞浸润,黏膜红肿充血,轻微水肿;++表示有少量炎症浸出液,黏膜轻微增生,有水肿;+++表示有炎症浸出液渗出明显,黏膜增生明显,有明显水肿;#表示炎症浸出液严重渗出,黏膜严重增生,严重水肿。Note: M is grade index, a positive value indicates that the morphology indicator is better than the model group, and the larger the value, the better the morphology. T is the value of the t test with the model group, T 0.05 =1.98. + means occasionally a small amount of white blood cell infiltration, mucous membrane redness, swelling and congestion, and slight edema; ++ means a small amount of inflammatory leachate, slight hyperplasia of mucosa, and edema; +++ means obvious exudation of inflammatory leachate, obvious mucosal hyperplasia, and obvious edema; # Indicates severe exudation of inflammatory leachate, severe mucosal hyperplasia, and severe edema.

结果如表2所示,本发明组合物能对多种细菌混合感染所致家兔阴道炎的阴道黏膜病变有明显的保护作用,能有效治疗阴道炎,其疗效与聚维酮碘相当。The results are shown in Table 2, the composition of the present invention can have obvious protective effect on the vaginal mucosal lesion of rabbit vaginitis caused by mixed bacterial infection, can effectively treat vaginitis, and its curative effect is equivalent to that of povidone-iodine.

综上所述,本发明组合物能杀灭多种阴道致病菌,并治疗多种细菌混合感染造成的实验性阴道炎。In summary, the composition of the invention can kill various vaginal pathogenic bacteria and treat experimental vaginitis caused by mixed infection of various bacteria.

具体实施方式Detailed ways

例1(洗剂)Example 1 (lotion)

1、本发明药物组合物:莪术油0.5g、猪去氧胆酸20g1. The pharmaceutical composition of the present invention: turmeric oil 0.5g, hyodeoxycholic acid 20g

2、洗剂的制备:取70ml去离子水,加入猪去氧胆酸,滴加10%氢氧化钠溶液约20ml使猪去氧胆酸溶解,过滤,得猪去氧胆酸水溶液;取莪术油与2g吐温80混合,加入猪去氧胆酸水溶液中,用去离子水调整重量至100g,混匀,即得。外用,每次取本品1~10ml,加入1000ml清水稀释后,抹洗或坐浴。2. Preparation of lotion: take 70ml of deionized water, add hyodeoxycholic acid, add about 20ml of 10% sodium hydroxide solution dropwise to dissolve hyodeoxycholic acid, filter to obtain hyodeoxycholic acid aqueous solution; take turmeric oil and 2g Mix with Tween 80, add to hyodeoxycholic acid aqueous solution, adjust the weight to 100g with deionized water, mix well, and obtain. For external use, take 1-10ml of this product each time, add 1000ml of water to dilute, and then wipe clean or take a hip bath.

例2(洗剂)Example 2 (lotion)

1、本发明药物组合物:莪术油4g、猪去氧胆酸2g。1. The pharmaceutical composition of the present invention: turmeric oil 4g, hyodeoxycholic acid 2g.

2、洗剂的制备:取70ml去离子水,加入猪去氧胆酸,滴加10%氢氧化钠溶液约2ml使猪去氧胆酸溶解,过滤,得猪去氧胆酸水溶液;取莪术油与8g吐温80混合,加入猪去氧胆酸水溶液中,用去离子水调整重量至100g,混匀,即得。外用,每次取本品1~10ml,加入1000ml清水稀释后,抹洗或坐浴。2. Preparation of lotion: take 70ml of deionized water, add hyodeoxycholic acid, add about 2ml of 10% sodium hydroxide solution dropwise to dissolve hyodeoxycholic acid, filter to obtain hyodeoxycholic acid aqueous solution; take turmeric oil and 8g Mix with Tween 80, add to hyodeoxycholic acid aqueous solution, adjust the weight to 100g with deionized water, mix well, and obtain. For external use, take 1-10ml of this product each time, add 1000ml of water to dilute, and then wipe clean or take a hip bath.

例3(软膏剂)Example 3 (ointment)

1、本发明药物组合物:莪术油20g、猪去氧胆酸0.5g。1. The pharmaceutical composition of the present invention: turmeric oil 20g, hyodeoxycholic acid 0.5g.

2、软膏剂的制备:取20ml去离子水,加入猪去氧胆酸,滴加10%氢氧化钠溶液约0.5ml使猪去氧胆酸溶解,过滤,得猪去氧胆酸水溶液,加入1g卡波姆,4g甘油,混匀,得水相;取莪术油与20g吐温80混合,得油相,将水相和油相混合,高速均质机乳化,用去离子水调整重量至100g,加入猪去氧胆酸水溶液中,混匀,即得。外用,每次取本品1~2g,抹于患处。2. Preparation of ointment: Take 20ml of deionized water, add hyodeoxycholic acid, add about 0.5ml of 10% sodium hydroxide solution dropwise to dissolve hyodeoxycholic acid, filter to obtain hyodeoxycholic acid aqueous solution, add 1g of carbopol Glycerin, 4g glycerin, mix well to get the water phase; take zedoary oil and mix it with 20g Tween 80 to get the oil phase, mix the water phase and the oil phase, emulsify with a high-speed homogenizer, adjust the weight to 100g with deionized water, add Hyodeoxycholic acid aqueous solution, mixing, that is. For external use, take 1-2g of this product each time and apply it to the affected area.

例4(软膏剂)Example 4 (ointment)

1、本发明药物组合物:莪术油10g、猪去氧胆酸2g。1. The pharmaceutical composition of the present invention: turmeric oil 10g, hyodeoxycholic acid 2g.

2、软膏剂的制备:取20ml去离子水,加入猪去氧胆酸,滴加10%氢氧化钠溶液约2ml使猪去氧胆酸溶解,过滤,得猪去氧胆酸水溶液,加入1g卡波姆,4g甘油,混匀,得水相;取莪术油与10g吐温80混合,得油相,将水相和油相混合,高速均质机乳化,用去离子水调整重量至100g,混匀,即得。外用,每次取本品1~2g,抹于患处。2. Preparation of ointment: Take 20ml of deionized water, add hyodeoxycholic acid, add about 2ml of 10% sodium hydroxide solution dropwise to dissolve hyodeoxycholic acid, filter to obtain hyodeoxycholic acid aqueous solution, add 1g of carbomer , 4g glycerin, mix well to get the water phase; take zedoary oil and mix it with 10g Tween 80 to get the oil phase, mix the water phase and the oil phase, emulsify with a high-speed homogenizer, adjust the weight to 100g with deionized water, mix well , that is. For external use, take 1-2g of this product each time and apply it to the affected area.

例5(凝胶剂)Example 5 (Gel)

1、本发明药物组合物:莪术油4g、猪去氧胆酸2g。1. The pharmaceutical composition of the present invention: turmeric oil 4g, hyodeoxycholic acid 2g.

2、凝胶剂的制备:取80ml去离子水,加入猪去氧胆酸,滴加10%氢氧化钠溶液约2ml使猪去氧胆酸溶解,过滤,得猪去氧胆酸水溶液,加入40g Poloxamer 407,3g甲基纤维素,4g甘油,混匀,得水相;取莪术油与8g吐温80混合,得油相,将水相和油相混合,高速均质机乳化,用去离子水调整重量至100g,混匀,即得。外用,每次取本品1~2g,抹于患处。2. Preparation of the gel: Take 80ml of deionized water, add hyodeoxycholic acid, drop about 2ml of 10% sodium hydroxide solution to dissolve the hyodeoxycholic acid, filter to obtain a hyodeoxycholic acid aqueous solution, add 40g of Poloxamer 407 , 3g methyl cellulose, 4g glycerin, mix well to get the water phase; take zedoary oil and mix it with 8g Tween 80 to get the oil phase, mix the water phase and the oil phase, emulsify with a high-speed homogenizer, adjust with deionized water The weight reaches 100g, mix well, and you get it. For external use, take 1-2g of this product each time and apply it to the affected area.

例6(气雾剂)Example 6 (Aerosol)

1、本发明药物组合物:莪术油4g、猪去氧胆酸2g。1. The pharmaceutical composition of the present invention: turmeric oil 4g, hyodeoxycholic acid 2g.

2、泡沫剂的制备:取20ml乙醇,加入猪去氧胆酸,使猪去氧胆酸溶解,过滤,得猪去氧胆酸乙醇溶液,加入苯甲醇5g,莪术油4g,吐温808g,甘油4g,三乙醇胺1g、硬脂酸2g和平平加O10g,混匀,高速均质机乳化,加蒸馏水调整至100g;与二甲醚一起灌入密封容器中,即得。外用,每次取本品1~2g,喷于患处。2. Preparation of foam agent: Take 20ml of ethanol, add hyodeoxycholic acid, dissolve hyodeoxycholic acid, filter to obtain hyodeoxycholic acid ethanol solution, add 5g of benzyl alcohol, 4g of turmeric oil, 808g of Tween, 4g of glycerin, Triethanolamine 1g, stearic acid 2g and Pingjiao 10g, mix well, emulsify with a high-speed homogenizer, add distilled water to adjust to 100g; pour it into a sealed container together with dimethyl ether, and obtain. For external use, take 1-2g of this product each time and spray it on the affected area.

例7(泡沫剂)Example 7 (foaming agent)

1、本发明药物组合物:莪术油4g、猪去氧胆酸2g。1. The pharmaceutical composition of the present invention: turmeric oil 4g, hyodeoxycholic acid 2g.

2、气雾剂的制备:取20ml乙醇,加入猪去氧胆酸,使猪去氧胆酸溶解,过滤,得猪去氧胆酸乙醇溶液,加入苯甲醇5g,莪术油4g,吐温80 8g,甘油4g,三乙醇胺1g、硬脂酸2g和平平加O 10g,混匀,高速均质机乳化,加蒸馏水调整至100g;灌入密封容器中,即得。外用,每次取本品1~2g,喷于患处。2. Preparation of aerosol: Take 20ml of ethanol, add hyodeoxycholic acid, dissolve hyodeoxycholic acid, filter to obtain hyodeoxycholic acid ethanol solution, add 5g of benzyl alcohol, 4g of zedoary oil, Tween 80 8g, glycerin 4g, 1g of triethanolamine, 2g of stearic acid, and 10g of Oxygenate, mix well, emulsify with a high-speed homogenizer, add distilled water to adjust to 100g; pour into a sealed container to obtain. For external use, take 1-2g of this product each time and spray it on the affected area.

例8(栓剂)Example 8 (suppository)

I、本发明药物组合物:莪术油4g、猪去氧胆酸2g。1, pharmaceutical composition of the present invention: turmeric oil 4g, hyodeoxycholic acid 2g.

2、栓剂的制备:取可可豆脂80g,加入猪去氧胆酸和莪术油共熔后共制成100粒栓剂。外用,每次取本品1粒,置于女性阴道中。2. Preparation of suppositories: take 80 g of cocoa butter, add hyodeoxycholic acid and zedoary oil to make 100 suppositories in total. For external use, take 1 capsule of this product each time and place it in the female vagina.

例9(泡腾片)Example 9 (Effervescent Tablets)

1、本发明药物组合物:莪术油4g、猪去氧胆酸2g。1. The pharmaceutical composition of the present invention: turmeric oil 4g, hyodeoxycholic acid 2g.

2、泡腾片的制备:取20g环糊精,加入莪术油,搅拌使环糊精包合莪术油,加入猪去氧胆酸2g,硼酸7.5g、酒石酸22.5g、碳酸氢钠30g,加入淀粉调整重量至100g,压片,每片1~2g,即得。外用,每次取本品1粒,置于女性阴道中。2. Preparation of effervescent tablets: Take 20g of cyclodextrin, add zedoary oil, stir to make cyclodextrin include zedoary oil, add 2g of hyodeoxycholic acid, 7.5g of boric acid, 22.5g of tartaric acid, 30g of sodium bicarbonate, add starch Adjust the weight to 100g, press into tablets, 1-2g per tablet, and you get it. For external use, take 1 capsule of this product each time and place it in the female vagina.

Claims (10)

1、一种杀精和治疗阴道炎的药物组合物,该组合物由活性成份和医学上可接受的辅料组成,其特征是含有以下重量百分比的活性成份:莪术油0.5~20%、猪去氧胆酸0.5~20%。1. A pharmaceutical composition for killing sperm and treating vaginitis, the composition is composed of active ingredients and medically acceptable auxiliary materials, and is characterized in that it contains the following active ingredients in weight percent: zedoary oil 0.5-20%, porcine deoxygenation Cholic acid 0.5-20%. 2、根据权利要求1所述的杀精和治疗阴道炎的药物组合物,其特征是含有以下重量百分比的活性成份:莪术油4%、猪去氧胆酸2%。2. The pharmaceutical composition for killing sperm and treating vaginitis according to claim 1, which is characterized in that it contains the following active ingredients in weight percentage: zedoary oil 4%, hyodeoxycholic acid 2%. 3、权利要求1或2所述的杀精和治疗阴道炎的药物组合物,其特征是所述的组合物是洗剂、软膏剂、凝胶剂、泡沫剂、栓剂、气雾剂或阴道泡腾片。3. The pharmaceutical composition for killing sperm and treating vaginitis according to claim 1 or 2, characterized in that the composition is lotion, ointment, gel, foam, suppository, aerosol or vaginal effervescent tablet. 4、权利要求3所述的杀精和治疗阴道炎的药物组合物,其特征是所述洗剂的辅料是吐温-80和水。4. The pharmaceutical composition for killing sperm and treating vaginitis according to claim 3, characterized in that the auxiliary materials of the lotion are Tween-80 and water. 5、权利要求3所述的杀精和治疗阴道炎的药物组合物,其特征是所述软膏剂的辅料是卡波姆、甘油和乳化剂吐温-80。5. The pharmaceutical composition for killing sperm and treating vaginitis according to claim 3, characterized in that the auxiliary materials of the ointment are carbomer, glycerin and emulsifier Tween-80. 6、权利要求3所述的杀精和治疗阴道炎的药物组合物,其特征是所述凝胶剂的辅料是Poloxamer 407、甲基纤维素、甘油和吐温-80。6. The pharmaceutical composition for killing sperm and treating vaginitis according to claim 3, characterized in that the excipients of the gel are Poloxamer 407, methylcellulose, glycerin and Tween-80. 7、权利要求3所述的杀精和治疗阴道炎的药物组合物,其特征是所述栓剂的的辅料是可可豆脂。7. The pharmaceutical composition for killing sperm and treating vaginitis according to claim 3, characterized in that the auxiliary material of the suppository is cocoa butter. 8、权利要求3所述的杀精和治疗阴道炎的药物组合物,其特征是所述气雾剂的辅料是吐温-80、甘油、苯甲醇、三乙醇胺、硬脂酸、平平加O和二甲醚。8. The pharmaceutical composition for killing sperm and treating vaginitis according to claim 3, characterized in that the auxiliary materials of the aerosol are Tween-80, glycerin, benzyl alcohol, triethanolamine, stearic acid, Pingpingjiao and dimethyl ether. 9、权利要求3所述的杀精和治疗阴道炎的药物组合物,其特征是所述阴道泡腾片的辅料是环糊精、硼酸、酒石酸和碳酸氢钠。9. The pharmaceutical composition for killing sperm and treating vaginitis according to claim 3, characterized in that the excipients of the vaginal effervescent tablet are cyclodextrin, boric acid, tartaric acid and sodium bicarbonate. 10、权利要求3所述的杀精和治疗阴道炎的药物组合物,其特征是所述泡沫剂的辅料是吐温-80、甘油、苯甲醇、三乙醇胺、硬脂酸和平平加O。10. The pharmaceutical composition for killing sperm and treating vaginitis according to claim 3, characterized in that the excipients of the foaming agent are Tween-80, glycerin, benzyl alcohol, triethanolamine, stearic acid and Pingjiao O.
CNA2007100281791A 2007-05-25 2007-05-25 A pharmaceutical composition for killing sperm and treating vaginitis Pending CN101066409A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102614124A (en) * 2012-04-12 2012-08-01 石家庄诺利达医疗器械有限公司 Vaginal sterilizing foaming agent and preparation method thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102614124A (en) * 2012-04-12 2012-08-01 石家庄诺利达医疗器械有限公司 Vaginal sterilizing foaming agent and preparation method thereof
CN102614124B (en) * 2012-04-12 2013-08-21 石家庄诺利达医疗器械有限公司 Vaginal sterilizing foaming agent and preparation method thereof

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