CN1099465C - 自然避孕检测排卵试剂盒及制作方法 - Google Patents
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Abstract
本发明涉及一种自然避孕检测排卵周期的试剂盒及制作方法,其特征在于试剂盒由1-10%浓度的联苯胺类化合物和稳定剂组成的试剂A和1-10%浓度的过氧化氢溶液的试剂B,棉签和量杯组成,该试剂盒具有检测方便,快速,准确率高,稳定性好,无任何痛苦,无副作用,用于育龄妇女的自然避孕,也适合哺乳动物的排卵周期。
Description
本发明涉及一种自然避孕检测排卵试剂盒,用于育龄妇女自检排卵周期,以达到自然避孕和受孕,也适用哺乳动物排卵周期检测。
本发明还涉及该试剂盒的制作方法。
目前育龄妇女的避孕方法,主要是使用节育环,也有服用避孕药,或外用药环或置入阴道隔膜,这些方法,虽然能达到避孕的目的,但是使用不方便,有时还会给使用者带来不同程度的痛苦,适用性差;也有通过测定体温方法,掌握温度变化与排卵周期的关系,这种方法,除了麻烦,而且准确率低,不易掌握,近20年来,国内外许多专家研究宫颈粘液中过氧化物酶在月经周期的变化与排卵的关系,并在实验室内进行理论方面的探讨研究,这种方法是取宫颈粘液样品,取样较困难,需医生用扩阴器协助取样,而不能自取宫颈粘液,同时宫颈粘液中的过氧化物酶的含量在排卵期与非排卵期的临界点不明晰,不易掌握排卵规律,因此目前尚未能广泛应用推广。
本发明的目的正是为了克服上述已有技术的缺点与不足,根据阴道分泌物中过氧化物酶的含量变化与排卵周期呈相关性的规律,利用过氧化物酶与试剂反应发生颜色变化的原理,而提供一种自然避孕检测排卵试剂盒,用于育龄妇女的自然避孕和选择受孕时机,可自控自检。
本发明的目的是通过下列技术方案实现的:
本发明的试剂盒以检测阴道分泌物中过氧化物酶的含量,阴道分泌物中过氧化物酶的含量临界点为25×10-3-25×10-5u/ml,根据试剂反应颜色的变化为判定排卵周期,在月经周期中颜色变化呈曲线型为有排卵,如月经周期为28-29天,为一周期时,以下列图示进行说明:即月经周期的检测结果:△△△△△△ ×××× ××××××××××××月经期 安全期 ○○○○○○○ 安全期
排卵期
图中△表示月经天数,×表示试剂显色天数,即安全期,○表示试剂为不变色天数,即排卵期。
从图中检测结果表明,颜色显色为安全期,在该期间行房事无妨。颜色不变为排卵期,该时期持续为5-7天左右定为排卵期,宜禁房事,一般是在见到不变色的第4、第5天为排卵日。
在月经周期中,全月测试试剂均显色,即为无排卵妇女,说明卵泡发育不成熟。
在月经周期中,全月测试试剂不变色,即为无排卵妇女,说明卵泡不发育。
上述两种情况检测均为无排卵,都为安全期,行房事无妨。
试剂盒的具体的使用方法:
将试剂A和试剂B按10-20∶1混合液装入量杯中,然后用棉签卷取阴道分泌物,放入已配好试剂的量杯中观察颜色,试剂不变色即为排卵期,显色为安全期。
本发明的试剂进行灵敏度、稳定性,临床试验,其结果分述如下:
a)灵敏度试验
试验(1)用四甲基联苯胺简称为TMB,按5%浓度配制溶液再加入1%浓度的苯甲酸钠溶液制备的试剂A,用过氧化氢(H2O2)配制2%浓度制备试剂B,取试剂A1ml加入试剂B0.5ml作平衡样品三份,加入已配好的25×10-3u/ml的过氧化物酶标准液50ul,另三份空白对照,观察试验结果,见表1。
表1项目名称 试验样 空白样
1 2 3 1 2 3试剂A(TMB)+试剂B(H2O2) A+B A+B A+B A+B A+B A+B反应时间(秒) 15 15 15 15 15 15颜色显示 蓝色 蓝色 蓝色 无色 无色 无色灵敏度% 100% 100% 100% 100% 100% 100%
试验(2)用3-氨基-9-乙基咔唑,简称AEC,按2%浓度配制溶液加入1%浓度的苯甲酸钠溶液制备试剂A,用过氧化氢(H2O2)配制2%浓度制备试剂B,取试剂A1ml加入试剂B0.5ml,按试验(1)方法进行观察,其结果见表2。
表2项目名称 试验样 空白样
1 2 3 1 2 3试剂A(TMB)+试剂B(H2O2) A+B A+B A+B A+B A+B A+B反应时间(秒) 30 30 30 30 30 30颜色显示 红色 红色 红色 *黄色 *黄色 *黄色灵敏度% 100% 100% 100% 100% 100% 100%
*空白试验显示黄色,即为无反应,为试剂本色。
从表1、2实验结果表明,当灵敏度在15-30秒内达100%
b)稳定性试验,以四甲基联苯胺为试剂A,按5%浓度配制,与以四甲基联苯胺为试剂A按5%浓度配制再加1%浓度的苯甲酸钠进行存放6-30个月对比测定灵敏度,其结果如下:见表3
表3试剂A组成 有效时间 灵敏度%TMB 6个月 100%TMB 6个月-12个月 50%TMB+苯甲酸钠 24个月-30个月 100%
试验结果表明,试验A加了苯甲酸钠,增加稳定性,由原来的6个月提高到24个月以上。
c)临床试验:
在全国六家医院进行临床使用,经过二年以上的使用,其结果如下:
见表4
表4医院名称 检测排卵(人次) 符合率% 自然避孕 成功率北京妇产医院 34 100% 66 100%北京医院 0 0 50 100%南京医大二附院 40 100% 10 100%济南市妇幼保健院 30 94% 20 100%无锡市第五人民医院 75 100% 25 100%无锡市第四人民医院 35 100% 15 100%总计 241 98.8% 186 100%临床结果表明,214例检测排卵,准确率达98.8%。
186例用于安全期避孕,均未采取任何避孕措施,连续使用半年至2年以上,按规定操作,未发生一例妊娠,自然避孕成功率达100%。
本发明与已有技术相比具有如下优点及效果。
a)本发明的试剂通过阴道分泌物过氧化物酶含量,进行自检排卵周期,方法简便,快速无痛苦,无副作用;
b)产品稳定性好,灵敏度高,使用效果好,安全可靠;
c)制作方法简单,原料易得,成本低,易推广,易工业化生产。
实施例1:
将四甲基联苯胺5kg加入95kg医用水配制成5%浓度溶液再加入1%浓度的苯甲酸钠溶液1kg,混合以10次/min转数搅拌1.0小时后,静置8小时,去沉淀,取上清,按15ml/每瓶装灌装,制成试剂A,将过氧化氢1kg加入99kg医用水,制成1%浓度溶液,以15次/min转速搅拌1小时后静置6小时,去沉淀取上清,按2ml/每瓶灌装,制成试剂B,然后将试剂A、试剂B按用量配比10∶1取A、B试剂瓶数,棉签和量杯装入盒内,即制成试剂盒产品。
实施例2:
将3-氨基-9-乙基咔唑1kg加入99kg医用水配制成1%浓度溶液再加入1.5%浓度的苯甲酸钠溶液1.5kg,混合以12次/min转数搅拌0.8小时后,静置9小时,去沉淀,取上清,按30ml/每瓶装灌装,制成试剂A,将过氧化氢5kg加入95kg医用水,制成5%浓度溶液,以12次/min转速搅拌0.8小时后静置7小时,去沉淀取上清,按2ml/每瓶灌装,制成试剂B,然后将试剂A、试剂B按用量配比15∶1取A、B试剂瓶数,棉签和量杯装入盒内,即制成试剂盒产品。
实施例3:
将4-甲氧基-α-萘酚10kg加入90kg医用水配制成10%浓度溶液再加入2%浓度的苯甲酸钠溶液2kg,混合以15次/min转数搅拌0.5小时后,静置10小时,去沉淀,取上清,按5ml/每瓶装灌装,制成试剂A,将过氧化氢10kg加入90kg医用水,制成10%浓度溶液,以7次/min转速搅拌0.5小时后静置8小时,去沉淀取上清,按2ml/每瓶灌装,制成试剂B,然后将试剂A、试剂B按用量配比20∶1取A、B试剂瓶数,棉签和量杯装入盒内,即制成试剂盒产品。
Claims (4)
1、自然避孕检测排卵试剂盒,它由试剂A、试剂B、量杯和棉签组成,其特征在于试剂A由化学纯3-氨基-9-乙基咔唑或4-甲氧基-2-萘酚配制成1-10%浓度的溶液和化学纯苯甲钠配制的1-2%浓度的溶液组成,其配比为100∶1-2,试剂B为化学纯过氧化氢配制的1-10%浓度的溶液,试剂A与试剂B两者用量比为10-20∶1。
2、根据权利要求1所述的试剂盒,其特征在于所述的3-氨基-9-乙基咔唑或4-甲氧基-2-萘酚化合物也可以是二氨基联苯胺,四甲基联苯胺,盐酸联苯胺其中的任意一种化合物。
3、根据权利要求1所述的试剂盒,其特征在于所述的3-氨基-9-乙基咔唑或4-甲氧基-2-萘酚化合物也可用邻苯二胺、邻联甲苯胺,联大茴香胺、5-氨基水杨酸、2.2-连氮-双[3-乙基苯并噻唑啉-6-磺胺盐]、邻苯三酚、邻甲氧基苯酚其中的任意一种化合物。
4、权利要求1所述试剂盒的制作方法,其特征在于它按下述步骤进行:
a)试剂A的制备,将化学纯3-氨基-9-乙基咔唑或4-甲氧基-2-萘酚化合物用医用水配成1-10%浓度的溶液,将化学纯苯甲酸钠用医用水配制成1-2%浓度的溶液,再将上述两种溶液按重量比100∶1-2比例混合,加入搅拌机内以10-15次/min转速搅拌0.5-1.0小时后静置8-10小时,去沉淀取上清液,即为试剂A产品;
b)试剂B的制备:将化学纯过氧化氢用医用水配成1-10%浓度的溶液,以10-15次/min转速搅拌0.5-1.0小时后静置6-8小时,取上清液,即为试剂B产品;
c)最后将(a)项的试剂A按每瓶5-30ml灌装和(b)项的试剂B按每瓶2-5ml灌装,再配装棉签和量杯装入包装盒,即为本发明的试剂盒。
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
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CN99118909A CN1099465C (zh) | 1999-08-25 | 1999-08-25 | 自然避孕检测排卵试剂盒及制作方法 |
AU62581/00A AU6258100A (en) | 1999-08-25 | 2000-08-08 | Ovulation detecting agents and the use thereof |
PCT/CN2000/000226 WO2001013799A1 (fr) | 1999-08-25 | 2000-08-08 | Agents de detection de l'ovulation et leur utilisation |
US09/644,676 US6827691B1 (en) | 1999-08-25 | 2000-08-24 | Ovulation-period-detecting reagents and the use thereof |
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CN99118909A CN1099465C (zh) | 1999-08-25 | 1999-08-25 | 自然避孕检测排卵试剂盒及制作方法 |
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CN1247900A CN1247900A (zh) | 2000-03-22 |
CN1099465C true CN1099465C (zh) | 2003-01-22 |
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CN99118909A Expired - Fee Related CN1099465C (zh) | 1999-08-25 | 1999-08-25 | 自然避孕检测排卵试剂盒及制作方法 |
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US (1) | US6827691B1 (zh) |
CN (1) | CN1099465C (zh) |
AU (1) | AU6258100A (zh) |
WO (1) | WO2001013799A1 (zh) |
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CN2266992Y (zh) * | 1996-09-10 | 1997-11-12 | 黄蕴 | 预测排卵试剂盒 |
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US3406015A (en) * | 1965-02-01 | 1968-10-15 | Raymond O. Foster | Means for detecting the fertile period |
US3472738A (en) * | 1967-06-12 | 1969-10-14 | Weston Lab Inc | Test implement for detecting peroxidase |
WO1980002596A1 (en) * | 1979-05-16 | 1980-11-27 | G Oster | Impending ovulation test |
US4614715A (en) * | 1982-05-14 | 1986-09-30 | The Board Of Trustees Of The University Of Illinois | Predictive test for impending ovulation in mammals |
FR2652092A1 (fr) * | 1989-09-15 | 1991-03-22 | Fama | Procede de mesure de l'activite peroxydase de la glaire cervicale. |
FR2677126B1 (fr) * | 1991-05-27 | 1994-06-03 | Fama Sa | Reactif pour mesurer l'activite peroxydasique de la glaire cervicale, dispositif de mise en óoeuvre de ce reactif et procede de realisation. |
JP3155685B2 (ja) * | 1995-07-20 | 2001-04-16 | 財団法人山形県企業振興公社 | ペルオキシダーゼの測定方法 |
US5620658A (en) * | 1995-09-11 | 1997-04-15 | Industrial Test Systems, Inc. | Colorimetric test strip |
CN1152713A (zh) * | 1995-10-24 | 1997-06-25 | 彭晓虹 | 自然法避孕检测排卵试剂盒 |
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1999
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2000
- 2000-08-08 WO PCT/CN2000/000226 patent/WO2001013799A1/zh active Application Filing
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CN2266992Y (zh) * | 1996-09-10 | 1997-11-12 | 黄蕴 | 预测排卵试剂盒 |
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WO2001013799A1 (fr) | 2001-03-01 |
US6827691B1 (en) | 2004-12-07 |
AU6258100A (en) | 2001-03-19 |
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