CN1089843A - 抗乙肝胎盘转移因子的制备方法 - Google Patents
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Abstract
本发明是以乙型肝炎病毒标志物抗原体阳性和
抗原阴性、抗体阳性胎盘为原料，通过研磨、加氯化钠
溶液、二步灭活(56℃加热5—15小时，加甲醛)、过
滤、超滤等步骤制备抗乙型肝炎胎盘特异性转移因子
注射液的方法。用该方法制得的制剂不仅具有非特
异免疫活性，而且对乙肝病毒尚有明确特异免疫活
性，长期使用无任何毒副反应，对治疗多种肝病均有
较好效果。
Description
本发明涉及一种抗乙肝胎盘转移因子的制备方法。
现在已知急慢性乙型肝炎患者均存在细胞免疫功能低下现象，因而急性乙肝炎患者病后少数不能顺利清除体内病毒，转为慢性;慢性肝炎（慢性迁延型、慢性活动型、慢活肝体早期肝硬变和肝硬变）则因免疫功能低下，体内长期存在乙肝病毒，肝组织不断受到免疫反应破坏，由慢性肝炎缓慢转入早期肝硬变，再转为肝硬变，甚至在肝硬变基础上再出现肝细胞癌变。因此，试用免疫调节剂提高病体免疫功能，特别是细胞免疫功能，促进肝内病变恢复和血内乙肝病毒阴转，是70年代后探讨重点。在现有的各种免疫调节剂中，虽多可证明对人体具有程度不一的非特异免疫活性，但并不能证明对乙肝病毒具有明确的特异免疫活性，因而治疗效果亦较差。因此，治疗乙肝病毒感染的特异性免调节剂一直是近年研究探讨的重点。
转移因子是免疫调节剂之一，自50年代初提出到现在，国外仍以人体的细胞，特别是淋巴细胞为提取原材料，由于材料难得，价格昂贵，特别缺乏对乙肝病毒明确特异活性，结果限制了推广使用。试用大动物相应器官组织，作原材料或先给抗原注射致敏，制备普通转移因子（非特异性）或特异性转移因子，除同样存在上述缺点外，尚有人畜有别问题。近年国内虽有一些有关从胎盘中提取转移因子的报道，如：郭金刚等著《胎盘转移因子的提取、理化性法及临床应用》（江苏省金县科技委员会资料1984/10），刘月新等著《一种新的免疫调节剂-胎盘因子的制备与研究》（中国免疫学杂志1985，1（5）），但他们所用胎盘均为普通胎盘，缺乏对乙肝病毒明确特异免疫活性。
本发明的目的是研制一种以乙肝病毒感染臻敏的胎盘为原料，用经过改进的提取转移因子注射液的方法，克服上述不足之处，制备抗乙肝特异性转移因子。
本发明的目的是这样实现的：选用乙型肝炎病毒标志物抗原、抗体阳性或抗原阴性、抗体阳性胎盘为原料，将胎盘剪成小块，反复冻融3-5次，加入适量的蒸馏水，将其磨碎;再加入氯化钠溶液，使其在胎盘浆中的浓度为0.9%（重量比），搅匀，向匀浆内加入36%甲醛，使匀浆内含甲醛浓度为0.125%（体积比），置56℃水浴5-15小时，并不断搅拌;将匀浆离心后取上清液以NaOH调整PH值为6.8～7.0，再静置35-40℃孵箱内100小时以上;将上述液体过滤、超滤后即成抗乙肝胎盘特异性转移因子注射液。
本发明原料易得，制备工艺亦不太复杂，实验证明除非特异免疫活性外，对乙肝病毒尚有明确特异性免疫活性，治疗效果较好，无任何毒剂反应。
下面结合实施例对本发明作进一步说明。
取出乙型肝炎病毒标志物抗原、抗体阳性的胎盘（或抗原阴性、抗体阳性胎盘）将其洗净，切成小碎块，反复冻融3次;置于胶体磨内（或高速捣碎机内），加胎盘相等重量蒸馏水，反复研磨（捣碎）3次;加入3倍胎盘重量1.2%氯化钠溶液，搅匀，使匀浆内含氯化钠0.9%（重量比），胎盘组织与水的重量比为1∶4;加入36%甲醛，使匀浆内含甲醛浓度为0.125%（V/V），混匀后，置56℃水浴5小时，并不断搅拌使温度均匀;匀浆经3000vpm离心20分钟，取出上清液用NaOH调整PH为6.8～7.0，再静置35℃孵箱内100小时;然后用西氏滤器、甲3除菌板过滤，G6耐酸滤过漏斗除菌过滤，再用截面分子量10000道而顿超滤膜超滤，即成抗乙肝胎盘特异性转移因子注射液。
Claims (2)
1、一种抗乙型肝炎胎盘特异性转移因子注射液的制备方法，其特征是：选用乙型肝炎病毒标志物抗原抗体阳性或抗原阴性抗体阳性胎盘为制备原料。
2、根据权利要求1所述的使用乙肝病毒感染致敏的胎盘为原料，制备抗乙型肝炎胎盘特异性转移因子注射液的方法，其特征是，它包括以下步骤：
a.取乙肝病毒感染致敏的胎盘，将其剪成小块，反复冻融3～5次;
b.在胎盘中加入适量的蒸馏水，将其磨碎;
c.加入氯化钠溶液，使匀浆内氯化钠浓度为0.9%（重量比）;
d.向浆内加入36%甲醛，使匀浆内含甲醛浓度为0.125%（体积比）;
e.将匀浆置于56℃水浴5-15小时，并不断搅拌;
f.将匀浆离心，取离心后的上清液以NaOH调整PH值为6.8～7.0;
g.将上述液体静置于35℃-40℃孵箱内100小时以上;
h.将上述液体进行过滤和超滤。
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| CN93100357A CN1049119C (zh) | 1993-01-19 | 1993-01-19 | 抗乙肝胎盘转移因子注射液的制备方法 |
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| CN1089843A true CN1089843A (zh) | 1994-07-27 |
| CN1049119C CN1049119C (zh) | 2000-02-09 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103463131A (zh) * | 2013-09-23 | 2013-12-25 | 河南牧翔动物药业有限公司 | 一种羊胎盘转移因子溶液的制备方法 |
| TWI669157B (zh) * | 2016-11-06 | 2019-08-21 | 微邦科技股份有限公司 | 微結構噴嘴 |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1299763C (zh) * | 2003-07-31 | 2007-02-14 | 张光曙 | 抗乙肝人体胎盘转移因子粉针剂的制备方法 |
| CN100406058C (zh) * | 2006-04-28 | 2008-07-30 | 北京大学人民医院 | 一种胎盘因子及其制备方法与应用 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1022462C (zh) * | 1990-03-31 | 1993-10-20 | 王鸿鸣 | 激活增生t细胞制剂的制备工艺 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103463131A (zh) * | 2013-09-23 | 2013-12-25 | 河南牧翔动物药业有限公司 | 一种羊胎盘转移因子溶液的制备方法 |
| CN103463131B (zh) * | 2013-09-23 | 2015-09-30 | 河南牧翔动物药业有限公司 | 一种羊胎盘转移因子溶液的制备方法 |
| TWI669157B (zh) * | 2016-11-06 | 2019-08-21 | 微邦科技股份有限公司 | 微結構噴嘴 |
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