CN114869906A - 一种透析浓缩物及其制备及质量检测方法 - Google Patents
一种透析浓缩物及其制备及质量检测方法 Download PDFInfo
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- 238000000502 dialysis Methods 0.000 title claims abstract description 59
- 239000012141 concentrate Substances 0.000 title claims abstract description 33
- 238000002360 preparation method Methods 0.000 title claims abstract description 13
- 238000001514 detection method Methods 0.000 title claims abstract description 12
- 238000002156 mixing Methods 0.000 claims abstract description 76
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims abstract description 34
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 34
- CYDQOEWLBCCFJZ-UHFFFAOYSA-N 4-(4-fluorophenyl)oxane-4-carboxylic acid Chemical compound C=1C=C(F)C=CC=1C1(C(=O)O)CCOCC1 CYDQOEWLBCCFJZ-UHFFFAOYSA-N 0.000 claims abstract description 32
- 239000001540 sodium lactate Substances 0.000 claims abstract description 32
- 229940005581 sodium lactate Drugs 0.000 claims abstract description 32
- 235000011088 sodium lactate Nutrition 0.000 claims abstract description 32
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- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 18
- 229920002177 Icodextrin Polymers 0.000 claims abstract description 18
- 239000008103 glucose Substances 0.000 claims abstract description 18
- 229940016836 icodextrin Drugs 0.000 claims abstract description 18
- 239000002357 osmotic agent Substances 0.000 claims abstract description 18
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims abstract description 18
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- 239000001110 calcium chloride Substances 0.000 claims abstract description 17
- 229910001628 calcium chloride Inorganic materials 0.000 claims abstract description 17
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- 239000011780 sodium chloride Substances 0.000 claims abstract description 17
- 229930091371 Fructose Natural products 0.000 claims abstract description 16
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims abstract description 16
- 239000005715 Fructose Substances 0.000 claims abstract description 16
- 229920000881 Modified starch Polymers 0.000 claims abstract description 16
- 239000004368 Modified starch Substances 0.000 claims abstract description 16
- 150000002337 glycosamines Chemical class 0.000 claims abstract description 16
- 235000019426 modified starch Nutrition 0.000 claims abstract description 16
- 102000004169 proteins and genes Human genes 0.000 claims abstract description 16
- 108090000623 proteins and genes Proteins 0.000 claims abstract description 16
- 150000005846 sugar alcohols Polymers 0.000 claims abstract description 16
- 239000000872 buffer Substances 0.000 claims abstract description 13
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 claims abstract description 9
- 229940001447 lactate Drugs 0.000 claims abstract description 9
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 4
- 230000003750 conditioning effect Effects 0.000 claims abstract description 4
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims abstract description 3
- LCTONWCANYUPML-UHFFFAOYSA-M Pyruvate Chemical compound CC(=O)C([O-])=O LCTONWCANYUPML-UHFFFAOYSA-M 0.000 claims abstract description 3
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims abstract description 3
- 239000001509 sodium citrate Substances 0.000 claims abstract description 3
- DAEPDZWVDSPTHF-UHFFFAOYSA-M sodium pyruvate Substances [Na+].CC(=O)C([O-])=O DAEPDZWVDSPTHF-UHFFFAOYSA-M 0.000 claims abstract description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 23
- 230000001954 sterilising effect Effects 0.000 claims description 21
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- 239000002994 raw material Substances 0.000 claims description 15
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- 239000011259 mixed solution Substances 0.000 claims description 10
- 150000003893 lactate salts Chemical class 0.000 claims description 9
- 238000000034 method Methods 0.000 claims description 8
- 238000001704 evaporation Methods 0.000 claims description 7
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- 238000002844 melting Methods 0.000 claims description 7
- 230000008018 melting Effects 0.000 claims description 7
- 239000006172 buffering agent Substances 0.000 claims description 5
- 238000004128 high performance liquid chromatography Methods 0.000 claims description 4
- 238000002347 injection Methods 0.000 claims description 3
- 239000007924 injection Substances 0.000 claims description 3
- 239000000243 solution Substances 0.000 claims description 3
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- 238000003908 quality control method Methods 0.000 claims 1
- 150000002500 ions Chemical class 0.000 abstract description 3
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- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 5
- 239000012535 impurity Substances 0.000 description 5
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- 239000000126 substance Substances 0.000 description 4
- 208000010444 Acidosis Diseases 0.000 description 2
- 206010027417 Metabolic acidosis Diseases 0.000 description 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 2
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- 239000012528 membrane Substances 0.000 description 2
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- 239000012503 blood component Substances 0.000 description 1
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- 238000000691 measurement method Methods 0.000 description 1
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- 238000006386 neutralization reaction Methods 0.000 description 1
- 231100000572 poisoning Toxicity 0.000 description 1
- 230000000607 poisoning effect Effects 0.000 description 1
- 239000001103 potassium chloride Substances 0.000 description 1
- 235000011164 potassium chloride Nutrition 0.000 description 1
- 208000007645 potassium deficiency Diseases 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
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Abstract
本发明提供了一种透析浓缩物及其制备及质量检测方法,属于透析液技术领域,所述透析浓缩物包括乳酸盐、渗透剂和缓冲剂;所述乳酸盐包括氯化钠、氯化钙、氯化镁;所述渗透剂包括葡萄糖、艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖;所述渗透剂还包括调节剂;所述缓冲剂为乳酸钠,碳酸氢盐、丙酮酸盐、柠檬酸盐中的至少一种。本发明所述的透析浓缩物采用乳酸盐、渗透剂和缓冲剂混合而成,氯化钠、氯化钙、氯化镁为透析液的离子含量,而加入的葡萄糖、艾考糊精、环糊精渗透剂,能够有助于透析液渗透,且该渗透剂对乳酸钠几乎没有干扰,确保了乳酸钠混合后的含量准确度。
Description
技术领域
本发明涉及透析浓缩物技术领域,尤其涉及一种透析浓缩物及其制备及质量检测方法。
背景技术
目前,肾病的透析方式多有腹膜透析和血液透析,腹膜透析是以腹膜为半透膜,腹膜毛细血管与透析液之间进行水和溶质的交换,电解质及小分子物质从浓度高的一侧向低的一侧移动,水分子则从渗透浓度低的一侧向渗透浓度高的一侧移动。通过溶质浓度梯度差可使血液中尿毒物质从透析液中清除,并维持电解质及酸碱平衡,代替了肾脏的部分功能,常规的血液透析浓缩物最终用于患者的透析液中各种离子浓度需要根据人体血液成分进行设计,并符合治疗要求。
已有大量临床证据表明,透析液质量直接影响血液透析治疗的质量,从而影响透析患者的生活质量。因此,透析液不但要求含有合适的有效成分,而且不能含有对人体有害的物质,这些有害物质可直接进入病人体内,将会引起透析患者的一系列并发症,透析浓缩物中要含有乳酸钠,用于纠正代谢性酸中毒,用作腹膜透析液中的缓冲剂,对于缓冲剂的在透析液中的含量有要求,一般需要控制,放置过量引起碱中毒,而如果含量达不到要求,纠正代谢性酸中毒效果不佳,而透析液采用多种原料混合的时候,可能会收到其他成分的影响导致乳酸钠的含量发生变化,从而一种混合稳定性高的可用于调节酸碱平衡度的透析浓缩物及其制备及质量检测方法十分重要。
发明内容
针对现有技术存在的上述问题,本发明提供了一种透析浓缩物及其制备及质量检测方法。
本发明的技术方案如下:
一种透析浓缩物,包括乳酸盐、渗透剂和缓冲剂;
所述乳酸盐包括氯化钠、氯化钙、氯化镁;
所述渗透剂包括葡萄糖、艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖;
所述渗透剂还包括调节剂;
所述缓冲剂为乳酸钠,碳酸氢盐、丙酮酸盐、柠檬酸盐中的至少一种;
所述的透析浓缩物的制备方法的具体步骤如下:
S1、取混合量杯和混合容器,首先利用纯水将量杯和混合容器内外壁重新干净,然后依次通过高温蒸发消毒、高压灭菌、最后经过紫外线灭菌;
S2、将氯化钠、氯化钙、氯化镁、缓冲剂、葡萄糖分别倒入步骤S1处理过后的量杯,且分别加入透析用的纯水搅拌融化,然后将各量杯中的原料导入混合容器中混合均匀;
S3、另准备混合量杯和混合容器,进行步骤S1的清洗灭菌操作;
S4、将艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖、调节剂倒入量杯中,然后量取定量的原料导入混合容器中,向混合容器中加入透析用的纯水搅拌均匀;
S5、将步骤S2和步骤S4中的混合溶液混合在一起支撑透析液。
优选的,其特征在于,所述调节剂为氨丁三醇。
优选的,所述浓缩物的各组分含量如下:
优选的,将各组分按如下配比进行混合:
优选的,在混合完成后利用紫外线对混合液进行灭菌。
优选的,在步骤S2和步骤S4中混合后的药液,利用药液泵,使药液分别经5μm、0.45μm滤芯,进行过滤处理,并放入透析袋中保存。
本发明还提供了所述的透析浓缩物的质量检测方法,采用高效液相色谱法测定乳酸钠含量。
进一步地,透析浓缩物的质量检测方法所述采用惠普1050型高效液相色谱仪,色谱柱为ODSC18,检测波长为212nm,进样量为20μL,流速为1.0ml/min,柱温为28度。
本发明有益的技术效果在于:
透析浓缩物,采用乳酸盐、渗透剂和缓冲剂混合而成,氯化钠、氯化钙、氯化镁为透析液的离子含量,而加入的葡萄糖、艾考糊精、环糊精渗透剂,能够有助于透析液渗透,且该渗透剂对乳酸钠几乎没有干扰,确保了乳酸钠混合后的含量准确度。
另外渗透剂还可以采用葡萄糖、艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖,均不会与乳酸钠产生反应,确保乳酸钠加入混合前后的含量稳定。
本发明提供的透析浓缩物的质量检测方法操作简便,快速,测量的准确度高,受到外界的检查影响低,测量的混合后的乳酸钠的含量准确可靠。
具体实施方式
下面结合实施例,对本发明进行具体描述。显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1:
一种透析浓缩物,包括乳酸盐、渗透剂,所述乳酸盐包括氯化钠、氯化钙、氯化镁;所述渗透剂包括葡萄糖、艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖,缓冲剂为乳酸钠,调节剂为氨丁三醇;
制备方法按照以下组分进行混合形成透析液:
具体步骤如下:
S1、取混合量杯和混合容器,首先利用纯水将量杯和混合容器内外壁重新干净,然后依次通过高温蒸发消毒、高压灭菌、最后经过紫外线灭菌;
S2、将氯化钠、氯化钙、氯化镁、乳酸钠、葡萄糖分别倒入步骤S1处理过后的量杯,且分别加入透析用的纯水搅拌融化,然后将各量杯中的原料导入混合容器中混合均匀;
S3、另准备混合量杯和混合容器,进行步骤S1的清洗灭菌操作;
S4、将艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖、氨丁三醇倒入量杯中,然后量取定量的原料导入混合容器中,向混合容器中加入透析用的纯水搅拌均匀;
S5、将步骤S2和步骤S4中的混合溶液混合在一起支撑透析液。
其中在具体的实施的时候,为了去除杂质,在步骤S2和步骤S4中混合后的药液,利用药液泵,使药液分别经5μm、0.45μm滤芯,进行过滤处理,并放入透析袋中保存。
实施例2:
针对缺钾的患者还可以加入氯化钾,包括一种透析浓缩物,包括乳酸盐、渗透剂,所述乳酸盐包括氯化钠、氯化钙、氯化镁;所述渗透剂包括葡萄糖、艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖,缓冲剂为乳酸钠,调节剂为氨丁三醇;
制备方法按照以下组分进行混合形成透析液:
具体步骤如下:
S1、取混合量杯和混合容器,首先利用纯水将量杯和混合容器内外壁重新干净,然后依次通过高温蒸发消毒、高压灭菌、最后经过紫外线灭菌;
S2、将氯化钠、氯化钙、氯化镁、乳酸钠、葡萄糖分别倒入步骤S1处理过后的量杯,且分别加入透析用的纯水搅拌融化,然后将各量杯中的原料导入混合容器中混合均匀;
S3、另准备混合量杯和混合容器,进行步骤S1的清洗灭菌操作;
S4、将艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖、氨丁三醇倒入量杯中,然后量取定量的原料导入混合容器中,向混合容器中加入透析用的纯水搅拌均匀;
S5、将步骤S2和步骤S4中的混合溶液混合在一起支撑透析液。
其中在具体的实施的时候,为了去除杂质,在步骤S2和步骤S4中混合后的药液,利用药液泵,使药液分别经5μm、0.45μm滤芯,进行过滤处理,并放入透析袋中保存。
实施例3:
一种透析浓缩物,包括乳酸盐、渗透剂,所述乳酸盐包括氯化钠、氯化钙、氯化镁;所述渗透剂包括葡萄糖、艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖,缓冲剂为乳酸钠,调节剂为氨丁三醇;
制备方法按照以下组分进行混合形成透析液:
具体步骤如下:
S1、取混合量杯和混合容器,首先利用纯水将量杯和混合容器内外壁重新干净,然后依次通过高温蒸发消毒、高压灭菌、最后经过紫外线灭菌;
S2、将氯化钠、氯化钙、氯化镁、乳酸钠、葡萄糖分别倒入步骤S1处理过后的量杯,且分别加入透析用的纯水搅拌融化,然后将各量杯中的原料导入混合容器中混合均匀;
S3、另准备混合量杯和混合容器,进行步骤S1的清洗灭菌操作;
S4、将艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖、氨丁三醇倒入量杯中,然后量取定量的原料导入混合容器中,向混合容器中加入透析用的纯水搅拌均匀;
S5、将步骤S2和步骤S4中的混合溶液混合在一起支撑透析液。
其中在具体的实施的时候,为了去除杂质,在步骤S2和步骤S4中混合后的药液,利用药液泵,使药液分别经5μm、0.45μm滤芯,进行过滤处理,并放入透析袋中保存。
实施例4:
一种透析浓缩物,包括乳酸盐、渗透剂,所述乳酸盐包括氯化钠、氯化钙、氯化镁;所述渗透剂包括葡萄糖、艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖,缓冲剂为乳酸钠,调节剂为氨丁三醇;
制备方法按照以下组分进行混合形成透析液:
具体步骤如下:
S1、取混合量杯和混合容器,首先利用纯水将量杯和混合容器内外壁重新干净,然后依次通过高温蒸发消毒、高压灭菌、最后经过紫外线灭菌;
S2、将氯化钠、氯化钙、氯化镁、乳酸钠、葡萄糖分别倒入步骤S1处理过后的量杯,且分别加入透析用的纯水搅拌融化,然后将各量杯中的原料导入混合容器中混合均匀;
S3、另准备混合量杯和混合容器,进行步骤S1的清洗灭菌操作;
S4、将艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖、氨丁三醇倒入量杯中,然后量取定量的原料导入混合容器中,向混合容器中加入透析用的纯水搅拌均匀;
S5、将步骤S2和步骤S4中的混合溶液混合在一起支撑透析液。
其中在具体的实施的时候,为了去除杂质,在步骤S2和步骤S4中混合后的药液,利用药液泵,使药液分别经5μm、0.45μm滤芯,进行过滤处理,并放入透析袋中保存。
实施例5:
一种透析浓缩物,包括乳酸盐、渗透剂,所述乳酸盐包括氯化钠、氯化钙、氯化镁;所述渗透剂包括葡萄糖、艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖,缓冲剂为乳酸钠,调节剂为氨丁三醇;
制备方法按照以下组分进行混合形成透析液:
具体步骤如下:
S1、取混合量杯和混合容器,首先利用纯水将量杯和混合容器内外壁重新干净,然后依次通过高温蒸发消毒、高压灭菌、最后经过紫外线灭菌;
S2、将氯化钠、氯化钙、氯化镁、乳酸钠、葡萄糖分别倒入步骤S1处理过后的量杯,且分别加入透析用的纯水搅拌融化,然后将各量杯中的原料导入混合容器中混合均匀;
S3、另准备混合量杯和混合容器,进行步骤S1的清洗灭菌操作;
S4、将艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖、氨丁三醇倒入量杯中,然后量取定量的原料导入混合容器中,向混合容器中加入透析用的纯水搅拌均匀;
S5、将步骤S2和步骤S4中的混合溶液混合在一起支撑透析液。
其中在具体的实施的时候,为了去除杂质,在步骤S2和步骤S4中混合后的药液,利用药液泵,使药液分别经5μm、0.45μm滤芯,进行过滤处理,并放入透析袋中保存。
测试例:
针对实施例1-5,采用高效液相色谱法测定乳酸钠含量,具体的测量方法如下:采用惠普1050型高效液相色谱仪,色谱柱为ODSC18,检测波长为212nm,进样量为20μL,流速为1.0ml/min,柱温为28度;测量各实施例乳酸钠含量如下表1所示:
表1
加入含量 | 混合液色谱柱测量含量 | |
实施例1 | 5.32g/L | 5.315g/L |
实施例2 | 4.9g/L | 4.9g/L |
实施例3 | 5.10g/L | 5.111g/L |
实施例4 | 4.88g/L | 4.9g/L |
实施例5 | 5.11g/L | 5.10g/L |
由上表可知,本专利的实施方式,乳酸钠含量受其他成分干扰低,加入前的含量和混合后的透析液的乳酸钠含量受其他成分影响第,使得最后混合而成的透析液的乳酸钠精度高,提高了酸碱平衡准确度,有效的避免了,实际加入乳酸钠,由于其他组分干扰,导致最后混合液中的乳酸钠含量发生较大变化,确保了再测得病人的血液酸碱度后,加入乳酸钠酸碱中和的准确度。
尽管本发明的实施方案已公开如上,但其并不仅仅限于说明书和实施方式中所列运用,它完全可以被适用于各种适合本发明的领域,对于熟悉本领域的人员而言,对于本领域的普通技术人员而言,在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型,因此在不背离权利要求及等同范围所限定的一般概念下,本发明并不限于特定的细节。
Claims (8)
1.一种透析浓缩物,其特征在于,包括乳酸盐、渗透剂和缓冲剂;
所述乳酸盐包括氯化钠、氯化钙、氯化镁;
所述渗透剂包括葡萄糖、艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖;
所述渗透剂还包括调节剂;
所述缓冲剂为乳酸钠,碳酸氢盐、丙酮酸盐、柠檬酸盐中的至少一种;
所述的透析浓缩物的制备方法的具体步骤如下:
S1、取混合量杯和混合容器,首先利用纯水将量杯和混合容器内外壁重新干净,然后依次通过高温蒸发消毒、高压灭菌、最后经过紫外线灭菌;
S2、将氯化钠、氯化钙、氯化镁、缓冲剂、葡萄糖分别倒入步骤S1处理过后的量杯,且分别加入透析用的纯水搅拌融化,然后将各量杯中的原料导入混合容器中混合均匀;
S3、另准备混合量杯和混合容器,进行步骤S1的清洗灭菌操作;
S4、将艾考糊精、环糊精、改性淀粉、多元醇、果糖、蛋白质、氨基糖、调节剂倒入量杯中,然后量取定量的原料导入混合容器中,向混合容器中加入透析用的纯水搅拌均匀;
S5、将步骤S2和步骤S4中的混合溶液混合在一起支撑透析液。
2.根据权利要求1所述的透析浓缩物,其特征在于,所述调节剂为氨丁三醇。
5.根据权利要求1所述的透析浓缩物,其特征在于,在混合完成后利用紫外线对混合液进行灭菌。
6.根据权利要求1所述的透析浓缩物,其特征在于,在步骤S2和步骤S4中混合后的药液,利用药液泵,使药液分别经5μm、0.45μm滤芯,进行过滤处理,并放入透析袋中保存。
7.一种权利要求1所述的透析浓缩物的质量检测方法,其特征在于,采用高效液相色谱法测定乳酸钠含量。
8.根据权利要求1所述的透析浓缩物的质量检测方法,其特征在于,采用惠普1050型高效液相色谱仪,色谱柱为ODSC18,检测波长为212nm,进样量为20μL,流速为1.0ml/min,柱温为28度。
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