CN113876699A - 一种复方锌铁钙口服溶液及其制备方法 - Google Patents
一种复方锌铁钙口服溶液及其制备方法 Download PDFInfo
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- 150000001875 compounds Chemical class 0.000 title claims abstract description 50
- 238000002360 preparation method Methods 0.000 title claims abstract description 11
- 239000004376 Sucralose Substances 0.000 claims abstract description 23
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 claims abstract description 23
- 235000019408 sucralose Nutrition 0.000 claims abstract description 23
- AUNGANRZJHBGPY-UHFFFAOYSA-N D-Lyxoflavin Natural products OCC(O)C(O)C(O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-UHFFFAOYSA-N 0.000 claims abstract description 22
- AUNGANRZJHBGPY-SCRDCRAPSA-N Riboflavin Chemical compound OC[C@@H](O)[C@@H](O)[C@@H](O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-SCRDCRAPSA-N 0.000 claims abstract description 22
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- 235000013927 calcium gluconate Nutrition 0.000 claims description 22
- NEEHYRZPVYRGPP-UHFFFAOYSA-L calcium;2,3,4,5,6-pentahydroxyhexanoate Chemical compound [Ca+2].OCC(O)C(O)C(O)C(O)C([O-])=O.OCC(O)C(O)C(O)C(O)C([O-])=O NEEHYRZPVYRGPP-UHFFFAOYSA-L 0.000 claims description 22
- 239000004222 ferrous gluconate Substances 0.000 claims description 22
- 235000013924 ferrous gluconate Nutrition 0.000 claims description 22
- 229960001645 ferrous gluconate Drugs 0.000 claims description 22
- VRIVJOXICYMTAG-IYEMJOQQSA-L iron(ii) gluconate Chemical compound [Fe+2].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O VRIVJOXICYMTAG-IYEMJOQQSA-L 0.000 claims description 22
- 239000011670 zinc gluconate Substances 0.000 claims description 22
- 235000011478 zinc gluconate Nutrition 0.000 claims description 22
- 229960000306 zinc gluconate Drugs 0.000 claims description 22
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims description 21
- 239000004299 sodium benzoate Substances 0.000 claims description 21
- 235000010234 sodium benzoate Nutrition 0.000 claims description 21
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- 235000003599 food sweetener Nutrition 0.000 abstract description 6
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- 230000004060 metabolic process Effects 0.000 abstract description 3
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 abstract description 2
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- 229910052742 iron Inorganic materials 0.000 description 3
- 230000001737 promoting effect Effects 0.000 description 3
- 239000008213 purified water Substances 0.000 description 3
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
- 102000001554 Hemoglobins Human genes 0.000 description 2
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Abstract
本发明提供了一种复方锌铁钙口服溶液及其制备方法,属于医药技术领域。本发明的复方锌铁钙口服溶液中含有pH调节剂,能够保证维生素B2溶解完全,同时保证维生素B2在湿热和光照条件下不容易降解,进而使维生素B2含量稳定;同时,本发明选择使用三氯蔗糖作为甜味剂,该甜味剂为蔗糖的衍生物,甜味与蔗糖接近,安全性高,稳定性好,在体内不参与代谢,是糖尿病患者理想的甜味替代品,能够使本发明的复方锌铁钙口服溶液能够被糖尿病患者服用;本发明加入枸橼酸钠,防止在长期放置过程中会出现沉淀的问题。实施例的数据表明,本发明提供的复方锌铁钙口服溶液在60℃下放置10天后维生素B2主峰纯度大于95.0%。
Description
技术领域
本发明涉及医药技术领域,尤其涉及一种复方锌铁钙口服溶液及其制备方法。
背景技术
复方锌铁钙口服溶液用于因锌、铁、钙缺乏引起的有关疾病。
铁是红细胞中血红蛋白的组成元素。缺铁时,红细胞合成血红蛋白量减少,致使红细胞体积变小,携氧能力下降,形成缺铁性贫血。口服葡萄糖酸亚铁可补充铁元素,纠正缺铁性贫血;锌为体内许多酶的重要组成成份,具有促进生长发育、改善味觉等作用,缺乏时生长停滞、生殖无能、伤口易愈合、机体衰弱,还可发生结膜炎、口腔炎、舌炎、食欲缺乏、慢性腹泻、味觉丧失、神经症状等。口服葡萄糖酸锌可纠正之;钙可参与骨骼的形成与骨折后骨组织的再建以及肌肉收缩、神经传递、凝血机制并降低毛细血管的渗透性。口服葡萄糖酸钙可补充钙不足;维生素B2是辅酶的重要组成部分,参与糖、蛋白质、脂肪的代谢,维持正常视觉功能和促进生长,促进铁离子的吸收。
现有技术中的复方锌铁钙口服溶液在高温条件下维生素B2含量下降的问题。
发明内容
有鉴于此,本发明的目的在于提供一种复方锌铁钙口服溶液及其制备方法。本发明提供的复方锌铁钙口服溶液中维生素B2含量稳定。
为了实现上述发明目的,本发明提供以下技术方案:
本发明提供了一种复方锌铁钙口服溶液,包括以下含量的组分:
葡萄糖酸钙30~50g/L、葡萄糖酸锌1~5g/L、葡萄糖酸亚铁10~30g/L、维生素B20.1~0.5g/L、三氯蔗糖1~2g/L、苯甲酸钠0.5~2g/L、枸橼酸钠0.5~2.5g/L、香精0.5~1g/L、pH调节剂30~40g/L以及水,所述pH调节剂为盐酸溶液,所述盐酸溶液的浓度为1~3mol/L。
优选地,所述复方锌铁钙口服溶液包括以下含量的组分:
葡萄糖酸钙40g/L、葡萄糖酸锌3g/L、葡萄糖酸亚铁10g/L、维生素B20.3g/L、三氯蔗糖1.25~1.5g/L、苯甲酸钠0.5~2g/L、枸橼酸钠1~2g/L、香精0.6~0.8g/L、pH调节剂30~40g/L。
优选地,所述复方锌铁钙口服溶液包括以下含量的组分:
葡萄糖酸钙40g/L、葡萄糖酸锌3g/L、葡萄糖酸亚铁10g/L、维生素B20.3g/L、三氯蔗糖1.25g/L、苯甲酸钠0.5g/L、枸橼酸钠0.5g/L、香精0.67g/L、pH调节剂30g/L,所述盐酸水溶液的浓度为2mol/L。
优选地,所述复方锌铁钙口服溶液包括以下含量的组分:
葡萄糖酸钙40g/L、葡萄糖酸锌3g/L、葡萄糖酸亚铁10g/L、维生素B20.3g/L、三氯蔗糖1.25g/L、苯甲酸钠1g/L、枸橼酸钠1g/L、香精0.6g/L、pH调节剂35g/L,所述盐酸水溶液的浓度为2mol/L。
优选地,所述复方锌铁钙口服溶液包括以下含量的组分:
葡萄糖酸钙40g/L、葡萄糖酸锌3g/L、葡萄糖酸亚铁10g/L、维生素B20.3g/L、三氯蔗糖1.5g/L、苯甲酸钠2g/L、枸橼酸钠2.5g/L、香精0.8g/L、pH调节剂40g/L,所述盐酸水溶液的浓度为2mol/L。
优选地,所述复方锌铁钙口服溶液的pH值为3~4。
优选地,所述复方锌铁钙口服溶液的pH值为3.2~3.8。
本发明还提供了上述技术方案所述的复方锌铁钙口服溶液的制备方法,包括以下步骤:
在避光条件下,将部分pH调节剂、维生素B2与部分水进行第一混合,得到第一溶液;
将所述第一溶液与葡萄糖酸钙进行第二混合,得到第二溶液;
将所述第二溶液、葡萄糖酸锌和葡萄糖酸亚铁进行第三混合,得到第三溶液;
将所述第三溶液、三氯蔗糖、苯甲酸钠、枸橼酸钠、香精、剩余水和剩余pH调节剂进行第四混合,得到所述复方锌铁钙口服溶液。
优选地,所述第一混合的温度为70~80℃。
优选地,所述第四混合后还包括用0.8μm纤维素滤膜过滤。
本发明提供了一种复方锌铁钙口服溶液,包括以下含量的组分:葡萄糖酸钙30~50g/L、葡萄糖酸锌1~5g/L、葡萄糖酸亚铁10~30g/L、维生素B20.1~0.5g/L、三氯蔗糖1~2g/L、苯甲酸钠0.5~2g/L、枸橼酸钠0.5~2.5g/L、香精0.5~1g/L、pH调节剂30~40g/L以及水,所述pH调节剂为盐酸溶液,所述盐酸溶液的浓度为1~3mol/L。
本发明的复方锌铁钙口服溶液中含有pH调节剂,能够保证维生素B2溶解完全,同时保证维生素B2在湿热和光照条件下不容易降解,进而使维生素B2含量稳定;同时,本发明选择使用三氯蔗糖作为甜味剂,该甜味剂为蔗糖的衍生物,甜味与蔗糖接近,安全性高,稳定性好,在体内不参与代谢,是糖尿病患者理想的甜味替代品,能够使本发明的复方锌铁钙口服溶液能够被糖尿病患者服用;本发明加入枸橼酸钠,防止在长期放置过程中会出现沉淀的问题。本发明提供了一种口感俱佳、维生素B2稳定和糖尿病患者可服用的复方锌铁钙口服溶液。实施例的数据表明,本发明提供的复方锌铁钙口服溶液在60℃下放置10天后维生素B2主峰纯度大于95.0%。
本发明还提供了上述技术方案所述的复方锌铁钙口服溶液的制备方法,包括以下步骤:在避光条件下,将部分pH调节剂、维生素B2与部分水进行第一混合,得到第一溶液;将所述第一溶液与葡萄糖酸钙进行第二混合,得到第二溶液;将所述第二溶液、葡萄糖酸锌和葡萄糖酸亚铁进行第三混合,得到第三溶液;将所述第三溶液、三氯蔗糖、苯甲酸钠、枸橼酸钠、香精、剩余水和剩余pH调节剂进行第四混合,得到所述复方锌铁钙口服溶液。本发明在避光条件下溶解维生素B2,能够实现维生素B2的完全溶解,使维生素B2含量稳定。
具体实施方式
本发明提供了一种复方锌铁钙口服溶液,包括以下含量的组分:
葡萄糖酸钙30~50g/L、葡萄糖酸锌1~5g/L、葡萄糖酸亚铁10~30g/L、维生素B20.1~0.5g/L、三氯蔗糖1~2g/L、苯甲酸钠0.5~2g/L、枸橼酸钠0.5~2.5g/L、香精0.5~1g/L、pH调节剂30~40g/L以及水,所述pH调节剂为盐酸溶液,所述盐酸溶液的浓度为1~3mol/L。
在本发明中,所述水优选为纯化水。
本发明对各原料的来源没有特殊的限定,采用本领域技术人员熟知的市售商品即可。
在本发明中,所述复方锌铁钙口服溶液的pH值优选为3~4,更优选为3.2~3.8。
在本发明中,所述复方锌铁钙口服溶液优选包括以下含量的组分:
葡萄糖酸钙40g/L、葡萄糖酸锌3g/L、葡萄糖酸亚铁10g/L、维生素B20.3g/L、三氯蔗糖1.25~1.5g/L、苯甲酸钠0.5~2g/L、枸橼酸钠1~2g/L、香精0.6~0.8g/L、pH调节剂30~40g/L。
在本发明的具体实施例中,所述复方锌铁钙口服溶液包括以下含量的组分:
葡萄糖酸钙40g/L、葡萄糖酸锌3g/L、葡萄糖酸亚铁10g/L、维生素B20.3g/L、三氯蔗糖1.25g/L、苯甲酸钠0.5g/L、枸橼酸钠0.5g/L、香精0.67g/L、pH调节剂30g/L,所述盐酸水溶液的浓度为2mol/L;
或葡萄糖酸钙40g/L、葡萄糖酸锌3g/L、葡萄糖酸亚铁10g/L、维生素B20.3g/L、三氯蔗糖1.25g/L、苯甲酸钠1g/L、枸橼酸钠1g/L、香精0.6g/L、pH调节剂35g/L,所述盐酸水溶液的浓度为2mol/L;
或葡萄糖酸钙40g/L、葡萄糖酸锌3g/L、葡萄糖酸亚铁10g/L、维生素B20.3g/L、三氯蔗糖1.5g/L、苯甲酸钠2g/L、枸橼酸钠2.5g/L、香精0.8g/L、pH调节剂40g/L,所述盐酸水溶液的浓度为2mol/L。
本发明还提供了上述技术方案所述的复方锌铁钙口服溶液的制备方法,包括以下步骤:
在避光条件下,将部分pH调节剂、维生素B2与部分水进行第一混合,得到第一溶液;
将所述第一溶液与葡萄糖酸钙进行第二混合,得到第二溶液;
将所述第二溶液、葡萄糖酸锌和葡萄糖酸亚铁进行第三混合,得到第三溶液;
将所述第三溶液、三氯蔗糖、苯甲酸钠、枸橼酸钠、香精、剩余水和剩余pH调节剂进行第四混合,得到所述复方锌铁钙口服溶液。
在本发明中,所述部分pH调节剂与剩余pH调节剂的体积比优选为4:1。
在本发明中,所述部分水与剩余水的体积比优选为9:1。
在本发明中,所述第一混合的温度优选为70~80℃。
在本发明中,所述第三混合的温度优选为40℃。
在本发明中,所述第四混合后优选还包括用0.8μm纤维素滤膜过滤。
在本发明中,所述过滤后优选还包括灌装、密封和灭菌。
在本发明中,所述灌装的规格优选为10mL/支。
在本发明中,所述灭菌的温度优选为105℃,时间优选为45min。
本发明对所述第一混合、第一混合、第三混合和第四混合的具体方式没有特殊的限定,采用本领域技术人员熟知的方式即可。
为了进一步说明本发明,下面结合实例对本发明提供的复方锌铁钙口服溶液及其制备方法和应用进行详细地描述,但不能将它们理解为对本发明保护范围的限定。
实施例
实施例一~三的配方如表1所示。
表1实施例一~三的配方
制备工艺
①避光操作,取80vol%稀盐酸于烧杯中,加入90vol%的纯化水,开启搅拌;加入维生素B2,搅拌并加热至70℃溶解,待溶解完全后停止加热;
②加入葡萄糖酸钙,搅拌溶解;
③待溶液恢复至40℃后,加入葡萄糖酸锌和葡萄糖酸亚铁搅拌溶解;
④加入三氯蔗糖,无水亚硫酸钠,苯甲酸钠,氯化钠,香精搅拌溶解;
⑤加入纯化水至全量后,加入剩余稀盐酸;
⑥搅拌混合均匀后溶液用0.8μm纤维素滤膜过滤后灌装规格为10mL/支,密封,于105℃灭菌45min。
对实施例一、二、三与上市复方锌铁钙口服溶液稳定性、口感对比,见表2~4。由表2~4可知,本发明提供了一种口感俱佳、维生素B2稳定和糖尿病患者可服用的复方锌铁钙口服溶液。
表2 60℃放置后维生素B2主峰纯度稳定性变化结果
表3室温放置口服溶液析晶情况
表4口感对比
以上所述仅是本发明的优选实施方式,并非对本发明作任何形式上的限制。应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种复方锌铁钙口服溶液,其特征在于,包括以下含量的组分:
葡萄糖酸钙30~50g/L、葡萄糖酸锌1~5g/L、葡萄糖酸亚铁10~30g/L、维生素B20.1~0.5g/L、三氯蔗糖1~2g/L、苯甲酸钠0.5~2g/L、枸橼酸钠0.5~2.5g/L、香精0.5~1g/L、pH调节剂30~40g/L以及水,所述pH调节剂为盐酸溶液,所述盐酸溶液的浓度为1~3mol/L。
2.根据权利要求1所述的复方锌铁钙口服溶液,其特征在于,所述复方锌铁钙口服溶液包括以下含量的组分:
葡萄糖酸钙40g/L、葡萄糖酸锌3g/L、葡萄糖酸亚铁10g/L、维生素B20.3g/L、三氯蔗糖1.25~1.5g/L、苯甲酸钠0.5~2g/L、枸橼酸钠1~2g/L、香精0.6~0.8g/L、pH调节剂30~40g/L。
3.根据权利要求1所述的复方锌铁钙口服溶液,其特征在于,所述复方锌铁钙口服溶液包括以下含量的组分:
葡萄糖酸钙40g/L、葡萄糖酸锌3g/L、葡萄糖酸亚铁10g/L、维生素B20.3g/L、三氯蔗糖1.25g/L、苯甲酸钠0.5g/L、枸橼酸钠0.5g/L、香精0.67g/L、pH调节剂30g/L,所述盐酸水溶液的浓度为2mol/L。
4.根据权利要求1所述的复方锌铁钙口服溶液,其特征在于,所述复方锌铁钙口服溶液包括以下含量的组分:
葡萄糖酸钙40g/L、葡萄糖酸锌3g/L、葡萄糖酸亚铁10g/L、维生素B20.3g/L、三氯蔗糖1.25g/L、苯甲酸钠1g/L、枸橼酸钠1g/L、香精0.6g/L、pH调节剂35g/L,所述盐酸水溶液的浓度为2mol/L。
5.根据权利要求1所述的复方锌铁钙口服溶液,其特征在于,所述复方锌铁钙口服溶液包括以下含量的组分:
葡萄糖酸钙40g/L、葡萄糖酸锌3g/L、葡萄糖酸亚铁10g/L、维生素B20.3g/L、三氯蔗糖1.5g/L、苯甲酸钠2g/L、枸橼酸钠2.5g/L、香精0.8g/L、pH调节剂40g/L,所述盐酸水溶液的浓度为2mol/L。
6.根据权利要求1~5任一项所述的复方锌铁钙口服溶液,其特征在于,所述复方锌铁钙口服溶液的pH值为3~4。
7.根据权利要求6所述的复方锌铁钙口服溶液,其特征在于,所述复方锌铁钙口服溶液的pH值为3.2~3.8。
8.权利要求1~7任一项所述的复方锌铁钙口服溶液的制备方法,其特征在于,包括以下步骤:
在避光条件下,将部分pH调节剂、维生素B2与部分水进行第一混合,得到第一溶液;
将所述第一溶液与葡萄糖酸钙进行第二混合,得到第二溶液;
将所述第二溶液、葡萄糖酸锌和葡萄糖酸亚铁进行第三混合,得到第三溶液;
将所述第三溶液、三氯蔗糖、苯甲酸钠、枸橼酸钠、香精、剩余水和剩余pH调节剂进行第四混合,得到所述复方锌铁钙口服溶液。
9.根据权利要求8所述的制备方法,其特征在于,所述第一混合的温度为70~80℃。
10.根据权利要求8所述的制备方法,其特征在于,所述第四混合后还包括用0.8μm纤维素滤膜过滤。
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