CN116270450A - 一种葡萄糖酸钙锌口服溶液及其制备方法 - Google Patents
一种葡萄糖酸钙锌口服溶液及其制备方法 Download PDFInfo
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- 235000011478 zinc gluconate Nutrition 0.000 title claims abstract description 39
- 239000011670 zinc gluconate Substances 0.000 title claims abstract description 39
- 229960000306 zinc gluconate Drugs 0.000 title claims abstract description 39
- 229940100688 oral solution Drugs 0.000 title claims abstract description 29
- IHBCFWWEZXPPLG-UHFFFAOYSA-N [Ca].[Zn] Chemical compound [Ca].[Zn] IHBCFWWEZXPPLG-UHFFFAOYSA-N 0.000 title claims abstract description 28
- 238000002360 preparation method Methods 0.000 title abstract description 9
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims abstract description 26
- 239000000796 flavoring agent Substances 0.000 claims abstract description 18
- 235000013355 food flavoring agent Nutrition 0.000 claims abstract description 17
- 238000003756 stirring Methods 0.000 claims abstract description 15
- 108010011485 Aspartame Proteins 0.000 claims abstract description 14
- UDIPTWFVPPPURJ-UHFFFAOYSA-M Cyclamate Chemical compound [Na+].[O-]S(=O)(=O)NC1CCCCC1 UDIPTWFVPPPURJ-UHFFFAOYSA-M 0.000 claims abstract description 14
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims abstract description 14
- 239000000605 aspartame Substances 0.000 claims abstract description 14
- 229960003438 aspartame Drugs 0.000 claims abstract description 14
- 235000010357 aspartame Nutrition 0.000 claims abstract description 14
- 239000000625 cyclamic acid and its Na and Ca salt Substances 0.000 claims abstract description 14
- 239000007788 liquid Substances 0.000 claims abstract description 14
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims abstract description 14
- 235000010234 sodium benzoate Nutrition 0.000 claims abstract description 14
- 239000004299 sodium benzoate Substances 0.000 claims abstract description 14
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- BVHLGVCQOALMSV-JEDNCBNOSA-N L-lysine hydrochloride Chemical compound Cl.NCCCC[C@H](N)C(O)=O BVHLGVCQOALMSV-JEDNCBNOSA-N 0.000 claims abstract description 11
- WHMDKBIGKVEYHS-IYEMJOQQSA-L Zinc gluconate Chemical compound [Zn+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 WHMDKBIGKVEYHS-IYEMJOQQSA-L 0.000 claims abstract description 11
- 229960004494 calcium gluconate Drugs 0.000 claims abstract description 11
- 239000004227 calcium gluconate Substances 0.000 claims abstract description 11
- 235000013927 calcium gluconate Nutrition 0.000 claims abstract description 11
- 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 abstract description 11
- 229960005337 lysine hydrochloride Drugs 0.000 claims abstract description 11
- 239000008213 purified water Substances 0.000 claims abstract description 9
- 238000009835 boiling Methods 0.000 claims abstract description 8
- 238000001816 cooling Methods 0.000 claims abstract description 4
- 238000011049 filling Methods 0.000 claims abstract description 4
- 238000010438 heat treatment Methods 0.000 claims abstract description 4
- 229960000448 lactic acid Drugs 0.000 claims abstract description 4
- 239000003814 drug Substances 0.000 claims description 7
- 238000000034 method Methods 0.000 claims description 6
- 238000001914 filtration Methods 0.000 claims description 5
- 244000144730 Amygdalus persica Species 0.000 claims description 3
- 239000004695 Polyether sulfone Substances 0.000 claims description 3
- 235000006040 Prunus persica var persica Nutrition 0.000 claims description 3
- 238000009924 canning Methods 0.000 claims description 3
- 229920006393 polyether sulfone Polymers 0.000 claims description 3
- 239000002994 raw material Substances 0.000 claims description 3
- 238000005303 weighing Methods 0.000 claims description 3
- 235000016623 Fragaria vesca Nutrition 0.000 claims description 2
- 240000009088 Fragaria x ananassa Species 0.000 claims description 2
- 235000011363 Fragaria x ananassa Nutrition 0.000 claims description 2
- 235000005805 Prunus cerasus Nutrition 0.000 claims description 2
- 244000207449 Prunus puddum Species 0.000 claims description 2
- 235000009226 Prunus puddum Nutrition 0.000 claims description 2
- 239000000022 bacteriostatic agent Substances 0.000 abstract description 2
- 230000000694 effects Effects 0.000 abstract description 2
- 239000008280 blood Substances 0.000 description 2
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- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
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- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
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- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 239000013049 sediment Substances 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
- 235000016804 zinc Nutrition 0.000 description 1
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Abstract
本发明公开了一种葡萄糖酸钙锌口服溶液及其制备方法,其成分包括:葡萄糖酸钙、葡萄糖酸锌、盐酸赖氨酸0.1g、乳酸0.11‑0.13g、苯甲酸钠0.012‑0.015g、矫味剂0.012‑0.016g、香精0.0045‑0.0065g、纯化水。制备过程包括:加入部分处方量的纯化水,加热,依次加入葡萄糖酸钙、乳酸、葡萄糖酸锌、盐酸赖氨酸、矫味剂,搅拌然后煮沸;停止煮沸,加入苯甲酸钠,搅拌,冷却至室温,加入香精,搅拌;余量纯化水定容,搅拌,过滤;中间体检测;灌装。本发明优点包括:不采用糖类矫味剂;口服液体系稳定;矫味剂采用阿司帕坦和环拉酸钠搭配可以改善口感不佳的问题;适量的抑菌剂苯甲酸钠,能够使体系保质效果好。
Description
技术领域
本发明涉及一种药物制剂技术领域,尤其涉及葡萄糖酸钙锌口服溶液。
背景技术
葡萄糖酸钙锌口服溶液适应症为用于治疗因缺钙、锌引起的疾病,其主要的药效成分是葡萄糖酸钙、葡萄糖酸锌、盐酸赖氨酸;口服液体系中搭配矫味剂、pH调节剂、抑菌剂、香精等辅料来维持体系的稳定。然而现有的葡萄糖酸钙锌口服溶液存在较多不足:1、矫味剂是糖类,不适宜需要控制血糖的人群服用;2、辅料用量不科学,容易出现体系中析出沉淀物现象;3、为了把握体系稳定,矫味剂、香精等用量、种类局限,导致口服液服用体验差。因此,研发一种体系稳定、服用体验良好的葡萄糖酸钙锌口服溶液是必要的。
发明内容
本发明的目的在于提供一种葡萄糖酸钙锌口服溶液及其制备方法,以解决现有口服液不能适宜不同人群服用、体系稳定性差、服用体验差等问题。
为了达到上述目的本发明采用如下技术方案:
一种葡萄糖酸钙锌口服溶液,按10mL体积计,其成分包括:
葡萄糖酸钙0.6g;
葡萄糖酸锌0.03g;
盐酸赖氨酸0.1g;
乳酸0.11-0.13g;
苯甲酸钠0.012-0.015g;
矫味剂0.012-0.016g;
香精0.0045-0.0065g;
纯化水余量。
进一步地,葡萄糖酸钙锌口服溶液按10mL体积计,所述乳酸含量为0.12g。
进一步地,葡萄糖酸钙锌口服溶液按10mL体积计,所述苯甲酸钠含量为0.015g。
进一步地,所述矫味剂包括阿司帕坦和环拉酸钠。
进一步地,按10mL体积计,所述阿司帕坦含量为0.006-0.008g,环拉酸钠含量为0.006-0.008g。
进一步地,所述阿司帕坦含量为0.008g,环拉酸钠含量为0.008g。
进一步地,所述香精选自液体水蜜桃香精、草莓香精、橙子香精、酸樱桃香精中的任一种。
一种所述的葡萄糖酸钙锌口服溶液的制备方法,步骤包括:
(1)称取原料;
(2)加入处方量80%的纯化水,加热至65~75℃,依次加入葡萄糖酸钙、乳酸、葡萄糖酸锌、盐酸赖氨酸、矫味剂,搅拌10min;将上述溶液煮沸60min;
(3)停止煮沸,加入苯甲酸钠,搅拌5min,冷却至室温,加入香精,搅拌5min;
(4)定容,按处方量补加纯化水至目的体积,搅拌10min;
(5)过滤;
(6)中间体检测;
(7)灌装:过滤后的药液进行罐装。
优选地,所述步骤(2)中矫味剂的加入顺序是阿司帕坦、环拉酸钠。
优选地,所述步骤(5)过程是:药液进行两次过滤,过滤使用的滤芯是聚醚砜折叠式滤芯0.22μm,滤芯尺寸:5英寸。
本发明的优点包括:
1、不采用糖类矫味剂,需要控制血糖的人群也可以无障碍服用;
2、pH调节剂乳酸和香精的科学用量,有助于稳定口服液体系;
3、不同的矫味剂虽然能够为口服液改善口感,但当用量达到一定程度时,不同矫味剂会具备不同的不良风味,矫味剂采用阿司帕坦和环拉酸钠搭配可以避免大量使用单一矫味剂导致口感不佳的问题;
4、适量的抑菌剂苯甲酸钠,能够使体系保质效果好。
具体实施方式
下面将结合具体实施例来详细说明本发明,在此以本发明的示意性实施例及说明用来解释本发明,但并不作为对本发明的限定。
实施例一
葡萄糖酸钙锌口服溶液,按10mL体积计,其成分包括:
葡萄糖酸钙0.6g;
葡萄糖酸锌0.03g;
盐酸赖氨酸0.1g;
乳酸0.12g;
苯甲酸钠0.015g;
阿司帕坦0.008g;
环拉酸钠0.008g;
液体水蜜桃香精0.0045g;
纯化水余量。
其制备方法是:
(1)称取原料;
(2)加入处方量80%的纯化水,加热至65~75℃,依次加入葡萄糖酸钙、乳酸、葡萄糖酸锌、盐酸赖氨酸、阿司帕坦、环拉酸钠,搅拌10min。将上述溶液煮沸60min;
(3)停止煮沸,加入苯甲酸钠,搅拌5min,冷却至室温,加入香精,搅拌5min;
(4)定容,按处方量补加纯化水至目的体积,搅拌10min,密度约为1.0290g/mL;
(5)过滤:药液进行两次过滤,采用聚醚砜折叠式滤芯0.22μm,滤芯尺寸:5英寸;
(6)中间体检测;符合葡萄糖酸钙锌口服溶液中间体质量标准;
(7)灌装:过滤后的药液进行罐装。
实施例二
一种葡萄糖酸钙锌口服溶液,按10mL体积计,其成分包括:
葡萄糖酸钙0.6g;
葡萄糖酸锌0.03g;
盐酸赖氨酸0.1g;
乳酸0.11g;
苯甲酸钠0.014g;
阿司帕坦0.008g;
环拉酸钠0.008g;
香精0.0045g;
纯化水余量。
制备方法参考实施例一。
实施例三
一种葡萄糖酸钙锌口服溶液,按10mL体积计,其成分包括:
葡萄糖酸钙0.6g;
葡萄糖酸锌0.03g;
盐酸赖氨酸0.1g;
乳酸0.13g;
苯甲酸钠0.014g;
阿司帕坦0.008g;
环拉酸钠0.008g;
香精0.0065g;
纯化水余量。
制备方法参考实施例一。
以上对本发明实施例所提供的技术方案进行了详细介绍,本文中应用了具体个例对本发明实施例的原理以及实施方式进行了阐述,以上实施例的说明只适用于帮助理解本发明实施例的原理;同时,对于本领域的一般技术人员,依据本发明实施例,在具体实施方式以及应用范围上均会有改变之处,综上所述,本说明书内容不应理解为对本发明的限制。
Claims (10)
1.一种葡萄糖酸钙锌口服溶液,其特征在于:
按10mL体积计,其成分包括:
葡萄糖酸钙0.6g;
葡萄糖酸锌0.03g;
盐酸赖氨酸0.1g;
乳酸0.11-0.13g;
苯甲酸钠0.012-0.015g;
矫味剂0.012-0.016g;
香精0.0045-0.0065g;
纯化水余量。
2.根据权利要求1所述的一种葡萄糖酸钙锌口服溶液,其特征在于:
葡萄糖酸钙锌口服溶液按10mL体积计,所述乳酸含量为0.12g。
3.根据权利要求1或2所述的一种葡萄糖酸钙锌口服溶液,其特征在于:
葡萄糖酸钙锌口服溶液按10mL体积计,所述苯甲酸钠含量为0.015g。
4.根据权利要求3所述的一种葡萄糖酸钙锌口服溶液,其特征在于:
所述矫味剂包括阿司帕坦和环拉酸钠。
5.根据权利要求4所述的一种葡萄糖酸钙锌口服溶液,其特征在于:
按10mL体积计,所述阿司帕坦含量为0.006-0.008g,环拉酸钠含量为0.006-0.008g。
6.根据权利要求5所述的一种葡萄糖酸钙锌口服溶液,其特征在于:
所述阿司帕坦含量为0.008g,环拉酸钠含量为0.008g。
7.根据权利要求1所述的一种葡萄糖酸钙锌口服溶液,其特征在于:
所述香精选自液体水蜜桃香精、草莓香精、橙子香精、酸樱桃香精中的任一种。
8.一种如权利要求1-7任一所述的葡萄糖酸钙锌口服溶液的制备方法,其特征在于:
步骤包括:
(1)称取原料;
(2)加入处方量80%的纯化水,加热至65~75℃,依次加入葡萄糖酸钙、乳酸、葡萄糖酸锌、盐酸赖氨酸、矫味剂,搅拌10min;将上述溶液煮沸60min;
(3)停止煮沸,加入苯甲酸钠,搅拌5min,冷却至室温,加入香精,搅拌5min;
(4)定容,按处方量补加纯化水至目的体积,搅拌10min;
(5)过滤;
(6)中间体检测;
(7)灌装:过滤后的药液进行罐装。
9.根据权利要求8所述的葡萄糖酸钙锌口服溶液的制备方法,其特征在于:
所述步骤(2)中矫味剂的加入顺序是阿司帕坦、环拉酸钠。
10.根据权利要求8所述的葡萄糖酸钙锌口服溶液的制备方法,其特征在于:
所述步骤(5)过程是:药液进行两次过滤,过滤使用的滤芯是聚醚砜折叠式滤芯0.22μm,滤芯尺寸:5英寸。
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