CN1230175C - 注射用盐酸川芎嗪冻干剂及其制备方法 - Google Patents
注射用盐酸川芎嗪冻干剂及其制备方法 Download PDFInfo
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- CN1230175C CN1230175C CN 02160783 CN02160783A CN1230175C CN 1230175 C CN1230175 C CN 1230175C CN 02160783 CN02160783 CN 02160783 CN 02160783 A CN02160783 A CN 02160783A CN 1230175 C CN1230175 C CN 1230175C
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- ligustrazine
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- potassium
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- 238000002347 injection Methods 0.000 title claims abstract description 25
- 239000007924 injection Substances 0.000 title claims abstract description 25
- RQKFOGXUTRDQPB-UHFFFAOYSA-N hydron;2,3,5,6-tetramethylpyrazine;chloride Chemical compound Cl.CC1=NC(C)=C(C)N=C1C RQKFOGXUTRDQPB-UHFFFAOYSA-N 0.000 title claims abstract description 16
- 238000002360 preparation method Methods 0.000 title claims abstract description 13
- 238000000034 method Methods 0.000 title abstract description 3
- 239000000243 solution Substances 0.000 claims abstract description 6
- FINHMKGKINIASC-UHFFFAOYSA-N Tetramethylpyrazine Chemical compound CC1=NC(C)=C(C)N=C1C FINHMKGKINIASC-UHFFFAOYSA-N 0.000 claims description 26
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 14
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 9
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims description 8
- 239000011591 potassium Substances 0.000 claims description 8
- 229910052700 potassium Inorganic materials 0.000 claims description 8
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 6
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- 229930195725 Mannitol Natural products 0.000 claims description 4
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- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 4
- 239000000594 mannitol Substances 0.000 claims description 4
- 235000010355 mannitol Nutrition 0.000 claims description 4
- CDBYLPFSWZWCQE-UHFFFAOYSA-L sodium carbonate Substances [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 4
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 3
- 238000012856 packing Methods 0.000 claims description 3
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- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 2
- WQZGKKKJIJFFOK-QTVWNMPRSA-N D-mannopyranose Chemical compound OC[C@H]1OC(O)[C@@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-QTVWNMPRSA-N 0.000 claims description 2
- 229920002307 Dextran Polymers 0.000 claims description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 2
- 239000002253 acid Substances 0.000 claims description 2
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims description 2
- 229910000397 disodium phosphate Inorganic materials 0.000 claims description 2
- 235000019800 disodium phosphate Nutrition 0.000 claims description 2
- 238000004108 freeze drying Methods 0.000 claims description 2
- 239000004310 lactic acid Substances 0.000 claims description 2
- 235000014655 lactic acid Nutrition 0.000 claims description 2
- 239000008101 lactose Substances 0.000 claims description 2
- 239000012982 microporous membrane Substances 0.000 claims description 2
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims description 2
- 235000019799 monosodium phosphate Nutrition 0.000 claims description 2
- 229910000029 sodium carbonate Inorganic materials 0.000 claims description 2
- 239000011780 sodium chloride Substances 0.000 claims description 2
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims description 2
- 239000001488 sodium phosphate Substances 0.000 claims description 2
- 229910000162 sodium phosphate Inorganic materials 0.000 claims description 2
- 235000011008 sodium phosphates Nutrition 0.000 claims description 2
- 239000000600 sorbitol Substances 0.000 claims description 2
- 230000001954 sterilising effect Effects 0.000 claims description 2
- 238000004659 sterilization and disinfection Methods 0.000 claims description 2
- 238000003756 stirring Methods 0.000 claims description 2
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims description 2
- 238000010792 warming Methods 0.000 claims description 2
- 235000007686 potassium Nutrition 0.000 claims 2
- 229910019142 PO4 Inorganic materials 0.000 claims 1
- 239000010452 phosphate Substances 0.000 claims 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 1
- 235000011007 phosphoric acid Nutrition 0.000 claims 1
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- ONBIUAZBGHXJDM-UHFFFAOYSA-J bismuth;potassium;tetraiodide Chemical compound [K+].[I-].[I-].[I-].[I-].[Bi+3] ONBIUAZBGHXJDM-UHFFFAOYSA-J 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- LGZXYFMMLRYXLK-UHFFFAOYSA-N mercury(2+);sulfide Chemical compound [S-2].[Hg+2] LGZXYFMMLRYXLK-UHFFFAOYSA-N 0.000 description 2
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Abstract
一种注射用盐酸川芎嗪冻干剂，含盐酸川芎嗪5～100%，余为辅料，有10、20、30、40、50、80mg/支不同规格。当原辅料配制成一定浓度和PH的溶液后采用速冻干燥法加工得到。本制剂能规模化生产，质量稳定，方便运输和贮存，特别临床使用时，对一定小体积注射液可根据剂量的需要调整使用浓度。
Description
一、技术领域
本发明涉及一种药物制剂及其制备方法，具体地说是一种注射用川芎嗪冻干剂及其制备方法。
二、背景技术
盐酸川芎嗪(Ligustrazine Hydrochloride)，分子式为C8H12N2·HCl·2H2O，分子量为208.69，从70年代中期以来，为我国广泛应用于脑血管系统疾病的药物，是从活血化瘀中药川芎中提取的一种生物碱单体的盐酸盐，化学结构为四甲基吡嗪，现已人工合成。川芎嗪具有扩张血管、增加冠脉血流量、提高心肌耐缺氧能力，并有降低血小板活性，抑制血小板聚集、改善微循环等广泛的作用。
在八十年代先后有片剂和注射液上市，在临床上广泛应用于改善微循环、改善血液流变学等，治疗各种缺血性脑血管疾病，另外还具有治疗肾衰、偏头痛、妊高症、流行性出血热、眼底病等多方面的作用。
中国药典在1977版一部已收载了盐酸川芎嗪的原料及其小容量的注射剂，规格为2ml∶40mg，静脉注射，用量一次40-80mg，用5％葡萄糖注射液或氯化钠注射液250-500ml稀释后滴注；穴位注射，选3-4穴位，每穴10-20mg隔日一次。穴位注射时，对注射液的体积有限制。然而现有制剂的含量是固定，这就难以在有限体积的注射液中根据患者的情况对其内有效成分的含量进行调整。
三、发明内容
为了解决上述临床使用中的问题，需要一种能任意调整使用浓度的制剂，这一理想的制剂就是能速溶的注射用盐酸川芎嗪冻干剂。
本发明所述的注射用盐酸川芎嗪冻干制剂，由以下成分组成(重量百分比)∶盐酸川芎嗪5～100％，辅料0～95％。
上述的盐酸川芎嗪为符合中国药典标准的物质，辅料包括磷酸、磷酸氢二钠或钾、磷酸二氢钠或钾、磷酸钠或钾、盐酸、氯化钠、碳酸钠、氢氧化钠或钾、乳酸、乳糖、甘露糖、甘露醇、山梨醇、低分子右旋糖苷等。
本发明所述的注射用盐酸川芎嗪冻干剂制备方法包括配料、除菌和速冻，具体工艺过程如下：
1、按处方称取各原辅料，置于容器中，加适量磷酸盐缓冲液溶解，用酸或碱调pH至2.0～4.0，加注射用水或磷酸盐缓冲液稀释至指定规格所需体积，摇匀。
2、向溶液中加针用活性炭，室温搅拌、过滤；再用微孔滤膜过滤或超滤除菌，小瓶分装。
3、采用速冻干燥法，先速冻降温至-20～-50℃，维持1～6小时，抽真空，在真空状态下缓缓升温至35～40℃，降至室温后取出，加盖密封。
本发明所述的注射用盐酸川芎嗪冻干剂是以盐酸川芎嗪为主要成分，本冻干制剂为白色或类白色疏松块状物或粉末，在含量、有关物质、热源、内毒素和pH值等项的检验中均符合有关规定。
本发明所述的注射用盐酸川芎嗪的水溶液加碘化铋钾试液2滴，即产生橘红色沉淀。
本发明所述的注射用盐酸川芎嗪水溶液，照分光光度法(中国药典2000年版二部附录IVA)，在296±1nm的波长处有最大吸收。
盐酸川芎嗪冻干剂能规模化生产，质量稳定，方便运输和贮存，特别是临床使用时，对一定小体积注射液可根据剂量的需要调整使用浓度。
四、具体实施方式
以下为非限定实施例，叙述如下：
规格为含盐酸川芎嗪：10、20、30、40、50、80mg/支，以下以规格40mg/支为例阐述注射用盐酸川芎嗪冻干剂的制备过程。
各原辅料配比：以40mg/支为例
盐酸川芎嗪(C8H12N2·HCl·2H2O) 40g
甘露醇 100g
磷酸盐缓冲液(0.36mol/L pH2.5) 适量
注射用水 加至1000ml
冻干共制备1000支
按以上用量称取盐酸川芎嗪和甘露醇，置于容器中，加适量的磷酸盐缓冲液溶解，用1mol/L磷酸溶液或1mol/L氢氧化钠调pH值至2.5，加注射用水至1000ml，摇匀，加3～50g针用活性炭，室温下搅拌10～60分钟，粗滤，并用0.22μm滤膜过滤除菌，分装，每瓶1ml，采用速冻法，每分钟降温0.1～10℃，降温至-45℃，维持3小时，抽真空，在真空状态下缓缓加温，升温速度每小时0.5～10℃，到35℃时停止升温，降至室温后取出，加盖密封。
成品检验结果：
性状：白色块状物。
鉴别：(1)本品的水溶液加碘化铋钾试液2滴，即产生橘红色沉淀。
(2)本品的水溶液，照分光光度法(中国药典2000年版二部附录IVA)，在296±1nm的波长处有最大吸收。
检验：pH值2.6
含量：98.5％
其它指标均符合有关规定。
Claims (2)
1、一种注射用盐酸川芎嗪冻干剂，其特征在于：由盐酸川芎嗪5～100重量％，辅料0～95重量％组成，其中，所述的辅料选自磷酸、磷酸氢二钠或钾、磷酸二氢钠或钾、磷酸钠/钾、盐酸、氯化钠、碳酸钠、氢氧化钠或钾、乳酸、乳糖、甘露糖、甘露醇、山梨醇、低分子右旋糖苷；
将所述的盐酸川芎嗪和辅料用磷酸盐缓冲溶解、经调pH至2.0～4.0、再稀释定容得到的溶液经冷冻干燥制备而成。
2、如权利要求1所述的注射用盐酸川芎嗪冻干剂的制备方法，其包括如下步骤：
(1)称取盐酸川芎嗪和辅料，置于容器中，加适量磷酸盐缓冲液溶解，用酸或碱调pH至2.0～4.0，加注射用水或磷酸盐缓冲液稀释至所需体积，摇匀；
(2)向步骤(1)得到的溶液中加针用活性炭，室温搅拌、过滤；再用微孔滤膜过滤或超滤除菌，小瓶分装；
(3)速冻降温至-20～-50℃，维持1～6小时，抽真空，在真空状态下缓缓升温至35～40℃，降至室温后取出，加盖密封。
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| CN 02160783 CN1230175C (zh) | 2002-12-27 | 2002-12-27 | 注射用盐酸川芎嗪冻干剂及其制备方法 |
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| CN 02160783 CN1230175C (zh) | 2002-12-27 | 2002-12-27 | 注射用盐酸川芎嗪冻干剂及其制备方法 |
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| CN1425375A CN1425375A (zh) | 2003-06-25 |
| CN1230175C true CN1230175C (zh) | 2005-12-07 |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101544610B (zh) * | 2008-03-24 | 2012-07-04 | 沈阳华泰药物研究有限公司 | 川芎嗪盐 |
| CN101647781B (zh) * | 2009-09-03 | 2011-06-29 | 海南新中正制药有限公司 | 注射用磷酸川芎嗪粉针的制备方法 |
| CN101961310B (zh) * | 2010-09-15 | 2012-01-25 | 河南辅仁怀庆堂制药有限公司 | 盐酸川芎嗪注射液配制工艺 |
| CN105213328A (zh) * | 2015-11-10 | 2016-01-06 | 瑞阳制药有限公司 | 注射用磷酸川芎嗪冻干粉针及其制备方法 |
| CN110755440B (zh) * | 2019-11-20 | 2023-02-28 | 中国海洋大学 | 川芎嗪和甘露糖醛酸的组合物在用于制备治疗血栓性疾病和神经系统疾病的药物中的应用 |
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