The invention discloses a ferric pyrophosphate solution of citric acid, which comprises the following components: citric acid pyrophosphate iron (iron content) 4.352 to 6.528 grams, one or more pH regulator, and the right amount of water for injection. Citrate ferric pyrophosphate solution for the green and yellow transparent liquid, each ml solution containing iron labeled amount is 5.44mg. Among them, pH regulator includes anhydrous sodium carbonate, sodium bicarbonate, sodium citrate, citric acid, sodium hydroxide and its solution. During the preparation of the citrate ferric pyrophosphate adding water for injection mixing, dissolution, pH regulator solution pH value to 4.0~5.5, fully stirring and dissolving, dissolving and adding water for injection to volume 1000 ml. Said 0.01%~0.5% (W/V) activated carbon is added to the solution, stirring 30min~60min at the temperature of 40 DEG C to 60 DEG C; and then, the carbon dioxide is filtered, sterilized, filtered, filled and packaged. The ferric pyrophosphate solution provided by the invention has the advantages of high safety, simple preparation method, no special equipment, short preparation cycle and low cost.
【技术实现步骤摘要】
本专利技术涉及医药
,特别涉及一种枸橼酸焦磷酸铁溶液及其制备方法领域。
技术介绍
随着人民生活水平的不断提高,广大人民群众对身体健康日益重视。为了预防和控制缺铁性贫血,采取了多种途径,如膳食途径、食物强化等,也取得了很好得效果。然而对孕妇、儿童以及其它严重缺铁性贫血等病人,药物治疗就显得尤为必需。早期治疗方法多以口服无机铁盐为治疗手段,最常见的为硫酸亚铁。无机金属铁盐被人体摄入后,部分金属离子不仅不易被吸收,还会刺激胃肠,引起腹泻。不同金属元素之间的拮抗作用也会使吸收进入体内的金属元素利用率和沉积效率受到限制,导致其生物有效性降低。而传统注射用铁剂使用时有严重的副作用,存在严重不足。
技术实现思路
为解决以上问题,本专利技术提供一种枸橼酸焦磷酸铁溶液及其制备方法,其特征在于包括以下组份:枸橼酸焦磷酸铁(以铁含量计)4.352~6.528克,一或多种pH调节剂、注射用水适量;一或多种所述pH调节剂包括无水碳酸钠及其溶液。所述注射用水为经过无菌过滤后的水,不含有其他物质。所述枸橼酸焦磷酸铁的分子式为Fe4(C6H4O7)3(H2P2O7)2(P2O7),在专利号为US7816404的文献中公开了这种枸橼酸焦磷酸铁的制备工艺。其制备方法如下:(1)量取处方量的80%的注射用水;(2)称取枸橼酸焦磷酸铁加入步骤(1)中的注射用水中,加入量为以铁含量计4.352~6.528,用pH调节剂调pH值至4.0~5.5,充分搅拌溶解,溶解后再加入注射用水定容至处方量1000mL;(3)称取与步骤(2)获得溶液质量体积比为0.01%~0.5%的活性炭,加入到步骤(2)中1 ...
【技术保护点】
一种枸橼酸焦磷酸铁溶液,其特征在于,所述枸橼酸焦磷酸铁溶液包括以下组份:以铁含量计,浓度为4.352‑6.528[A1] [A2] mg/ml的枸橼酸焦磷酸铁、pH调节剂和注射用水,溶液pH值为4.0~5.5;所述枸橼酸焦磷酸铁的分子式为Fe4(C6H4O7)3(H2P2O7)2(P2O7)。
【技术特征摘要】
1.一种枸橼酸焦磷酸铁溶液,其特征在于,所述枸橼酸焦磷酸铁溶液包括以下组份:以铁含量计,浓度为4.352-6.528[A1][A2]mg/ml的枸橼酸焦磷酸铁、pH调节剂和注射用水,溶液pH值为4.0~5.5;所述枸橼酸焦磷酸铁的分子式为Fe4(C6H4O7)3(H2P2O7)2(P2O7)。2.如权利要求1所述的枸橼酸焦磷酸铁溶液,其特征在于,所述pH调节剂为:碳酸氢钠、枸橼酸钠、枸橼酸、氢氧化钠及其溶液、或无水碳酸钠及其溶液中的一种或多种。3.如权利要求1或2所述枸橼酸焦磷酸铁溶液的制备方法,其特征在于,具体步...
【专利技术属性】
技术研发人员:陆小平,王华,
申请(专利权)人:泰州海达医药科技有限公司,
类型:发明
国别省市:江苏;32
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