CN115804751A - A kind of carbetocin injection and preparation method thereof - Google Patents
A kind of carbetocin injection and preparation method thereofDownload PDFInfo
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Abstract
Translated fromChineseDescription
Translated fromChinese技术领域technical field
本发明涉及医药技术领域，尤其涉及一种卡贝缩宫素注射液及其制备方法。The invention relates to the technical field of medicine, in particular to a carbetocin injection and a preparation method thereof.
背景技术Background technique
卡贝缩宫素(英文名称：Carbetocin)，化学名称去氨-2-氧-甲基酪氨酸-1-κ缩宫素，分子式C45H69N11O12S，分子量988.16，其化学结构式如下：Carbetocin (English name: Carbetocin), chemical name deamin-2-oxo-methyltyrosine-1-κ oxytocin, molecular formula C45 H69 N11 O12 S, molecular weight 988.16, its chemical The structural formula is as follows:
卡贝缩宫素是一种人工合成的缩宫素类似物，用于选择性硬膜外或腰麻下剖腹产术后，以预防子宫收缩乏力和产后出血，其起效快、作用时间长、临床使用有效，副作用小等优点。因此卡贝缩宫素具体很高的开发价值。Carbetocin is a synthetic oxytocin analogue, used for selective epidural or spinal anesthesia after caesarean section to prevent uterine atony and postpartum hemorrhage. The clinical use is effective, and the side effect is small. Therefore, carbetocin has a very high development value.
卡贝缩宫素临床上使用的该药品是溶液型注射液，规格是1ml:100μg，用法用量是：抽取1mL含100μg卡贝缩宫素，并在有充分医疗监管条件的医院内仅通过静脉注射给药。仅在剖腹产术婴儿娩出后在1分钟内缓慢给药。分娩后应尽快给药，最好在胎盘娩出前给药。仅供单剂量使用。卡贝缩宫素不可多次给药。The drug carbetocin clinically used is a solution-type injection, the specification is 1ml: 100μg, the usage and dosage is: extract 1mL containing 100μg carbetocin, and only through the vein in the hospital with sufficient medical supervision conditions Administration by injection. Administer slowly over 1 minute only after cesarean delivery of the baby. Administration should be given as soon as possible after delivery, preferably before delivery of the placenta. For single dose use only. Carbetocin should not be administered multiple times.
目前临床上使用的卡贝缩宫素为1ml:100μg的小容量注射液，典型的产品如卡贝缩宫素注射液(Carbetocin injection，商品名
中国专利CN201911226538.3公开了一种可以常温储存的含卡贝缩宫素及稳定剂的注射液，所述注射液可以常温下存储，包含卡贝缩宫素、稳定剂、pH调节剂和注射用水，由于稳定性的存在，产品的稳定性大大提高。中国专利CN201911280024.6公开了一种卡贝缩宫素注射液的制备方法，所述卡贝缩宫素注射液由卡贝缩宫素、pH调节剂、渗透压调节剂、稳定剂、注射用水组成；所述制备方法至少包括容器具清洗，将卡贝缩宫素及辅料溶解，加水定容，搅拌混合、过滤、灌装步骤，其特征在于，配液过程中所用的金属器具均采用含金属螯合剂的水溶液进行清洗，制备的产品稳定性好。中国专利CN201010526006.4公开了一种更加稳定的醋酸卡贝缩宫素静脉注射及肌肉注射给药制剂，由卡贝缩宫素及等渗调节剂、pH调节剂、抗氧化剂、局部止痛剂和溶剂组成，其中，局部止痛剂为苯甲醇、三氯叔丁醇或盐酸普鲁卡因，该制剂质量稳定，疗效确切，利于患者接受。中国专利CN202111620574.5公开了一种卡贝缩宫素制剂的制备方法，选用合适温度的注射用水，匹配优化的灭菌工艺，通过缓冲对与其他组分的配合，药物制剂的有效成分可在室温或环境温度下长期稳定存在，实现了高稳定性和有效灭菌，降低了储存过程以及临床使用上的风险。Chinese patent CN201911226538.3 discloses an injection containing carbetocin and a stabilizer that can be stored at room temperature. The injection can be stored at room temperature and includes carbetocin, a stabilizer, a pH regulator and injection With water, due to the existence of stability, the stability of the product is greatly improved. Chinese patent CN201911280024.6 discloses a preparation method of carbetocin injection, said carbetocin injection is composed of carbetocin, pH regulator, osmotic pressure regulator, stabilizer, water for injection Composition; the preparation method at least includes cleaning the container, dissolving carbetocin and auxiliary materials, adding water to constant volume, stirring and mixing, filtering, and filling steps, and it is characterized in that the metal utensils used in the liquid preparation process are all made of The aqueous solution of the metal chelating agent is used for cleaning, and the prepared product has good stability. Chinese patent CN201010526006.4 discloses a more stable drug preparation of carbetocin acetate for intravenous injection and intramuscular injection, which consists of carbetocin and isotonic regulator, pH regulator, antioxidant, local analgesic and The preparation is composed of a solvent, wherein the local analgesic is benzyl alcohol, chlorobutanol or procaine hydrochloride, and the preparation has stable quality, definite curative effect and is favorable for patients to accept. Chinese patent CN202111620574.5 discloses a method for preparing carbetocin preparations. Water for injection at a suitable temperature is selected, matched with an optimized sterilization process, and the active ingredients of the pharmaceutical preparation can be obtained by combining the buffer with other components. Long-term stable existence at room temperature or ambient temperature, achieving high stability and effective sterilization, reducing the risk of storage and clinical use.
以上制备的卡贝缩宫素药物组合物或注射液，还均存在稳定性不好等问题，其稳定性还需进一步提高。因此，仍需要寻找一种新的针对卡贝缩宫素注射液的制备方法。The above-prepared carbetocin pharmaceutical composition or injection also has problems such as poor stability, and its stability needs to be further improved. Therefore, there is still a need to find a new preparation method for carbetocin injection.
发明内容Contents of the invention
本发明的目的是为了解决现有技术中存在的缺点，而提出的一种卡贝缩宫素注射液及其制备方法。The purpose of the present invention is in order to solve the shortcoming that exists in the prior art, and propose a kind of carbetocin injection and preparation method thereof.
为了实现上述目的，本发明采用了如下技术方案：In order to achieve the above object, the present invention adopts the following technical solutions:
一种卡贝缩宫素注射液，包括：A carbetocin injection, comprising:
卡贝缩宫素；Carbetocin;
缓冲剂；buffer;
抗氧化剂；Antioxidants;
等渗剂；Isotonic agent;
稳定剂；stabilizer;
所述卡贝缩宫素注射液的工作浓度在以下范围内：The working concentration of the carbetocin injection is in the following ranges:
所述卡贝缩宫素的浓度为0.001～0.1％w/v，所述缓冲剂的浓度为0.1～2.0％w/v，所述抗氧化剂的浓度为0.1～3.0％w/v，所述等渗剂的浓度为40.0～47.0％w/v，所述稳定剂的浓度为0.1～3.0％w/v。The concentration of the carbetocin is 0.001-0.1% w/v, the concentration of the buffer is 0.1-2.0% w/v, the concentration of the antioxidant is 0.1-3.0% w/v, the The concentration of the isotonic agent is 40.0-47.0% w/v, and the concentration of the stabilizer is 0.1-3.0% w/v.
优选的，所述缓冲剂包括乙酸、柠檬酸、马来酸、琥珀酸和磷酸盐中的至少一种。Preferably, the buffering agent includes at least one of acetic acid, citric acid, maleic acid, succinic acid and phosphate.
优选的，所述抗氧剂包括甲硫氨酸、EDTA、焦亚硫酸钠中的至少一种。Preferably, the antioxidant includes at least one of methionine, EDTA, and sodium metabisulfite.
优选的，所述等渗剂包括蔗糖、氯化钠、甘露醇和枸橼酸盐中的至少一种。Preferably, the isotonic agent includes at least one of sucrose, sodium chloride, mannitol and citrate.
优选的，所述稳定剂包括赖氨酸、组氨酸、异亮氨酸和色氨酸中的至少一种。Preferably, the stabilizer includes at least one of lysine, histidine, isoleucine and tryptophan.
一种卡贝缩宫素注射液的制备方法，包括以下步骤：A preparation method for carbetocin injection, comprising the following steps:
步骤一：称取所需的原辅料；Step 1: Weigh the required raw and auxiliary materials;
步骤二：加入注射用水于容器中，加入缓冲剂、抗氧化剂、等渗剂和稳定剂，搅拌溶解；加入卡贝缩宫素，搅拌混合；调节药液pH值为3.0～6.0，补加注射用水至所需配制量；Step 2: Add water for injection into the container, add buffer, antioxidant, isotonic agent and stabilizer, stir to dissolve; add carbetocin, stir and mix; adjust the pH value of the liquid to 3.0-6.0, and add additional injection Water to the required preparation volume;
步骤三：溶液经0.45μm、0.22μm两级滤芯过滤后进入灌封设备，进行灌封。Step 3: After the solution is filtered by 0.45 μm and 0.22 μm two-stage filter elements, it enters the potting equipment for potting.
优选的，所述步骤二中，调节药液pH值为5.1～5.8。Preferably, in the second step, the pH of the medicinal solution is adjusted to 5.1-5.8.
优选的，所述步骤二和步骤三的制备温度为30～50℃。Preferably, the preparation temperature of the step 2 and step 3 is 30-50°C.
与现有技术相比，本发明的有益效果是：Compared with prior art, the beneficial effect of the present invention is:
本发明卡贝缩宫素注射液的制备方法简单，有利于产业化生产，得到的卡贝缩宫素注射液在室温及高温环境下杂质含量少，pH稳定，具有优异的稳定性。The preparation method of the carbetocin injection of the present invention is simple, and is beneficial to industrial production. The obtained carbetocin injection has less impurity content, stable pH and excellent stability under room temperature and high temperature environments.
本发明的卡贝缩宫素注射液加入甲硫氨酸作为抗氧化剂，起到更好的抗氧化效果；加入琥珀酸作为缓冲剂，可更好的稳定药物组合物的pH为5.2-5.6；通过卡贝缩宫素、稳定剂的配合作用及适宜的pH，可获得性能更加稳定的卡贝缩宫素注射液，可以在室温或环境温度下保存，减少药物生产风险及运输贮存成本，提高临床用药的安全性。Adding methionine to the carbetocin injection of the present invention as an antioxidant has a better antioxidant effect; adding succinic acid as a buffer can better stabilize the pH of the pharmaceutical composition to 5.2-5.6; Carbetocin injection with more stable properties can be obtained through the combination of carbetocin and stabilizer and appropriate pH, which can be stored at room temperature or ambient temperature, reducing drug production risks and transportation and storage costs, and improving safety of clinical medication.
具体实施方式Detailed ways
下面将对本发明实施例中的技术方案进行清楚、完整地描述，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。The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some of the embodiments of the present invention, but not all of them.
实施例1Example 1
一种卡贝缩宫素注射液的制备方法，包括以下步骤：A preparation method for carbetocin injection, comprising the following steps:
步骤一：称取所需的原辅料：卡贝缩宫素0.10g、琥珀酸2g、甲硫氨酸1g、氯化钠47g、赖氨酸3g、注射用水加至1L；Step 1: Weigh the required raw materials: carbetocin 0.10g, succinic acid 2g, methionine 1g, sodium chloride 47g, lysine 3g, water for injection to 1L;
步骤二：在30～50℃加入注射用水于容器中，加入琥珀酸、甲硫氨酸、氯化钠和赖氨酸，搅拌溶解；加入卡贝缩宫素，搅拌混合；加入盐酸或氢氧化钠溶液调节pH值至5.2±0.2，补加注射用水至所需配制量；Step 2: Add water for injection into the container at 30-50°C, add succinic acid, methionine, sodium chloride and lysine, stir to dissolve; add carbetocin, stir to mix; add hydrochloric acid or hydroxide Adjust the pH value of the sodium solution to 5.2±0.2, and add water for injection to the required preparation amount;
步骤三：溶液经0.45μm、0.22μm两级滤芯过滤后进入灌封设备，进行灌封。Step 3: After the solution is filtered by 0.45 μm and 0.22 μm two-stage filter elements, it enters the potting equipment for potting.
实施例2Example 2
一种卡贝缩宫素注射液的制备方法，包括以下步骤：A preparation method for carbetocin injection, comprising the following steps:
步骤一：称取所需的原辅料：卡贝缩宫素0.001g、琥珀酸0.1g、甲硫氨酸0.1g、氯化钠40g、赖氨酸0.1g、注射用水加至1L；Step 1: Weigh the required raw materials: carbetocin 0.001g, succinic acid 0.1g, methionine 0.1g, sodium chloride 40g, lysine 0.1g, water for injection to 1L;
步骤二：在30～50℃加入注射用水于容器中，加入琥珀酸、甲硫氨酸、氯化钠和赖氨酸，搅拌溶解；加入卡贝缩宫素，搅拌混合；加入盐酸或氢氧化钠溶液调节pH值至5.4±0.2，补加注射用水至所需配制量；Step 2: Add water for injection into the container at 30-50°C, add succinic acid, methionine, sodium chloride and lysine, stir to dissolve; add carbetocin, stir to mix; add hydrochloric acid or hydroxide Adjust the pH value of the sodium solution to 5.4±0.2, and add water for injection to the required preparation amount;
步骤三：溶液经0.45μm、0.22μm两级滤芯过滤后进入灌封设备，进行灌封。Step 3: After the solution is filtered by 0.45 μm and 0.22 μm two-stage filter elements, it enters the potting equipment for potting.
实施例3Example 3
一种卡贝缩宫素注射液的制备方法，包括以下步骤：A preparation method for carbetocin injection, comprising the following steps:
步骤一：称取所需的原辅料：卡贝缩宫素0.050g、琥珀酸1g、甲硫氨酸0.5g、氯化钠43g、赖氨酸1.5g、注射用水加至1L；Step 1: Weigh the required raw materials: carbetocin 0.050g, succinic acid 1g, methionine 0.5g, sodium chloride 43g, lysine 1.5g, water for injection to 1L;
步骤二：在30～50℃加入注射用水于容器中，加入琥珀酸、甲硫氨酸、氯化钠和赖氨酸，搅拌溶解；加入卡贝缩宫素，搅拌混合；加入盐酸或氢氧化钠溶液调节pH值至5.6±0.2，补加注射用水至所需配制量；Step 2: Add water for injection into the container at 30-50°C, add succinic acid, methionine, sodium chloride and lysine, stir to dissolve; add carbetocin, stir to mix; add hydrochloric acid or hydroxide Adjust the pH value of the sodium solution to 5.6±0.2, and add water for injection to the required preparation amount;
步骤三：溶液经0.45μm、0.22μm两级滤芯过滤后进入灌封设备，进行灌封。Step 3: After the solution is filtered by 0.45 μm and 0.22 μm two-stage filter elements, it enters the potting equipment for potting.
实施例4Example 4
一种卡贝缩宫素注射液的制备方法，包括以下步骤：A preparation method for carbetocin injection, comprising the following steps:
步骤一：称取所需的原辅料：卡贝缩宫素0.10g、乙酸2g、EDTA1g、蔗糖47g、组氨酸3g、注射用水加至1L；Step 1: Weigh the required raw materials: carbetocin 0.10g, acetic acid 2g, EDTA 1g, sucrose 47g, histidine 3g, water for injection to 1L;
步骤二：在30～50℃加入注射用水于容器中，加入乙酸、EDTA、蔗糖和组氨酸，搅拌溶解；加入卡贝缩宫素，搅拌混合；加入盐酸或氢氧化钠溶液调节pH值至5.2±0.2，补加注射用水至所需配制量；Step 2: Add water for injection into the container at 30-50°C, add acetic acid, EDTA, sucrose and histidine, stir to dissolve; add carbetocin, stir and mix; add hydrochloric acid or sodium hydroxide solution to adjust the pH value to 5.2±0.2, add water for injection to the required preparation volume;
步骤三：溶液经0.45μm、0.22μm两级滤芯过滤后进入灌封设备，进行灌封。Step 3: After the solution is filtered by 0.45 μm and 0.22 μm two-stage filter elements, it enters the potting equipment for potting.
实施例5Example 5
一种卡贝缩宫素注射液的制备方法，包括以下步骤：A preparation method for carbetocin injection, comprising the following steps:
步骤一：称取所需的原辅料：卡贝缩宫素0.10g、柠檬酸2g、焦亚硫酸钠1g、甘露醇47g、异亮氨酸3g、注射用水加至1L；Step 1: Weigh the required raw and auxiliary materials: carbetocin 0.10g, citric acid 2g, sodium metabisulfite 1g, mannitol 47g, isoleucine 3g, and water for injection to 1L;
步骤二：在30～50℃加入注射用水于容器中，加入柠檬酸、焦亚硫酸钠、甘露醇和异亮氨酸，搅拌溶解；加入卡贝缩宫素，搅拌混合；加入盐酸或氢氧化钠溶液调节pH值至5.4±0.2，补加注射用水至所需配制量；Step 2: Add water for injection into the container at 30-50°C, add citric acid, sodium metabisulfite, mannitol and isoleucine, and stir to dissolve; add carbetocin, stir and mix; add hydrochloric acid or sodium hydroxide solution to adjust When the pH value reaches 5.4±0.2, add water for injection to the required preparation amount;
步骤三：溶液经0.45μm、0.22μm两级滤芯过滤后进入灌封设备，进行灌封。Step 3: After the solution is filtered by 0.45 μm and 0.22 μm two-stage filter elements, it enters the potting equipment for potting.
实施例6Example 6
一种卡贝缩宫素注射液的制备方法，包括以下步骤：A preparation method for carbetocin injection, comprising the following steps:
步骤一：称取所需的原辅料：卡贝缩宫素0.10g、磷酸盐2g、甲硫氨酸1g、枸橼酸盐47g、色氨酸3g、注射用水加至1L；Step 1: Weigh the required raw materials: carbetocin 0.10g, phosphate 2g, methionine 1g, citrate 47g, tryptophan 3g, water for injection to 1L;
步骤二：在30～50℃加入注射用水于容器中，加入磷酸盐、甲硫氨酸、枸橼酸盐和色氨酸，搅拌溶解；加入卡贝缩宫素，搅拌混合；加入盐酸或氢氧化钠溶液调节pH值至5.6±0.2，补加注射用水至所需配制量；Step 2: Add water for injection into the container at 30-50°C, add phosphate, methionine, citrate and tryptophan, stir to dissolve; add carbetocin, stir to mix; add hydrochloric acid or hydrogen Adjust the pH value of the sodium oxide solution to 5.6±0.2, and add water for injection to the required preparation amount;
步骤三：溶液经0.45μm、0.22μm两级滤芯过滤后进入灌封设备，进行灌封。Step 3: After the solution is filtered by 0.45 μm and 0.22 μm two-stage filter elements, it enters the potting equipment for potting.
对比例1Comparative example 1
一种卡贝缩宫素注射液的制备方法，包括以下步骤：A preparation method for carbetocin injection, comprising the following steps:
步骤一：称取所需的原辅料：卡贝缩宫素0.10g、磷酸盐2g、甲硫氨酸1g、枸橼酸盐47g、注射用水加至1L；Step 1: Weigh the required raw materials: carbetocin 0.10g, phosphate 2g, methionine 1g, citrate 47g, water for injection to 1L;
步骤二：在30～50℃加入注射用水于容器中，加入磷酸盐、甲硫氨酸和枸橼酸盐，搅拌溶解；加入卡贝缩宫素，搅拌混合；加入盐酸或氢氧化钠溶液调节pH值至5.6±0.2，补加注射用水至所需配制量；Step 2: Add water for injection into the container at 30-50°C, add phosphate, methionine and citrate, stir to dissolve; add carbetocin, stir to mix; add hydrochloric acid or sodium hydroxide solution to adjust When the pH value reaches 5.6±0.2, add water for injection to the required preparation amount;
步骤三：溶液经0.45μm、0.22μm两级滤芯过滤后进入灌封设备，进行灌封。Step 3: After the solution is filtered by 0.45 μm and 0.22 μm two-stage filter elements, it enters the potting equipment for potting.
分别采用实施例1、2、3、4、5、6和原研样品质量进行对比研究。结果见表1所示。Adopt embodiment 1, 2, 3, 4, 5, 6 and original research sample quality to carry out comparative research respectively. The results are shown in Table 1.
结果表明，本发明的技术方案实施例1、2、3、4、5、6与原研样品的质量基本一致。The results show that the quality of the technical solution embodiments 1, 2, 3, 4, 5, and 6 of the present invention is basically the same as that of the original research sample.
制剂成品加速稳定性研究：Accelerated stability study of finished preparations:
采用实施例6制备成品，放置在加速条件下(温度25℃±2℃，RH60％±5％)，考察样品的稳定性情况，结果见表2所示：Adopt embodiment 6 to prepare finished product, be placed under accelerated condition (temperature 25 ℃ ± 2 ℃, RH60% ± 5%), investigate the stability situation of sample, the results are shown in Table 2:
采用对比例1制备成品，放置在加速条件下(温度25℃±2℃，RH60％±5％)，考察样品的稳定性情况，结果见表3所示：Adopt comparative example 1 to prepare finished product, be placed under accelerated condition (temperature 25 ℃ ± 2 ℃, RH60% ± 5%), investigate the stability situation of sample, the results are shown in Table 3:
结果表明，本发明的技术方案实施例6制备的成品在加速条件下的各项检测符合要求，产品质量稳定可靠，对比例1中将稳定剂去掉，制备的成品在加速条件下的无菌检测并不符合要求，而且杂质总量比实施例6多了很多，产品质量明显下降。The results show that the finished product prepared by technical solution embodiment 6 of the present invention meets the requirements in each detection under accelerated conditions, and the product quality is stable and reliable. Do not meet the requirements, and the total amount of impurities is much more than that of Example 6, and the product quality obviously declines.
本发明的稳定剂优选赖氨酸、组氨酸、异亮氨酸和色氨酸，当配合抗氧剂为甲硫氨酸时，两种氨基酸具有协同增效的作用，进一步提高了卡贝缩宫素注射液的稳定性，可获得性能更加稳定的卡贝缩宫素注射液，可以在室温或环境温度下保存，减少药物生产风险及运输贮存成本，提高临床用药的安全性。The preferred stabilizer of the present invention is lysine, histidine, isoleucine and tryptophan. When the antioxidant is methionine, the two amino acids have a synergistic effect, further improving the carbe The stability of oxytocin injection can obtain carbetocin injection with more stable performance, which can be stored at room temperature or ambient temperature, reducing the risk of drug production and transportation and storage costs, and improving the safety of clinical medication.
以上所述，仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，根据本发明的技术方案及其发明构思加以等同替换或改变，都应涵盖在本发明的保护范围之内。The above is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto, any person familiar with the technical field within the technical scope disclosed in the present invention, according to the technical solution of the present invention Any equivalent replacement or change of the inventive concepts thereof shall fall within the protection scope of the present invention.
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| CN118615242A (en)* | 2024-07-05 | 2024-09-10 | 杭州汉库医药科技有限公司 | Oxytocin injection capable of being stored at room temperature and preparation method thereof |
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