CN104644669A - Plasma substitute medicine composition used in first aid and preparation method thereof - Google Patents
Plasma substitute medicine composition used in first aid and preparation method thereof Download PDFInfo
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- 238000002360 preparation method Methods 0.000 title claims abstract description 10
- 239000003814 drug Substances 0.000 title claims abstract description 9
- 239000000203 mixture Substances 0.000 title claims abstract description 9
- 239000003058 plasma substitute Substances 0.000 title abstract description 13
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 42
- 229920001612 Hydroxyethyl starch Polymers 0.000 claims abstract description 26
- 239000011780 sodium chloride Substances 0.000 claims abstract description 21
- 208000032456 Hemorrhagic Shock Diseases 0.000 claims abstract description 9
- 206010049771 Shock haemorrhagic Diseases 0.000 claims abstract description 9
- 239000008194 pharmaceutical composition Substances 0.000 claims description 18
- 238000003756 stirring Methods 0.000 claims description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 11
- 239000008215 water for injection Substances 0.000 claims description 10
- 229940027278 hetastarch Drugs 0.000 claims 6
- 238000010438 heat treatment Methods 0.000 claims 2
- 239000012467 final product Substances 0.000 claims 1
- 230000001954 sterilising effect Effects 0.000 claims 1
- 229940050526 hydroxyethylstarch Drugs 0.000 abstract description 20
- 208000014674 injury Diseases 0.000 abstract description 4
- 230000000694 effects Effects 0.000 abstract description 3
- 238000009825 accumulation Methods 0.000 abstract description 2
- 230000023555 blood coagulation Effects 0.000 abstract description 2
- 208000027418 Wounds and injury Diseases 0.000 abstract 1
- 230000006378 damage Effects 0.000 abstract 1
- 230000036772 blood pressure Effects 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 210000004369 blood Anatomy 0.000 description 4
- 239000008280 blood Substances 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 4
- 239000000819 hypertonic solution Substances 0.000 description 4
- 229940021223 hypertonic solution Drugs 0.000 description 4
- 239000000644 isotonic solution Substances 0.000 description 4
- 210000002381 plasma Anatomy 0.000 description 4
- 238000006467 substitution reaction Methods 0.000 description 4
- 208000010718 Multiple Organ Failure Diseases 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 208000029744 multiple organ dysfunction syndrome Diseases 0.000 description 3
- 210000002700 urine Anatomy 0.000 description 3
- 241000282472 Canis lupus familiaris Species 0.000 description 2
- 208000035473 Communicable disease Diseases 0.000 description 2
- 206010019280 Heart failures Diseases 0.000 description 2
- 208000001953 Hypotension Diseases 0.000 description 2
- 208000012902 Nervous system disease Diseases 0.000 description 2
- 230000004872 arterial blood pressure Effects 0.000 description 2
- 210000000601 blood cell Anatomy 0.000 description 2
- 239000000084 colloidal system Substances 0.000 description 2
- 230000000004 hemodynamic effect Effects 0.000 description 2
- 230000036543 hypotension Effects 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 230000008733 trauma Effects 0.000 description 2
- 206010001052 Acute respiratory distress syndrome Diseases 0.000 description 1
- 229920000945 Amylopectin Polymers 0.000 description 1
- 229920002261 Corn starch Polymers 0.000 description 1
- 241000711549 Hepacivirus C Species 0.000 description 1
- 241000725303 Human immunodeficiency virus Species 0.000 description 1
- 206010020852 Hypertonia Diseases 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- 208000001647 Renal Insufficiency Diseases 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 239000008120 corn starch Substances 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 210000001105 femoral artery Anatomy 0.000 description 1
- 210000003191 femoral vein Anatomy 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 230000004217 heart function Effects 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 229940036998 hypertonic sodium chloride Drugs 0.000 description 1
- 230000006749 inflammatory damage Effects 0.000 description 1
- 230000028709 inflammatory response Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 201000006370 kidney failure Diseases 0.000 description 1
- 238000002690 local anesthesia Methods 0.000 description 1
- 230000005923 long-lasting effect Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000000440 neutrophil Anatomy 0.000 description 1
- 230000008816 organ damage Effects 0.000 description 1
- 229940021222 peritoneal dialysis isotonic solution Drugs 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000007670 refining Methods 0.000 description 1
- 230000008085 renal dysfunction Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
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- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract
Description
技术领域technical field
本发明涉及急救用的代血浆药物组合物及其制备方法，属于药物组合物技术领域。The invention relates to a blood plasma replacement pharmaceutical composition for emergency use and a preparation method thereof, belonging to the technical field of pharmaceutical compositions.
背景技术Background technique
失血性休克的传统复苏是用等渗晶体液和/或胶体液早期、快速、足量输入，以尽快恢复血流动力学为目标，往往存在复苏后内脏灌注不足，全身炎症反应综合征（SIRS）,甚至发展成为多脏器功能障碍综合征（MODS）。目前急性呼吸窘迫综合征（ARDS）和MODS是创伤-失血性休克复苏后延迟死亡的主要原因。能减轻复苏后炎症反应和器官损伤的复苏方法，是目前治疗失血性休克的关注焦点。The traditional resuscitation of hemorrhagic shock is to use isotonic crystalloid and/or colloid fluid to infuse early, quickly, and in sufficient quantities, with the goal of restoring hemodynamics as soon as possible. ), and even developed into multiple organ dysfunction syndrome (MODS). Acute respiratory distress syndrome (ARDS) and MODS are currently the main causes of delayed death after resuscitation of trauma-hemorrhagic shock. Resuscitation methods that can reduce the inflammatory response and organ damage after resuscitation are the current focus of attention in the treatment of hemorrhagic shock.
与等渗溶液相比，高渗溶液具有抑制中性粒细胞活化和减轻炎症损伤的优点，小容量复苏即可获得满意的血流动力学效果，应用于战场和医院前的急救具有便于运输、易于实施的优势。Compared with isotonic solutions, hypertonic solutions have the advantages of inhibiting the activation of neutrophils and reducing inflammatory damage, and small volume resuscitation can obtain satisfactory hemodynamic effects. It is easy to transport, The advantage of being easy to implement.
为了解决输血所存在的导致各种血源性传染病的问题，技术人员曾经研究用高渗氯化钠治疗出血性休克。高渗溶液例如7.5%（w/v）氯化钠、7.2%氯化钠，但此高渗浓度的氯化钠对机体有一定的毒性，往往会导致并发症，例如低血压、过高渗导致的血细胞破裂、心功能不全、肾功能减退及神经系统障碍等。In order to solve the problem of various blood-borne infectious diseases caused by blood transfusion, technicians once studied the treatment of hemorrhagic shock with hypertonic sodium chloride. Hypertonic solutions such as 7.5% (w/v) sodium chloride and 7.2% sodium chloride, but this hypertonic concentration of sodium chloride has certain toxicity to the body and often leads to complications, such as hypotension, hypertonicity Blood cell rupture, cardiac insufficiency, renal insufficiency, and nervous system disorders.
目前已有的血浆代用品还不能很好的满足临床应用的需要，还需要更好的代血浆药物组合物应用于伤病员的急救领域，特别是应用于急性创伤造成的失血性休克的抢救。At present, the existing plasma substitutes can not meet the needs of clinical application well, and a better plasma substitute pharmaceutical composition is needed to be used in the field of first aid for the wounded and sick, especially for the rescue of hemorrhagic shock caused by acute trauma .
发明内容Contents of the invention
本发明提供一种急救用的代血浆药物组合物及其制备方法。The invention provides a first-aid medical composition for replacing blood plasma and a preparation method thereof.
本发明的技术方案如下：Technical scheme of the present invention is as follows:
一种代血浆药物组合物，包括2-4.5%（w/v，即100mL组合物中含有2-4.5g）的氯化钠和3-7%（w/v，即100mL组合物中含有3-7g）的羟乙基淀粉，以及余量的注射用水，其中，所述的羟乙基淀粉的平均分子量为130000±20000道尔顿。A plasma substitute pharmaceutical composition, comprising 2-4.5% (w/v, 2-4.5g in 100mL composition) sodium chloride and 3-7% (w/v, 3 -7g) of hydroxyethyl starch, and the rest of water for injection, wherein the average molecular weight of the hydroxyethyl starch is 130000±20000 Daltons.
优选的，所述代血浆药物组合物包括4.2%（w/v）的氯化钠和6%（w/v）的羟乙基淀粉。Preferably, the plasma replacement pharmaceutical composition includes 4.2% (w/v) sodium chloride and 6% (w/v) hydroxyethyl starch.
优选的，所述的羟乙基淀粉平均分子量为130000±20000道尔顿，置换度为0.4±0.1。Preferably, the average molecular weight of the hydroxyethyl starch is 130000±20000 Daltons, and the degree of substitution is 0.4±0.1.
优选的，所述的羟乙基淀粉平均分子量为130000±20000道尔顿，置换度为0.4±0.1，C2∶C6大于8。Preferably, the average molecular weight of the hydroxyethyl starch is 130,000±20,000 Daltons, the degree of substitution is 0.4±0.1, and C2:C6 is greater than 8.
本发明所称置换度又称为取代度。The degree of substitution referred to in the present invention is also called the degree of substitution.
本发明药物组合物的制备方法如下：The preparation method of pharmaceutical composition of the present invention is as follows:
将羟乙基淀粉溶于注射用水，80-95℃搅拌加热10-20分钟，加入氯化钠搅拌溶解，80-95℃搅拌加热5-20分钟，过滤，灌装，灭菌，即得。Dissolve hydroxyethyl starch in water for injection, stir and heat at 80-95°C for 10-20 minutes, add sodium chloride and stir to dissolve, stir and heat at 80-95°C for 5-20 minutes, filter, fill, and sterilize to obtain the product.
本发明采用一定浓度的羟乙基淀粉和氯化钠溶液作为代血浆药物组合物，具有以下优点：The present invention uses a certain concentration of hydroxyethyl starch and sodium chloride solution as a plasma substitute pharmaceutical composition, which has the following advantages:
1、避免使用输血方式治疗失血性休克时，带来的血源性传染病，例如HIV病毒、丙肝病毒等。与血液相比，本发明药物组合物常温保存即可。1. Avoid blood-borne infectious diseases, such as HIV virus and hepatitis C virus, caused by blood transfusion in the treatment of hemorrhagic shock. Compared with blood, the pharmaceutical composition of the present invention can be stored at room temperature.
2、使用4.2%浓度的氯化钠形成高渗溶液，与等渗溶液相比，可以减少代血浆溶液的用量，减少由于等渗溶液造成的水肿、心脏、肾脏负荷过重；并且与等渗溶液相比较，能够短时起效，5-10分钟内即可明显改善失血症状；同时也避免了7.5%或者7.2%浓度的氯化钠高渗溶液所引起的各种并发症，例如低血压、过高渗导致的血细胞破裂、心功能不全、肾功能减退及神经系统障碍等。2. Using 4.2% sodium chloride to form hypertonic solution, compared with isotonic solution, can reduce the amount of plasma replacement solution, reduce edema, heart and kidney overload caused by isotonic solution; and isotonic solution Compared with the solution, it can take effect in a short time, and the symptoms of blood loss can be significantly improved within 5-10 minutes; at the same time, various complications caused by 7.5% or 7.2% sodium chloride hypertonic solution, such as hypotension, can be avoided , blood cell rupture caused by hyperosmosis, cardiac insufficiency, renal dysfunction and nervous system disorders.
3、使用平均分子量130,000道尔顿的羟乙基淀粉作为胶体，形成胶体溶液，与分子量25,000-45,000的羟乙基淀粉溶液相比，血浆扩容作用强、效力持久、药物蓄积倾向低、安全性高，对人体凝血作用的影响更小。3. Use hydroxyethyl starch with an average molecular weight of 130,000 Daltons as the colloid to form a colloidal solution. Compared with the hydroxyethyl starch solution with a molecular weight of 25,000-45,000, it has a strong plasma expansion effect, long-lasting effect, low drug accumulation tendency, and safety High, less impact on human blood coagulation.
本发明药物组合物的用途为，用于治疗各种原因引起的失血性休克，作为血浆代用品用于外伤、烧伤病人的抢救，在各种手术中作为血浆代用品使用。The application of the pharmaceutical composition of the present invention is to treat hemorrhagic shock caused by various reasons, to be used as a plasma substitute for rescuing trauma and burn patients, and to be used as a plasma substitute in various operations.
具体实施方式Detailed ways
以下通过实施例对本发明作进一步说明，但这并非是对本发明的限制，本领域技术人员根据本发明的基本思想，可以做出各种修改或改进，但是只要不脱离本发明的基本思想，均在本发明的范围之内。The present invention will be further described below by embodiment, but this is not restriction of the present invention, those skilled in the art can make various modifications or improvements according to the basic idea of the present invention, but as long as not departing from the basic idea of the present invention, all within the scope of the present invention.
实施例1：Example 1:
羟乙基淀粉130/0.4原料药制备：以支链玉米淀粉为起始原料，经过水解、羟乙基化、精制制得。Hydroxyethyl starch 130/0.4 raw material preparation: It is prepared from amylopectin corn starch through hydrolysis, hydroxyethylation and refining.
实施例2：Example 2:
羟乙基淀粉130/0.4 6克Hydroxyethyl starch 130/0.4 6 grams
氯化钠 4.2克Sodium chloride 4.2 g
注射用水 加到100毫升Add water for injection to 100ml
将羟乙基淀粉溶于注射用水，90℃搅拌加热15分钟，加入氯化钠搅拌溶解，90℃搅拌加热10分钟，过滤，灌装，灭菌，即得。Dissolve hydroxyethyl starch in water for injection, stir and heat at 90°C for 15 minutes, add sodium chloride and stir to dissolve, stir and heat at 90°C for 10 minutes, filter, fill, and sterilize to obtain the product.
实施例3：Example 3:
羟乙基淀粉130/0.4 7克Hydroxyethyl starch 130/0.4 7 grams
氯化钠 2克Sodium chloride 2 grams
注射用水 加到100毫升Add water for injection to 100ml
将羟乙基淀粉溶于注射用水，90℃搅拌加热15分钟，加入氯化钠搅拌溶解，90℃搅拌加热10分钟，过滤，灌装，灭菌，即得。Dissolve hydroxyethyl starch in water for injection, stir and heat at 90°C for 15 minutes, add sodium chloride and stir to dissolve, stir and heat at 90°C for 10 minutes, filter, fill, and sterilize to obtain the product.
实施例4：Example 4:
羟乙基淀粉130/0.4 4克Hydroxyethyl starch 130/0.4 4 g
氯化钠 4.5克Sodium chloride 4.5 g
注射用水 加到100毫升Add water for injection to 100ml
将羟乙基淀粉溶于注射用水，90℃搅拌加热15分钟，加入氯化钠搅拌溶解，90℃搅拌加热10分钟，过滤，灌装，灭菌，即得。Dissolve hydroxyethyl starch in water for injection, stir and heat at 90°C for 15 minutes, add sodium chloride and stir to dissolve, stir and heat at 90°C for 10 minutes, filter, fill, and sterilize to obtain the product.
实验例：Experimental example:
成年健康杂种狗，雌雄均可，局麻下分离出股动脉、静脉，分别插入导管，动脉导管与心功能检测仪连接以检测其动脉压，使狗放血到平均动脉压（MAP）为40-50mmHg，放血时间控制在15分钟左右，使该血压维持1小时后，按8ml/kg输入本发明实施例2药物组合物、对比例1、对比例2药物组合物。Adult healthy mongrel dogs, both male and female, were separated from the femoral artery and vein under local anesthesia, and catheters were inserted respectively. The arterial catheter was connected to a heart function detector to detect its arterial pressure, and the dog was bled until the mean arterial pressure (MAP) was 40- 50mmHg, the bloodletting time was controlled at about 15 minutes, and after the blood pressure was maintained for 1 hour, the pharmaceutical composition of Example 2 of the present invention, the pharmaceutical composition of Comparative Example 1, and Comparative Example 2 were injected at 8ml/kg.
对比例1：7.2%氯化钠和6%羟乙基淀粉（平均分子量130,000），制备方法同本发明实施例2。Comparative example 1: 7.2% sodium chloride and 6% hydroxyethyl starch (average molecular weight 130,000), the preparation method is the same as that of Example 2 of the present invention.
对比例2：4.2%氯化钠和7.6%羟乙基淀粉（平均分子量40,000），制备方法同本发明实施例2。Comparative example 2: 4.2% sodium chloride and 7.6% hydroxyethyl starch (average molecular weight 40,000), the preparation method is the same as that of Example 2 of the present invention.
在输液后4小时例检测血压和尿量。Blood pressure and urine output were measured 4 hours after the infusion.
下表中，血压为恢复到基础血压水平的百分数，尿量单位为ml/kg体重/小时。In the table below, blood pressure is the percentage of recovery to the baseline blood pressure level, and the unit of urine output is ml/kg body weight/hour.
（续上表）(continued from the above table)
可见，本发明的药物组合物能迅速而且持久的恢复血压，并且不会由于摄入过多水分而引起尿量过度增加。It can be seen that the pharmaceutical composition of the present invention can quickly and sustainably restore blood pressure, and will not cause excessive increase in urine output due to excessive intake of water.
Claims (6)
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Citations (4)
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|---|---|---|---|---|
| CN1235833A (en) * | 1998-05-15 | 1999-11-24 | 赵超英 | Novel drug composition for treating and curing and its preparing method |
| CN1739561A (en) * | 2005-09-23 | 2006-03-01 | 赵超英 | Application of high permeability medicine composition in preparing pre-nacrosis medicine |
| CN101209344A (en) * | 2006-12-28 | 2008-07-02 | 赵超英 | Application of hyperosmotic fluid composition in preparing medicament for improving wound healing |
| CN101579307A (en) * | 2008-05-14 | 2009-11-18 | 北京申科联华科技有限公司 | Application of hypertonic injection to preparation of medicament accelerating wound healing |
-
2013
- 2013-11-19 CN CN201310585559.0A patent/CN104644669A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1235833A (en) * | 1998-05-15 | 1999-11-24 | 赵超英 | Novel drug composition for treating and curing and its preparing method |
| CN1739561A (en) * | 2005-09-23 | 2006-03-01 | 赵超英 | Application of high permeability medicine composition in preparing pre-nacrosis medicine |
| CN101209344A (en) * | 2006-12-28 | 2008-07-02 | 赵超英 | Application of hyperosmotic fluid composition in preparing medicament for improving wound healing |
| CN101579307A (en) * | 2008-05-14 | 2009-11-18 | 北京申科联华科技有限公司 | Application of hypertonic injection to preparation of medicament accelerating wound healing |
Non-Patent Citations (1)
| Title |
|---|
| 王玉琨 等: "《军事药物学》", 31 May 2013, 第四军医大学出版社 * |
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