技术领域technical field
本发明涉及血浆采集方法，特别涉及一种用于采集活猪血浆的方法。The invention relates to a plasma collection method, in particular to a method for collecting live pig plasma.
背景技术Background technique
在医疗领域中，随着医疗科技的迅猛发展，为了减少临床医药产品对人体血浆的依赖性，越来越倾向于采用动物的血浆。例如，以活猪的血浆为主要原料的猪源纤维蛋白粘合剂等生物医药制品，其已经被广泛应用于临床外科手术。特别是在脏器手术之后，此类制品经创面喷涂代替缝合，可以快速地完成创面的止血，从而减少了病人术后的弥漫性出血风险。这样可以有效地降低病人的手术痛苦，同时减少临床血液需求，对社会有显著的效益。In the medical field, with the rapid development of medical technology, in order to reduce the dependence of clinical pharmaceutical products on human plasma, it is more and more inclined to use animal plasma. For example, biomedical products such as pig-derived fibrin adhesives, which use live pig plasma as the main raw material, have been widely used in clinical surgery. Especially after organ surgery, such products can be sprayed on the wound surface instead of suturing, which can quickly complete the hemostasis of the wound surface, thereby reducing the risk of diffuse bleeding for patients after surgery. This can effectively reduce the patient's surgical pain and reduce the clinical blood demand, which has significant benefits to the society.
然而，目前相关生物医药企业的原料均来自于活猪屠宰过程中的现场采集。这种采集过程容易受屠宰环境影响，无法避免相关原料的微生物及不明杂质污染。对于现场采集的猪血需要二次分离才能获得血浆，分离后的残余猪血难以处理，分离过程不仅容易造成血浆的二次污染，而且极易破坏血浆的有效活性成分。However, at present, the raw materials of relevant biopharmaceutical companies all come from on-site collection during the slaughtering process of live pigs. This collection process is easily affected by the slaughter environment, and it is impossible to avoid the contamination of microorganisms and unknown impurities of related raw materials. Pig blood collected on site requires secondary separation to obtain plasma, and the residual pig blood after separation is difficult to handle. The separation process not only easily causes secondary pollution of plasma, but also easily destroys the effective active components of plasma.
此外，由于无法预知活猪被屠宰前是否感染病菌或病毒，这种方法获得的血浆难以从源头上解决人畜共患疾病的传播问题，不能满足相关医药法规对药品的可追溯要求，因此相关药品质量就难以保证。In addition, since it is impossible to predict whether live pigs will be infected with bacteria or viruses before slaughter, the plasma obtained by this method is difficult to solve the problem of the spread of zoonotic diseases from the source, and cannot meet the traceability requirements of relevant pharmaceutical regulations for drugs, so related drugs Quality is difficult to guarantee.
因此，为符合相关法规的控制要求，确保相关药品安全有效，必须对供体猪长期封闭健康养殖并定期在洁净环境下活体采集，本领域技术人员亟待获取一种有效且安全的采集血浆的方法。Therefore, in order to comply with the control requirements of relevant laws and regulations and ensure the safety and effectiveness of relevant drugs, it is necessary to keep the donor pigs closed and healthy for a long time and collect them regularly in a clean environment. Those skilled in the art urgently need to obtain an effective and safe plasma collection method. .
发明内容Contents of the invention
本发明要解决的技术问题是为了克服现有技术中采集活猪血浆容易受到环境影响，造成血浆二次污染的缺陷，提供一种用于采集活猪血浆的方法。The technical problem to be solved by the present invention is to provide a method for collecting live pig plasma in order to overcome the defects in the prior art that the collection of live pig plasma is easily affected by the environment and cause secondary pollution of plasma.
本发明是通过下述技术方案来解决上述技术问题的：一种用于采集活猪血浆的方法，其特点在于，所述方法包括以下步骤：The present invention solves the above-mentioned technical problems through the following technical solutions: a method for collecting live pig blood plasma, characterized in that the method comprises the following steps:
步骤一、将待采猪全身捆绑固定至采血车上；Step 1. Bind and fix the whole body of the pig to be collected on the blood collection vehicle;
步骤二、选取待采猪的头颈部位进行消毒处理；Step 2, select the head and neck of the pig to be harvested for disinfection;
步骤三、用连接注射器的穿刺针缓慢穿刺所述待采猪的头颈部位，待注射器内见到红色血液后拔去注射器，将导丝插入所述穿刺针内，拔出所述穿刺针；Step 3, slowly puncture the head and neck of the pig to be harvested with a puncture needle connected to a syringe, pull out the syringe after seeing red blood in the syringe, insert the guide wire into the puncture needle, and pull out the puncture needle;
步骤四、将采集导管沿所述导丝缓慢推入血管内，抽出所述导丝。Step 4: Slowly push the collection catheter into the blood vessel along the guide wire, and pull out the guide wire.
较佳地，在所述步骤一之前还包括以下步骤：采用捕猪器将待采猪捕捉夹紧、提升及翻转，并推送至采血车上。Preferably, the following steps are also included before the first step: using a pig trap to catch, clamp, lift and turn over the pigs to be collected, and push them to the blood collection vehicle.
较佳地，所述方法还包括步骤五：将所述采集导管与所述采浆耗材连接，所述采浆耗材与全自动采浆机连接，且所述采浆耗材与抗凝剂连接。Preferably, the method further includes step 5: connecting the collecting conduit to the consumable pulp collection, the consumable pulp collection is connected to a fully automatic pulp collection machine, and the consumable pulp collection is connected to an anticoagulant.
较佳地，在所述全自动采浆机上连接有血浆收集袋，所述血浆收集袋与所述采浆耗材连通。Preferably, a plasma collection bag is connected to the automatic plasma collection machine, and the plasma collection bag communicates with the plasma collection consumables.
较佳地，所述全自动采浆机的采浆速度为90ml/min，回输速度为60ml/min，单程采集量为200ml。Preferably, the pulp extraction speed of the automatic pulp harvester is 90ml/min, the reinfusion speed is 60ml/min, and the single-pass collection volume is 200ml.
较佳地，所述方法还包括步骤六：启动所述全自动采浆机进行血浆的自动采集。Preferably, the method further includes step six: starting the automatic plasma collection machine for automatic collection of plasma.
较佳地，所述方法还包括步骤七：当单程采集血浆达到200ml后，所述全自动采浆机自动切换至回输状态；当所述全自动采浆机内血球回输完毕后，再自动切换至下一个采集单程，直至设定的总采集量完成为止。Preferably, the method further includes step seven: when the single-pass collection of plasma reaches 200ml, the automatic plasma collection machine automatically switches to the reinfusion state; Automatically switch to the next acquisition process until the set total acquisition volume is completed.
较佳地，所述方法还包括步骤八：待所述全自动采浆机停止工作后，采用热合机将所述血浆收集袋的管路热合封闭；Preferably, the method further includes step 8: after the automatic plasma harvester stops working, use a heat sealing machine to heat seal the pipeline of the plasma collection bag;
步骤九：保留所述血浆收集袋上的管路长度为30cm，其余管路剪除，将所述血浆收集袋倒置，并确保保留的所述管路内充满血浆；Step 9: Keep the length of the pipeline on the plasma collection bag as 30cm, cut off the remaining pipelines, turn the plasma collection bag upside down, and ensure that the retained pipeline is filled with plasma;
步骤十：在保留的所述管路的10cm和20cm处分别采用热合封闭形成三段检测样品管，在所述血浆收集袋和三段所述检测样品管上分别贴上与所述待采猪相同的编号标贴；Step 10: Use heat sealing to form three sections of test sample tubes at 10 cm and 20 cm of the reserved pipeline, respectively, and paste the pigs to be collected on the plasma collection bag and the three sections of test sample tubes. the same numbered sticker;
步骤十一：剪下两段所述检测样品管，用于血浆质量检测及复检，将所述血浆收集袋立即放至-20℃的冷库中保存。Step 11: Cut off two sections of the test sample tube for plasma quality testing and re-examination, and immediately put the plasma collection bag in a -20°C freezer for storage.
较佳地，所述步骤二中选取待采猪的头颈部位为15cm×20cm，采用纯化水清洁，且用75％的乙醇进行消毒。Preferably, in the second step, the head and neck of the pig to be harvested is selected to be 15cm×20cm, cleaned with purified water, and sterilized with 75% ethanol.
较佳地，所述导丝的直径为0.021cm，长度为20cm，所述采集导管的长度为6cm。Preferably, the guide wire has a diameter of 0.021 cm and a length of 20 cm, and the collection catheter has a length of 6 cm.
本发明的积极进步效果在于：本发明用于采集活猪血浆的方法可以有效便捷地获取猪血浆，而且所述猪血浆无需二次分离，减少了环境污染以及环境对血浆造成的二次污染。同时可以降低血浆初始的染菌数，杜绝了人畜共患疾病的传播，避免溶血现象发生，提高了血浆中活性蛋白的含量，从而为以猪血浆为原料的生物制品提供了可靠的质量保障。The positive and progressive effect of the present invention is that the method for collecting live pig plasma can effectively and conveniently obtain pig plasma, and the pig plasma does not require secondary separation, reducing environmental pollution and secondary pollution of plasma caused by the environment. At the same time, it can reduce the initial number of bacteria in plasma, prevent the spread of zoonotic diseases, avoid hemolysis, and increase the content of active protein in plasma, thus providing reliable quality assurance for biological products made of pig plasma.
附图说明Description of drawings
图1为本发明用于采集活猪血浆的方法的采集示意图。Fig. 1 is a collection schematic diagram of the method for collecting living pig plasma according to the present invention.
具体实施方式detailed description
下面结合附图给出本发明的较佳实施例，以详细说明本发明的技术方案。The preferred embodiments of the present invention are given below in conjunction with the accompanying drawings to describe the technical solution of the present invention in detail.
本发明用于采集活猪血浆的方法主要包括活猪免疫接种、封闭健康养殖、猪血液病原体检测、健康猪捕捉固定并待采、采集部位表皮清洁消毒处理、穿刺预埋采集导管、连接全自动采浆机的配套耗材、自动采集、速冻及人畜共患疾病窗口期检测等过程。The method for collecting live pig plasma of the present invention mainly includes live pig immunization, closed healthy breeding, detection of pig blood pathogens, healthy pig capture and fixation and waiting for collection, cleaning and disinfection of the surface of the collection site, puncture and pre-embedded collection catheters, and automatic connection. Processes such as supporting consumables for pulp harvesters, automatic collection, quick freezing, and window period detection of zoonotic diseases.
在进行采集活猪血浆之前，首先要求选择健康的幼猪编号进行口蹄疫、高致病性猪蓝耳病、猪瘟等动物疫病进行免疫接种。此处的免疫程序按照《2013年国家动物疫病强制免疫计划》进行，免疫后进行相关病原体检测并建立免疫健康档案，不合格者立即隔离。Before collecting live pig plasma, it is first required to select healthy young pig numbers for immunization against animal diseases such as foot-and-mouth disease, highly pathogenic porcine blue-ear disease, and swine fever. The immunization procedures here are carried out in accordance with the "2013 National Compulsory Immunization Plan for Animal Diseases". After immunization, relevant pathogens are tested and immune health records are established. Those who fail to pass the test are immediately isolated.
将经过免疫的健康猪饲养于封闭的洁净环境内，分圈饲养。喂养高蛋白幼猪饲料至健康猪的体重达到50公斤后，改喂成猪粗料，将猪的体重控制在每周增加值约为2公斤。The immunized healthy pigs are raised in a closed clean environment and raised in separate pens. Feed high-protein young pig feed until the weight of healthy pigs reaches 50 kg, then switch to coarse feed for pigs, and control the weight of pigs at a weekly gain of about 2 kg.
通常，选取体重50公斤以上的健康猪进行血浆采集，50公斤-80公斤的单次总采浆量为1000ml；体重81公斤-100公斤的单次总采浆量为1600ml；体重101公斤以上的单次总采浆量为2000ml。每两次采集的间隔时间要大于等于6天。Usually, healthy pigs with a body weight of more than 50 kg are selected for plasma collection. The total plasma volume of a single pig with a weight of 50 kg to 80 kg is 1000ml; The total slurry volume for a single time is 2000ml. The interval between two collections should be greater than or equal to 6 days.
图1为本发明用于采集活猪血浆的方法的采集示意图。如图1所示，本发明用于采集活猪血浆的方法包括以下步骤：Fig. 1 is a collection schematic diagram of the method for collecting living pig plasma according to the present invention. As shown in Figure 1, the present invention is used for collecting the method for living pig blood plasma and comprises the following steps:
步骤一：将待采猪全身捆绑固定至采血车上。Step 1: Bind and fix the whole body of the pig to be collected on the blood collection vehicle.
在对待采猪进行采血浆之前，需要先采用捕猪器将待采猪捕捉夹紧、提升及翻转，并推送至采血车上，然后将其全身捆绑固定，从而保证采集血浆过程中待采猪的稳固，避免其挣脱采集设备。这样即可为后续血浆采集提供全程稳定可靠的固定条件。Before collecting blood from the pigs to be collected, it is necessary to use a pigtrap to catch, clamp, lift and flip the pigs to be collected, and push them to the blood collection vehicle, and then bind and fix them all over the body, so as to ensure that the pigs to be collected during the plasma collection process stable to prevent it from breaking away from the collection device. In this way, stable and reliable fixed conditions can be provided for the subsequent plasma collection.
步骤二：选取待采猪的头颈部位进行消毒处理。Step 2: Select the head and neck of the pigs to be harvested for disinfection.
具体地，可以选取待采猪头颈部位的合适部位15cm×20cm大小的区域进行备皮，用500ml的纯化水清洁并擦干备皮部位，然后用75％乙醇棉球表面消毒处理。Specifically, a suitable area of 15 cm × 20 cm in the head and neck of the pig to be harvested can be selected for skin preparation, cleaned and dried with 500 ml of purified water, and then surface-sterilized with 75% ethanol cotton balls.
步骤三：用连接注射器的穿刺针缓慢穿刺所述待采猪的头颈部位，待注射器内见到红色血液后拔去注射器，将导丝插入所述穿刺针内，拔出所述穿刺针。Step 3: Slowly puncture the head and neck of the pig to be harvested with a puncture needle connected to a syringe, pull out the syringe after seeing red blood in the syringe, insert a guide wire into the puncture needle, and pull out the puncture needle.
所述导丝优选为不锈钢导丝。所述导丝的直径优选为0.021cm，长度为20cm。The guide wire is preferably a stainless steel guide wire. The guide wire preferably has a diameter of 0.021 cm and a length of 20 cm.
步骤四：将采集导管沿所述导丝缓慢推入血管内，抽出所述导丝。将采集导管500留在血管内备用，所述采集导管的长度优选为6cm，其直径优选为20G，即约等于0.812mm。Step 4: Slowly push the collection catheter into the blood vessel along the guide wire, and pull out the guide wire. The collection catheter 500 is left in the blood vessel for use. The length of the collection catheter is preferably 6 cm, and its diameter is preferably 20G, which is approximately equal to 0.812 mm.
步骤五：将采集导管500与采浆耗材400连接，采浆耗材400与全自动采浆机200连接，且采浆耗材400与抗凝剂300连接(如图1所示)。Step 5: Connect the collecting conduit 500 to the pulp collection consumable 400, connect the pulp collection consumable 400 to the automatic pulp collection machine 200, and connect the pulp collection consumable 400 to the anticoagulant 300 (as shown in FIG. 1 ).
在采集血浆时，采集导管500如上述步骤四所述，缓慢推入待采猪100的血管内，从而实现待采猪100与整套采集系统的连接。在全自动采浆机200上连接有血浆收集袋600，血浆收集袋600与采浆耗材400连通。特别将血浆收集袋600挂于称重挂钩上，完成装配连接后的示意图如图1所示。When collecting plasma, the collection catheter 500 is slowly pushed into the blood vessel of the pig 100 to be collected as described in step 4 above, so as to realize the connection between the pig 100 to be collected and the entire collection system. A plasma collection bag 600 is connected to the automatic plasma collection machine 200 , and the plasma collection bag 600 communicates with the plasma collection consumable 400 . In particular, the plasma collection bag 600 is hung on the weighing hook, and the schematic diagram after the assembly and connection is completed is shown in FIG. 1 .
步骤六：启动所述全自动采浆机进行血浆的自动采集。Step 6: Start the automatic plasma collection machine to collect plasma automatically.
优选地，在启动之前，将全自动采浆机200的采浆速度调节为90ml/min，回输速度为60ml/min，单程采集量为200ml。当然全自动采浆机200的这些参数可以根据待采猪100的体重设定总采集量。当开始进行采集血浆时，启动全自动采浆机200的充液按钮，保证采集管道内充满抗凝剂300，按下采集按钮开始采集。Preferably, before starting, the pulp extraction speed of the automatic pulp harvester 200 is adjusted to 90ml/min, the reinfusion speed is 60ml/min, and the single-pass collection volume is 200ml. Of course, these parameters of the fully automatic pulp harvester 200 can set the total collection amount according to the body weight of the pig 100 to be harvested. When starting to collect plasma, start the liquid filling button of the automatic plasma collection machine 200 to ensure that the collection pipeline is filled with anticoagulant 300, and press the collection button to start collection.
步骤七：当单程采集血浆达到200ml后，所述全自动采浆机自动切换至回输状态；当所述全自动采浆机内血球回输完毕后，再自动切换至下一个采集单程，直至设定的总采集量完成为止。Step 7: When the one-way collection of plasma reaches 200ml, the automatic plasma collection machine automatically switches to the reinfusion state; when the blood cell reinfusion in the automatic plasma collection machine is completed, it automatically switches to the next collection single-pass until until the set total collection amount is completed.
步骤八：待所述全自动采浆机停止工作后，采用热合机将血浆收集袋600的管路热合封闭。Step 8: After the automatic plasma harvester stops working, use a heat sealing machine to heat seal the pipeline of the plasma collection bag 600 .
步骤九：保留所述血浆收集袋上的管路长度为30cm，其余管路剪除，将所述血浆收集袋倒置，并确保保留的所述管路内充满血浆。Step 9: Keep the length of the pipeline on the plasma collection bag as 30 cm, cut off the remaining pipelines, turn the plasma collection bag upside down, and ensure that the retained pipeline is filled with plasma.
步骤十：在保留的所述管路的10cm和20cm处分别采用热合封闭形成三段检测样品管，在血浆收集袋600和三段所述检测样品管上分别贴上与所述待采猪相同的编号标贴。Step 10: Use heat sealing to form three-section test sample tubes at 10 cm and 20 cm of the reserved pipeline, respectively, and paste the same labels as the pigs to be collected on the plasma collection bag 600 and the three-section test sample tubes. number stickers.
步骤十一：剪下两段所述检测样品管，用于血浆质量检测及复检，将所述血浆收集袋立即放至-20℃的冷库中保存。Step 11: Cut off two sections of the test sample tube for plasma quality testing and re-examination, and immediately put the plasma collection bag in a -20°C freezer for storage.
对于同一待采猪100，在间隔60天的窗口期后进行再次采集血浆，只有前后两侧采集的血浆经检测均合格后，才可以确定前次(即60日前)的血浆为合格血浆。具体地操作方式是：当对血浆质量的检测合格后，相应编号的血浆将继续冷冻保存。待大概60日后，该相应编号的猪可以再次进行采集血浆或耳静脉血液样本检测合格后，前次采集的血浆即为合格血浆，可以用于生产。如后次样本不合格，则前次血浆视为不合格品，该相应编号的猪需要进行立即隔离。For the same pig 100 to be collected, the plasma is collected again after a window period of 60 days. Only after the plasma collected on the front and rear sides are all qualified can it be determined that the plasma of the previous time (ie 60 days ago) is qualified plasma. The specific operation method is: when the quality of the plasma is qualified, the plasma with the corresponding number will continue to be frozen and stored. After about 60 days, the pigs with the corresponding number can collect plasma or ear vein blood samples again and pass the test. The plasma collected last time is qualified plasma and can be used for production. If the latter sample is unqualified, the previous plasma is regarded as unqualified, and the pigs with the corresponding number need to be isolated immediately.
由于设定了60日的窗口期，这样就可以完全剔除在窗口期内可能存在的因病原体滴度过低而无法检出的不合格血浆，从而有效地确保用于医药产品生产的原料血浆无人畜共患疾病传播的风险。Since a window period of 60 days is set, it is possible to completely eliminate unqualified plasma that may exist during the window period due to low pathogen titer and thus effectively ensure that the raw material plasma used for the production of pharmaceutical products is free from contamination. Risk of zoonotic disease transmission.
综上所述，本发明用于采集活猪血浆的方法通过对活猪免疫接种、封闭地健康养殖和猪血液病原体检测，以及在采集血浆过程中对健康猪进行牢固固定、对采集部位表皮进行清洁消毒处理、穿刺预埋采集导管等等一系列方式，可以全自动地采集活猪血浆，有效地实现了快速全封闭健康活猪血浆的自动采集。这样即可满足相关法规的控制要求，确保了相关药品的安全有效。In summary, the method of the present invention for collecting live pig plasma is through immunization of live pigs, closed healthy breeding and detection of pig blood pathogens, as well as firmly fixing healthy pigs in the process of collecting plasma, and performing surface inspection on the epidermis of the collection site. A series of methods such as cleaning and disinfection treatment, puncture and pre-embedded collection catheter, etc., can automatically collect live pig plasma, effectively realizing the automatic collection of fast and fully enclosed healthy live pig plasma. In this way, the control requirements of relevant laws and regulations can be met, and the safety and effectiveness of related drugs can be ensured.
采用本发明用于采集活猪血浆的方法获得的猪血浆无需二次分离，减少了环境污染以及环境对血浆造成的二次污染，可以降低血浆初始的染菌数，杜绝了人畜共患疾病的传播，避免溶血现象发生，提高了血浆中活性蛋白的含量，从而为以猪血浆为原料的生物制品提供了可靠的质量保障。The pig plasma obtained by the method for collecting living pig plasma of the present invention does not need secondary separation, which reduces environmental pollution and secondary pollution of the plasma caused by the environment, can reduce the initial number of bacteria in the plasma, and prevents the occurrence of zoonotic diseases. Spread, avoid hemolysis, increase the content of active protein in plasma, thus provide reliable quality assurance for biological products using pig plasma as raw material.
虽然以上描述了本发明的具体实施方式，但是本领域的技术人员应当理解，这些仅是举例说明，本发明的保护范围是由所附权利要求书限定的。本领域的技术人员在不背离本发明的原理和实质的前提下，可以对这些实施方式作出多种变更或修改，但这些变更和修改均落入本发明的保护范围。Although the specific embodiments of the present invention have been described above, those skilled in the art should understand that these are only examples, and the protection scope of the present invention is defined by the appended claims. Those skilled in the art can make various changes or modifications to these embodiments without departing from the principle and essence of the present invention, but these changes and modifications all fall within the protection scope of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510033368.2ACN105854107A (en) | 2015-01-22 | 2015-01-22 | Method for collecting plasma of live pig |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510033368.2ACN105854107A (en) | 2015-01-22 | 2015-01-22 | Method for collecting plasma of live pig |
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| CN105854107Atrue CN105854107A (en) | 2016-08-17 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510033368.2APendingCN105854107A (en) | 2015-01-22 | 2015-01-22 | Method for collecting plasma of live pig |
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| CN (1) | CN105854107A (en) |
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| Date | Code | Title | Description |
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| C06 | Publication | ||
| PB01 | Publication | ||
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