CN104101522A - Composite efficient blood coagulation promoting powder - Google Patents
Composite efficient blood coagulation promoting powder Download PDFInfo
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- CN104101522A CN104101522A CN201310122350.0A CN201310122350A CN104101522A CN 104101522 A CN104101522 A CN 104101522A CN 201310122350 A CN201310122350 A CN 201310122350A CN 104101522 A CN104101522 A CN 104101522A
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- 239000000843 powder Substances 0.000 title claims abstract description 31
- 230000023555 blood coagulation Effects 0.000 title claims abstract description 17
- 239000002131 composite material Substances 0.000 title claims abstract description 8
- 230000001737 promoting effect Effects 0.000 title abstract 8
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 67
- 210000004369 blood Anatomy 0.000 claims abstract description 35
- 239000008280 blood Substances 0.000 claims abstract description 35
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- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
The invention discloses blood rapid coagulation promoting powder, and in particular relates to the blood rapid coagulation promoting powder comprising the following a variety of blood rapid coagulation promoting matters in ratio invented by people: 1) 500IU 10000IU of a blood coagulation agent; 2) 7-100g of an adsorbent; 3) 6-1000mg of a stabilizer; 4) 1000ml of a fixing agent; 5) 3-5ml of a blood cell wall remover; and 0.15-5g of an antifibrinolytic agent; at room temperature the blood coagulation agent, the adsorbent, the stabilizer, the blood cell wall remover and the antifibrinolytic agent are added into the fixing agent for sufficient and even mixing, filtering and drying or natural drying to obtain the composite coagulation promoting powder, the drying temperature is limited to 100 DEG C, the drying time is performed according to the principle of high temperature and short time, and low temperature and long time. The blood rapid coagulation promoting powder is applied to a vacuum or non-vacuum blood collecting container. The blood rapid coagulation promoting powder is good in procoagulant effect and easy to store, can prevent low temperature hemolysis phenomenon, and can eliminate serum fibrin. The blood rapid coagulation promoting powder can be mixed with alcohols and isopropanols to prepare suspensions, also can be mixed with water to prepare suspensions.
Description
Technical field
The present invention is a kind of short solidifying powder of short solidifying powder, particularly a kind of composite highly effective blood that impels blood rapid solidification
Background technology
Along with the high speed development of laboratory medicine and biotechnology, the requirement of clinical accuracy to sample collection and sample quality is more and more higher.Serum and plasma is two large samples of clinical examination, and serum and plasma consistance in the indices of inspection is very high, but also has any different.At present, clinical major part is biochemical, immune etc., and index is all used serum specimen, and in vitro blood sample oozes out general needs about 1 hour from being solidified to serum, becomes so obtain as early as possible high-quality serum the front topic that improves checkability and accuracy.Therefore, people have invented the various short condensates that impel blood rapid solidification.Early stage coagulant comprises simple rabbit brain powder, Cab-O-sil, snake venom etc., and Chinese patent CN1362618A has introduced the spherical set accelerator of composition such as comprising silicon dioxide, aminocaproic acid and blood coagulation accelerator; Chinese patent CN101137902A has introduced the set accelerator that one-tenth such as comprising fibrin ferment, silicon dioxide, polyoxyalkylene hydrocarbons and their derivates, water is grouped into.Use and occur that the problems such as fibrin, serum amount are low, blood cell wall built-up, storage life is short, transport is difficult easily appear in haemolysis, serum but above-mentioned patented product still exists short solidifying weak effect, not resistance to irradiation, low temperature.
Summary of the invention
The object of the invention is in order to overcome the defects such as the short solidifying not resistance to irradiation of weak effect of existing short blood coagulation substance is not low temperature resistant, invention is a kind of is combined into the short solidifying powder of a kind of composite highly effective blood by coagulant, adsorbent, stabilizing agent, fixing agent, the de-wall agent of blood cell, antifibrinolysis agent.
The object of the invention is to realize as follows: the short solidifying powder of described composite highly effective blood, combined by coagulant, coagulant adsorbent, coagulant stabilizing agent, coagulant fixing agent, the de-wall agent of blood cell, antifibrinolysis agent, each component is pressed following proportioning:
1) coagulant 500IU-10000IU (IU is unit of enzyme activity)
2) adsorbent 7-100g;
3) stabilizing agent 6-1000mg
4) fixing agent 1000ml
5) the de-wall agent 3-5ml of blood cell
6) antifibrinolysis agent 0.15-5g;
At normal temperatures coagulant, adsorbent, stabilizing agent, the de-wall agent of blood cell and antifibrinolysis agent are joined in fixing agent, fully mix filter post-drying or naturally dry the compound short powder that coagulates, bake out temperature is limited in 100 DEG C, drying time is according to high temperature, short time, and principle when low temperature is long is carried out.
Described coagulant comprises fibrin ferment and snake venom class blood coagulation substance;
Described adsorbent comprises calcium carbonate, porcelain earth, zeyssatite, talcum powder, white carbon, alumina powder, glass dust, mica powder, silica flour, carbon fiber, bentonitic clay, attapulgite, polyvinylpyrrolidone, sodium carboxymethyl cellulose;
Described stabilizing agent comprises trehalose, glycocoll, surfactant and Beta-alanine;
Described fixing agent comprises neutral formalin and sustained release agent thereof, more than 50% concentration ethanol or isopropyl alcohol; Preferably 95% above ethanol is as fixing agent;
The de-wall agent of described blood cell comprises polysiloxane, non-ionic surfactant, polyethylene glycol type surfactant or polyol-based non-ionic surfactant;
Described antifibrinolysis agent comprises the material that anti-fibrinolytic protein dissolves, preferably Aprotinin, aminocaproic acid, gumbix, etamsylate, tranexamic acid, aminomethylbenzoic acid.
Good effect of the present invention is as follows:
1) short solidifying effective, in collection container, add this product 0.2-1mg content can make the in vitro blood of 1-5ml solidify and clot contraction in 1-10 minute, serum amount is large.
2) this product is mainly pulvis and is easy to storage, condition of storage room temperature.
3) this product can, according to need of production, be made into ethanol, isopropyl alcohol or water formulation by the concentration of 0.3-4%, is conducive to production and processing.
4) can be by 3) matched proportion density, in every collection container, add 10-30 microlitre, can reach 1) effect, stop low temperature haemolysis.
5) short solidifying effect can more adapt to clinical demand by the variation of the variation of compound concentration and addition, stops fibrin in serum.
6) this product is that pulvis is easy to transport, belongs to non-dangerous article.
7) use producer cost-saving.
8) the resistance to irradiation of this product.
9) this product, can also water modulation suspension except manufacturing suspension with alcohol and isopropyl alcohols.
Embodiment
Further illustrate this compound below by some concrete embodiments.
Embodiment 1
1) coagulant 1000IU
2) adsorbent 20g
3) stabilizing agent 10mg
4) fixing agent 1000ml
5) the de-wall agent 3ml of blood cell
6) antifibrinolysis agent 0.2g
Manufacture method: normal temperature joins above-mentioned substance in coagulant fixing agent, fully mix filter post-drying or naturally dry the compound short powder that coagulates.In manufacture method, do not limit addition sequence and drying time, bake out temperature is limited in 100 DEG C, and drying time is according to high temperature, short time, and principle when low temperature is long is carried out.
Embodiment 2
1) coagulant 500IU
2) adsorbent 18g
3) stabilizing agent 6mg
4) fixing agent 1000ml
5) the de-wall agent 3ml of blood cell
6) antifibrinolysis agent 0.15g
Manufacture method is with embodiment 1.
Embodiment 3
1) coagulant 5000IU
2) adsorbent 100g
3) stabilizing agent 300mg
4) fixing agent 1000ml
5) the de-wall agent 3ml of blood cell
6) antifibrinolysis agent 1.5g
Manufacture method is with embodiment 1.
Embodiment 4
1) coagulant 1000IU
2) adsorbent 7g
3) stabilizing agent 20mg
4) fixing agent 1000ml
5) the de-wall agent 3ml of blood cell
6) antifibrinolysis agent 1.5g
Manufacture method is with embodiment 1.
Embodiment 5
1) coagulant 5000IU
2) adsorbent 70g
3) stabilizing agent 300mg
4) fixing agent 1000ml
5) the de-wall agent 3ml of blood cell
6) antifibrinolysis agent 2g
Manufacture method is with embodiment 1.
Embodiment 6
1) coagulant 10000IU
2) adsorbent 100g
3) stabilizing agent 1000mg
4) fixing agent 1000ml
5) the de-wall agent 5ml of blood cell
6) antifibrinolysis agent 5g
Manufacture method is with embodiment 1.
The present invention is mainly used in vacuum or antivacuum blood collection container, and the product relevant to blood clotting and occasion.When use, it is that the alcohol of 0.3-5% or the suspension of isopropyl alcohol are annotated in container that short solidifying powder is mixed with to concentration.
The result: short solidifying powder is mixed with to 1% suspension, try to please each 6 of long-pending 7ml glass tube and plastic tube, after every collection tube adds 1% concentration suspension 25ul to dry, gather 5ml whole blood (experimenter is normal population), observe the variation of blood coagulation time, centrifugal rear pipe wall-hanging blood situation, serum amount, clot contraction state, clinical examination value, concrete outcome is in table 1.Table 1, experiment results (numerical value is mean value)
| ? | The blood clotting time | Pipe wall-hanging blood | Serum amount | Clot contraction | After test value predose, add up |
| Embodiment 1 | 2 | Nothing | 2.9ml | Comprehensively | P＞0.01 |
| Embodiment 2 | 4 | Nothing | 3.1 | Comprehensively | P＞0.01 |
| Embodiment 3 | 1 | Nothing | 2.5 | Comprehensively | P＞0.01 |
| Embodiment 4 | 1.5 | Nothing | 2.8 | Comprehensively | P＞0.01 |
| Embodiment 5 | 1.5 | Nothing | 2.8 | Comprehensively | P＞0.01 |
| Embodiment 6 | 1 | Nothing | 2.5 | Comprehensively | P＞0.01 |
Experimental judgment principle: 1) normal subjects's blood clotting time should be within the scope of 15 minutes.2) the centrifugal rear tube wall of collection tube can not have blood cell to stick.3) serum amount should reach the more than 1/3rd of blood drawing amount after centrifugal.4) clot has obvious contraction .5 placing after 10 minutes) test value do not have statistical significant difference after predose.
The physicochemical property of each component are described respectively below.
Coagulant: coagulant comprises that all can accelerate organic factor of blood clotting, comprise the various factors and the enzyme that accelerate blood clotting, comprise more specifically all clotting factor and derivant and other some serine proteases of intrinsic coagulation and extrinsic coagulation.They comprise factor I-XI work I and serine stretch protein enzyme material, preferential fibrin ferment and the snake venom class blood coagulation substance of using in these factors and enzyme.More preferably fibrin ferment, the use amount of fibrin ferment is: 500IU-10000IU.
Adsorbent: adsorbent is mainly selected drug excipient, has certain specific surface area and the factor of porosity drug excipient as filling agent and disintegrant.Can include but not limited to the drug excipients such as calcium carbonate, porcelain earth, zeyssatite, talcum powder, white carbon, alumina powder, glass dust, mica powder, silica flour, carbon fiber, bentonitic clay, attapulgite, polyvinylpyrrolidone, sodium carboxymethyl cellulose, preferably the combination of one or more in attapulgite, silicon dioxide and porcelain earth.Use amount is 7-100g.
Stabilizing agent: stabilizing agent is mainly selected proteinase stabilizing agent, fibrin ferment and many clotting factor thereof are serine stretch protein enzyme.Fibrin ferment less stable, normal temperature is difficult to preserve, and is conventionally made into freeze-dried powder sealing and is kept under 4-10 DEG C of condition.Some bibliographical information carbohydrate, surfactant and amino acids albumen and enzyme are had to protective effect; the preferred trehalose of the present invention, surfactant, glycocoll and Beta-alanine or several potpourri be as fibrin ferment stabilizing agent, more preferably trehalose and amino acid whose potpourri.Preferably use amount is 1-1000mg.More preferably 6-500mg.
Fixing agent: fixing agent is mainly selected alcohols and neutral formalin class material, some fixing agent makes albuminous degeneration but can keep its structure not to be destroyed.The preferred neutral formalin of the present invention and sustained release agent thereof, more than 50% concentration ethanol and isopropyl alcohol are as fixing agent, and more selecting concentration is that 95% above ethanol is as coagulant fixing agent.Because fixing agent serves as solvent role simultaneously, can be according to producing container increase or dwindling use amount.Formulation ratio use amount is 1000ml,
Blood cell takes off wall agent: this compound is mainly used in blood collection container, comprises vacuum and antivacuum blood collection container.After touching in vitro blood, above-mentioned coagulant can start clotting mechanism, in vitro blood was solidified in 3-5 minute, because blood contact coagulant exists inequality, be easy to occur blood cell wall cling phenomenon on blood collection container wall, in serum after centrifugal, occur that blood cell is floating or stick container inner wall phenomenon, affect the use of sample.Be attached on collection container wall in order to reduce and to stop blood cell, the present invention has used blood cell to take off wall agent, emulsifying agent and the lubricant in drug excipient mainly selected in the de-wall agent of blood cell, they are polysiloxane-based, nonionic surfactants preferably, more preferably water-soluble poly siloxane, polyethylene glycol type surfactant and polyol-based non-ionic surfactant and their combination.The preferred 1-10ml of use amount, more preferably 3-5ml.
Antifibrinolysis agent: owing to existing plasminogen, Plasminogen activation to become after fibrinolysin in blood, affect blood clotting by solution fibrin is former with fibrin.In order to prevent the activation of plasminogen, the present invention adds anti-fibrinolytic protein lytic agent in this compound, preferably one or more potpourri of Aprotinin, aminocaproic acid, gumbix, etamsylate, tranexamic acid, aminomethylbenzoic acid, more preferably Aprotinin and aminocaproic acid and composition thereof.Preferably use amount is 0.1-10g, and more preferably use amount is 0.15-5g.
The present invention is mainly used in blood collection container, comprises vacuum and antivacuum blood collection container and product and the occasion relevant to blood clotting.
Using method: this product can be used by directly adding, make the modes such as suspension.
Preferably make suspension use-pattern.
1, directly add: 1) manual adding: take corresponding use amount and add in collection container.2) equipment adds: this product is put into equipment pulvis reservoir vessel, the amount of dusting of conditioning equipment.
2, suspension addition method: this product is mixed with to suspension by the concentration of 0.3-5%, no
Be limited to this concentration, preferably 0.7%-2% concentration proportioning.Add mode: 1) manual adding, be mixed with after suspension by above-mentioned concentration method, use the utensil with function of measuring, get the suspension preparing and add collection container, then dry or dry, adding amount 1-200ul in each collection container, preferably 10-30ul.2) equipment filling: will be mixed with suspension by above-mentioned concentration method and join in the corresponding reservoir vessel of equipment, and adjust equipment quantity for spray, the adding amount of each collection container adds with manual, and drying mode is for drying or drying.The preferred suspension equipment filling of dosing method.
By the deteriorated experiment of storage below, can prove that the present invention is within 1 year, short solidifying successful, can be used as blood collection container adjuvant and uses.
By the short solidifying powder 50g of described method preparation.
1, Accelarated aging test
Prepared short solidifying powder 12g is divided and installed in 2 bottles, every small bottle packing 6g this product.2 bottles are all placed in 55 DEG C of incubators, take out wherein one bottle at the 7th day, and short the 3g in bottle solidifying powder is taken out, be mixed with the alcohol suspension 300ml of 1% concentration, then spray in 12 plastic blood sampling pipes, every arm sprays 25 microlitres, and it is for subsequent use that 4ml vacuum is taken out in oven dry; Another 3g is made into the water for injection suspension 300ml of 1% concentration, sprays in 12 plastic blood sampling pipes, and every arm sprays 25 microlitres, takes out 4ml vacuum for subsequent use after oven dry.Get respectively each 6 of the heparin tube that alcohol and aqueous suspension make, gather respectively 6 normal subjects's blood, record test value comparison after clotting time, pipe wall-hanging blood situation, serum amount, clot contraction situation, predose, the results are shown in Table 2.The heparin tube of 6 of another alcohol suspensions and 6 making of aqueous suspension carries out 60Coradiation, irradiation dose 15-23KGy, and blood drawing test method is identical with above-mentioned predose.Within the 14th day, take out the short solidifying grain weight experiment of multiple the 7th day in another bottle, the results are shown in Table 2.
Table 2,55 DEG C of quick aging experimental results
Checking criterion is the same, that is: 1) and normal subjects's blood clotting time should be within the scope of 15 minutes.2) the centrifugal rear tube wall of collection tube can not have blood cell to stick.3) serum amount should reach the more than 1/3rd of blood drawing amount after centrifugal.4) clot has obvious contraction in placement after 10 minutes.5) test value does not have statistical significant difference after to predose.
2, chronic storage experiment
Prepared short solidifying powder 38g is placed in cool place, ventilation, dry warehouse, at latter 1 month, 3 months, 6 months, 9 months, 12 months each 6g that take out of manufacture, deposits senile experiment by quick aging experimental technique respectively, the concentration of preparation is identical.The results are shown in Table 3
Table 3,1 year storage senile experiment result
Checking criterion is the same.
Claims (2)
1. the short solidifying powder of composite highly effective blood, is characterized in that: it is combined by coagulant, coagulant adsorbent, coagulant stabilizing agent, coagulant fixing agent, the de-wall agent of blood cell, antifibrinolysis agent, and each component is pressed following proportioning:
1) coagulant 500IU-10000IU
2) adsorbent 7-100g;
3) stabilizing agent 6-1000mg
4) fixing agent 1000ml
5) the de-wall agent 3-5ml of blood cell
6) antifibrinolysis agent 0.15-5g;
The described IU of unit, g, ml can change other corresponding units in proportion into;
At normal temperatures coagulant, adsorbent, stabilizing agent, the de-wall agent of blood cell and antifibrinolysis agent are joined in fixing agent, fully mix filter post-drying or naturally dry the compound short powder that coagulates, bake out temperature is limited in 100 DEG C, drying time is according to high temperature, short time, and principle when low temperature is long is carried out.
2. the short solidifying powder of composite highly effective blood according to claim 1, is characterized in that:
Described coagulant comprises fibrin ferment and snake venom class blood coagulation substance;
Described adsorbent comprises calcium carbonate, porcelain earth, zeyssatite, talcum powder, white carbon, alumina powder, glass dust, mica powder, silica flour, carbon fiber, bentonitic clay, attapulgite, polyvinylpyrrolidone, sodium carboxymethyl cellulose;
Described stabilizing agent comprises trehalose, glycocoll and Beta-alanine or trehalose and amino acid whose potpourri;
Described fixing agent comprises neutral formalin and sustained release agent thereof, more than 50% concentration ethanol or isopropyl alcohol; Preferably 95% above ethanol is as fixing agent;
The de-wall agent of described blood cell comprises this polysiloxane, non-ionic surfactant, polyethylene glycol type surfactant or polyol-based non-ionic surfactant;
Described antifibrinolysis agent comprises anti-fibrinolytic protein lytic agent, preferably Aprotinin, aminocaproic acid, gumbix, etamsylate, tranexamic acid, aminomethylbenzoic acid.
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| CN111253750A (en) * | 2020-01-17 | 2020-06-09 | 安徽信灵检验医学科技股份有限公司 | Blood coagulation accelerator for blood collection tube and preparation method thereof |
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