CN102397290B - Hydroxyethyl starch injection and preparation method thereof - Google Patents
Hydroxyethyl starch injection and preparation method thereof Download PDFInfo
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- CN102397290B CN102397290B CN 201110174861 CN201110174861A CN102397290B CN 102397290 B CN102397290 B CN 102397290B CN 201110174861 CN201110174861 CN 201110174861 CN 201110174861 A CN201110174861 A CN 201110174861A CN 102397290 B CN102397290 B CN 102397290B
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Abstract
The present invention provides a hydroxyethyl starch 130/0.4 sodium chloride injection, wherein the injection uses hydroxyethyl starch 130/0.4 as the main raw material, and further contains sodium chloride, potassium chloride, calcium chloride, glucose and sodium acetate. (1) The injection has the reasonable formula, and the capacity expanding time of the hydroxyethyl starch 130/0.4 injection of the invention and the stay time in vivo is better than that of the hydroxyethyl starch injection of the prior art. (2) The injection has well stability, and the injection property, the clarity and the content and the stabilization of the molecular weight of the hydroxyethyl starch 130/0.4 can also be kept for long time preservation. (3) The injection has the short capacity expanding time and takes fast effect in the treatment of hemorrhagic shock. (4) The injection is more approaching to the human body internal environment, is propitious to regulate the body fluid, balance the electrolyte, and reduce the damage to the liver and kidney function.
Description
Technical field
The present invention relates to a kind of hydroxyethyl starch injection liquid that is used as blood plasma substitute and its preparation method and application, a kind of hetastarch (130/0.4) injection especially is provided.Belong to field of medicaments.
Background technology
From the thirties in 20th century, since the gelatin gels plasma substitute comes out, had so far the history of nearly 80 years.invented the polyvinylpyrrolidone (PVP) of synthetic during the World War I, the synthetic dextrorotation candy acid anhydride (Dextran) of microorganism has appearred again in World War II, the mid-1970s U.S. develops hetastarch (HydroxyethylStarch, HES), China is by China Concord Medical Science University, Chinese Academy of Medical Sciences's blood transfusion and Blood Research Institute, studied respectively successful dextrorotation candy acid anhydride and hetastarch in 1958 and 1967, and form rapidly at home industrialization, this has brought into play significant role to China prevention and treatment Hypovolemia and shock patients, millions of life have been saved.Clinically, the hetastarch volume treatment of doing commonly used, after intravenously administrable, blood volume can increase sharply, be usually used in treatment because of massive hemorrhage, burn or other wounds shock or the hemorrhage that cause, can prevent each organic blood flow volume that circulatory disturbance that the backflow blood volume causes causes, oxygen for the amount minimizing organ failure of appearance.Experimentation and the clinical application practice of decades show, really estimate from clinical practice safety and blood plasma dilatation dose-effect, and hetastarch has become first-use drug--the blood plasma substitute that common people are used for the treatment of the shock patient that losing blood property and a variety of causes cause.Abroad report between 1978 to 1992 15 years, three kinds of blood plasma substitute quantity of clinical use gelatin, dextrorotation candy acid anhydride, hetastarch relatively, to hetastarch consumption in 1992 be that the first two plants more than 10 times; Aspect safety, see with the anaphylaxis of clinical worry the most, be also that hetastarch is minimum (0.054%), only be equivalent to 1/6 of gelatin, 1/4.7 of dextrorotation candy acid anhydride is even than also low one times of human albumin; Add raw material from natural corn, not only easily obtain but also good and cheap, and technique letter relatively, be convenient to promote and produce.Separately to be similar to the human body glycogen former due to the chemical composition and structure of hetastarch, is easy to metabolism at the blood vessel internal recycle, and the overwhelming majority is discharged from urine, thus in organ almost without savings, vast clinical position person is happy to employing.
Abroad, the hetastarch sodium chloride injection is at country variant, selected kind is different clinically for it, the hetastarch mean molecule quantity is 480KD ten thousand on American market, mainly produced by du pont company (DuPont), commodity are respectively HESPan, and this product is widely used in the U.S., its blood volume expands large, and is lasting and effective.6% (480/0.7) average out to 24h action time, the defective on performance is that it is influential and poultry is long-pending in vivo to blood coagulation system, and expensive ($ 43/500ml 6%480/0.7) thereby limited its application clinically.on the European market, Germany's Fresenius card has been succeeded in developing commodity He Si (HAES) 200/0.5 hetastarch product by name than company (Fresenius kabi) in nineteen eighty-two, this product occupies the European market more than 70%, and entered Chinese market in 1999 by standard, this product mean molecule quantity 200KD, substitution value 0.43-0.55, be used for blood plasma substitute, dilatation intensity is large, 6%HES dilatation effect is 100%, dilatation effective time 4-8 hour, half-life is 3-4 hour, irritated incidence rate is low, the leading products on European blood plasma substitute market, it is 130KD that nearest Fresenius card is released again its mean molecule quantity of hetastarch product Voluven of new generation than company, substitution value is 0.4, they think lower molecular weight and low mole degree of exchange, can further improve Product Safety and effectiveness.By studies show that hetastarch chemical constitution characteristics and physiological function Relations Among, larger its dilatation intensity of hetastarch mean molecule quantity is larger, molecular size range determines dilatation effect, the degree of exchange size determines half-life length in its blood circulation, making a general survey of the development of external hetastarch can find out, hetastarch just from the high mole degree of exchange of high molecular towards low-molecular-weight and low degree of exchange production development.Domestic hetastarch 40 or 20 products (706 plasma substitute), because molecular weight is lower, and degree of exchange higher (0.8-1.2), blood plasma dilatation effect is relatively poor, in blood circulation, the half-life is shorter, the anti-hemorrhagic shock function is lower, clinically at home is mainly used in improving blood flow, treatment circulation or microcirculation disturbance patient.
Hetastarch is third generation artificial colloid, is to be made after degraded, hydroxyethylation and further processed by the high molecular amylopectin.Press molecular weight and divide, low-molecular-weight hetastarch (Mw40000-7000D), middle molecular weight hydroxyethyl starch (Mw1300000-2000000D) and high molecular weight hydroxyethyl starch (Mw4500000-4800000D) are arranged.Divide by the replacement degree, low level hetastarch (Ms0.3-0.5) and the high level hetastarch (Ms0.6-0.7) that replaces of replacing arranged.What commonly use on Chinese market at present is mainly Hetastarch 200/0.5, the hetastarch of molecular weight in genus, this product beginning of the nineties in last century is by German Fresenius Developed (trade name: He Si HES), and successively in some country's listings, especially be most widely used in Europe.He Si entered Chinese market in 1998, was subject to clinician's welcome.Become the leading products on present market.But single Hetastarch 200/0.5 preparation still can not satisfy clinical demand.
Clinically, hetastarch is widely used in artificial plasm's succedaneum.Announced a kind of hydroxy ethyl starch for injection and preparation method thereof in CN1650885A.CN1235833A, CN1195527A have announced the injection of hetastarch, be comprised of hetastarch and sodium chloride, but there are the deficiency that easily causes high chlorine metabolic acidosis in it when using.
Summary of the invention
Be safety and the effectiveness that improves clinical use, the present invention aims to provide a kind of human internal environment that more meets, and has reliable and stable capacity effect and persistent period, and the fast whole effective dilatation of energy also improves hypovolemic shock patient's the state of an illness.Hetastarch 130/0.4 injection of the present invention has good stability, and clinical use is safer, effective.
Technical solution of the present invention is as follows:
A kind of hetastarch 130/0.4 injection, take weight average molecular weight as 130 with hetastarch as plasma expander, 000 dalton, molar substitution is that 0.4 (130/0.4) hetastarch is primary raw material, and contains sodium chloride, potassium chloride, calcium chloride, glucose and sodium acetate composition.
The embodiment of hetastarch 130/0.4 injection of the present invention, described hydroxyethyl starch injection liquid, wherein contain in every 100ml injection: hetastarch 130/0.48-10g, sodium chloride 0.5-1.0g, glucose 0.05-0.1g, potassium chloride 0.02-0.04g, calcium chloride 0.02-0.04g, sodium acetate 0.01-0.02mg, surplus is water for injection.
As the preferred embodiments of the invention, described hetastarch 130/0.4 injection wherein contains in every 100ml injection: hetastarch 130/0.4 8g, sodium chloride 0.5g, glucose 0.1g, potassium chloride 0.02g, calcium chloride 0.02g, sodium acetate 0.01mg, surplus is water for injection.Hydroxyethyl starch injection liquid people pH value of the present invention is 5-7, preferably 6.5-7.
The preparation method of hetastarch 130/0.4 injection of the present invention:
(1) take hetastarch 130/0.4, sodium chloride, potassium chloride, calcium chloride, glucose and the sodium acetate of recipe quantity, mix, add water for injection to dissolve fully;
(2) activated carbon adsorption: add the decolouring of 0.1% needle-use activated carbon, boil insulation 20 minutes, adjust pH is to 5.0-7.0;
(3) fine straining: with diameter 0.45um microporous filter membrane; Fill; In 115 ℃ of sterilizations 30 minutes; Lamp inspection, packing; Get injection.
Hydroxyethyl starch injection liquid described above can be used as artificial plasm's succedaneum.As be used for the treatment of hypovolemic shock, for example lose hemorrhagic shock, septic shock, burn and traumatic shock; Perhaps reduce operation blood consumption, as Acute Normovolemic Hemodilution, the property controlled blood dilution etc.
Hetastarch 130/0.4 injection of the present invention contains sodium, potassium, the calcium close to the normal physiological level, more meets human internal environment's demand.In addition, also contain glucose in hetastarch 130/0.4 injection of the present invention, helping provides energy to patient, reduces protein depletion.In addition, also contain acetic acid in hetastarch 130/0.4 injection of the present invention.In water, sodium acetate is dissociated into Na
+And C
3H
5O
3 -Acetate anion is alkalescence, removes simultaneously acetic acid and hydrion by liver.In liver, acetic acid is metabolised to glycogen, and final oxidized metabolism changes into carbon dioxide and water.Produce and utilize when acetic acid is normal, can not cause that acetic Acid Metabolism is disorderly, acetate anion can be used as the alternate source of bicarbonate radical.
Hetastarch 130/0.4 injection of the present invention, its Cl-level, and contain near physiological level Ca closer to the normal physiological scope than 0.9% sodium chloride injection
2+, K
+, Na+, C
3H
5O
3-, the electrolyte such as glucose, dilatation is suitable with its sodium chloride injection, and more is conducive to improve hypovolemic shock patient's water-electrolyte balance.
The hetastarch 130/0.4 that uses in plasma substitute injection of the present invention, belong to a kind of middle molecular weight hydroxyethyl starch, its molecular weight is 130000 left and right dalton, and molecular distribution is more concentrated, further reduce than the existing molecular weight of 200/0.5 hetastarch of report that uses, the replacement level of ethoxy is reduced to 0.4 from 0.5, and can be with the replacement mode from C
2With C
5(or C
6) ratio increased to 9: 1 by 5: 1, be conducive to obtain better effect.On this basis, simultaneously again with sodium acetate and the common compound injection that forms of multiple electrolyte ingredient optimum organization, can reach the target of " desirable colloid solution ".It not only can provide reliable and stable capacity effect and persistent period, and more meet the interior environment of human blood, impact and the effect of expansion blood appearance on blood system also all are better than Hetastarch 200/plasma substitutes such as 0.5 sodium acetate ringer's injection, more desirable comprehensive therapeutic effect can be arranged, also convenient clinical use.
Therefore, when adopting this product treatment hypovolemic shock patient, compare with existing expander, can replenishment of blood content and multiple electrolyte ingredient to regulate body fluid, electrolyte and acid-base balance.Simultaneously, less to the detrimental effect of renal function, can not produce high chlorine metabolic acidosis, clinical use is safer, improves safety and the effectiveness of clinical use.And can save blood used in clinic, and solved to a great extent the nervous problem in blood source, reduced the complication of allogeneic transfusion, the effectiveness and the safety that have also greatly improved volume treatment, and thus to the prognosis of disease with lapse to the generation wholesome effect.
The present invention compared with prior art the most outstanding advantage is: the formula of (1) injection is reasonable, dilatation time of hetastarch 130/0.4 the injection of the present invention and time of staying is better than the hydroxyethyl starch injection liquid of prior art in vivo; (2) good stability, long preservation still guarantee the stable of injection character, clarity, hetastarch 130/0.4 content and molecular weight; (3) the dilatation time short rapid-action, rapidly onset in treating hemorrhagic shock; (4) closer to environment in the mankind, be conducive to regulate body fluid, electrolyte balance, reduce liver, renal function injury.
The specific embodiment by the following examples is described in further detail foregoing of the present invention again.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.Do not breaking away from the above-mentioned technological thought situation of the present invention, various replacements or change according to ordinary skill knowledge and customary means are made all should comprise within the scope of the invention.
Inventive embodiments
Embodiment 1
Injection forms (by every 100ml injection):
(1) take hetastarch 130/0.4, sodium chloride, potassium chloride, calcium chloride, glucose and the sodium acetate of recipe quantity, mix, add water for injection to dissolve fully;
(2) activated carbon adsorption: add the decolouring of 0.1% needle-use activated carbon, boil insulation 20 minutes, adjust pH is to 6.5-7.0;
(3) fine straining: with diameter 0.45um microporous filter membrane; Fill; In 115 ℃ of sterilizations 30 minutes; Lamp inspection, packing; Get injection.
Embodiment 2
Injection forms (by every 100ml injection):
Preparation method is with embodiment 1.
Embodiment 3
Injection forms (by every 100ml injection):
Preparation method is with embodiment 1.
Embodiment 4
Injection forms (by every 100ml injection):
Preparation method is with embodiment 1.
Galenic pharmacy is investigated
(1) freezing-thawing test
In freezing-thawing test, the sample of selecting embodiment 1-4 was respectively placed two days respectively under-10 ℃ and 40 ℃ of acceleration environments, then checked clarity of solution, clarity and principal agent (hetastarch (130/0.4)) content, the results are shown in Table 1.
Table 1 freezing and thawing test result
By result as can be known, before and after freezing-thawing test, clarity of solution, clarity and molecular weight are almost unchanged.After freezing-thawing test, visible hetastarch 130/0.4 injection of the present invention.
(2) accelerated stability test
In the long-time stability examination, select the sample of embodiment 1-4, carry out with reference to Chinese Pharmacopoeia appendix XIXC crude drug pharmaceutical preparation stability test guideline, each sample, get three batches, be 40 ℃ ± 2 ℃ in temperature, relative humidity is to place under 75% ± 5% condition 6 months, respectively at 1,2,3, the sampling in June investigates character, microorganism restriction, visible foreign matters, principal agent (hetastarch (130/0.4)) content, the pH value of sample.Result is as follows:
Table 2 accelerated stability test result (January)
Table 3 accelerated stability test result (February)
Table 4 accelerated stability test result (March)
Table 5 accelerated stability test result (June)
(3) pharmacodynamics and dilatation effect test
Select hetastarch (130/0.4) injection of embodiment 1-4 as sample, evidence beneficial effect of the present invention in Hemorrhagic Shock in Rats.After administration 30 minutes, measure the mean arterial pressure lift-off value.
Hetastarch (130/0.4) injection of table 6 embodiment 1-4 is to the mean arterial pressure lift-off value
| Embodiment | 1 | 2 | 3 | 4 |
| Mean arterial pressure | 85 | 90 | 87 | 88 |
| Lift-off value mmHg |
As seen the hetastarch of embodiment 1-4 (130/0.4) injection onset rapidly in treating hemorrhagic shock.
Infusion 500ml sample after the hemorrhage 500ml of healthy volunteer, sample are selected from hetastarch (130/0.4) injection of embodiment 1-4, can produce to losing blood the volume replacement effect.Measure the time of staying in hetastarch (130/0.4) body, and dilatation is relaxed the notes time.
In sum, prior art of the present invention is compared the most outstanding advantage and is: the formula of (1) injection is reasonable, dilatation time of hetastarch 130/0.4 the injection of the present invention and time of staying is better than the hydroxyethyl starch injection liquid of prior art in vivo; (2) good stability, long preservation still guarantee the stable of injection character, clarity, hetastarch 130/0.4 content and molecular weight; (3) the dilatation time short rapid-action, rapidly onset in treating hemorrhagic shock; (4) closer to environment in the mankind, be conducive to regulate body fluid, electrolyte balance, reduce liver, renal function injury.
According to preferred embodiment, the present invention is described.Should be understood that the description of front and embodiment are just to illustrating the present invention.Under prerequisite without departing from the spirit and scope of the present invention, those skilled in the art can design multiple alternative of the present invention and improvement project, within it all should be understood to be in protection scope of the present invention.
Claims (5)
1. hetastarch 130/0.4 injection, is characterized in that
Injection forms by every 100ml injection:
Hetastarch 130/0.4 8g,
Sodium chloride 0.5g,
Glucose 0.05g,
Potassium chloride 0.02g,
Calcium chloride 0.04g,
Sodium acetate 0.02mg,
Water for injection is supplemented to capacity, and its preparation method is:
(1) take hetastarch 130/0.4, sodium chloride, potassium chloride, calcium chloride, glucose and the sodium acetate of recipe quantity, mix, add water for injection to dissolve fully;
(2) activated carbon adsorption: add the decolouring of 0.1% needle-use activated carbon, boil insulation 20 minutes, adjust pH is to 6.5-7.0;
(3) fine straining: with diameter 0.45 μ m microporous filter membrane; Fill; In 115 ℃ of sterilizations 30 minutes; Lamp inspection, packing; Get injection.
2. hetastarch 130/0.4 injection, is characterized in that
Injection forms by every 100ml injection:
Hetastarch 130/0.4 10g,
Sodium chloride 1.0g,
Glucose 0.1g,
Potassium chloride 0.03g,
Calcium chloride 0.03g,
Sodium acetate 0.01mg,
Water for injection is supplemented to capacity, and its preparation method is:
(1) take hetastarch 130/0.4, sodium chloride, potassium chloride, calcium chloride, glucose and the sodium acetate of recipe quantity, mix, add water for injection to dissolve fully;
(2) activated carbon adsorption: add the decolouring of 0.1% needle-use activated carbon, boil insulation 20 minutes, adjust pH is to 6.5-7.0;
(3) fine straining: with diameter 0.45 μ m microporous filter membrane; Fill; In 115 ℃ of sterilizations 30 minutes; Lamp inspection, packing; Get injection.
3. hetastarch 130/0.4 injection, is characterized in that
Injection forms by every 100ml injection:
Hetastarch 130/0.4 9g,
Sodium chloride 0.5g,
Glucose 0.1g,
Potassium chloride 0.02g,
Calcium chloride 0.02g,
Sodium acetate 0.01mg,
Water for injection is supplemented to capacity, and its preparation method is:
(1) take hetastarch 130/0.4, sodium chloride, potassium chloride, calcium chloride, glucose and the sodium acetate of recipe quantity, mix, add water for injection to dissolve fully;
(2) activated carbon adsorption: add the decolouring of 0.1% needle-use activated carbon, boil insulation 20 minutes, adjust pH is to 6.5-7.0;
(3) fine straining: with diameter 0.45 μ m microporous filter membrane; Fill; In 115 ℃ of sterilizations 30 minutes; Lamp inspection, packing; Get injection.
4. hetastarch 130/0.4 injection, is characterized in that
Injection forms by every 100ml injection:
Hetastarch 130/0.4 10g,
Sodium chloride 0.5g,
Glucose 0.05g,
Potassium chloride 0.03g,
Calcium chloride 0.02g,
Sodium acetate 0.02mg,
Water for injection is supplemented to capacity, and its preparation method is:
(1) take hetastarch 130/0.4, sodium chloride, potassium chloride, calcium chloride, glucose and the sodium acetate of recipe quantity, mix, add water for injection to dissolve fully;
(2) activated carbon adsorption: add the decolouring of 0.1% needle-use activated carbon, boil insulation 20 minutes, adjust pH is to 6.5-7.0;
(3) fine straining: with diameter 0.45 μ m microporous filter membrane; Fill; In 115 ℃ of sterilizations 30 minutes; Lamp inspection, packing; Get injection.
In claim 1-4 described hetastarch 130/0.4 injection of any one for the preparation of the treatment hemorrhagic shock medicine in application.
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| KR20190137839A (en) * | 2017-04-18 | 2019-12-11 | 마리누스 파마슈티컬스 인코포레이티드 | Neurosteroid preparations for sustained release injection |
| WO2022045903A1 (en) * | 2020-08-25 | 2022-03-03 | Cytorex International, Inc. | Method for producing mixtures to achieve ionic compositions for therapeutic use, which can be administered to humans or animals orally, parenterally, intraperitoneally, topically, otically, nasally or by means of washes, which result in improvement in diseases |
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