CN102008727B - Injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation - Google Patents
Injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation Download PDFInfo
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- CN102008727B CN102008727B CN201010576889A CN201010576889A CN102008727B CN 102008727 B CN102008727 B CN 102008727B CN 201010576889 A CN201010576889 A CN 201010576889A CN 201010576889 A CN201010576889 A CN 201010576889A CN 102008727 B CN102008727 B CN 102008727B
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Abstract
The invention discloses an injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation and a preparation method of the injection-purpose medicine composition. The injection-purpose medicine composition is prepared by the method comprising following steps: dissolving ligustrazine salt in water for injection, adjusting the pH value of the liquid medicine by adding citric acid and/or sodium citrate used as a pH regulator, wherein the dosage of the citric acid and/or sodium citrate ranges from (0.1mg to 200.0mg)/100ml. In the invention, pH value of the injection liquid can be more stable, the content of ligustrazine degradation substance is greatly reduced compared with that of the prior art, the clarity of the ligustrazine injection liquid is improved under the condition of not using other cosolvents to increase the clinical application risk, particularly, the problems of small white spots, white blocks and solution turbidity are solved under the condition that the ligustrazine injection liquid is stored for a long time by adopting the prior art, and the medicine composition ensures that the inspection of visible foreign substances of the product is in accordance to the formulation of medicine quality standard, and is convenient for clinical medication and popularization.
Description
Technical field
The invention belongs to medical technical field, particularly, relate to a kind of medicinal composition for injections that improves ligustrazine medicine ejection preparation stability.
Background technology
Ligustrazine is the alkaloid that from the Chinese medicine Rhizoma Chuanxiong, extracts; Chemical constitution is a tetramethylpyazine; It is a kind of novel agents of calcium ion antagonist; Have multiple effects such as blood circulation promoting and blood stasis dispelling, anti-platelet aggregation, excited medullary respiratory center and vasomotor center, blood vessel dilating and bronchial smooth muscle, microcirculation improvement, clinical obliterated cerebral vascular disease such as incomplete brain blood supply, cerebral thrombosis, cerebral embolism and other ischemic angiopathys such as coronary heart disease, the vasculitis etc. of being used for.The injection of ligustrazine is made very big contribution for the modern difficult disease of Chinese medicine.
Because therefore ligustrazine dissolubility extreme difference in aqueous solution is made into ligustrazine salt hydrochlorate or ligustrazine microcosmic salt to increase its water solublity.At present commercially available ligustrazine injection mainly contains the injection with small volume of ligustrazine salt hydrochlorate, ligustrazine microcosmic salt, and in ligustrazine salt hydrochlorate, ligustrazine microcosmic salt solution, adds the high-capacity injection that glucose or sodium chloride are processed as osmotic pressure regulator.But when the above-mentioned injection of preparation; Must the pH value of medicinal liquid be adjusted to the certain limit that is fit to human injection's administration; The pH value regulator of bibliographical information use at present is sodium hydroxide solution or uses hydrochloric acid solution, phosphoric acid solution; But the ligustrazine injection that adopts above-mentioned pH value regulator preparation is separated out precipitate such as tiny white point, white piece, solution muddiness easily under long term store and winter low temperature condition, cause the visible foreign matters inspection item of product defective.Prior art is in solution, to add polyoxyethylene sorbitan monoleate as cosolvent, problems of sediment formation such as small particles, white piece, solution muddiness occur to solve product.But polyoxyethylene sorbitan monoleate is owing to have the effect of haemolysis and blood pressure lowering, and store and the high temperature sterilize process in become sour easily, the injection clinical practice risk that causes containing polyoxyethylene sorbitan monoleate is higher, makes troubles to clinical application and popularization.
Summary of the invention
Technical problem to be solved by this invention provides a kind of medicinal composition for injections that improves ligustrazine medicine ejection preparation stability.This medicinal composition for injections adopts citric acid, sodium citrate as the pH regulator agent; And when find adopting citric acid, sodium citrate as the pH regulator agent through creative work; The medicinal liquid pH value is more stable; The ligustrazine degradation material reduces than prior art greatly, under the situation that avoids the use of other cosolvents that increase the clinical practice risks, has solved ligustrazine injection is separated out tiny white point, white piece, solution muddiness easily under long term store and winter low temperature condition problem satisfactorily.
The present invention addresses the above problem the technical scheme that is adopted: a kind of medicinal composition for injections that improves ligustrazine medicine ejection preparation stability; Mainly the salt by ligustrazine is dissolved in water for injection; Add osmotic pressure regulator; And adding citric acid and/or sodium citrate is regulated the medicinal composition for injections that the medicinal liquid pH value is processed as the pH regulator agent, the consumption of said citric acid and/or sodium citrate is 0.1mg～200.0mg/100ml.
Said osmotic pressure regulator is any one or a few in glucose, sodium chloride, xylitol, mannitol, the fructose.The consumption of osmotic pressure regulator is a prior art, and the sodium chloride consumption is 0.9g/100ml; Glucose, xylitol, mannitol, fructose consumption are 5g/100ml～10g/100ml.
The salt of said ligustrazine comprises ligustrazine salt hydrochlorate, ligustrazine microcosmic salt.
The concentration of the salt of said ligustrazine is calculated as 10mg～10g/100ml with ligustrazine.
Said medicinal liquid pH value is 3.0～6.0.
Said ligustrazine medicine ejection preparation dosage form is an injection.
The method for preparing of the medicinal composition for injections of above-mentioned raising ligustrazine medicine ejection preparation stability comprises the steps:
(1) salt that takes by weighing ligustrazine is with ligustrazine amount of calculation 0.1g～100g, citric acid and/or sodium citrate 2mg～4.0g;
(2) citric acid, sodium citrate are mixed with the solution of 10g/100ml～20g/100ml respectively, and be subsequent use;
(3) salt of ligustrazine, sodium chloride add among 30 ℃～40 ℃ the water for injection 500ml, be stirred to dissolving fully after, the active carbon of adding, said amount of activated is 0.02g/100ml, stirs the filtration decarburization 15 minutes;
(4) step (3) gained filtrating is 3.0～7.0 with the citric acid and/or the liquor sodii citratis adjusting pH value of step (2) configuration, and the water for injection that adds (30 ℃～40 ℃) below 40 ℃ is to 1000ml;
(5) with the extremely clarification of step (4) gained medical filtration, fill, sterilization promptly gets.
The citric acid consumption is that 1mg～2.0g, sodium citrate consumption are 1mg～2.0g in the said step (1).
Said step also comprises osmotic pressure regulator 9.0g in (1).
Said osmotic pressure regulator is a sodium chloride.
In the such scheme, what add that citric acid and/or sodium citrate be meant adding can be in citric acid, the sodium citrate any, or citric acid, sodium citrate are with the arbitrary proportion proportioning; In step (2), a kind of in the citric acid of adding, the sodium citrate then processes a kind of solution, as comprises and then be mixed with solution for standby respectively by two kinds of citric acid, sodium citrate; The salt of ligustrazine, the consumption of osmotic pressure regulator can adopt the consumption of prior art, according to the consumption adjustment of prior art.
In sum; The invention has the beneficial effects as follows: the present invention finds through experimentation; In ligustrazine medicine ejection preparation; When adopting citric acid, sodium citrate as the pH regulator agent, the medicinal liquid pH value is more stable, and the ligustrazine degradation material reduces than prior art greatly; Under the situation that avoids the use of other cosolvents that increase the clinical practice risk; Solve ligustrazine injection satisfactorily and adopted prior art products in storage process, to separate out the problem of tiny white point, white piece, solution muddiness easily, can guarantee that the visible foreign matters of the maintenance injection that ligustrazine injection can be stable in storage process detects the regulation that meets drug standard, be convenient to clinical application and popularization.
The present invention passes through creative work; Reason to the tiny white point of separating out in the ligustrazine injection, white piece, solution muddiness is analyzed and is studied; Confirm that deposit mainly is raw material free alkali crystallize and small amount of degradation product, above-mentioned reason occurring maybe be relevant with the kind of the pH value of solution and the used acid of pH regulator agent, alkali.Therefore use sodium citrate as the pH regulator agent; And use citric acid as pH value counter regulation agent; Under the situation that avoids the use of other cosolvents that increase the clinical practice risk, under long term store and winter low temperature condition, separate out the problem of tiny white point, white piece, solution muddiness easily to solve these article.
The specific embodiment
Below in conjunction with embodiment, the present invention is done further detailed description, but embodiment of the present invention is not limited thereto.
Embodiment 1
A kind of method for preparing that improves the medicinal composition for injections of ligustrazine medicine ejection preparation stability comprises the steps: that (1) weighting raw materials is with ligustrazine amount of calculation 0.1g～100g, sodium chloride 9.0g, citric acid 1mg～2.0g, sodium citrate 1mg～2.0g; (2) citric acid, sodium citrate are mixed with 10%～20% solution respectively, and be subsequent use.(3) add among the water for injection 500ml below 40 ℃, be stirred to dissolving fully after, add the active carbon of 0.02% (g/ml), stirred the filtration decarburization 15 minutes.(4) filtrating use citric acid or liquor sodii citratis adjusting pH value are 3.0～7.0, and the water for injection of adding below 40 ℃ is to 1000ml; (5) medical filtration is to clarification, and fill is sterilized, and promptly gets.
The composition and the content thereof of concrete each component of present embodiment are following:
Ligustrazine hydrochloride 0.8g
Sodium chloride 9.0g
Citric acid 1.0g
Sodium citrate 2.0g
Citric acid, sodium citrate are mixed with 10%～20% solution respectively, and be subsequent use.Ligustrazine hydrochloride, sodium chloride add among the water for injection 500ml below 40 ℃, be stirred to dissolving fully after, add 0.02% active carbon (being that amount of activated is 0.02g/100ml), stirred the filtration decarburization 15 minutes.It is 3.8～4.2 that filtrating uses citric acid or liquor sodii citratis to regulate pH value, and the water for injection of adding below 40 ℃ is to 1000ml.Medical filtration is to clarification, and fill is sterilized, and promptly gets.
Embodiment 2
Perhaps, the medicinal composition for injections of above-mentioned raising ligustrazine medicine ejection preparation stability prepares by following step:
(1) weighting raw materials is with ligustrazine amount of calculation 0.1g～100g, citric acid 1mg～2.0g, sodium citrate 1mg～2.0g; (2) citric acid, sodium citrate are mixed with 10%～20% solution respectively, and be subsequent use.(3) add among the water for injection 500ml below 40 ℃, be stirred to dissolving fully after, add the active carbon of 0.02% (g/ml), stirred the filtration decarburization 15 minutes.(4) filtrating use citric acid or liquor sodii citratis adjusting pH value are 3.0～7.0, and the water for injection of adding below 40 ℃ is to 1000ml; (5) medical filtration is to clarification, and fill is sterilized, and promptly gets.
The composition and the content thereof of concrete each component of present embodiment are following:
Ligustrazine hydrochloride 20g
Citric acid 1.0g
Sodium citrate 2.0g
Citric acid, sodium citrate are mixed with 10%～20% solution respectively, and be subsequent use.Ligustrazine hydrochloride adds among the water for injection 500ml below 40 ℃, be stirred to dissolving fully after, add 0.02% active carbon (being that amount of activated is 0.02g/100ml), stirred the filtration decarburization 15 minutes.It is 3.8～4.2 that filtrating uses citric acid or liquor sodii citratis to regulate pH value, and the water for injection of adding below 40 ℃ is to 1000ml.Medical filtration is to clarification, and fill is sterilized, and promptly gets.
Embodiment 3
The comparative test of ligustrazine sodium chloride injection stability
Utilize the visible foreign matters of the obtained ligustrazine sodium chloride injection of the present invention to detect the regulation that meets drug standard; And stability of solution is fine; Under the situation that avoids the use of other cosolvents that increase the clinical practice risk, solved the ligustrazine sodium chloride injection and in storage process, be prone to problems such as small particles, white piece, solution muddiness.Utilize the related request of the prepared ligustrazine sodium chloride injection of the present invention according to two appendix XI of Chinese Pharmacopoeia version in 2005 X C pharmaceutical preparation stability test guideline; Investigated respectively at 25 ℃ and placed 20 days medicine stabilities of 10 days, 0～5 ℃ low temperature placement of 6 months, 60 ℃ placements of 24 months, 40 ℃ placements; The result is constant product quality under above-mentioned experimental condition, and each item detects the regulation that index all meets this quality standard.
The pharmacological results shows: utilize the prepared stable ligustrazine sodium chloride injection of the present invention not have hemolytic, no anaphylaxis, nonirritant, meet the requirement of drug administration by injection.
25 ℃ of study on the stability results of table 1
60 ℃ of study on the stability results of table 2 ligustrazine hydrochloride sodium chloride injection
40 ℃ of study on the stability results of table 3
0～5 ℃ of low temperature visible foreign matters of table 4 is investigated the result
Can know according to The above results; Ligustrazine medicine ejection preparation of the present invention can improve the clarity of ligustrazine injection; Particularly under the long situation of ligustrazine injection period of storage; The visible foreign matters of maintenance injection that can be stable detects the regulation that meets drug standard; Solved the ligustrazine medicine and adopted existing technical products small particles, white piece, problem that solution is muddy under the long situation of period of storage, to occur, can guarantee that the visible foreign matters inspection of product meets the regulation of drug standard, is convenient to clinical application and popularization.
As stated, just can realize the present invention preferably.
Claims (5)
1. one kind is improved the stable medicinal composition for injections of ligustrazine medicine ejection preparation; It is characterized in that; Mainly the salt by ligustrazine is dissolved in water for injection; Add citric acid and sodium citrate and regulate the medicinal composition for injections that the medicinal liquid pH value is processed as the pH regulator agent, the consumption of said citric acid and sodium citrate is 0.1mg～200.0mg/100ml, and said medicinal liquid pH value is 3.0～6.0.
2. a kind of medicinal composition for injections that improves ligustrazine medicine ejection preparation stability according to claim 1; It is characterized in that; Also comprise osmotic pressure regulator, said osmotic pressure regulator is any one or a few in glucose, sodium chloride, xylitol, mannitol, the fructose.
3. a kind of medicinal composition for injections that improves ligustrazine medicine ejection preparation stability according to claim 1 is characterized in that the salt of said ligustrazine is selected from ligustrazine salt hydrochlorate, ligustrazine microcosmic salt.
4. according to claim 1 or 3 described a kind of medicinal composition for injections that improve ligustrazine medicine ejection preparation stability, it is characterized in that the concentration of the salt of said ligustrazine is calculated as 10mg～10g/100ml with ligustrazine.
5. a kind of medicinal composition for injections that improves ligustrazine medicine ejection preparation stability according to claim 1 is characterized in that said ligustrazine medicine ejection preparation dosage form is an injection.
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