CN102008727A - Injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation and preparation method of injection-purpose medicine composition - Google Patents
Injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation and preparation method of injection-purpose medicine composition Download PDFInfo
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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 and preparation method thereof.
Background technology
Ligustrazine is the alkaloid that extracts from the Chinese medicine Rhizoma Chuanxiong, 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 adds the high-capacity injection that glucose or sodium chloride are made as osmotic pressure regulator in ligustrazine salt hydrochlorate, ligustrazine microcosmic salt solution.But when the above-mentioned injection of preparation, the pH value of medicinal liquid must 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 of product to check that item is defective.Prior art is to add polyoxyethylene sorbitan monoleate as cosolvent in solution, 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 and preparation method thereof.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 by creative work, the medicinal liquid pH value is more stable, the ligustrazine degradation material reduces greatly than prior art, under the situation of avoiding using other cosolvents that increase the clinical practice risks, 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 made as the pH regulator agent, the consumption of described citric acid and/or sodium citrate is 0.1mg～200.0mg/100ml.
Described 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 described ligustrazine comprises ligustrazine salt hydrochlorate, ligustrazine microcosmic salt.
The concentration of the salt of described ligustrazine is calculated as 10mg～10g/100ml with ligustrazine.
Described medicinal liquid pH value is 3.0～6.0.
Described ligustrazine medicine ejection preparation dosage form is an injection.
The preparation method of the medicinal composition for injections of above-mentioned raising ligustrazine medicine ejection preparation stability comprises the steps:
(1) takes by weighing the salt of ligustrazine 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 standby;
(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, described activated carbon dosage is 0.02g/100ml, stirs the filtration decarburization 15 minutes;
(4) step (3) gained filtrate 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.
The citric acid consumption is that 1mg～2.0g, sodium citrate consumption are 1mg～2.0g in the described step (1).
Described step also comprises osmotic pressure regulator 9.0g in (1).
Described 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 makes 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 discovers by experiment, in ligustrazine medicine ejection preparation, adopt citric acid, sodium citrate is during as the pH regulator agent, the medicinal liquid pH value is more stable, the ligustrazine degradation material reduces greatly than prior art, avoiding using under the situation of other cosolvents that increase the clinical practice risk, having solved ligustrazine injection satisfactorily adopts prior art products to separate out tiny white point easily in storage process, white piece, the problem of solution muddiness, the visible foreign matters that can guarantee the maintenance injection that ligustrazine injection can be stable in storage process detects the regulation that meets drug standard, is 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, determine that deposit mainly is raw material free alkali crystallize and small amount of degradation product, above-mentioned reason occurring may 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, avoiding using under the situation of other cosolvents that increase the clinical practice risk, under long term store and winter low temperature condition, separating out the problem of tiny white point, white piece, solution muddiness easily to solve this product.
The specific embodiment
Below in conjunction with embodiment, the present invention is described in further detail, but embodiments of the present invention are not limited thereto.
Embodiment 1
A kind of preparation method 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 standby.(3) add among the water for injection 500ml below 40 ℃, be stirred to dissolving fully after, add 0.02%(g/ml) active carbon, stirred the filtration decarburization 15 minutes.(4) filtrate is 3.0～7.0 with citric acid or liquor sodii citratis adjusting pH value, and the water for injection of adding below 40 ℃ is to 1000ml; (5) medical filtration is to clarification, and fill is sterilized, promptly.
The composition and the content thereof of concrete each component of present embodiment are as follows:
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 standby.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 activated carbon dosage is 0.02g/100ml), stirred the filtration decarburization 15 minutes.It is 3.8～4.2 that filtrate is regulated pH value with citric acid or liquor sodii citratis, and the water for injection of adding below 40 ℃ is to 1000ml.Medical filtration is to clarification, and fill is sterilized, promptly.
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 standby.(3) add among the water for injection 500ml below 40 ℃, be stirred to dissolving fully after, add 0.02%(g/ml) active carbon, stirred the filtration decarburization 15 minutes.(4) filtrate is 3.0～7.0 with citric acid or liquor sodii citratis adjusting pH value, and the water for injection of adding below 40 ℃ is to 1000ml; (5) medical filtration is to clarification, and fill is sterilized, promptly.
The composition and the content thereof of concrete each component of present embodiment are as follows:
Ligustrazine hydrochloride 20g
Citric acid 1.0g
Sodium citrate 2.0g
Citric acid, sodium citrate are mixed with 10%～20% solution respectively, and be standby.Ligustrazine hydrochloride adds among the water for injection 500ml below 40 ℃, be stirred to dissolving fully after, add 0.02% active carbon (being that activated carbon dosage is 0.02g/100ml), stirred the filtration decarburization 15 minutes.It is 3.8～4.2 that filtrate is regulated pH value with citric acid or liquor sodii citratis, and the water for injection of adding below 40 ℃ is to 1000ml.Medical filtration is to clarification, and fill is sterilized, promptly.
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 of avoiding using other cosolvents that increase the clinical practice risks, 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 every detection index all meets the regulation of this product 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
According to The above results as can be known, 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, having solved the ligustrazine medicine adopts existing technical products the problem of small particles, white piece, solution muddiness to occur under the long situation of period of storage, can guarantee that the visible foreign matters inspection of product meets the regulation of drug standard, is convenient to clinical application and popularization.
As mentioned above, just can realize the present invention preferably.
Claims (10)
1. medicinal composition for injections that improves ligustrazine medicine ejection preparation stability, it is characterized in that, mainly the salt by ligustrazine is dissolved in water for injection, add citric acid and/or sodium citrate and regulate the medicinal composition for injections that the medicinal liquid pH value is made as the pH regulator agent, the consumption of described citric acid and/or sodium citrate is 0.1mg～200.0mg/100ml.
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, described 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 described ligustrazine comprises 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 described 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 described medicinal liquid pH value is 3.0～6.0.
6. a kind of medicinal composition for injections that improves ligustrazine medicine ejection preparation stability according to claim 1 is characterized in that, described ligustrazine medicine ejection preparation dosage form is an injection.
7. the preparation method of the medicinal composition for injections of an above-mentioned raising ligustrazine medicine ejection preparation stability is characterized in that, comprises the steps:
(1) takes by weighing the salt of ligustrazine 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 standby;
(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, described activated carbon dosage is 0.02g/100ml, stirs the filtration decarburization 15 minutes;
(4) step (3) gained filtrate 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 of adding below 40 ℃ is to 1000ml;
(5) with the extremely clarification of step (4) gained medical filtration, fill, sterilization, promptly.
8. a kind of preparation method that improves the medicinal composition for injections of ligustrazine medicine ejection preparation stability according to claim 7 is characterized in that, the citric acid consumption is that 1mg～2.0g, sodium citrate consumption are 1mg～2.0g in the described step (1).
9. a kind of preparation method that improves the medicinal composition for injections of ligustrazine medicine ejection preparation stability according to claim 7 is characterized in that described step also comprises osmotic pressure regulator 9.0g in (1).
10. a kind of preparation method that improves the medicinal composition for injections of ligustrazine medicine ejection preparation stability according to claim 9 is characterized in that described osmotic pressure regulator is a sodium chloride.
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| CN107970427A (en) * | 2017-12-01 | 2018-05-01 | 成都源来来科技有限公司 | A kind of medicinal composition for injections of gingerol |
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