CN105106110A - Injectable medicine composition capable of improving stability of puerarin medicine injection preparation and preparation method of injectable medicine composition - Google Patents
Injectable medicine composition capable of improving stability of puerarin medicine injection preparation and preparation method of injectable medicine composition Download PDFInfo
- Publication number
- CN105106110A CN105106110A CN201510610529.XA CN201510610529A CN105106110A CN 105106110 A CN105106110 A CN 105106110A CN 201510610529 A CN201510610529 A CN 201510610529A CN 105106110 A CN105106110 A CN 105106110A
- Authority
- CN
- China
- Prior art keywords
- puerarin
- medicine
- injection preparation
- injection
- preparation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- HKEAFJYKMMKDOR-VPRICQMDSA-N puerarin Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1C1=C(O)C=CC(C2=O)=C1OC=C2C1=CC=C(O)C=C1 HKEAFJYKMMKDOR-VPRICQMDSA-N 0.000 title claims abstract description 72
- RXUWDKBZZLIASQ-UHFFFAOYSA-N Puerarin Natural products OCC1OC(Oc2c(O)cc(O)c3C(=O)C(=COc23)c4ccc(O)cc4)C(O)C(O)C1O RXUWDKBZZLIASQ-UHFFFAOYSA-N 0.000 title claims abstract description 71
- 238000002347 injection Methods 0.000 title claims abstract description 58
- 239000007924 injection Substances 0.000 title claims abstract description 58
- 239000003814 drug Substances 0.000 title claims abstract description 34
- 239000000203 mixture Substances 0.000 title claims abstract description 26
- 238000002360 preparation method Methods 0.000 title claims abstract description 26
- 229940124508 injectable medicine Drugs 0.000 title abstract 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract description 93
- 239000001509 sodium citrate Substances 0.000 claims abstract description 26
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims abstract description 26
- 229940079593 drug Drugs 0.000 claims abstract description 22
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 14
- 239000008215 water for injection Substances 0.000 claims abstract description 13
- 239000007788 liquid Substances 0.000 claims abstract description 9
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 18
- 230000003204 osmotic effect Effects 0.000 claims description 9
- 150000003839 salts Chemical class 0.000 claims description 9
- 239000011780 sodium chloride Substances 0.000 claims description 9
- 239000003002 pH adjusting agent Substances 0.000 claims description 7
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 4
- 229910019142 PO4 Inorganic materials 0.000 claims description 4
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 4
- 239000008103 glucose Substances 0.000 claims description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 4
- 239000010452 phosphate Substances 0.000 claims description 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 3
- 239000005715 Fructose Substances 0.000 claims description 3
- 229930091371 Fructose Natural products 0.000 claims description 3
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims description 3
- 229930195725 Mannitol Natural products 0.000 claims description 3
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 3
- 235000001727 glucose Nutrition 0.000 claims description 3
- 239000000594 mannitol Substances 0.000 claims description 3
- 235000010355 mannitol Nutrition 0.000 claims description 3
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 3
- 239000000811 xylitol Substances 0.000 claims description 3
- 235000010447 xylitol Nutrition 0.000 claims description 3
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 3
- 229960002675 xylitol Drugs 0.000 claims description 3
- 238000009472 formulation Methods 0.000 claims description 2
- 235000002639 sodium chloride Nutrition 0.000 claims description 2
- 239000000243 solution Substances 0.000 abstract description 23
- 239000000126 substance Substances 0.000 abstract description 2
- 239000002904 solvent Substances 0.000 abstract 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 11
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 10
- 238000003860 storage Methods 0.000 description 9
- 229910052799 carbon Inorganic materials 0.000 description 8
- 238000001914 filtration Methods 0.000 description 8
- 239000000047 product Substances 0.000 description 8
- 238000005352 clarification Methods 0.000 description 5
- 239000006184 cosolvent Substances 0.000 description 5
- 238000005261 decarburization Methods 0.000 description 5
- 239000003889 eye drop Substances 0.000 description 5
- 229940012356 eye drops Drugs 0.000 description 5
- 239000000706 filtrate Substances 0.000 description 5
- 239000012467 final product Substances 0.000 description 5
- 230000001954 sterilising effect Effects 0.000 description 5
- 238000003756 stirring Methods 0.000 description 5
- 238000000034 method Methods 0.000 description 4
- -1 white block Substances 0.000 description 4
- 229920001214 Polysorbate 60 Polymers 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 239000002245 particle Substances 0.000 description 3
- 239000002994 raw material Substances 0.000 description 3
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- 239000003513 alkali Substances 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 238000012423 maintenance Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 206010059245 Angiopathy Diseases 0.000 description 1
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 1
- 206010008088 Cerebral artery embolism Diseases 0.000 description 1
- 206010008132 Cerebral thrombosis Diseases 0.000 description 1
- 206010018910 Haemolysis Diseases 0.000 description 1
- 201000001429 Intracranial Thrombosis Diseases 0.000 description 1
- 206010047115 Vasculitis Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 229930013930 alkaloid Natural products 0.000 description 1
- 150000003797 alkaloid derivatives Chemical class 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 230000036783 anaphylactic response Effects 0.000 description 1
- 208000003455 anaphylaxis Diseases 0.000 description 1
- 239000005557 antagonist Substances 0.000 description 1
- 230000000702 anti-platelet effect Effects 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 230000036770 blood supply Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 229910001424 calcium ion Inorganic materials 0.000 description 1
- 230000002490 cerebral effect Effects 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 230000000916 dilatatory effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000008588 hemolysis Effects 0.000 description 1
- 230000002949 hemolytic effect Effects 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 201000010849 intracranial embolism Diseases 0.000 description 1
- 230000000302 ischemic effect Effects 0.000 description 1
- 230000004089 microcirculation Effects 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 210000001034 respiratory center Anatomy 0.000 description 1
- 210000002460 smooth muscle Anatomy 0.000 description 1
- 208000010110 spontaneous platelet aggregation Diseases 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 208000019553 vascular disease Diseases 0.000 description 1
- 230000001457 vasomotor Effects 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention discloses an injectable medicine composition capable of improving the stability of a puerarin medicine injection preparation and a preparation method of the injectable medicine composition. The injectable medicine composition is mainly prepared by dissolving a puerarin salt in water for injection to obtain a liquid medicine, and adding citric acid and/or sodium citrate as a pH regulator to regulate the pH value of the liquid medicine, wherein the dose of citric acid and/or sodium citrate is 0.1-200.0 mg/100 ml. Through adoption of the injectable medicine composition, the pH value of the puerarin medicine injection preparation can be more stable; compared with those in the prior art, degraded substances in puerarin are greatly reduced; under the circumstance that other solubilizing agents increasing the clinical application risk are avoided, the clarity of the puerarin medicine injection preparation is improved; particularly, the problem that when the conventional puerarin injection product is stored for a relatively long time, small white dots and white blocks are generated to result in solution turbidity can be solved. Therefore, examination of visible foreign matters in the puerarin medicine injection preparation can be guaranteed to accord with the medicine quality standard regulation, and clinical medication and promotion are facilitated.
Description
Technical field
The invention belongs to medical art, specifically refer to a kind of medicinal composition for injections improving puerarin drug injection preparation stability.
Background technology
Puerarin is the alkaloid extracted from Chinese medicine Herba Gelsemii Elegantis, chemical constitution is tetramethylpyazine, it is a kind of novel agents of calcium ion antagonist, there is blood circulation promoting and blood stasis dispelling, anti-platelet aggregation, excited medullary respiratory center and vasomotor center, blood vessel dilating and bronchial smooth muscle, improve the multiple effects such as microcirculation, clinical for for obliterated cerebral vascular disease if incomplete brain blood supply, cerebral thrombosis, cerebral embolism and other ischemic angiopathys are as coronary heart disease, vasculitis etc.The injection of puerarin is for the modern difficult disease of Chinese medicine makes very big contribution.
Due to puerarin dissolubility extreme difference in aqueous, be therefore made into puerarin hydrochlorate or puerarin phosphate to increase its water solublity.Puerarin injection commercially available at present mainly contains puerarin hydrochlorate, the phosphatic injection with small volume of puerarin, and in puerarin hydrochlorate, puerarin phosphate solution, add the high-capacity injection that glucose or sodium chloride makes as osmotic pressure regulator.But when preparing above-mentioned injection, the pH value of medicinal liquid must be adjusted to the certain limit of applicable human injection's administration, the pH value regulator that current bibliographical information uses is sodium hydroxide solution or uses hydrochloric acid solution, phosphoric acid solution, but the puerarin injection adopting above-mentioned pH value regulator to prepare easily separates out the precipitate such as tiny white point, white block, solution muddiness under long storage periods and winter low temperature condition, causes the visible foreign matters check item of product defective.Prior art adds polyoxyethylene sorbitan monoleate in the solution as cosolvent, occurs the sedimentary problems such as small particles, white block, solution are muddy to solve product.But polyoxyethylene sorbitan monoleate is owing to having the effect of haemolysis and blood pressure lowering, and easily become sour in storage and autoclaving process, cause the injection clinical practice risk containing polyoxyethylene sorbitan monoleate higher, make troubles to clinical application and popularization.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of medicinal composition for injections improving puerarin drug injection preparation stability.This medicinal composition for injections adopts citric acid, sodium citrate as pH adjusting agent, and when finding to adopt citric acid, sodium citrate as pH adjusting agent by creative work, medicinal liquid pH value is more stable, puerarin degradation material comparatively prior art reduces greatly, when avoiding using other to increase the cosolvent of clinical practice risk, solve the problem that puerarin injection easily separates out tiny white point, white block, solution muddiness under long storage periods and winter low temperature condition satisfactorily.
The present invention's adopted technical scheme that solves the problem is: a kind of medicinal composition for injections improving puerarin drug injection preparation stability, salt primarily of puerarin is dissolved in water for injection, add osmotic pressure regulator, and adding the medicinal composition for injections that citric acid and/or sodium citrate regulate medicinal liquid pH value to make as pH adjusting 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, fructose.The consumption of osmotic pressure regulator is prior art, and sodium chloride consumption is 0.9g/100ml; Glucose, xylitol, mannitol, fructose consumption are 5g/100ml ~ 10g/100ml.
The salt of described puerarin comprises puerarin hydrochlorate, puerarin phosphate.
The concentration of the salt of described puerarin is calculated as 10mg ~ 10g/100ml with puerarin.
Described medicinal liquid pH value is 3.0 ~ 6.0.
Described puerarin drug injection preparation formulation is injection.
The preparation method of the medicinal composition for injections of above-mentioned raising puerarin drug injection preparation stability, comprises the steps:
(1) salt of puerarin is taken with puerarin 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, for subsequent use;
(3) salt of puerarin, sodium chloride add in the water for injection 500ml of 30 DEG C ~ 40 DEG C, and be stirred to after dissolving completely, the active carbon added, described activated carbon dosage is 0.02g/100ml, stirs 15 minutes, filtration decarburization;
(4) citric acid that configures of step (3) gained filtrate step (2) and/or liquor sodii citratis adjust ph are 3.0 ~ 7.0, add the water for injection of less than 40 DEG C (30 DEG C ~ 40 DEG C) to 1000ml;
(5) by the extremely clarification of step (4) gained medical filtration, fill, sterilizing, to obtain final product.
The middle citric acid consumption of described step (1) is 1mg ~ 2.0g, sodium citrate consumption is 1mg ~ 2.0g.
Described step also comprises osmotic pressure regulator 9.0g in (1).
Described osmotic pressure regulator is sodium chloride.
In such scheme, add citric acid and/or sodium citrate and refer to that what add can be any one in citric acid, sodium citrate, or citric acid, sodium citrate is with arbitrary proportion proportioning; In step (2), the one in the citric acid added, sodium citrate, then make a kind of solution, as comprised citric acid, sodium citrate two kinds, is then mixed with solution for standby respectively; The salt of puerarin, the consumption of osmotic pressure regulator can adopt the consumption of prior art, and the consumption according to prior art adjusts.
In sum, the invention has the beneficial effects as follows: the present invention studies discovery by experiment, in puerarin drug injection preparation, adopt citric acid, when sodium citrate is as pH adjusting agent, medicinal liquid pH value is more stable, puerarin degradation material comparatively prior art reduces greatly, when avoiding using other to increase the cosolvent of clinical practice risk, solving puerarin injection satisfactorily adopts prior art products easily to separate out tiny white point in storage process, white block, the problem of solution muddiness, can ensure that the visible foreign matters of the maintenance injection that puerarin injection can be stable in storage process detects the regulation meeting drug standard, be convenient to clinical application and popularization.
The present invention passes through creative work, the reason of the tiny white point of separating out in puerarin injection, white block, solution muddiness is analyzed and studied, determine deposit mainly raw material free alkali crystallize and a small amount of catabolite, occur that above-mentioned reason may be relevant with the kind of the pH value of solution and pH adjusting agent acid used, alkali.Therefore use sodium citrate as pH adjusting agent, and use citric acid as pH value counter regulation agent, when avoiding using other to increase the cosolvent of clinical practice risk, to solve the problem that this product easily separates out tiny white point, white block, solution muddiness under long storage periods and winter low temperature condition.
Detailed description of the invention
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
Improve a preparation method for the medicinal composition for injections of puerarin drug injection preparation stability, comprise the steps: that (1) weighting raw materials is with puerarin 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 the solution of 10% ~ 20% respectively, for subsequent use.(3) add in the water for injection 500ml of less than 40 DEG C, be stirred to completely dissolve after, add 0.02%(g/ml) active carbon, stirs 15 minutes, filtration decarburization.(4) filtrate citric acid or liquor sodii citratis adjust ph are 3.0 ~ 7.0, add the water for injection of less than 40 DEG C to 1000ml; (5) medical filtration is to clarification, and fill, sterilizing, to obtain final product.
Composition and the content thereof of the concrete each component of the present embodiment are as follows:
Hydrochloric acid puerarin 0.8g
Sodium chloride 9.0g
Citric acid 1.0g
Sodium citrate 2.0g
Citric acid, sodium citrate are mixed with the solution of 10% ~ 20% respectively, for subsequent use.Hydrochloric acid puerarin, sodium chloride add in the water for injection 500ml of less than 40 DEG C, are stirred to after dissolving completely, add the active carbon (namely activated carbon dosage is 0.02g/100ml) of 0.02%, stir 15 minutes, filter decarburization.Filtrate citric acid or liquor sodii citratis adjust ph are 3.8 ~ 4.2, add the water for injection of less than 40 DEG C to 1000ml.Medical filtration is to clarification, and fill, sterilizing, to obtain final product.
embodiment 2
Or the medicinal composition for injections of above-mentioned raising puerarin drug injection preparation stability is prepared in the steps below:
(1) weighting raw materials is with puerarin amount of calculation 0.1g ~ 100g, citric acid 1mg ~ 2.0g, sodium citrate 1mg ~ 2.0g; (2) citric acid, sodium citrate are mixed with the solution of 10% ~ 20% respectively, for subsequent use.(3) add in the water for injection 500ml of less than 40 DEG C, be stirred to completely dissolve after, add 0.02%(g/ml) active carbon, stirs 15 minutes, filtration decarburization.(4) filtrate citric acid or liquor sodii citratis adjust ph are 3.0 ~ 7.0, add the water for injection of less than 40 DEG C to 1000ml; (5) medical filtration is to clarification, and fill, sterilizing, to obtain final product.
Composition and the content thereof of the concrete each component of the present embodiment are as follows:
Hydrochloric acid puerarin 20g
Citric acid 1.0g
Sodium citrate 2.0g
Citric acid, sodium citrate are mixed with the solution of 10% ~ 20% respectively, for subsequent use.Hydrochloric acid puerarin adds in the water for injection 500ml of less than 40 DEG C, is stirred to after dissolving completely, adds the active carbon (namely activated carbon dosage is 0.02g/100ml) of 0.02%, stir 15 minutes, filters decarburization.Filtrate citric acid or liquor sodii citratis adjust ph are 3.8 ~ 4.2, add the water for injection of less than 40 DEG C to 1000ml.Medical filtration is to clarification, and fill, sterilizing, to obtain final product.
embodiment 3
The comparative test of puerarin eye drops stability
The visible foreign matters of puerarin eye drops obtained by the present invention is utilized to detect the regulation meeting drug standard, and stability of solution is fine, when avoiding using other to increase the cosolvent of clinical practice risk, solving puerarin eye drops in storage process, easily occurring the problems such as small particles, white block, solution are muddy.Utilize the puerarin eye drops obtained by the present invention according to the related request of China's coastal port two annex Ⅺ Ⅹ C pharmaceutical preparation stability test guidelines, investigate respectively and placed 20 days medicine stabilities at 25 DEG C of placements, 24 months, 40 DEG C placements, 6 months, 60 DEG C placements, 10 days, 0 ~ 5 DEG C low temperature, result is constant product quality at the conditions of the experiments described above, and every Testing index all meets the regulation of this product quality standard.
The pharmacological results shows: utilize stable puerarin eye drops obtained by the present invention without hemolytic, without anaphylaxis, nonirritant, meet the requirement of drug administration by injection.
According to the above results, puerarin drug injection preparation of the present invention can improve the clarity of puerarin injection, particularly when puerarin injection period of storage is longer, the visible foreign matters of maintenance injection that can be stable detects the regulation meeting drug standard, solving puerarin medicine adopts existing technical products to occur the problem of small particles, white block, solution muddiness when period of storage is longer, can ensure that the visible foreign matters inspection of product meets the regulation of drug standard, be convenient to clinical application and popularization.
As mentioned above, just the present invention can be realized preferably.
Claims (6)
1. one kind is improved the medicinal composition for injections of puerarin drug injection preparation stability, it is characterized in that, salt primarily of puerarin is dissolved in water for injection, add the medicinal composition for injections that citric acid and/or sodium citrate regulate medicinal liquid pH value to make as pH adjusting 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 improving puerarin drug injection 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, fructose.
3. a kind of medicinal composition for injections improving puerarin drug injection preparation stability according to claim 1, is characterized in that, the salt of described puerarin comprises puerarin hydrochlorate, puerarin phosphate.
4. a kind of medicinal composition for injections improving puerarin drug injection preparation stability according to claim 1 or 3, it is characterized in that, the concentration of the salt of described puerarin is calculated as 10mg ~ 10g/100ml with puerarin.
5. a kind of medicinal composition for injections improving puerarin drug injection 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 improving puerarin drug injection preparation stability according to claim 1, is characterized in that, described puerarin drug injection preparation formulation is injection.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201510610529.XA CN105106110A (en) | 2015-09-23 | 2015-09-23 | Injectable medicine composition capable of improving stability of puerarin medicine injection preparation and preparation method of injectable medicine composition |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201510610529.XA CN105106110A (en) | 2015-09-23 | 2015-09-23 | Injectable medicine composition capable of improving stability of puerarin medicine injection preparation and preparation method of injectable medicine composition |
Publications (1)
Publication Number | Publication Date |
---|---|
CN105106110A true CN105106110A (en) | 2015-12-02 |
Family
ID=54654398
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201510610529.XA Pending CN105106110A (en) | 2015-09-23 | 2015-09-23 | Injectable medicine composition capable of improving stability of puerarin medicine injection preparation and preparation method of injectable medicine composition |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN105106110A (en) |
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106344501A (en) * | 2016-11-06 | 2017-01-25 | 成都先先先生物科技有限公司 | Pharmaceutical composition for injection capable of improving stability of berberine drug injection preparation |
CN106344506A (en) * | 2016-11-06 | 2017-01-25 | 成都先先先生物科技有限公司 | Preparation method of berberine injection preparation pharmaceutical composition |
CN106344503A (en) * | 2016-11-06 | 2017-01-25 | 成都先先先生物科技有限公司 | Method for preparing pharmaceutical composition of lutein injection preparation |
CN106361803A (en) * | 2016-11-06 | 2017-02-01 | 成都先先先生物科技有限公司 | Pharmaceutical composition for injection for improving stability of Astragalus membranaceus medicine injection preparation |
CN106377571A (en) * | 2016-11-06 | 2017-02-08 | 成都先先先生物科技有限公司 | Method for preparing pharmaceutical composition of milkvetch root injection preparation |
CN106377592A (en) * | 2016-11-06 | 2017-02-08 | 成都先先先生物科技有限公司 | Pharmaceutical composition for injection capable of improving stability of Yinzhihuang medication injection agent |
CN106420918A (en) * | 2016-11-06 | 2017-02-22 | 成都先先先生物科技有限公司 | Pharmaceutical composition used for injection and enhanced in stability of Danhong pharmaceutical injection preparation |
CN106474056A (en) * | 2016-11-06 | 2017-03-08 | 成都先先先生物科技有限公司 | A kind of medicinal composition for injections improving phylloxanthin drug injection preparation stability |
CN106474186A (en) * | 2016-11-06 | 2017-03-08 | 成都先先先生物科技有限公司 | A kind of preparation method improving DANHONG drug injection preparation stability |
CN113143861A (en) * | 2021-06-15 | 2021-07-23 | 华北制药股份有限公司 | Puerarin composition for injection and preparation method thereof |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1389211A (en) * | 2002-07-18 | 2003-01-08 | 北京四环科宝制药有限公司 | Puerarin injection and its prepn. process |
CN101416939A (en) * | 2008-12-02 | 2009-04-29 | 上海华源药业(宁夏)沙赛制药有限公司 | Puerarin liquid formulation and preparation method thereof |
CN104688672A (en) * | 2014-12-29 | 2015-06-10 | 浙江莎普爱思药业股份有限公司 | Application of puerarin gel eye drop in preparation of drugs for treating ischemic ocular fundus diseases |
-
2015
- 2015-09-23 CN CN201510610529.XA patent/CN105106110A/en active Pending
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1389211A (en) * | 2002-07-18 | 2003-01-08 | 北京四环科宝制药有限公司 | Puerarin injection and its prepn. process |
CN101416939A (en) * | 2008-12-02 | 2009-04-29 | 上海华源药业(宁夏)沙赛制药有限公司 | Puerarin liquid formulation and preparation method thereof |
CN104688672A (en) * | 2014-12-29 | 2015-06-10 | 浙江莎普爱思药业股份有限公司 | Application of puerarin gel eye drop in preparation of drugs for treating ischemic ocular fundus diseases |
Non-Patent Citations (1)
Title |
---|
徐俭等: "生产厂房、设备变化对葛根素注射液稳定性影响的研究", 《齐齐哈尔医学院学报》 * |
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106344501A (en) * | 2016-11-06 | 2017-01-25 | 成都先先先生物科技有限公司 | Pharmaceutical composition for injection capable of improving stability of berberine drug injection preparation |
CN106344506A (en) * | 2016-11-06 | 2017-01-25 | 成都先先先生物科技有限公司 | Preparation method of berberine injection preparation pharmaceutical composition |
CN106344503A (en) * | 2016-11-06 | 2017-01-25 | 成都先先先生物科技有限公司 | Method for preparing pharmaceutical composition of lutein injection preparation |
CN106361803A (en) * | 2016-11-06 | 2017-02-01 | 成都先先先生物科技有限公司 | Pharmaceutical composition for injection for improving stability of Astragalus membranaceus medicine injection preparation |
CN106377571A (en) * | 2016-11-06 | 2017-02-08 | 成都先先先生物科技有限公司 | Method for preparing pharmaceutical composition of milkvetch root injection preparation |
CN106377592A (en) * | 2016-11-06 | 2017-02-08 | 成都先先先生物科技有限公司 | Pharmaceutical composition for injection capable of improving stability of Yinzhihuang medication injection agent |
CN106420918A (en) * | 2016-11-06 | 2017-02-22 | 成都先先先生物科技有限公司 | Pharmaceutical composition used for injection and enhanced in stability of Danhong pharmaceutical injection preparation |
CN106474056A (en) * | 2016-11-06 | 2017-03-08 | 成都先先先生物科技有限公司 | A kind of medicinal composition for injections improving phylloxanthin drug injection preparation stability |
CN106474186A (en) * | 2016-11-06 | 2017-03-08 | 成都先先先生物科技有限公司 | A kind of preparation method improving DANHONG drug injection preparation stability |
CN113143861A (en) * | 2021-06-15 | 2021-07-23 | 华北制药股份有限公司 | Puerarin composition for injection and preparation method thereof |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN102008727B (en) | Injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation | |
CN105106110A (en) | Injectable medicine composition capable of improving stability of puerarin medicine injection preparation and preparation method of injectable medicine composition | |
CN105125485A (en) | Preparation method of injecting drug improving stability of puerarin drug injection preparation | |
CN105963247A (en) | Preparation method of injection medicine for improving stability of quercetin medicine injection preparation | |
CN106361969A (en) | Preparation method of drug composition for improving stability of Shengmai drug injection preparation | |
CN106474056A (en) | A kind of medicinal composition for injections improving phylloxanthin drug injection preparation stability | |
CN106389315A (en) | Injection pharmaceutical composition for improving stability of sharpleaf galangal fruit drug injection preparation | |
CN106361693A (en) | Preparation method of leech injection preparation pharmaceutical composition | |
CN106344502A (en) | Pharmaceutical composition for injection capable of improving stability of leech drug injection preparation | |
CN106344636A (en) | Preparation method of Chinese thorowax root injection preparation pharmaceutical composition | |
CN105902487A (en) | Injection pharmaceutical composition capable of improving stability of quercetin medication injection preparation | |
CN106389316A (en) | Injection pharmaceutical composition capable of improving stability of abrotani herba drug injection preparation | |
CN106377592A (en) | Pharmaceutical composition for injection capable of improving stability of Yinzhihuang medication injection agent | |
CN106214629A (en) | A kind of preparation method of breviscapine drug injection preparation stability compositions | |
CN106344503A (en) | Method for preparing pharmaceutical composition of lutein injection preparation | |
CN106344501A (en) | Pharmaceutical composition for injection capable of improving stability of berberine drug injection preparation | |
CN105999278A (en) | Injecting medicine composition for improving stability of ginsenoside medicine injection | |
CN106361692A (en) | Injection pharmaceutical composition capable of enhancing radix bupleuri pharmaceutical injection preparation stability | |
CN106377571A (en) | Method for preparing pharmaceutical composition of milkvetch root injection preparation | |
CN106361803A (en) | Pharmaceutical composition for injection for improving stability of Astragalus membranaceus medicine injection preparation | |
CN106389321A (en) | Pharmaceutical composition capable of improving stability of Shenmai drug injection | |
CN106361855A (en) | Method for preparing pharmaceutical composition of Yinzhihuang injection | |
CN106511424A (en) | Preparation method of herba artemisiae annuae injection preparation medicinal composition | |
CN106344506A (en) | Preparation method of berberine injection preparation pharmaceutical composition | |
CN106176589A (en) | Improve the medicinal composition for injections of quinidine sulfate drug injection preparation stability |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
RJ01 | Rejection of invention patent application after publication | ||
RJ01 | Rejection of invention patent application after publication |
Application publication date: 20151202 |