CN1732913A - Propylgallate injection liquid with favorable stability and its preparation process - Google Patents
Propylgallate injection liquid with favorable stability and its preparation process Download PDFInfo
- Publication number
- CN1732913A CN1732913A CN 200510097969 CN200510097969A CN1732913A CN 1732913 A CN1732913 A CN 1732913A CN 200510097969 CN200510097969 CN 200510097969 CN 200510097969 A CN200510097969 A CN 200510097969A CN 1732913 A CN1732913 A CN 1732913A
- Authority
- CN
- China
- Prior art keywords
- propyl ester
- injection
- fructus citri
- citri tangerinae
- water
- 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
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention provides a propylgallate injection with good stability and its preparing process, wherein the injection is prepared by using right auxiliary solvent and charging anti-oxidant, the water-solubility problem of the propylgallate injection can also be solved. The injection is used for treating cardiovascular and cerebrovascular diseases.
Description
Technical field
The invention belongs to field of medicaments, relate to Gallate propyl ester injection of a kind of good stability and preparation method thereof.
Background technology
The Gallate propyl ester has another name called the ester of promoting blood circulation, Radix Paeoniae Rubra 801, is the monomer medicine that is formed through the chemical constitution transformation by the former composition of Chinese medicine Radix Paeoniae Rubra, and chemical name is propyl gallate (C
10H
12O
5).The Gallate propyl ester has various pharmacological activities to cardio-cerebrovascular: anti-platelet aggregation, improve effects such as hemorheology, microcirculation improvement, help the mediation of thromboembolism; Vascular smooth muscle can relax; coronary artery dilating also increases its flow; treating myocardial ischemia damage there is obvious protective effect; lipid peroxidation injury due to the cerebral ischemia re-pouring had protective effect; the histiocyte of enhancing anti-anoxia ability is arranged; clinically be applicable to prevention and treatment cerebral thrombosis, coronary heart disease, and the complication behind the surgical operation, thrombosis deep phlebitis etc.
But, because the Gallate propyl ester is an ester type compound, in water, be difficult for dissolving, it is prepared into injection will solves multiple factors such as dissolubility, drug content, stability, difficulty is bigger.Therefore, a kind of dosage form of injectable powder was only arranged on the former market, need during application to add the transfusion iv drip and use with the propylene glycol dissolving, clinical use is very inconvenient, and bigger side effect is arranged, as local irritant effect etc.In JIUYUE, 2004 rises, and State Food and Drug Administration ratifies the listing of this novel form of Gallate propyl ester injection successively, but this novel formulation also has many deficiencies at aspects such as preparation stabilities, haves much room for improvement and improves.
The invention provides the method that improves Gallate propyl ester stability, the better stability of preparation of the Gallate propyl ester injection that makes thus.
Summary of the invention
The invention provides Gallate propyl ester injection of a kind of good stability and preparation method thereof.
Gallate propyl ester injection of the present invention comprises liquid drugs injection and transfusion.
Gallate propyl ester injection of the present invention contains Gallate propyl ester, cosolvent, antioxidant, the water for injection of effective dose, if the preparation infusion solution also will add an amount of isoosmotic adjusting agent.
As liquid drugs injection, every 1000ml, made by the raw material of following prescription:
Gallate propyl ester 6～24g
Cosolvent 50～500g
Antioxidant 0.1～1g
Water for injection adds to 1000ml
As transfusion, every 1000ml, made by the raw material of following prescription:
Gallate propyl ester 0.6～12g
Cosolvent 100～300g
Antioxidant 0.1～1g
Isoosmotic adjusting agent is an amount of
Water for injection adds to 1000ml
In preparation liquid drugs injection, transfusion is employed cosolvent, be selected from: ethanol, propylene glycol, glycerol, 2,2'-ethylenedioxybis(ethanol)., 1, in 3-butanediol, tertriary amylo alcohol, benzyl alcohol, Macrogol 200, Liquid Macrogol, PEG400 and the Macrogol 600, can be wherein any, also can be the mixture of appointing several compositions, the mixture of the mixture of preferably glycerine, ethanol, propylene glycol, Polyethylene Glycol-400, glycerol and propylene glycol or propylene glycol and Polyethylene Glycol-400.
In preparation liquid drugs injection, transfusion is employed antioxidant, be selected from: calcium disodium edetate, sodium sulfite, sodium pyrosulfite, vitamin C and L-cysteine hydrochloride, can be wherein any, it also can be the mixture of appointing several compositions, preferred calcium disodium edetate, sodium pyrosulfite or L-cysteine hydrochloride, more preferably calcium disodium edetate.
When the preparation infusion solution, needing regulator solution extremely to wait oozes, employed isoosmotic adjusting agent, can be selected from: any in sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium lactate, glucose, fructose, Nulomoline, maltose, xylitol, sorbitol and the dextran, preferred sodium chloride or glucose.
Gallate propyl ester injection with good stability provided by the present invention is to realize by the method for using suitable cosolvent, antioxidant.Preparation method of the present invention is by using cosolvent, preferred preferably glycerine, ethanol, propylene glycol, Polyethylene Glycol-400, glycerol and the mixture of propylene glycol or the mixture of propylene glycol and Polyethylene Glycol-400 of using, the Gallate propyl ester is carried out hydrotropy, solved the water solublity problem of Gallate propyl ester fully, re-use antioxidant, preferred calcium disodium edetate, sodium pyrosulfite or L-cysteine hydrochloride have further improved preparation stability.Use this preparation method, the finished product that makes is safer, more stable, makes clinical a large amount of medication also become possibility, and helps to improve curative effect.
Specific to preparation Gallate propyl ester aqueous injection of the present invention, its preparation method may further comprise the steps:
(1) takes by weighing Gallate propyl ester crude drug, cosolvent, antioxidant by described proportioning;
(2) Gallate propyl ester crude drug is added in the cosolvent, is heated to 70～80 ℃, be stirred to dissolving fully;
(3) add water for injection to cumulative volume 80%, add antioxidant then, and regulate pH value 3.0～5.0;
(4) filter the back and add water for injection or isosmotic solution to 1000 milliliter, fill behind the fine straining, sterilization, Gallate propyl ester aqueous injection finished product.
Specific to preparation Gallate propyl ester transfusion of the present invention, its preparation method may further comprise the steps:
(1) takes by weighing Gallate propyl ester crude drug, cosolvent, antioxidant, isoosmotic adjusting agent by described proportioning;
(2) Gallate propyl ester crude drug is added in the cosolvent, is heated to 70～80 ℃, be stirred to dissolving fully;
(3) add water for injection to cumulative volume 80%, add antioxidant, isoosmotic adjusting agent then, and regulate pH value 3.0～5.0;
(4) filter the back and add water for injection to 1000 milliliter;
(5) fill behind the fine straining, sterilization gets Gallate propyl ester infusion solution finished product.
The present invention preferably writes out a prescription:
For liquid drugs injection, every 1000ml, made by the raw material of following prescription:
Gallate propyl ester 12g
Glycerol 320g
Calcium disodium edetate 0.2g
Water for injection adds to 1000ml
For transfusion, every 1000ml, made by the raw material of following prescription:
Gallate propyl ester 0.6g
Glycerol 100g
Calcium disodium edetate 1g
Sodium chloride 9g
Water for injection adds to 1000ml
Gallate propyl ester transfusion of the present invention, every 1000ml, made by the raw material of following prescription:
Gallate propyl ester 0.6g
Glycerol 100g
Calcium disodium edetate 1g
Glucose 50g
Water for injection adds to 1000ml
Below in conjunction with embodiment the present invention is described in further detail.
The specific embodiment
Injection with small volume:
Embodiment 1
Prescription:
Gallate propyl ester 6g
Glycerol 50g
Calcium disodium edetate 0.1g
Water for injection adds to 1000ml
Get 6g Gallate propyl ester and be added to and be heated to 80 degrees centigrade in the 50g glycerol and be stirred to fully dissolving, add water for injection, add calcium disodium edetate to 800ml, stirring and dissolving is regulated pH3.0-5.0, adds the injection water to 1000ml, stir fine straining, check intermediate products, fill (specification 2ml/ props up, 5ml/ props up, 10ml/ prop up), 100 ℃, sterilization in 30 minutes, clarity test, packing, promptly.
Embodiment 2
Prescription:
Gallate propyl ester 24g
Glycerol 500g
Calcium disodium edetate 1g
Water for injection adds to 1000ml
Get 24g Gallate propyl ester and be added to and be heated to 80 degrees centigrade in the 500g glycerol and be stirred to fully dissolving, add water for injection, add calcium disodium edetate to 800ml, stirring and dissolving is regulated pH3.0-5.0, adds the injection water to 1000ml, stir fine straining, check intermediate products, fill (specification 2ml/ props up, 5ml/ props up, 10ml/ prop up), 100 ℃, sterilization in 30 minutes, clarity test, packing, promptly.
Embodiment 3
Prescription:
Gallate propyl ester 12g
Glycerol 320g
Calcium disodium edetate 0.1g
Water for injection adds to 1000ml
Get 12g Gallate propyl ester and be added to and be heated to 80 degrees centigrade in the 320g glycerol and be stirred to fully dissolving, add water for injection, add calcium disodium edetate to 800ml, stirring and dissolving is regulated pH3.0-5.0, adds the injection water to 1000m], stir fine straining, check intermediate products, fill (specification 2ml/ props up, 5ml/ props up, 10ml/ prop up), 100 ℃, sterilization in 30 minutes, clarity test, packing, promptly.
Embodiment 4:
Prescription:
Gallate propyl ester 12g
Propylene glycol 100g
Calcium disodium edetate 0.2g
Water for injection adds to 1000ml
Get 12g Gallate propyl ester and be added to and be heated to 80 degrees centigrade in the 100g propylene glycol and be stirred to fully dissolving, add water for injection, add calcium disodium edetate to 800ml, stirring and dissolving is regulated pH3.0-5.0, adds the injection water to 1000ml, stir fine straining, check intermediate products, fill (specification 2ml/ props up, 5ml/ props up, 10ml/ prop up), 100 ℃, sterilization in 30 minutes, clarity test, packing, promptly.
Embodiment 5:
Prescription:
Gallate propyl ester 12g
Glycerol 300g
L-cysteine hydrochloride 0.2g
Water for injection adds to 1000ml
Get 12g Gallate propyl ester and be added to and be heated to 80 degrees centigrade in the 300g glycerol and be stirred to fully dissolving, add water for injection, add the L-cysteine hydrochloride to 800ml, stirring and dissolving is regulated pH3.0-5.0, adds the injection water to 1000ml, stir fine straining, check intermediate products, fill (specification 2ml/ props up, 5ml/ props up, 10ml/ prop up), 100 ℃, sterilization in 30 minutes, clarity test, packing, promptly.
Embodiment 6:
Prescription:
Gallate propyl ester 12g
Ethanol 50g
L-cysteine hydrochloride 0.2g
Water for injection adds to 1000ml
Get 12g Gallate propyl ester and be added to and be heated to 80 degrees centigrade in the 50g ethanol and be stirred to fully dissolving, add water for injection, add the L-cysteine hydrochloride to 800ml, stirring and dissolving is regulated pH3.0-5.0, adds the injection water to 1000ml, stir fine straining, check intermediate products, fill (specification 2ml/ props up, 5ml/ props up, 50ml/ prop up), 100 ℃, sterilization in 30 minutes, clarity test, packing, promptly.
Embodiment 7
Prescription:
Gallate propyl ester 24g
Glycerol 100g
Propylene glycol 100g
Calcium disodium edetate 0.2g
Water for injection adds to 1000ml
Get 24g Gallate propyl ester is added to and be heated to 80 degrees centigrade in the mixture of 100g glycerol and 100g propylene glycol and be stirred to dissolving fully, add water for injection, add calcium disodium edetate to 800ml, stirring and dissolving is regulated pH3.0-5.0, adds the injection water to 1000ml, stir fine straining, check intermediate products, fill (specification 2ml/ props up, 5ml/ props up, 10ml/ prop up), 100 ℃, sterilization in 30 minutes, clarity test, packing, promptly.
Embodiment 8
Prescription:
Gallate propyl ester 12g
Propylene glycol 100g
Polyethylene Glycol-400 100g
Sodium pyrosulfite 0.2g
Water for injection adds to 1000ml
Get 12g Gallate propyl ester is added to and be heated to 80 degrees centigrade in the mixture of 100g propylene glycol and 100g Polyethylene Glycol and be stirred to dissolving fully, add water for injection, add sodium pyrosulfite to 800ml, stirring and dissolving is regulated pH3.0-5.0, adds the injection water to 1000ml, stir fine straining, check intermediate products, fill (specification 2ml/ props up, 5ml/ props up, 10ml/ prop up), 100 ℃, sterilization in 30 minutes, clarity test, packing, promptly.Transfusion:
Embodiment 9:
Prescription:
Gallate propyl ester 0.6g
Glycerol 100g
Calcium disodium edetate 0.2g
Sodium chloride 9g
Water for injection adds to 1000ml
Get 12g Gallate propyl ester and be added to and be heated to 80 degrees centigrade in the 320g glycerol and be stirred to fully dissolving, add water for injection, add calcium disodium edetate, sodium chloride to 800ml, stirring and dissolving is regulated pH3.0-5.0, adds the injection water to 1000ml, stir fine straining, check intermediate products, fill (specification 50ml/ bottle, 100ml/ bottle, 250ml/ bottle, 500ml/ bottle), 100 ℃, sterilization in 30 minutes, clarity test, packing, promptly.
Embodiment 10:
Prescription:
Gallate propyl ester 0.6g
Glycerol 100g
Calcium disodium edetate 0.2g
Glucose 50g
Water for injection adds to 1000ml
Get 12g Gallate propyl ester is added to and be heated to 80 degrees centigrade in the 320g glycerol and be stirred to fully dissolving, add water for injection, add calcium disodium edetate, glucose to 800ml, stirring and dissolving is regulated pH3.0-5.0, adds the injection water to 1000ml, stir fine straining, check intermediate products, fill (specification 50ml/ bottle, 100ml/ bottle, 250ml/ bottle, 500ml/ bottle), 100 ℃, sterilization in 30 minutes, clarity test, packing, promptly.
Embodiment 11:
Prescription:
Gallate propyl ester 12g
Glycerol 300g
Calcium disodium edetate 0.2g
Glucose 50g
Water for injection adds to 1000ml
Get 24g Gallate propyl ester is added to and be heated to 80 degrees centigrade in the 320g glycerol and be stirred to fully dissolving, add water for injection, add calcium disodium edetate, glucose to 800ml, stirring and dissolving is regulated pH3.0-5.0, adds the injection water to 1000ml, stir fine straining, check intermediate products, fill (specification 50ml/ bottle, 100ml/ bottle, 250ml/ bottle, 500ml/ bottle), 100 ℃, sterilization in 30 minutes, clarity test, packing, promptly.
Embodiment 12:
Prescription:
Gallate propyl ester 12g
Glycerol 300g
Calcium disodium edetate 0.2g
Sodium chloride 9g
Water for injection adds to 1000ml
Get 24g Gallate propyl ester and be added to and be heated to 80 degrees centigrade in the 320g glycerol and be stirred to fully dissolving, add water for injection, add calcium disodium edetate, sodium chloride to 800ml, stirring and dissolving is regulated pH3.0-5.0, adds the injection water to 1000ml, stir fine straining, check intermediate products, fill (specification 50ml/ bottle, 100ml/ bottle, 250ml/ bottle, 500ml/ bottle), 100 ℃, sterilization in 30 minutes, clarity test, packing, promptly.
Below test has the characteristics of good stability in order to explanation medicine of the present invention
The Gallate propyl ester injection of above-mentioned preparation carries out following stability test:
(1) influence factor's test
Sample source: self-control (5ml:60mg lot number: 040102)
1.1 exposure experiments to light:
Get this product, putting illumination is irradiation under 4500 ± 500LX lamp, by sampling in 0,5,10 day, measures every index, the results are shown in Table 1.
Table 1 exposure experiments to light result
Result of the test shows, this product illumination 5,10 days, and every index and comparison in 0 day, related substance increases, and content reduces.
1.2 hot test
Get this product, put under 60 ℃ of temperature,, measure every index, the results are shown in Table 2 by sampling in 0,5,10 day.
Table 2 hot test result
Result of the test shows, placed 5,10 days for 60 ℃, and every index and comparison in 0 day, related substance increases, and content reduces.
(2) accelerated test
Instrument: 303-1 type electric heating incubator
Condition: 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5%.
Sample: lot number is 040109,040111,040113
Sample thief by the listing packing, is put into temperature and humidity regulator after the packing, in 0,1, every index is measured in sampling in 2,3,6 months, the results are shown in Table 3
The result of the test of 40 ℃ of acceleration of table 3
| Time | HPLC checks | |||||
| Lot number (moon) | Character | pH | Clarity | Related substance % | Content % | |
| 040109 | 0 1 2 3 | The clear and bright clear and bright liquid of the little yellow of liquid of the little yellow of liquid that the little yellow of the liquid of achromatism and clarity is clear and bright | 3.9 3.8 3.9 3.9 | Up to specification | 0.521 1.107 1.616 2.995 | 98.1 97.6 97.0 96.3 |
| 040111 | 0 1 2 3 | The clear and bright clear and bright liquid of the little yellow of liquid of the little yellow of liquid that the little yellow of the liquid of achromatism and clarity is clear and bright | 4.0 3.9 3.9 4.0 | Up to specification | 0.521 1.108 1.676 2.977 | 100.7 100.1 99.7 98.5 |
| 040113 | 0 l 2 3 | The clear and bright clear and bright liquid of the little yellow of liquid of the little yellow of liquid that the little yellow of the liquid of achromatism and clarity is clear and bright | 4.2 4.2 4.1 4.2 | Up to specification | 0.573 1.146 1.697 2.922 | 102.4 102.0 101.2 100.1 |
40 ℃ ± 2 ℃, placed 1 month under relative humidity 75% ± 5% condition, related substance obviously strengthens, and sample is placed on 30 ℃ ± 2 ℃, investigates simultaneously under the condition of relative humidity 60% ± 5%, 40 ℃ are quickened 3 months experimental results and show, the related substance that quickens March exceeds the quality standard limit, and content obviously descends, and is not carrying out 40 ℃ ± 2 ℃, relative humidity 75% ± 5% condition is investigated, 30 ℃ ± 2 ℃, place under the condition of relative humidity 60% ± 5% and continue to investigate, in 0,1, sampling in 2,3,6 months, measure every index, the results are shown in Table 4
30 ℃ of accelerated test results of table 4
| Time | HPLC checks | |||||
| Lot number (moon) | Character | pH | Clarity | Related substance % | Content % | |
| 040109 | 0 1 2 3 6 | The clear and bright liquid of the light yellow color of liquid that the little yellow color of the liquid of the liquid achromatism and clarity of the liquid achromatism and clarity of achromatism and clarity is clear and bright | 3.9 4.2 3.9 3.9 3.8 | Up to specification up to specification | 0.521 0.743 1.058 1.265 1.813 | 98.1 97.8 97.5 96.9 96.1 |
| 040111 | 0 1 2 3 6 | The clear and bright liquid of the light yellow color of liquid that the little yellow color of the liquid of the liquid achromatism and clarity of the liquid achromatism and clarity of achromatism and clarity is clear and bright | 4.0 4.1 4.0 4.0 4.0 | Up to specification up to specification | 0.521 0.781 0.937 1.197 1.761 | 100.7 100.6 100.2 99.6 99.1 |
| 940113 | 0 l 2 3 6 | The clear and bright liquid of the light yellow color of liquid that the little yellow color of the liquid of the liquid achromatism and clarity of the liquid achromatism and clarity of achromatism and clarity is clear and bright | 4.2 4.1 4.2 4.2 4.2 | Up to specification up to specification | 0.573 0.778 0.933 1.199 1.799 | 102.4 102.3 102.1 101.6 101.3 |
(3) long term test is investigated
Condition: 25 ℃ ± 2 ℃ of temperature, relative humidity 60% ± 10%.
Packing: listing packing.
Lot number: 040109,040111,040113
The results are shown in Table 5.
Table 5 long-term test results
| Time | HPLC checks | |||||
| Lot number (moon) | Character | pH | Clarity | Related substance % | Content % | |
| 040109 | 0 3 6 | The liquid of the liquid achromatism and clarity of the liquid achromatism and clarity of achromatism and clarity | 3.9 4.0 3.8 | Up to specification up to specification | 0.521 0.805 1.070 | 98.1 97.7 97.2 |
| 040111 | 0 3 6 | The liquid of the liquid achromatism and clarity of the liquid achromatism and clarity of achromatism and clarity | 4.0 4.1 4.0 | Up to specification up to specification | 0.521 0.978 1.074 | 100.7 100.2 100.0 |
| 040113 | 0 3 6 | The liquid of the liquid achromatism and clarity of the liquid achromatism and clarity of achromatism and clarity | 4.2 4.0 4.2 | Up to specification up to specification | 0.573 0.858 1.005 | 102.4 102.2 102.0 |
Three, conclusion
1. accelerated test shows: this product was placed 6 months under 30 ℃ ± 2 ℃, RH60% ± 5% condition, and related substance slightly increases, and content slightly descends.
2. long term test is 6 months, and related substance has increase slightly, and content has decline slightly.
Claims (12)
1, a kind of Fructus Citri tangerinae propyl ester injection of good stability is characterized in that, contains Fructus Citri tangerinae propyl ester, cosolvent, antioxidant, water for injection and/or an amount of isoosmotic adjusting agent of effective dose.
2, the described Fructus Citri tangerinae propyl ester of claim 1 injection is characterized in that, is liquid drugs injection or transfusion.
3, the described Fructus Citri tangerinae propyl ester of claim 2 aqueous injection is characterized in that, every 1000ml is made by the raw material of following prescription:
Fructus Citri tangerinae propyl ester 6～24g
Cosolvent 50～500g
Antioxidant 0.1～1g
Water for injection adds to 1000ml
4, the described Fructus Citri tangerinae propyl ester transfusion of claim 2 is characterized in that every 1000ml is made by the raw material of following prescription:
Fructus Citri tangerinae propyl ester 0.6～12g
Cosolvent 100～300g
Antioxidant 0.1～1g
Isoosmotic adjusting agent is an amount of
Water for injection adds to 1000ml
5, claim 1,3,4 described cosolvents, it is characterized in that, can be selected from: ethanol, propylene glycol, glycerol, 2,2'-ethylenedioxybis(ethanol)., 1, in 3-butanediol, tertriary amylo alcohol, benzyl alcohol, Macrogol 200, Liquid Macrogol, PEG400 and the Macrogol 600 any or several, the mixture of the mixture of preferably glycerine, ethanol, propylene glycol, glycerol and propylene glycol or propylene glycol and Polyethylene Glycol-400.
6, claim 1,3,4 described antioxidants, it is characterized in that, can be selected from: any in calcium disodium edetate, sodium sulfite, sodium pyrosulfite, vitamin C and the L-cysteine hydrochloride or several, preferred calcium disodium edetate, sodium pyrosulfite or L-cysteine hydrochloride.
7, claim 1,4 described isoosmotic adjusting agent, it is characterized in that, can be selected from: any in sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium lactate, glucose, fructose, Nulomoline, maltose, xylitol, sorbitol and the dextran, preferred sodium chloride or glucose.
8, the preparation method of the described Fructus Citri tangerinae propyl ester of claim 3 aqueous injection is characterized in that its preparation method may further comprise the steps:
(1) takes by weighing Fructus Citri tangerinae propyl ester crude drug, cosolvent, antioxidant by described proportioning;
(2) Fructus Citri tangerinae propyl ester crude drug is added in the cosolvent, is heated to 70～80 ℃, be stirred to dissolving fully;
(3) add water for injection to cumulative volume 80%, add antioxidant then, and regulate pH value 3.0～5.0;
(4) filter the back and add water for injection or isosmotic solution to 1000 milliliter, fill behind the fine straining, sterilization, Fructus Citri tangerinae propyl ester aqueous injection finished product.
9, the preparation method of the described Fructus Citri tangerinae propyl ester transfusion of claim 3 is characterized in that its preparation method may further comprise the steps:
(1) takes by weighing Fructus Citri tangerinae propyl ester crude drug, cosolvent, antioxidant, isoosmotic adjusting agent by described proportioning;
(2) Fructus Citri tangerinae propyl ester crude drug is added in the cosolvent, is heated to 70～80 ℃, be stirred to dissolving fully;
(3) add water for injection to cumulative volume 80%, add antioxidant, isoosmotic adjusting agent then, and regulate pH value 3.0～5.0;
(4) filter the back and add water for injection to 1000 milliliter;
(5) fill behind the fine straining, sterilization gets Fructus Citri tangerinae propyl ester infusion solution finished product.
10, a kind of Fructus Citri tangerinae propyl ester liquid drugs injection is characterized in that every 1000ml is made by the raw material of following prescription:
Fructus Citri tangerinae propyl ester 12g
Glycerol 320g
Calcium disodium edetate 0.2g
Water for injection adds to 1000ml
11, a kind of Fructus Citri tangerinae propyl ester transfusion is characterized in that every 1000ml is made by the raw material of following prescription:
Fructus Citri tangerinae propyl ester 0.6g
Glycerol 320g
Calcium disodium edetate 1g
Sodium chloride 9g
Water for injection adds to 1000ml
12, a kind of Fructus Citri tangerinae propyl ester transfusion is characterized in that every 1000ml is made by the raw material of following prescription:
Fructus Citri tangerinae propyl ester 0.6g
Glycerol 320g
Calcium disodium edetate 1g
Glucose 50g
Water for injection adds to 1000ml
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510097969 CN1732913A (en) | 2005-09-02 | 2005-09-02 | Propylgallate injection liquid with favorable stability and its preparation process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510097969 CN1732913A (en) | 2005-09-02 | 2005-09-02 | Propylgallate injection liquid with favorable stability and its preparation process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1732913A true CN1732913A (en) | 2006-02-15 |
Family
ID=36075669
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510097969 Pending CN1732913A (en) | 2005-09-02 | 2005-09-02 | Propylgallate injection liquid with favorable stability and its preparation process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1732913A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103040744A (en) * | 2012-12-17 | 2013-04-17 | 海南百思特医药科技有限公司 | Propyl gallate liposome injection |
| CN104510709A (en) * | 2013-09-30 | 2015-04-15 | 瑞阳制药有限公司 | Small-volume propyl gallate freeze-dried powder injection, preparation method and producing apparatus thereof |
| CN108066280A (en) * | 2017-12-29 | 2018-05-25 | 山东威智百科药业有限公司 | A kind of propyl ester composition and preparation method thereof |
| CN113101275A (en) * | 2021-05-27 | 2021-07-13 | 海南通用康力制药有限公司 | Propyl gallate freeze-dried powder injection for injection and its preparation method |
-
2005
- 2005-09-02 CN CN 200510097969 patent/CN1732913A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103040744A (en) * | 2012-12-17 | 2013-04-17 | 海南百思特医药科技有限公司 | Propyl gallate liposome injection |
| CN103040744B (en) * | 2012-12-17 | 2015-01-07 | 海南圣欣医药科技有限公司 | Propyl gallate liposome injection |
| CN104510709A (en) * | 2013-09-30 | 2015-04-15 | 瑞阳制药有限公司 | Small-volume propyl gallate freeze-dried powder injection, preparation method and producing apparatus thereof |
| CN108066280A (en) * | 2017-12-29 | 2018-05-25 | 山东威智百科药业有限公司 | A kind of propyl ester composition and preparation method thereof |
| CN108066280B (en) * | 2017-12-29 | 2019-11-22 | 山东威智百科药业有限公司 | A kind of propyl ester composition and preparation method thereof |
| CN113101275A (en) * | 2021-05-27 | 2021-07-13 | 海南通用康力制药有限公司 | Propyl gallate freeze-dried powder injection for injection and its preparation method |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN100339078C (en) | Solid drug for oral use | |
| CN1309711C (en) | 3-amido-1,2-benzoisoxazole derivatives, process for preparation, and use thereof | |
| CN1895239A (en) | Curcumin preparation and its making method | |
| CN1694867A (en) | Crystal for oral solid drug and oral solid drug for dysuria treatment containing the same | |
| CN1093901A (en) | The stabilizing pharmaceutical composition of fumagillol derivatives | |
| CN1522144A (en) | Compositions for preventing human cancer and method of preventing human cancer | |
| CN1686533A (en) | Cyclosporia A microemulsion for eye and its preparation method | |
| CN1960974A (en) | Alkyl substituted piperidine derivatives and their use as monoamine neurotransmitter re-uptake inhibitors | |
| CN1399633A (en) | Pyrimidine derivatives | |
| CN1732913A (en) | Propylgallate injection liquid with favorable stability and its preparation process | |
| CN1142227A (en) | Novel thiazolidin-4-one derivatives | |
| CN1147490C (en) | Fused heterocyclic compounds and their use in the treatment of neurodegenerative diseases | |
| CN1568960A (en) | High purity chlorogenic acid prescription | |
| CN1600297A (en) | Loratadine paster of penetrating skin | |
| CN1219130A (en) | Composition comprising a nitrone compound for use in treating ocular inflammation | |
| CN1265793C (en) | Oral compound levocetirizine pseudoephedrine formulation and its preparation | |
| CN100344624C (en) | Pharmaceutical preparations containing arginine amides | |
| CN1323202A (en) | Sertraline oral concentrate | |
| CN1169721A (en) | Pyridine derivatives | |
| CN1593393A (en) | Prescription of liquid status of Vitamin K1 and its preparation | |
| CN1927206A (en) | Lornoxicam composition for injection and preparation process thereof | |
| CN1303987C (en) | Esmolol Hydrochloride freeze dried powder for injection and its preparation method | |
| CN1565438A (en) | Application of 5-hydroxymethylfurfural in preparation of medicines for nervous system | |
| CN1844106A (en) | Alkyl pyrazine phenolsulfonate and its preparation method and use | |
| CN1543957A (en) | Penciclovir gelling agent and its prepartion |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20060215 |