CN102514755A - Preparation method of xantinol nicotinate and sodium chloride injection packaged by using soft bag - Google Patents
Preparation method of xantinol nicotinate and sodium chloride injection packaged by using soft bag Download PDFInfo
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- CN102514755A CN102514755A CN2011103460516A CN201110346051A CN102514755A CN 102514755 A CN102514755 A CN 102514755A CN 2011103460516 A CN2011103460516 A CN 2011103460516A CN 201110346051 A CN201110346051 A CN 201110346051A CN 102514755 A CN102514755 A CN 102514755A
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- injection
- sodium chloride
- soft bag
- nitrogen
- sterilization
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Abstract
The invention discloses a preparation method of xantinol nicotinate and sodium chloride injection packaged by using a soft bag. The method comprises the following steps of: heating water for injection, introducing nitrogen gas, cooling, adding xantinol nicotinate and sodium chloride to prepare an injection, after the xantinol nicotinate and the sodium chloride are dissolved, adding active carbon, and stirring; filtering and removing the active carbon, and adjusting the pH value to 6.8-7.4; filling in the soft bag, sealing and sterilizing, wherein preparing, filling and sterilizing are all carried out in a nitrogen gas environment, and a sealed soft bag is sealed by using an oxidation resistant film in vacuum before being sterilized. The xantinol nicotinate and sodium chloride injection packaged by using the soft bag and produced by using the method provided by the invention is good in stability, easy to transport and convenient to use.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of preparation method of Retilian Simplex sodium chloride injection of packed in flexible pouchy.
Background technology
Retilian Simplex is the nicotinate of 1-[2-hydroxyl-3 (2-ethylol-methylamino) propyl group] theophylline, is applicable to (prevention of recurrence), myocarditis after treatment cerebrovascular disorder property disease (like the anoxic property encephalomalacia due to cerebral thrombosis, cerebral embolism, post-traumatic brain syndrome, brain operation sequelae, apoplexy sequelae, the carotid artery obstruction, old brain disorder etc.), coronary heart disease, angina pectoris, the miocardial infarction, antimigraine, aural vertigo disease, Raynaud's disease, intermittent limping disease, diabetic gangrene, thrombophlebitis, varicose ulcer, pulmonary embolism, bedsore, pernio and high fat of blood etc.
At present commercially available infusion products is the glass infusion bottle packing, the product of no plastic bottle and packed in flexible pouchy, major cause is both packaging materials after the directly use, adopt original explained hereafter after, the stability of product can not satisfy the requirement of quality loop.
Existing infusion products is the glass infusion bottle packing, and the transfusion of glass bottle packaging exists weight big, and is frangible, situation such as transportation inconvenience; And if directly change glass bottle packaging into packed in flexible pouchy by existing technology, then product also can't be promoted owing to reasons such as stability are not good.
Summary of the invention
How the technical matters that the present invention will solve produces the Retilian Simplex sodium chloride injection of up-to-standard packed in flexible pouchy.
The prescription of Retilian Simplex sodium chloride injection is following:
The present invention provides a kind of method for preparing the Retilian Simplex sodium chloride injection of packed in flexible pouchy, and this method comprises the steps: to get the 85-95% of water for injection total amount, is heated to 85-95 ℃; Feed nitrogen; Cooling water for injection adds Retilian Simplex and sodium chloride preparation parenteral solution to 30-35 ℃, and the dissolving back adds active carbon; Stir, supply water for injection; Remove by filter active carbon, obtain half-blank, regulate pH to 6.8-7.4; Soft bag filling seals, sterilization; Wherein, preparation, can, sterilization are all carried out under nitrogen environment, adopt oxygen-proof membrane that the soft bag that seals is carried out vacuum sealing before the sterilization.
In view of packed in flexible pouchy material water permeability and permeability to air increase under high temperature, high pressure; Therefore adopt oxygen-proof membrane that the packed in flexible pouchy material is carried out vacuum sealing before the sterilization; Promptly outside soft bag, coat oxygen-proof membrane; Adopt vacuum sealing between soft bag and the oxygen-proof membrane, the inside and outside gas exchange of soft bag, blocking oxygen simultaneously in the time of can preventing follow-up high-temperature sterilization like this.Soft bag is adopted the oxygen-proof membrane vacuum sealing, can guarantee the stability of product long preservation.
The packed in flexible pouchy material can adopt this area pharmaceutical packed in flexible pouchy film commonly used, three layers of for example medical non-PVC, five-layer co-squeezing film; Oxygen-proof membrane also can commercially obtain.
Preferably, contact with oxygen, strengthen the antioxygen property of packed in flexible pouchy parenteral solution, can after adding antioxidant between oxygen-proof membrane and the soft bag, carry out vacuum sealing again in order further to prevent soup.Can play the effect of duplicate protection like this to soup away from oxygen.
Said antioxidant is selected from one or more in sodium sulphite, dibutyl phenol, sodium bisulphite, the sodium thiosulphate.Antioxidant can be packaged in the packing such as filter paper class, nonwoven fabrics, extrusion coating paper or reticulate pattern paper and use.
In one embodiment of the invention, the time to water for injection feeding nitrogen is 25-35 minute.
In one embodiment of the invention, stirred 15-25 minute behind the adding active carbon.
In one embodiment of the invention, adopt the hydrochloric acid solution of 1M or the sodium hydroxide solution of 1M to regulate pH.
In one embodiment of the invention, the addition of active carbon is the 0.01%-0.02% (w/v) of parenteral solution cumulative volume.
In one embodiment of the invention, the content of nitrogen is more than 98% in the said nitrogen environment, and promptly the remaining oxygen of Nitrogen filling system is less than 2%.Preferably, in the said nitrogen environment content of nitrogen more than 99%.
In one embodiment of the invention, said sterilization is 115-121 ℃, constant temperature sterilization 12-35 minute.
In one embodiment of the invention, said preparation method comprises the steps:
Get 90% of water for injection total amount, be heated to 90 ℃, fed nitrogen 30 minutes; Behind the cooling water for injection to 30 ℃, add Retilian Simplex and sodium chloride preparation parenteral solution, abundant dissolving back adding proper amount of active carbon stirs and stops after 20 minutes, supplies water for injection; Active carbon under stirring in the filtering liquid medicine obtains half-blank, regulates pH to 6.8-7.4; Soft bag filling seals, sterilization; Wherein, preparation, can, sterilization are all carried out under nitrogen environment, adopt oxygen-proof membrane that the soft bag that seals is carried out vacuum sealing before the sterilization.Employing water-bath type sterilization, 115-121 ℃, constant temperature sterilization 12-35 minute.
The quality loop WS-452 of Retilian Simplex sodium chloride injection (X-381)-2002 is following:
The Retilian Simplex sodium chloride injection
YanSuan?Zhantinuo?Lühuana?Zhusheye
Xantinol?Nicotinate?and?Sodium?Chloride?Injection
These article are the sterile water solution of Retilian Simplex and sodium chloride.Contain Retilian Simplex
(C
19H
26N
6O
6) should be 93.0%～107.0% of labelled amount.Sodium chloride-containing (NaCl) should be 95.0%～105.0% of labelled amount.
[proterties]
These article are colourless clear liquid.
[discriminating]
(1) gets these article 2ml, drip the tannic acid test solution, promptly generate white precipitate.
(2) these article show the identification (two appendix III of Chinese Pharmacopoeia version in 2005) of sodium salt.
(3) these article show muriatic identification (two appendix III of Chinese Pharmacopoeia version in 2005).
(4) in the chromatlog that the assay item writes down down, test sample is answered consistent with the holding time of reference substance main peak.
[inspection]
PH value: should be 5.5～6.5 (two appendix VI of Chinese Pharmacopoeia version in 2005 H).
Heavy metal: get these article 20ml, it is an amount of to add acetate buffer (pH3.5) 2ml and water, is diluted to 25ml, and inspection (two appendix VIII of Chinese Pharmacopoeia version in 2005 H, first method) in accordance with the law contains heavy metal and must not surpass 5/10000000ths.
Particulate matter: get 1 bottle of these article, detect (two appendix IX of Chinese Pharmacopoeia version in 2005 C) in accordance with the law, should be up to specification.
Related substance: get these article, as need testing solution; Precision is measured in right amount, adds flowing phase and processes the solution that contains Retilian Simplex 30ug among every 1ml, as contrast solution.According to chromatographic condition under the assay item and method, get contrast solution 20ul and inject liquid chromatograph, regulate detection sensitivity, the peak height that makes the major component chromatographic peak is 20～25% of a full scale; Precision is measured above-mentioned two kinds of each 20ul of solution and is injected liquid chromatograph respectively again, 2 times of record chromatlog to the second a peak holding time.In the need testing solution chromatlog, the summation of each impurity peaks peak area must not be greater than contrast solution two peak area sums (1%).
Aseptic: get these article, inspection (two appendix XI of Chinese Pharmacopoeia version in 2005 H) in accordance with the law should be up to specification.
Bacterial endotoxin: get these article, inspection (two XI E of Chinese Pharmacopoeia version in 2005) in accordance with the law, containing the endotoxin amount among every 1ml should be less than 0.5EU.
Other: should meet each item regulation (two appendix I of Chinese Pharmacopoeia version in 2005 B) relevant under the injection item.
[assay]
Retilian Simplex: measure according to high performance liquid chromatography (two appendix V of Chinese Pharmacopoeia version in 2005 D).
Chromatographic condition and system suitability test: using octadecylsilane chemically bonded silica to be extending agent, is flowing phase with methanol-water-glacial acetic acid (30: 70: 0.1), and the detection wavelength is 267nm.Number of theoretical plate calculates by second peak should be not less than 1000.
Determination method: precision is measured these article 2ml, puts in the 100ml measuring bottle, is diluted to scale with flowing phase, shakes up, as need testing solution; Precision is measured 20ul and is injected liquid chromatograph, the record chromatlog.It is an amount of that precision takes by weighing the Retilian Simplex reference substance in addition, adds the also quantitative dilution of flowing phase dissolving and process the solution that contains Retilian Simplex 60ug among every 1ml approximately, measures with method., promptly get with calculated by peak area by external standard method.
Sodium chloride: precision is measured these article 10ml, adds water 40ml, and 5～8 of 2% dextrin solution 5ml and fluorescein indicator solutions are with silver nitrate titration liquid (0.1mol/L) titration.The silver nitrate titration liquid (0.1mol/L) of every 1ml is equivalent to the NaCl of 5.844mg.
[classification]: vasodilator agent.
[specification]: 100ml: Retilian Simplex 0.3g and sodium chloride 0.9g.
[storage]: shading, airtight preservation.
[subject word]: 24 months.
Beneficial effect of the present invention is following:
1. in the injection production technology of packed in flexible pouchy, original prescription changes.
2. preparation is when the can, and the pipeline of Nitrogen filling system is controlled within 2% with a jar interior remaining oxygen, to avoid the soup oxidation.
3. semi-finished pH value is adjusted into 6.8～7.4, after sterilization, can makes the pH value of finished product reach the requirement of product quality standard.
4. the packed in flexible pouchy film is under HTHP, and the water of film and vapour transit dose increase greatly, so when sterilization; The air that to sterilize in the cabinet with 99% high pure nitrogen is earlier drained, in the constant temperature sterilization with the cooling stage after sterilizing, additional high pure nitrogen in cabinet always; Even can guarantee like this under the situation of HTHP; The product of packed in flexible pouchy also can be avoided the main ingredient composition to be destroyed decomposition by oxygen to reach by nitrogen protection, and the controlled purpose of related substance.
Through method of the present invention; Retilian Simplex sodium chloride injection packed in flexible pouchy when producing, behind the final sterilization pH value in controlled scope, and then the stability of assurance product; Make active constituent content on rational inspection level, the bottled product of related substance and original glass quite or lower.Method of the present invention can reduce as far as possible produces the hardware facility input that new product brings, and under the prerequisite of ensuring the quality of products, reduces the productive costs of medicine.Adopt packed in flexible pouchy, light weight, non-friable, easy to use, convenient transportation.
The specific embodiment
Following examples are used to explain the present invention, but are not used for limiting scope of the present invention.
Embodiment 1
Get 900L water for injection, be heated to 90 ℃, fed nitrogen 30 minutes; Behind the cooling water for injection to 30 ℃, add 3kg Retilian Simplex and 9kg sodium chloride preparation parenteral solution, fully the dissolving back adds the active carbon of 0.01% (w/v) of parenteral solution cumulative volume, stirs to stop after 20 minutes, and additional water for injection is to 1000L; Active carbon under stirring in the filtering liquid medicine obtains half-blank, regulates pH to 6.8 with the hydrochloric acid solution of 1M; Soft bag filling seals; In the outer coating of the soft bag that seals one deck oxygen-proof membrane (available from middle Jin Matai company), vacuumize then and seal; Water-bath type sterilization was 115 ℃, constant temperature sterilization 30 minutes.
Nitrogen filled protection is carried out in omnidistance all operations under the environment of 99% high purity nitrogen of wherein preparation, can, sterilization; During sterilization; The air that to sterilize in the cabinet with 99% high pure nitrogen is earlier drained, in the constant temperature sterilization with the cooling stage after sterilizing, additional high pure nitrogen in cabinet always; Even can guarantee that like this under the situation of HTHP, the product of packed in flexible pouchy also can be by nitrogen protection.
Embodiment 2
Get 900L water for injection, be heated to 75 ℃, fed nitrogen 35 minutes; Behind the cooling water for injection to 25 ℃, add 3kg Retilian Simplex and 9kg sodium chloride preparation parenteral solution, fully the dissolving back adds the active carbon of 0.02% (w/v) of parenteral solution cumulative volume, stirs to stop after 15 minutes, and additional water for injection is to 1000L; Active carbon under stirring in the filtering liquid medicine obtains half-blank, regulates pH to 7.2 with the sodium hydroxide solution of 1M; Soft bag filling seals; In the outer coating of the soft bag that seals one deck oxygen-proof membrane (available from middle Jin Matai company), vacuumize then and seal; Water-bath type sterilization was 115 ℃, constant temperature sterilization 35 minutes.
Nitrogen filled protection is carried out in omnidistance all operations under the environment of 99% high purity nitrogen of wherein preparation, can, sterilization; During sterilization; The air that to sterilize in the cabinet with 99% high pure nitrogen is earlier drained, in the constant temperature sterilization with the cooling stage after sterilizing, additional high pure nitrogen in cabinet always; Even can guarantee that like this under the situation of HTHP, the product of packed in flexible pouchy also can be by nitrogen protection.
Embodiment 3
Get 900L water for injection, be heated to 95 ℃, fed nitrogen 35 minutes; Behind the cooling water for injection to 35 ℃, add 3kg Retilian Simplex and 9kg sodium chloride preparation parenteral solution, fully the dissolving back adds the active carbon of 0.01% (w/v) of parenteral solution cumulative volume, stirs to stop after 25 minutes, and additional water for injection is to 1000L; Active carbon under stirring in the filtering liquid medicine obtains half-blank, regulates pH to 7.4 with the sodium hydroxide solution of 1M; Soft bag filling seals; At the outer one deck oxygen-proof membrane (available from middle Jin Matai company) that coats of the soft bag that seals, a small amount of antioxidant sodium sulphite of adding vacuumizes then and seals between soft bag and oxygen-proof membrane; Water-bath type sterilization was 121 ℃, constant temperature sterilization 12 minutes.
Nitrogen filled protection is carried out in omnidistance all operations under the environment of 98% high purity nitrogen of wherein preparation, can, sterilization; During sterilization; The air that to sterilize in the cabinet with 98% high pure nitrogen is earlier drained, in the constant temperature sterilization with the cooling stage after sterilizing, additional high pure nitrogen in cabinet always; Even can guarantee that like this under the situation of HTHP, the product of packed in flexible pouchy also can be by nitrogen protection.
Experimental example 1
According to the scheme of embodiment of the invention 1-3, produced 3 batches of products continuously, every batch batch is 10000 bags; Lot number is respectively: 08051511,08051512,08051513.These 3 batches of medicines have been carried out the long-time stability investigation respectively, operated by the quality loop WS-452 (X-381)-2002 of Retilian Simplex sodium chloride injection, concrete outcome is seen table 1-3:
Table 1 (lot number: 08051511, specification: 100ml: Retilian Simplex 0.3g and sodium chloride 0.9g)
Table 2 (lot number: 08051512, specification: 100ml: Retilian Simplex 0.3g and sodium chloride 0.9g)
Table 3 (lot number: 08051513, specification: 100ml: Retilian Simplex 0.3g and sodium chloride 0.9g)
Experimental example 2
Adopt the production technology of the Retilian Simplex sodium chloride injection of existing glass bottle, only glass bottle is replaced with the packed in flexible pouchy material, produce the Retilian Simplex sodium chloride injection of packed in flexible pouchy.To filling nitrogen (purity of nitrogen is 95%) in the preparing tank, the online nitrogen (purity of nitrogen is 95%) that fills during can is directly sterilized after soft bag seals during preparation.Soft bag is not carried out the oxygen-proof membrane vacuum sealing before the sterilization, and under nitrogen environment, do not carry out during sterilization.Obtaining a collection of contrast product, is 1000 bags in batches, and lot number is 08041211.This batch product is carried out long-time stability investigate, concrete outcome is seen table 4:
Table 4 (lot number: 08041211, specification: 100ml: Retilian Simplex 0.3g and sodium chloride 0.9g)
Can know according to above stability result; Directly the technology of the original glass bottle of employing is produced the Retilian Simplex sodium chloride injection of packed in flexible pouchy; Product pH value after the sterilization and content descend bigger, and related substance exceeds standard more than 3 times, and grave fault closes the requirement of Retilian Simplex sodium chloride injection product quality standard; Therefore the product that only is changed to packed in flexible pouchy by original technology is an off gauge, can't use and list marketing.Working method after the present invention improves can access the Retilian Simplex sodium chloride injection of up-to-standard packed in flexible pouchy, and each item index testing result is all up to specification, and the stability in 24 months is all fine.
Conclusion
More than investigating the result shows; These article are in shading; Deposit under the airtight condition, investigate through long-term test, its proterties has no significant change with the prima facies ratio with discriminating, pH value, heavy metal, particulate matter, related substance, visible foreign matters, content etc.; In 24 months, meet standard code, product stability is good.
Though, the present invention has been done detailed description in the preceding text with general explanation and specific embodiments, on basis of the present invention, can to some modifications of do or improvement, this will be apparent to those skilled in the art.Therefore, these modifications or the improvement on the basis of not departing from spirit of the present invention, made all belong to the scope that requirement of the present invention is protected.
Claims (10)
1. a method for preparing the Retilian Simplex sodium chloride injection of packed in flexible pouchy is characterized in that, comprises the steps: to get the 85-95% of water for injection total amount; Be heated to 85-95 ℃, feed nitrogen, cooling water for injection is to 30-35 ℃; Add Retilian Simplex and sodium chloride preparation parenteral solution; The dissolving back adds active carbon, stirs, and supplies water for injection; Remove by filter active carbon, regulate pH to 6.8-7.4; Soft bag filling seals, sterilization; Wherein, preparation, can, sterilization are all carried out under nitrogen environment, adopt oxygen-proof membrane that the soft bag that seals is carried out vacuum sealing before the sterilization.
2. method according to claim 1 is characterized in that, after adding antioxidant between oxygen-proof membrane and the soft bag, carries out vacuum sealing.
3. method according to claim 1 and 2 is characterized in that, the time that feeds nitrogen to water for injection is 25-35 minute.
4. method according to claim 1 and 2 is characterized in that, stirs 15-25 minute behind the adding active carbon.
5. method according to claim 1 and 2 is characterized in that, regulates pH with the hydrochloric acid solution of 1M or the sodium hydroxide solution of 1M.
6. method according to claim 1 and 2 is characterized in that, the addition of active carbon is the 0.01%-0.02% of parenteral solution cumulative volume.
7. method according to claim 1 and 2 is characterized in that the content of nitrogen is more than 98% in the said nitrogen environment.
8. method according to claim 7 is characterized in that the content of nitrogen is more than 99% in the said nitrogen environment.
9. method according to claim 1 and 2 is characterized in that, said sterilization is 115-121 ℃, constant temperature sterilization 12-35 minute.
10. method according to claim 2 is characterized in that, said antioxidant is selected from one or more in sodium sulphite, dibutyl phenol, sodium bisulphite, the sodium thiosulphate.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105055345A (en) * | 2015-09-02 | 2015-11-18 | 海南葫芦娃制药有限公司 | Composition for injection of xantinol nicotinate, xantinol nicotinate lyophilized powder and preparation method thereof |
| CN113171340A (en) * | 2021-05-07 | 2021-07-27 | 四川科伦药业股份有限公司 | Alanyl glutamine injection and production process thereof |
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| US5767123A (en) * | 1994-11-17 | 1998-06-16 | Tanabe Seiyaku Co., Ltd. | Total parenteral nutrition solution containing water-soluble vitamin B |
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Application publication date: 20120627 |