CN109394684A - PHENYLEPHRINE HYDROCHLORIDE and its manufacture craft - Google Patents
PHENYLEPHRINE HYDROCHLORIDE and its manufacture craft Download PDFInfo
- Publication number
- CN109394684A CN109394684A CN201811495059.7A CN201811495059A CN109394684A CN 109394684 A CN109394684 A CN 109394684A CN 201811495059 A CN201811495059 A CN 201811495059A CN 109394684 A CN109394684 A CN 109394684A
- Authority
- CN
- China
- Prior art keywords
- solution
- phenylephrine hydrochloride
- injection
- water
- manufacture craft
- 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
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/02—Non-specific cardiovascular stimulants, e.g. drugs for syncope, antihypotensives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/06—Antiarrhythmics
Abstract
The invention discloses a kind of PHENYLEPHRINE HYDROCHLORIDE and its manufacture crafts, the ingredient of the PHENYLEPHRINE HYDROCHLORIDE are as follows: every 10000ml is included, and PHENYLEPHRINE HYDROCHLORIDE 100g, sodium chloride 50g-80g, natrium adetate 0.7g-1g, water for injection add to 10000ml.With the hot water for injection for preparing overall accumulated amount 90% is added in container, 30 DEG C are cooled to, leads to carbon dioxide to saturation；By a small amount of hot water for injection dissolution of natrium adetate；The natrium adetate solution that sodium chloride, PHENYLEPHRINE HYDROCHLORIDE and step (2) obtain is separately added into the water for injection of step (1) acquisition and is stirred to dissolution；Add and inject water to total amount, stirs evenly；Measure the pH value of solution, it is ensured that solution ph is between 2.8~4.8；With 0.45 μm, 0.22 μm of filter membrane filtering；Solution is potted by potting operation program, leads to N when encapsulating in ampoule2。
Description
Technical field
The present invention relates to a kind of production of slow releasing pharmaceutical more particularly to a kind of PHENYLEPHRINE HYDROCHLORIDEs.
Background technique
PHENYLEPHRINE HYDROCHLORIDE is suitable for maintaining blood pressure when treatment shock and anesthesia.It is supraventricular to be also used for control paroxysmal
Tachycardia, it may also be used for mydriasis inspection etc..
Summary of the invention
Technical problem to be solved by the invention is to provide a kind of PHENYLEPHRINE HYDROCHLORIDE and its manufacture crafts.
In order to solve the above technical problems, the technical scheme is that achieve the above object, the present invention discloses following skill
Art scheme: a kind of PHENYLEPHRINE HYDROCHLORIDE includes following component:
Every 10000ml injection includes,
PHENYLEPHRINE HYDROCHLORIDE 100g
50~80g of sodium chloride
Natrium adetate 0.7g~1g
Water for injection adds to 10000ml.
The manufacture craft of above-mentioned PHENYLEPHRINE HYDROCHLORIDE, the manufacture craft carry out in closed environment, comprising with
Lower step:
(1) with the hot water for injection for preparing overall accumulated amount 90% is added in container, 30 DEG C is cooled to, carbon dioxide 15 is led to
Minute, it is allowed to be saturated；
(2) a small amount of hot water for injection of natrium adetate is dissolved, for use；
(3) the natrium adetate solution that sodium chloride, PHENYLEPHRINE HYDROCHLORIDE and step (2) obtain is separately added into step
Suddenly it in the water for injection that (1) obtains, is stirred to dissolve；
(4) add and inject water to total amount, stir evenly；
(5) solution obtained to step (4) is sampled, and measures the pH value of solution, and pH value is controlled 2.8~4.8；
(6) solution obtained with the filtering membrane filtration step (5) of 0.45 μm, 0.22 μm；
(7) solution that step (6) obtain is potted by potting operation program, leads to N when encapsulating in ampoule2。
Described step (1)~(7) are carried out by sterile production technique as a preferred technical solution,.
Above-mentioned manufacture craft further includes sterilization steps as a preferred technical solution:
(8) by step (7) obtain product sterilize, sterilising conditions be 100 DEG C 30 minutes or 121 DEG C sterilizing 10~20
Minute.
In an embodiment of the present invention, the PHENYLEPHRINE HYDROCHLORIDE, also containing burnt sulfurous in every 10000ml injection
Sour sodium 8g~12g.
The manufacture craft of above-mentioned PHENYLEPHRINE HYDROCHLORIDE comprising the steps of:
(3) natrium adetate obtained sodium chloride, sodium pyrosulfite, PHENYLEPHRINE HYDROCHLORIDE and step (2) is molten
Liquid is separately added into the water for injection of step (1) acquisition, is stirred to dissolve；
(4) water for injection for adding 30 DEG C is stirred evenly to total amount；
(5) solution obtained to step (4) is sampled, and measures the pH value of each component content and solution, and pH value control exists
2.8~4.8；
(6) solution obtained with 0.45 μm, 0.22 μm of filtering membrane filtration step (5), in filter process in solution reservoir
Logical N2；
Described step (1)~(7) are carried out by sterile production technique as a preferred technical solution,.
Above-mentioned manufacture craft further includes sterilization steps as a preferred technical solution:
The positive effect of the present invention: providing one kind both can guarantee that the quality of PHENYLEPHRINE HYDROCHLORIDE met state food
While Drug Administration provides, and the prescription and its manufacture craft that cost can be reduced.
The present invention is described in detail with reference to embodiments, embodiment is intended to explain technology rather than limiting the invention
Scheme.
Above-mentioned technical proposal provides the prescription and its manufacture craft of a kind of lower-cost PHENYLEPHRINE HYDROCHLORIDE.
Specific embodiment
The above shows and describes the basic principle, main features and advantages of the invention.The technology of the industry
Personnel are it should be appreciated that the present invention is not limited to the above embodiments, and the above embodiments and description only describe this
The principle of invention, without departing from the spirit and scope of the present invention, various changes and improvements may be made to the invention, these changes
Change and improvement all fall within the protetion scope of the claimed invention.The claimed scope of the invention by appended claims and its
Equivalent thereof.
Embodiment 1
PHENYLEPHRINE HYDROCHLORIDE includes following component:
PHENYLEPHRINE HYDROCHLORIDE 100g
Sodium chloride 60g
Sodium pyrosulfite 10g
Natrium adetate 1g
Water for injection adds to 10000ml.
The manufacture craft of the PHENYLEPHRINE HYDROCHLORIDE comprising the steps of:
(1) with the water for injection for preparing overall accumulated amount 90% is added in container, 30 DEG C are cooled to, logical carbon dioxide 15 divides
Clock is allowed to be saturated；
(5) solution obtained to step (4) is sampled, and measures the pH value of each component content and solution, and pH value control exists
2.8~4.8；
(6) solution obtained with the filtering membrane filtration step (5) of 0.45 μm, 0.22 μm；
(7) solution that step (6) obtain is potted by potting operation program, is then sterilized, sterilising conditions are
100 DEG C sterilize 12 minutes for sterilizing 30 minutes or 121 DEG C.
According to Chinese Pharmacopoeia two quality criteria requirements in relation to PHENYLEPHRINE HYDROCHLORIDE of version in 2010, to above-mentioned difference
The two kinds of samples prepared under 100 DEG C of 30 minutes and 121 DEG C of 12 minutes sterilising conditions carry out study on the stability and detection, as a result
It is compared as follows:
In the present embodiment, sodium pyrosulfite is as antioxidant, for preventing the oxidation of PHENYLEPHRINE HYDROCHLORIDE.But it should
Prescription higher cost, we have carried out formulation optimization to it.Through overtesting, PHENYLEPHRINE HYDROCHLORIDE original prescription and removal are found
Prescription after antioxidant is compared, and 121 DEG C of terminal sterilizations, 10~20 minutes technique can be used, and every check item meets rule
It is fixed, it is ensured that SAL≤10-6, and F0 >=12；And be also suitable using sterile production technique, it can satisfy SAL no more than 10-3
Technical requirements.
Therefore, prescription is produced to simplify, save the cost, we are studied sodium pyrosulfite rejecting again.
Embodiment 2
Sodium chloride 50g
Natrium adetate 0.8g
Water for injection adds to 10000ml.
The manufacture craft of the PHENYLEPHRINE HYDROCHLORIDE carries out in closed environment comprising the steps of:
(6) solution obtained with 0.45 μm, 0.22 μm of filtering membrane filtration step (5), in filter process in solution reservoir
Logical N2；
(7) solution that step (6) obtain is potted by potting operation program, leads to N2 when encapsulating in ampoule, then into
Row sterilizing, sterilising conditions are that 100 DEG C of sterilizings sterilize 12 minutes for 30 minutes or 121 DEG C.
Certainly, step (1) to (5) can also carry out matching for injection using the method for sterile production in above-mentioned manufacture craft
System, the solution then obtained through 0.45 μm, 0.22 μm of filtering lead to N2, then carry out nothing to clarifying in solution reservoir in filter process
N is led in bacterium encapsulating when encapsulating in ampoule2。
Compared with Example 1, production process of the invention carries out in closed environment, and when filtering encapsulating by continuous
Ground leads to N2Closed protection is carried out to product, to ensure that raw material " PHENYLEPHRINE HYDROCHLORIDE " is not oxidized, to reach from
The purpose of antioxidant " sodium pyrosulfite " is removed in side.
Embodiment 3
Sodium chloride 60g
Natrium adetate 1g
Water for injection adds to 10000ml.
Its manufacture craft is same as Example 2.
Embodiment 4
Every 10000ml injection
Sodium chloride 80g
Natrium adetate 0.7g
Water for injection adds to 10000ml.
Its manufacture craft is same as Example 2.
The above shows and describes the basic principle, main features and advantages of the invention.The technology of the industry
Personnel are it should be appreciated that the present invention is not limited to the above embodiments, and the above embodiments and description only describe this
The principle of invention, without departing from the spirit and scope of the present invention, various changes and improvements may be made to the invention, these changes
Change and improvement all fall within the protetion scope of the claimed invention.The claimed scope of the invention by appended claims and its
Equivalent thereof.
Claims (5)
1. a kind of PHENYLEPHRINE HYDROCHLORIDE, which is characterized in that include following component: every 10000ml injection includes, and 100 grams
PHENYLEPHRINE HYDROCHLORIDE, 50g~80g sodium chloride, 0.7~1g natrium adetate.
2. PHENYLEPHRINE HYDROCHLORIDE as described in claim 1, which is characterized in that also include following component: every 10000ml note
It penetrates liquid to include, sodium pyrosulfite 8g~12g.
3. a kind of manufacture craft of PHENYLEPHRINE HYDROCHLORIDE as described in claim 1, which is characterized in that the manufacture craft
It is carried out in closed environment comprising the steps of:
(1) in container plus the hot water for injection of overall accumulated amount 90% is prepared, 30 DEG C are cooled to, leads to carbon dioxide to full
With；
(2) a small amount of hot water for injection of natrium adetate is dissolved；
(3) the natrium adetate solution that sodium chloride, PHENYLEPHRINE HYDROCHLORIDE and step (2) obtain is separately added into step
(1) obtain water for injection in and stir to dissolve；
(4) add and inject water to total amount, stir evenly；
(5) solution obtained to step (4) is sampled, and measures the pH value of solution, it is ensured that solution ph is between 2.8~4.8；
(6) solution obtained with the filtering membrane filtration step (5) of 0.45 μm, 0.22 μm；
(7) solution that step (6) obtain is potted by potting operation program, leads to N when encapsulating in ampoule2。
(8) aforementioned manufactured goods are subjected to high-temperature sterilization.
4. the manufacture craft of PHENYLEPHRINE HYDROCHLORIDE as claimed in claim 2, which is characterized in that comprise the steps of:
(1) with the water for injection for preparing overall accumulated amount 90% is added in container, 30 DEG C are cooled to, is led to carbon dioxide 15 minutes,
It is allowed to be saturated；
(3) the natrium adetate solution point obtained sodium chloride, sodium pyrosulfite, PHENYLEPHRINE HYDROCHLORIDE and step (2)
Not Jia Ru step (1) obtain water for injection in, be stirred to dissolve；
(5) solution obtained to step (4) is sampled, and measures the pH value of each component content and solution, pH value control 2.8~
4.8；
(6) solution obtained with the filtering membrane filtration step (5) of 0.45 μm, 0.22 μm；
(7) solution for obtaining step (6) carries out sterile encapsulating by potting operation program, leads to N in ampoule when encapsulating2。
5. manufacture craft as claimed in claim 4, which is characterized in that described step (1)~(7) by sterile production technique into
Row.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811495059.7A CN109394684A (en) | 2018-12-07 | 2018-12-07 | PHENYLEPHRINE HYDROCHLORIDE and its manufacture craft |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811495059.7A CN109394684A (en) | 2018-12-07 | 2018-12-07 | PHENYLEPHRINE HYDROCHLORIDE and its manufacture craft |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109394684A true CN109394684A (en) | 2019-03-01 |
Family
ID=65457793
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811495059.7A Pending CN109394684A (en) | 2018-12-07 | 2018-12-07 | PHENYLEPHRINE HYDROCHLORIDE and its manufacture craft |
Country Status (1)
| Country | Link |
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| CN (1) | CN109394684A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110507607A (en) * | 2019-09-27 | 2019-11-29 | 葵花药业集团北京药物研究院有限公司 | Diphenhydramine feritin oral solution and its preparation method and application |
-
2018
- 2018-12-07 CN CN201811495059.7A patent/CN109394684A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110507607A (en) * | 2019-09-27 | 2019-11-29 | 葵花药业集团北京药物研究院有限公司 | Diphenhydramine feritin oral solution and its preparation method and application |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20190301 |
|
| WD01 | Invention patent application deemed withdrawn after publication |