CN109364275A - A kind of sterilizing methods in Venenum Bufonis Injection preparation process - Google Patents
A kind of sterilizing methods in Venenum Bufonis Injection preparation process Download PDFInfo
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- CN109364275A CN109364275A CN201811221688.0A CN201811221688A CN109364275A CN 109364275 A CN109364275 A CN 109364275A CN 201811221688 A CN201811221688 A CN 201811221688A CN 109364275 A CN109364275 A CN 109364275A
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- China
- Prior art keywords
- ampoule
- venenum bufonis
- preparation process
- temperature
- sterilization
- 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.)
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- 230000001954 sterilising effect Effects 0.000 title claims abstract description 79
- 238000002347 injection Methods 0.000 title claims abstract description 30
- 239000007924 injection Substances 0.000 title claims abstract description 30
- 238000000034 method Methods 0.000 title claims abstract description 26
- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 63
- 239000003708 ampul Substances 0.000 claims abstract description 39
- 238000007789 sealing Methods 0.000 claims abstract description 9
- 238000010438 heat treatment Methods 0.000 claims description 5
- 238000005516 engineering process Methods 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 4
- 230000003749 cleanliness Effects 0.000 abstract description 3
- 239000003814 drug Substances 0.000 description 5
- 229940079593 drug Drugs 0.000 description 4
- 241000894006 Bacteria Species 0.000 description 3
- 241000269420 Bufonidae Species 0.000 description 3
- 210000004907 gland Anatomy 0.000 description 2
- 229920006395 saturated elastomer Polymers 0.000 description 2
- 239000002435 venom Substances 0.000 description 2
- 210000001048 venom Anatomy 0.000 description 2
- 231100000611 venom Toxicity 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 206010007247 Carbuncle Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 229930013930 alkaloid Natural products 0.000 description 1
- 150000003797 alkaloid derivatives Chemical class 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000000975 bioactive effect Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 230000001473 noxious effect Effects 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 239000002002 slurry Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 230000003637 steroidlike Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
- A61L2/10—Ultraviolet radiation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0023—Heat
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
- A61L2/06—Hot gas
- A61L2/07—Steam
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/23—Containers, e.g. vials, bottles, syringes, mail
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
The invention discloses the sterilizing methods in a kind of Venenum Bufonis Injection preparation process, comprising the following steps: ampoule is put into ultraviolet disinfection room and carries out sterilization treatment；Ampoule is taken out, is sequentially sent in bottle placer, it is by bottle placer that Venenum Bufonis Injection is filling into ampoule, then carry out sealing treatment；Ampoule after sealing is put into steam sterilization cabinet, temperature is increased, carries out sterilization treatment；After sterilization treatment, the temperature of steam sterilization cabinet is slowly reduced, takes out ampoule；It when ampoule temperatures are reduced to room temperature, put it into refrigerating chamber and is refrigerated, for use.The purpose of the present invention is to provide the sterilization effects that one kind can effectively improve toad element injection, improve the cleanliness of Conservation environment.
Description
Technical field
The invention belongs to Venenum Bufonis Injection technical fields, and in particular to the sterilizing side in a kind of Venenum Bufonis Injection preparation process
Method.
Background technique
The dried venom of toads is processed from strand by the ear rear gland and skin gland secretion object of Bufonidae amphibians faunal, is traditional Chinese medicine
Material.The bioactive substances such as steroidal object, alkaloid contained by the dried venom of toads have the multiple functions such as detoxify, ease pain, having one's ideas straightened out, is antitumor and by
It is widely applied.Taking crisp method is that toad is put into basket, is jiggled in water, after washing away the silt of body surface, draining the water just
Slurry can be scraped.Venenum Bufonis Injection has clearing heat and detoxicating effect, and it is slow can be widely used in the various urgency such as carbuncle swells sore of excessive noxious heat
Property pyogenic infection and the treatment of tumour.
The sterilizing of injection is concerning one of drug quality, the important process step for guaranteeing drug safety.Sterilization process is ground
Suitable sterilizing methods should be selected according to the concrete condition of drug and preparation in studying carefully, accomplish both to kill or remove microorganism, reach
Sterilizing purpose, and guarantee the therapeutic effect and stability of drug.Injection often includes moist heat sterilization with sterilizing methods and filters out excessively
Bacterium method.Moist hear heat test, which is meant, is placed on article in sterilizer, the method to be sterilized using means such as high-pressure saturated steams.Heat
Pressure sterilization ties up in closed sterilization container, heats the method to sterilize with the saturated steam that pressure is greater than normal pressure.
Summary of the invention
To solve the deficiencies in the prior art, the purpose of the present invention is to provide one kind can effectively improve going out for toad element injection
Bacterium effect improves the sterilizing methods in the Venenum Bufonis Injection preparation process of the cleanliness of Conservation environment.
In order to achieve the above objectives, the present invention adopts the following technical scheme that:
A kind of sterilizing methods in Venenum Bufonis Injection preparation process, comprising the following steps:
S1, it ampoule is put into ultraviolet disinfection room carries out sterilization treatment；
S2, ampoule is taken out, is sequentially sent in bottle placer, it is by bottle placer that Venenum Bufonis Injection is filling into ampoule, then
Carry out sealing treatment；
S3, the ampoule after sealing is put into steam sterilization cabinet, increases temperature, carry out sterilization treatment；
After S4, sterilization treatment, the temperature of steam sterilization cabinet is slowly reduced, when 40 ~ 50 DEG C, takes out ampoule；
S5, when ampoule temperatures are reduced to room temperature, put it into refrigerating chamber and refrigerated, for use.
Preferably, in abovementioned steps S1, the time of sterilization treatment is 15 ~ 20min.
More preferably, in abovementioned steps S1, ampoule uses drawing seal technology.
It is highly preferred that the temperature of steam sterilization cabinet is 140 ~ 160 DEG C in above mentioned step S3, sterilization time is 15 ~ 18min,
Sterilization pressure is 0.3 ~ 0.4MPa.
It is further preferred that the heating rate of steam sterilization cabinet is 13 ~ 20 DEG C/min in above mentioned step S3.
Specifically, in abovementioned steps S4, the rate of temperature fall of steam sterilization cabinet is 10 ~ 15 DEG C/min.
Preferably, in abovementioned steps S5, the temperature of refrigerating chamber is -8 ~ -6 DEG C.
The invention has the beneficial effects that: the sterilizing methods in Venenum Bufonis Injection preparation process of the invention are easy to operate,
The sterilization effect that toad element injection can be effectively improved, it is stored refrigerated by being carried out to the ampoule after sterilizing, it can prevent bacterium from entering,
Improve the cleanliness of Conservation environment.
Specific embodiment
Below in conjunction with detailed description of the invention by specific embodiments.
Embodiment 1
A kind of sterilizing methods in Venenum Bufonis Injection preparation process, comprising the following steps:
S1, ampoule is put into progress sterilization treatment 15min in ultraviolet disinfection room；
S2, ampoule is taken out, is sequentially sent in bottle placer, it is by bottle placer that Venenum Bufonis Injection is filling into ampoule, then
Carry out drawing seal processing；
S3, the ampoule after sealing is put into steam sterilization cabinet, increases temperature, carry out sterilization treatment, the temperature of steam sterilization cabinet
It is 140 DEG C, heating rate is 13 DEG C/min, sterilization time 15min, sterilization pressure 0.3MPa；
After S4, sterilization treatment, the temperature of steam sterilization cabinet is slowly reduced, rate of temperature fall is 10 DEG C/min, when 40 DEG C,
Take out ampoule；
S5, when ampoule temperatures are reduced to room temperature, put it into refrigerating chamber and refrigerated, the temperature of refrigerating chamber is -8 DEG C, to
With.
Embodiment 2
A kind of sterilizing methods in Venenum Bufonis Injection preparation process, comprising the following steps:
S1, ampoule is put into progress sterilization treatment 20min in ultraviolet disinfection room；
S2, ampoule is taken out, is sequentially sent in bottle placer, it is by bottle placer that Venenum Bufonis Injection is filling into ampoule, then
Carry out drawing seal processing；
S3, the ampoule after sealing is put into steam sterilization cabinet, increases temperature, carry out sterilization treatment, the temperature of steam sterilization cabinet
It is 160 DEG C, heating rate is 20 DEG C/min, sterilization time 18min, sterilization pressure 0.4MPa；
After S4, sterilization treatment, the temperature of steam sterilization cabinet is slowly reduced, rate of temperature fall is 15 DEG C/min, when 50 DEG C,
Take out ampoule；
S5, when ampoule temperatures are reduced to room temperature, put it into refrigerating chamber and refrigerated, the temperature of refrigerating chamber is -6 DEG C, to
With.
Embodiment 3
A kind of sterilizing methods in Venenum Bufonis Injection preparation process, comprising the following steps:
S1, ampoule is put into progress sterilization treatment 18min in ultraviolet disinfection room；
S2, ampoule is taken out, is sequentially sent in bottle placer, it is by bottle placer that Venenum Bufonis Injection is filling into ampoule, then
Carry out drawing seal processing；
S3, the ampoule after sealing is put into steam sterilization cabinet, increases temperature, carry out sterilization treatment, the temperature of steam sterilization cabinet
It is 150 DEG C, heating rate is 16 DEG C/min, sterilization time 16min, sterilization pressure 0.3MPa；
After S4, sterilization treatment, the temperature of steam sterilization cabinet is slowly reduced, rate of temperature fall is 12 DEG C/min, when 45 DEG C,
Take out ampoule；
S5, when ampoule temperatures are reduced to room temperature, put it into refrigerating chamber and refrigerated, the temperature of refrigerating chamber is -7 DEG C, to
With.
The basic principles, main features and advantages of the invention have been shown and described above.The technical staff of the industry should
Understand, the above embodiments do not limit the invention in any form, all obtained by the way of equivalent substitution or equivalent transformation
Technical solution is fallen within the scope of protection of the present invention.
Claims (7)
1. the sterilizing methods in a kind of Venenum Bufonis Injection preparation process, which comprises the following steps:
S1, it ampoule is put into ultraviolet disinfection room carries out sterilization treatment；
S2, ampoule is taken out, is sequentially sent in bottle placer, it is by bottle placer that Venenum Bufonis Injection is filling into ampoule, then
Carry out sealing treatment；
S3, the ampoule after sealing is put into steam sterilization cabinet, increases temperature, carry out sterilization treatment；
After S4, sterilization treatment, the temperature of steam sterilization cabinet is slowly reduced, when 40 ~ 50 DEG C, takes out ampoule；
S5, when ampoule temperatures are reduced to room temperature, put it into refrigerating chamber and refrigerated, for use.
2. the sterilizing methods in a kind of Venenum Bufonis Injection preparation process according to claim 1, which is characterized in that the step
In rapid S1, the time of sterilization treatment is 15 ~ 20min.
3. the sterilizing methods in a kind of Venenum Bufonis Injection preparation process according to claim 1, which is characterized in that the step
In rapid S1, ampoule uses drawing seal technology.
4. the sterilizing methods in a kind of Venenum Bufonis Injection preparation process according to claim 1, which is characterized in that the step
In rapid S3, the temperature of steam sterilization cabinet is 140 ~ 160 DEG C, and sterilization time is 15 ~ 18min, and sterilization pressure is 0.3 ~ 0.4MPa.
5. the sterilizing methods in a kind of Venenum Bufonis Injection preparation process according to claim 1, which is characterized in that the step
In rapid S3, the heating rate of steam sterilization cabinet is 13 ~ 20 DEG C/min.
6. the sterilizing methods in a kind of Venenum Bufonis Injection preparation process according to claim 1, which is characterized in that the step
In rapid S4, the rate of temperature fall of steam sterilization cabinet is 10 ~ 15 DEG C/min.
7. the sterilizing methods in a kind of Venenum Bufonis Injection preparation process according to claim 1, which is characterized in that the step
In rapid S5, the temperature of refrigerating chamber is -8 ~ -6 DEG C.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811221688.0A CN109364275A (en) | 2018-10-19 | 2018-10-19 | A kind of sterilizing methods in Venenum Bufonis Injection preparation process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811221688.0A CN109364275A (en) | 2018-10-19 | 2018-10-19 | A kind of sterilizing methods in Venenum Bufonis Injection preparation process |
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| Publication Number | Publication Date |
|---|---|
| CN109364275A true CN109364275A (en) | 2019-02-22 |
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|---|---|---|---|
| CN201811221688.0A Pending CN109364275A (en) | 2018-10-19 | 2018-10-19 | A kind of sterilizing methods in Venenum Bufonis Injection preparation process |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110652600A (en) * | 2019-09-27 | 2020-01-07 | 浙江都邦药业股份有限公司 | Multistage sterilization and disinfection equipment for injection and disinfection process thereof |
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| CN101822703A (en) * | 2010-02-08 | 2010-09-08 | 贵州柏强制药有限公司 | Production process of ginseng polysaccharide injection |
| CN201777979U (en) * | 2010-08-17 | 2011-03-30 | 芜湖康奇制药有限公司 | Filling and sealing device for ampoule wire-drawing filling and sealing machine |
| CN104013654A (en) * | 2014-06-03 | 2014-09-03 | 赣州百灵动物药业有限公司 | Preparing method of isatis root injection |
| CN107572017A (en) * | 2017-07-31 | 2018-01-12 | 芜湖杨燕制药有限公司 | A kind of filling process of traditional Chinese medicine |
| CN108272830A (en) * | 2018-03-12 | 2018-07-13 | 韩志波 | A kind of Venenum Bufonis Injection and preparation method thereof |
| CN108303220A (en) * | 2018-02-11 | 2018-07-20 | 李长寿 | A kind of bacterium sterilizing leak detection unit of medical ampoule bottle dress injection |
-
2018
- 2018-10-19 CN CN201811221688.0A patent/CN109364275A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101822703A (en) * | 2010-02-08 | 2010-09-08 | 贵州柏强制药有限公司 | Production process of ginseng polysaccharide injection |
| CN201777979U (en) * | 2010-08-17 | 2011-03-30 | 芜湖康奇制药有限公司 | Filling and sealing device for ampoule wire-drawing filling and sealing machine |
| CN104013654A (en) * | 2014-06-03 | 2014-09-03 | 赣州百灵动物药业有限公司 | Preparing method of isatis root injection |
| CN107572017A (en) * | 2017-07-31 | 2018-01-12 | 芜湖杨燕制药有限公司 | A kind of filling process of traditional Chinese medicine |
| CN108303220A (en) * | 2018-02-11 | 2018-07-20 | 李长寿 | A kind of bacterium sterilizing leak detection unit of medical ampoule bottle dress injection |
| CN108272830A (en) * | 2018-03-12 | 2018-07-13 | 韩志波 | A kind of Venenum Bufonis Injection and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110652600A (en) * | 2019-09-27 | 2020-01-07 | 浙江都邦药业股份有限公司 | Multistage sterilization and disinfection equipment for injection and disinfection process thereof |
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| PB01 | Publication | ||
| PB01 | Publication | ||
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Application publication date: 20190222 |