CN103043311B - Nitrogen charging sealing method of drugs - Google Patents
Nitrogen charging sealing method of drugs Download PDFInfo
- Publication number
- CN103043311B CN103043311B CN201310009666.9A CN201310009666A CN103043311B CN 103043311 B CN103043311 B CN 103043311B CN 201310009666 A CN201310009666 A CN 201310009666A CN 103043311 B CN103043311 B CN 103043311B
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- CN
- China
- Prior art keywords
- nitrogen
- medicine bottle
- fill
- air
- drugs
- 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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Links
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 title claims abstract description 87
- 229910052757 nitrogen Inorganic materials 0.000 title claims abstract description 43
- 239000003814 drug Substances 0.000 title claims abstract description 40
- 238000000034 method Methods 0.000 title claims abstract description 11
- 229940079593 drug Drugs 0.000 title abstract description 12
- 238000007789 sealing Methods 0.000 title abstract 3
- 238000012856 packing Methods 0.000 claims description 15
- XKMRRTOUMJRJIA-UHFFFAOYSA-N ammonia nh3 Chemical compound N.N XKMRRTOUMJRJIA-UHFFFAOYSA-N 0.000 claims description 9
- 239000007788 liquid Substances 0.000 claims description 7
- 230000002906 microbiologic effect Effects 0.000 claims description 6
- 239000003921 oil Substances 0.000 claims description 6
- 239000003182 parenteral nutrition solution Substances 0.000 claims description 5
- 241000894006 Bacteria Species 0.000 claims description 3
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims description 3
- 239000001301 oxygen Substances 0.000 claims description 3
- 229910052760 oxygen Inorganic materials 0.000 claims description 3
- 238000006073 displacement reaction Methods 0.000 claims description 2
- 238000007373 indentation Methods 0.000 claims description 2
- 239000010687 lubricating oil Substances 0.000 claims description 2
- 239000003595 mist Substances 0.000 claims description 2
- 238000012545 processing Methods 0.000 claims description 2
- 229910001220 stainless steel Inorganic materials 0.000 claims description 2
- 239000010935 stainless steel Substances 0.000 claims description 2
- 230000001954 sterilising effect Effects 0.000 claims description 2
- 238000004806 packaging method and process Methods 0.000 abstract description 14
- 206010020751 Hypersensitivity Diseases 0.000 abstract description 2
- 230000006378 damage Effects 0.000 abstract description 2
- 230000000694 effects Effects 0.000 abstract description 2
- 208000026935 allergic disease Diseases 0.000 abstract 1
- 230000007815 allergy Effects 0.000 abstract 1
- 238000002347 injection Methods 0.000 description 7
- 239000007924 injection Substances 0.000 description 7
- 238000002360 preparation method Methods 0.000 description 4
- 239000000825 pharmaceutical preparation Substances 0.000 description 3
- 229930182555 Penicillin Natural products 0.000 description 2
- JGSARLDLIJGVTE-MBNYWOFBSA-N Penicillin G Chemical compound N([C@H]1[C@H]2SC([C@@H](N2C1=O)C(O)=O)(C)C)C(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-MBNYWOFBSA-N 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 229940126534 drug product Drugs 0.000 description 2
- 239000007789 gas Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 230000003647 oxidation Effects 0.000 description 2
- 238000007254 oxidation reaction Methods 0.000 description 2
- 229940049954 penicillin Drugs 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 1
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 1
- NCFTXMQPRQZFMZ-WERGMSTESA-M Cefoperazone sodium Chemical compound [Na+].O=C1C(=O)N(CC)CCN1C(=O)N[C@H](C=1C=CC(O)=CC=1)C(=O)N[C@@H]1C(=O)N2C(C([O-])=O)=C(CSC=3N(N=NN=3)C)CS[C@@H]21 NCFTXMQPRQZFMZ-WERGMSTESA-M 0.000 description 1
- 229930186147 Cephalosporin Natural products 0.000 description 1
- 102000009123 Fibrin Human genes 0.000 description 1
- 108010073385 Fibrin Proteins 0.000 description 1
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 1
- NKZMPZCWBSWAOX-IBTYICNHSA-M Sulbactam sodium Chemical compound [Na+].O=S1(=O)C(C)(C)[C@H](C([O-])=O)N2C(=O)C[C@H]21 NKZMPZCWBSWAOX-IBTYICNHSA-M 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 229960001138 acetylsalicylic acid Drugs 0.000 description 1
- 208000030961 allergic reaction Diseases 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 229960005070 ascorbic acid Drugs 0.000 description 1
- 125000003289 ascorbyl group Chemical group [H]O[C@@]([H])(C([H])([H])O*)[C@@]1([H])OC(=O)C(O*)=C1O* 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 229960002417 cefoperazone sodium Drugs 0.000 description 1
- 229960004261 cefotaxime Drugs 0.000 description 1
- GPRBEKHLDVQUJE-VINNURBNSA-N cefotaxime Chemical compound N([C@@H]1C(N2C(=C(COC(C)=O)CS[C@@H]21)C(O)=O)=O)C(=O)/C(=N/OC)C1=CSC(N)=N1 GPRBEKHLDVQUJE-VINNURBNSA-N 0.000 description 1
- 229960004755 ceftriaxone Drugs 0.000 description 1
- VAAUVRVFOQPIGI-SPQHTLEESA-N ceftriaxone Chemical compound S([C@@H]1[C@@H](C(N1C=1C(O)=O)=O)NC(=O)\C(=N/OC)C=2N=C(N)SC=2)CC=1CSC1=NC(=O)C(=O)NN1C VAAUVRVFOQPIGI-SPQHTLEESA-N 0.000 description 1
- 229940124587 cephalosporin Drugs 0.000 description 1
- 150000001780 cephalosporins Chemical class 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000012790 confirmation Methods 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- AAOVKJBEBIDNHE-UHFFFAOYSA-N diazepam Chemical compound N=1CC(=O)N(C)C2=CC=C(Cl)C=C2C=1C1=CC=CC=C1 AAOVKJBEBIDNHE-UHFFFAOYSA-N 0.000 description 1
- 229910001873 dinitrogen Inorganic materials 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 238000005538 encapsulation Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000002662 enteric coated tablet Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 229950003499 fibrin Drugs 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- DJGAAPFSPWAYTJ-UHFFFAOYSA-M metamizole sodium Chemical compound [Na+].O=C1C(N(CS([O-])(=O)=O)C)=C(C)N(C)N1C1=CC=CC=C1 DJGAAPFSPWAYTJ-UHFFFAOYSA-M 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 229960000614 sulbactam sodium Drugs 0.000 description 1
- 238000004383 yellowing Methods 0.000 description 1
Landscapes
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
The invention relates to a nitrogen charging sealing method of drugs. After nitrogen is charged in a packaging container or a packaging bag of the drugs, the packaging container or the packaging bag is sealed. The nitrogen charging sealing method can effectively improve stability of the drugs, prolongs quality guarantee period of the drugs, effectively avoids damage such as allergy caused by side effects caused by instability of quality of the drugs to human health.
Description
Technical field
What the present invention relates to a kind of medicine fills nitrogen method for packing.
Background technology
In prior art, medicine preparation need encapsulate with packing container or packaging bag mostly, and as liquid drugs injection, powder-injection etc., in process of production, medicine can contact with the air in packing container or packaging bag, and stability of drug products is poor, is easy to go bad.
Summary of the invention
What the object of the invention was to provide a kind of medicine fills nitrogen method for packing, can effectively improve the stability of medicine, extends the quality guarantee period of medicament phase.
Realize the technical scheme of the object of the invention:
Medicine fill a nitrogen method for packing, it is characterized in that: in pharmaceutical packing container or packaging bag, be filled with after nitrogen, then packing container or packaging bag are sealed.
First medicine is placed in packing container or packaging bag, then fills nitrogen.
First packing container or packaging bag are filled to nitrogen, then medicine is placed in packing container or packaging bag.
Fill before nitrogen, need carry out degerming, oil removal treatment to nitrogen.
Fill the level of oxygen of nitrogen nitrogen used lower than 10 × 10
-6.
The microbiological indicator of filling nitrogen nitrogen used is that every cubic meter is no more than 1 bacterium.
Fill the oleaginousness of nitrogen nitrogen used lower than 1mg/m
3.
The beneficial effect that the present invention has:
Under normal temperature, nitrogen chemistry is very stable, is difficult to react with other material, can do the effect of quality supervision for arbitration gas at pharmaceutical industry.Nitrogen is unreactable gas, in pharmaceutical packing container or packaging bag, is filled with nitrogen, displaces the air in packing container or packaging bag; can prevent medicine oxidation deterioration, ensure product design, improve stability of drug products; effectively avoid medicine secondary action to occur; as the allergic reaction of injection, serious life that can crisis people, slight pruitus; gastrointestinal reaction; drug effect lowers, and rotten, variable color causes the injury to people.The inventive method can be used for the encapsulation of multiple medicine preparation:
(1) liquid drugs injection, as: vitamin c parenteral solution, analgin injection, compound Anlin Babituo injection etc.
(2) cephalosporin analog antibiotic and Penicillin antibiotics, as: ceftriaxone for inj, cefotaxime for inj are received, cefoperazone sodium sulbactam sodium, penicillin injection liquid etc.
(3) biopreparate freeze-dried powder, as: freeze-drying M-EGF, fibrin ferment freeze-dried powder etc.
(4) solid pharmaceutical preparation is bottled, packed, as: Ascorbyl c plate, aspirin enteric coated tablet etc.
(5) other medicine preparation encapsulating with packing container or packaging bag.
Observe through experiment, the drug quality that is filled with nitrogen is very stable, and the content of drug that is not filled with nitrogen reduces in various degree, oxidizable kind yellowing soon.
Detailed description of the invention
Fill before nitrogen, first carry out the confirmation of nitrogen system.Confirm mainly to comprise ability, nitrogen gas purity and microbiological indicator.Ability should be able to meet the requirement that medicine preparation is produced.The distribution system inspection of should hunting leak before use, to guarantee the quality of nitrogen, the purity of nitrogen.
Fill nitrogen nitrogen used and need carry out degerming processing, ensure the microbiological indicator of nitrogen, also need to carry out oil removal treatment, remove contained lubricating oil mist of oil in nitrogen, thereby reach production requirement.
The purity of nitrogen: level of oxygen is lower than 10 × 10
-6;
The microbiological indicator of nitrogen: every cubic meter is no more than 1 bacterium.
Fill the oleaginousness of nitrogen nitrogen used lower than 1mg/m
3.
Nitrogen system it should be noted with installing in design:
1. the nitrogen pipeline entering before people's originating firm workshop can be used galvanized pipe, but the pipeline entering in people's workshop should use stainless steel tube,
2. the sterilizing filter of 0.22 μ m should be installed in the pipeline at population place, producing tract;
3. Nitrogen Station should have the filtering installation of suitable oil removing, dedusting.
With the example that is encapsulated as of parenteral solution, first parenteral solution is poured in medicine bottle, then medicine bottle is filled to nitrogen, displace the air in medicine bottle, then medicine bottle is sealed.While filling nitrogen, note adjusting the position of pin mouth, should make pin mouth more than bottleneck, the general position at indentation point; By the effluent stream of the valve control nitrogen in nitrogen pipeline, there is minor fluctuations with liquid surface and be advisable, air-flow is excessive, and liquid easily splashes out, also causes producing burnt first-class problem; Air-flow is too small, can not be completely by the air displacement in medicine bottle.Can also first fill nitrogen to medicine bottle, then parenteral solution is poured into medicine bottle, this kind of method is more suitable for the medicine that is easy to oxidation, though cost is slightly high, can more effectively ensure the quality of medicine.
Claims (1)
- A medicine fill nitrogen method for packing, it is characterized in that: first parenteral solution is poured in medicine bottle, again medicine bottle is filled to nitrogen, displace the air in medicine bottle, then medicine bottle is sealed, fill before nitrogen, fill nitrogen nitrogen used and need carry out degerming processing, ensure the microbiological indicator of nitrogen, also need to carry out oil removal treatment, remove contained lubricating oil mist of oil in nitrogen, fill the level of oxygen of nitrogen nitrogen used lower than 10 × 10 -6, the microbiological indicator of filling nitrogen nitrogen used is that every cubic meter is no more than 1 bacterium, fills the oleaginousness of nitrogen nitrogen used lower than 1mg/m 3; While filling nitrogen, note adjusting the position of pin mouth, should make pin mouth more than bottleneck, remain on the position of indentation point; By the effluent stream of the valve control nitrogen in nitrogen pipeline, there is minor fluctuations with liquid surface and be advisable, air-flow is excessive, and liquid easily splashes out; Air-flow is too small, can not be completely by the air displacement in medicine bottle, and the nitrogen pipeline entering before originating firm workshop can be used galvanized pipe, and the pipeline entering in workshop should use stainless steel tube, and the sterilizing filter of 0.22 μ m is installed in the pipeline of entrance, producing tract.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310009666.9A CN103043311B (en) | 2013-01-11 | 2013-01-11 | Nitrogen charging sealing method of drugs |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310009666.9A CN103043311B (en) | 2013-01-11 | 2013-01-11 | Nitrogen charging sealing method of drugs |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103043311A CN103043311A (en) | 2013-04-17 |
| CN103043311B true CN103043311B (en) | 2014-08-20 |
Family
ID=48056211
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310009666.9A Active CN103043311B (en) | 2013-01-11 | 2013-01-11 | Nitrogen charging sealing method of drugs |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103043311B (en) |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE9503102D0 (en) * | 1995-09-08 | 1995-09-08 | Astra Ab | Aseptic transfer |
| CN1156112A (en) * | 1996-02-02 | 1997-08-06 | 李超文 | Storaging method without oxygen |
| CN101033030B (en) * | 2007-04-13 | 2011-04-06 | 西安力邦制药有限公司 | Application of nontoxic composite aluminum foil for exterior package of PVC or non-PVC soft packed transfusion agent |
| CN201119988Y (en) * | 2007-12-17 | 2008-09-24 | 丽珠集团利民制药厂 | Liquid medicine flexible package |
-
2013
- 2013-01-11 CN CN201310009666.9A patent/CN103043311B/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CN103043311A (en) | 2013-04-17 |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20150925 Address after: 100043, room 2, building 3, building 30, Xing Xing street, Shijingshan District, Beijing, Patentee after: United Nations housekeeping service (Beijing) Co., Ltd. Address before: Qiuxian Xin Ma Tou Zhen Wen Zhuang Cun 057450 Hebei city in Handan Province, a group of 6 Patentee before: Shen Zhengjun |
|
| DD01 | Delivery of document by public notice |
Addressee: United Nations housekeeping service (Beijing) Co., Ltd. Document name: Notification of Passing Examination on Formalities |