CN1251688C - Freeze dried arsenic trioxide injection and its preparation process - Google Patents
Freeze dried arsenic trioxide injection and its preparation process Download PDFInfo
- Publication number
- CN1251688C CN1251688C CN 200310118272 CN200310118272A CN1251688C CN 1251688 C CN1251688 C CN 1251688C CN 200310118272 CN200310118272 CN 200310118272 CN 200310118272 A CN200310118272 A CN 200310118272A CN 1251688 C CN1251688 C CN 1251688C
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- China
- Prior art keywords
- arsenic trioxide
- freeze
- injection
- present
- suspension
- 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.)
- Ceased
Links
- 238000002360 preparation method Methods 0.000 title abstract description 4
- 229940030689 arsenic trioxide injection Drugs 0.000 title description 2
- HJTAZXHBEBIQQX-UHFFFAOYSA-N 1,5-bis(chloromethyl)naphthalene Chemical compound C1=CC=C2C(CCl)=CC=CC2=C1CCl HJTAZXHBEBIQQX-UHFFFAOYSA-N 0.000 claims abstract description 26
- GOLCXWYRSKYTSP-UHFFFAOYSA-N arsenic trioxide Inorganic materials O1[As]2O[As]1O2 GOLCXWYRSKYTSP-UHFFFAOYSA-N 0.000 claims abstract description 26
- 239000000843 powder Substances 0.000 claims abstract description 15
- 239000008227 sterile water for injection Substances 0.000 claims abstract description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 8
- 239000000725 suspension Substances 0.000 claims abstract description 7
- 239000000243 solution Substances 0.000 claims abstract description 4
- 238000004519 manufacturing process Methods 0.000 claims description 11
- 238000001035 drying Methods 0.000 claims description 7
- 210000004907 gland Anatomy 0.000 claims description 7
- JGSARLDLIJGVTE-UHFFFAOYSA-N 3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Chemical compound O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-UHFFFAOYSA-N 0.000 claims description 5
- 238000005303 weighing Methods 0.000 claims description 5
- 238000002347 injection Methods 0.000 abstract description 8
- 239000007924 injection Substances 0.000 abstract description 8
- 238000002425 crystallisation Methods 0.000 abstract description 3
- 230000008025 crystallization Effects 0.000 abstract description 3
- 239000002699 waste material Substances 0.000 abstract description 3
- -1 chlorobutyl Chemical group 0.000 abstract description 2
- 229920005556 chlorobutyl Polymers 0.000 abstract description 2
- 238000004321 preservation Methods 0.000 abstract description 2
- 238000004108 freeze drying Methods 0.000 abstract 3
- 238000004090 dissolution Methods 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 238000000926 separation method Methods 0.000 abstract 1
- 230000001954 sterilising effect Effects 0.000 abstract 1
- 238000004659 sterilization and disinfection Methods 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 5
- 206010028980 Neoplasm Diseases 0.000 description 4
- 229910052785 arsenic Inorganic materials 0.000 description 4
- RQNWIZPPADIBDY-UHFFFAOYSA-N arsenic atom Chemical compound [As] RQNWIZPPADIBDY-UHFFFAOYSA-N 0.000 description 4
- 229940090044 injection Drugs 0.000 description 4
- 208000036762 Acute promyelocytic leukaemia Diseases 0.000 description 3
- 208000033826 Promyelocytic Acute Leukemia Diseases 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000012467 final product Substances 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 210000004881 tumor cell Anatomy 0.000 description 3
- 208000032839 leukemia Diseases 0.000 description 2
- 231100000614 poison Toxicity 0.000 description 2
- 208000031261 Acute myeloid leukaemia Diseases 0.000 description 1
- 101100372758 Danio rerio vegfaa gene Proteins 0.000 description 1
- 206010027476 Metastases Diseases 0.000 description 1
- 108010017842 Telomerase Proteins 0.000 description 1
- 101150030763 Vegfa gene Proteins 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- 210000001185 bone marrow Anatomy 0.000 description 1
- 238000009395 breeding Methods 0.000 description 1
- 230000001488 breeding effect Effects 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000030833 cell death Effects 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 241000411851 herbal medicine Species 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 231100000636 lethal dose Toxicity 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- 230000021332 multicellular organism growth Effects 0.000 description 1
- 239000002574 poison Substances 0.000 description 1
- 230000007096 poisonous effect Effects 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention provides a preparation method for arsenic trioxide freeze-drying power injections. The present invention comprises the procedures that 1, arsenic trioxide is weighed and is arranged in a sterile container, and proper sterile water for injection is added in sterile container so as to prepare suspension; 2, the suspension is heated, stirred and dissolved, and then the suspension is cooled to room temperature; 3, the solution is charged into 10 ml of Schering bottles, each bottle contains 5 ml, the solution is cooled at low temperature and dried, and then covers are pressed after sterilization. The present invention also provides an arsenic trioxide freeze-drying power injection prepared by the preparation method. The present invention not only has the advantages of convenient transportation and use and low breakage rate, but also reduces waste via making use of the repeated extracting use characteristic of chlorobutyl plastic plugs of the existing powder injection Schering bottles. The freeze-drying power injection has the advantages of rapid dissolution, no separation crystallization, stable performance and easy preservation.
Description
Technical field
The present invention relates to medicine preparation, especially a kind of arsenic trioxide freeze-dried powder.
Background technology
At present, arsenic trioxide is used for treating the effect of leukemia and other entity tumors extensively to be approved in the world, thereby arsenic trioxide becomes a big focus of leukemia and treatment of solid tumor research.
Studies show that, a small amount of arsenic (lethal dose is 70～180mg/ time) for oral administration can promote the synthetic of protein in body, stimulate bone marrow hematogenesis, help body growth and breeding, and may pass through protoplasmic poison kill tumor cell (referring to Guo Xiaozhuan, poisonous Chinese herbal medicine voluminous dictionary, Tianjin Scientific English Translation publishing house, 1992).
Arsenic trioxide all has significant curative effect to the acute promyelocytic leukemia (APL) with refractory that just control, recurrence, its complete remission rate (CR) is respectively 87.9%, 88.4% and 48.7%, 5 years and 7 probabilities of living in a year reach 90% and 70% respectively (referring to Zhang Peng, Chinese Journal of Hematology, 2000,2).
U.S. FDA official approval arsenic trioxide is used for the treatment of AML, MM, MDS, CML and five indications of APL.Aspect entity tumor, China and all have big quantity research document to prove that it is by following several mechanism of action treatment tumors abroad:
(1) cell death inducing;
(2) suppress the tumor cell vegf expression;
(3) antitumor cell signal conduction;
(4) expression of rise neoplasm metastasis inhibitive factor;
(5) suppress the tumor cell telomerase activation;
(6) artitumor multi-medicine-resistant factor expression etc.
But the production dosage form of the China and the U.S. is the liquid drugs injection type all at present, and it has the following disadvantages:
(1) breakage rate height all has higher breakage rate in producing, transport, store, using;
(2) present arsenic trioxide injection especially below 5 degrees centigrade the time, is easily separated out crystallization when temperature is lower than 16 degrees centigrade, not only cause the character instability, and affect the treatment;
(3) in case liquid drugs injection peace bottle opening just must once be used up, easily cause waste sometimes, the patient considers for economic aspect, uses preserving after once exhaustless liquid drugs injection breaks a seal sometimes, has increased the incidence rate of side effect such as infusion reaction.
Therefore, be necessary that research makes freeze-dried powder with arsenic trioxide, can make not only that transportation is easy to use, breakage rate is low, the characteristics that can also utilize existing powder injection vial chloro butyl glue plug to extract have repeatedly reduced waste; The more important thing is that the freeze-dried powder dissolving can not separated out crystallization rapidly, stable in properties is easy to preservation.
Summary of the invention
The invention provides a kind of production method of arsenic trioxide freeze-dried powder, it may further comprise the steps:
(1) takes by weighing arsenic trioxide, place sterile chamber, add an amount of sterile water for injection, make suspension;
(2) with the extremely dissolving of suspension heated and stirred, be cooled to room temperature;
(3) the solution branch is installed in the cillin bottle aseptic gland behind the frozen drying.
In the production method of above-mentioned arsenic trioxide freeze-dried powder, in described step (1), preferably the arsenic trioxide that uses and the ratio of sterile water for injection are 1mg: 1ml.
In the production method of above-mentioned arsenic trioxide freeze-dried powder, in described step (3), preferred frozen drying aseptic gland after about 35 hours.
The present invention also provides the arsenic trioxide that is made by aforementioned production method freeze-dried powder.
The specific embodiment
The following examples will be further explained the present invention, but the present invention is not limited only to these embodiment, the scope that these embodiment do not limit the present invention in any way.Some change that those skilled in the art is made within the scope of the claims and adjust also should be thought and belongs to scope of the present invention.
Embodiment 1
The indoor arsenic trioxide 1000mg that takes by weighing places suitable sterile chamber, adds sterile water for injection 1000ml, heated and stirred is cooled to room temperature to dissolving, is sub-packed in the 10ml cillin bottle, every bottle of 5ml, trioxygen-containingization two arsenic 5mg, frozen drying after about 35 hours aseptic gland get final product.
Embodiment 2
The indoor arsenic trioxide 2000mg that takes by weighing places suitable sterile chamber, adds sterile water for injection 2000ml, heated and stirred is cooled to room temperature to dissolving, is sub-packed in the 10ml cillin bottle, every bottle of 5ml, trioxygen-containingization two arsenic 5mg, frozen drying after about 36 hours aseptic gland get final product.
Embodiment 3
The indoor arsenic trioxide 1500mg that takes by weighing places suitable sterile chamber, adds sterile water for injection 1000ml, heated and stirred is cooled to room temperature to dissolving, is sub-packed in the 10ml cillin bottle, every bottle of 5ml, trioxygen-containingization two arsenic 7.5mg, frozen drying after about 35 hours aseptic gland get final product.
Claims (5)
1. the production method of an arsenic trioxide freeze-dried powder, it may further comprise the steps:
(1) takes by weighing arsenic trioxide, place sterile chamber, add an amount of sterile water for injection, make suspension;
(2) with the extremely dissolving of suspension heated and stirred, be cooled to room temperature;
(3) the solution branch is installed in the 10ml cillin bottle every bottle of 5ml, aseptic gland behind the frozen drying.
2. the production method of arsenic trioxide freeze-dried powder as claimed in claim 1 is characterized in that, in described step (1), the arsenic trioxide that uses and the ratio of sterile water for injection are 1mg: 1ml.
3. the production method of arsenic trioxide freeze-dried powder as claimed in claim 1 or 2 is characterized in that, in described step (3), frozen drying is aseptic gland after about 35 hours.
4. the arsenic trioxide freeze-dried powder that makes by claim 1 or 2 described production methods.
5. the arsenic trioxide freeze-dried powder that makes by the described production method of claim 3.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310118272 CN1251688C (en) | 2003-12-09 | 2003-12-09 | Freeze dried arsenic trioxide injection and its preparation process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310118272 CN1251688C (en) | 2003-12-09 | 2003-12-09 | Freeze dried arsenic trioxide injection and its preparation process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1546058A CN1546058A (en) | 2004-11-17 |
| CN1251688C true CN1251688C (en) | 2006-04-19 |
Family
ID=34337997
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200310118272 Ceased CN1251688C (en) | 2003-12-09 | 2003-12-09 | Freeze dried arsenic trioxide injection and its preparation process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1251688C (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI790191B (en) | 2015-02-01 | 2023-01-21 | 美商錫羅斯製藥公司 | High surface-area lyophilized compositions comprising arsenic for oral administration in patients |
| CN106214840A (en) * | 2016-08-01 | 2016-12-14 | 田云培 | The chemotherapy of a kind of cancer and oral medication method |
-
2003
- 2003-12-09 CN CN 200310118272 patent/CN1251688C/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| CN1546058A (en) | 2004-11-17 |
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| C06 | Publication | ||
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| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
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| C35 | Partial or whole invalidation of patent or utility model | ||
| CF01 | Termination of patent right due to non-payment of annual fee | ||
| IW01 | Full invalidation of patent right |
Decision date of declaring invalidation: 20080401 Decision number of declaring invalidation: 11136 |