CN104622814A - New freeze-drying technology of amikacin sulfate for injection - Google Patents
New freeze-drying technology of amikacin sulfate for injection Download PDFInfo
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- CN104622814A CN104622814A CN201310541029.6A CN201310541029A CN104622814A CN 104622814 A CN104622814 A CN 104622814A CN 201310541029 A CN201310541029 A CN 201310541029A CN 104622814 A CN104622814 A CN 104622814A
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Abstract
The invention relates to a new freeze-drying technology of amikacin sulfate for injection, and belongs to the technical field of biomedicines. The problems of low raw material utilization rate and high product rejection rate in the freeze-drying process of amikacin sulfate for injection are mainly solved. The new freeze-drying technology has the advantages of high raw material utilization rate, low product rejection rate and stable finished product quality. The technology comprises the following steps: 1, cooling a product to -35DEG C, and carrying out heat insulation for 60min to completely freeze the product; 2, evacuating, starting electric heating when the pressure is about 20Pa, controlling the heating speed at 1DEG C/h, cooling to -20DEG C when the temperature rises to -15DEG C, carrying out heat insulation for 1h, and then continuously heating; and 3, carrying out heat insulation for 1.5h when the temperature of the product reaches 30DEG C, and pressing the product out of a box under a pressure of 6Mpa. The finished product produced through the technology has the advantages of stable quality, obviously reduced cost and good market prospect, and is worth to be popularized.
Description
One, technical field
The present invention is amikacin sulfate for injection lyophilizing new technology, belongs to biomedicine technical field.
Two, background technology
Amikacin sulfate for injection, main component is amikacin sulfate, its chemistry 0-3-amino-3-deoxidation-a-D-Glucopyranyl-(1 → 6)-0-by name [(6-amino-6-deoxidation-a-D-Glucopyranyl-(1 → 4)]-N-(4-amino-2-hydroxyl-1-oxygen-butyl)-2-deoxidation-D-streptamine sulfate, be used for the treatment of bacteremia or septicemia, bacterial endocarditis, lower respiratory infection, bone joint infection, biliary tract infection, abdominal cavity infection, complexity urinary tract infection, skin soft-tissue infection etc.
This product processes Problems existing of domestic pharmaceutical industry industry
1. products temperature is down to less than-30 DEG C, cooling rate is 1 DEG C/h, is evacuated to 20Pa, opens electrical heating, when products temperature reaches 30 DEG C, is incubated about 1.5 hours, outlet
2., when adopting above explained hereafter, product has atrophy phenomenon, up and down flaggy character even not, and product qualified rate is low, and percent defective is high, and raw material availability is lower.
Traditional handicraft: products temperature is down to less than-30 DEG C, cold insulation about 30 minutes, ensure goods fully charge, when condenser be cooled to-45 DEG C ± 5 DEG C, be evacuated to about 20Pa time, open electrical heating, when products temperature reaches 30 DEG C, be incubated about 1.5 hours, goods crystal form is full even and fine, when in case, pressure no longer obviously increases, and total head plug outlet under pressure is 6Mpa state.
My company adopts new technology production amikacin sulfate for injection, major technique and innovative point are: pre-freeze cools to-35 DEG C, then the cold insulation time was increased to 60 minutes by 30 minutes, rear cabinet freezes, evacuation, controls programming rate during distillation, when being raised to-15 DEG C, again cooling to-20 DEG C keeps after 1 hour, continues to heat up.When products temperature reaches 30 DEG C, be incubated about 1.5 hours, total head plug outlet.
New technology reduces percent defective, and the corresponding raising of raw material yield, considerable economic benefit and social benefit can be created after large-scale production.Since amikacin sulfate for injection is put on market, the quality reliable and stable because of it and definite curative effect, obtain consistent accreditation and the favor of doctor and patient, for extensive patients relieves physiology and psychological misery.Meanwhile, this project has provided the job opportunity of nearly 100 people, has alleviated employment pressure to a certain extent, served positive effect to social stability, brought good social benefit since dropping into and implementing.
Three, summary of the invention
The object of the invention: the raw material availability solved in amikacin sulfate for injection freeze-drying process is lower, and the problem that product percent defective is high, provides a kind of raw material availability, percent defective low, and the lyophilizing procedure technology that end product quality is more stable is mainly:
Pre-freeze cools to-35 DEG C, and then the cold insulation time was increased to 60 minutes by 30 minutes, and rear cabinet freezes, evacuation, controls programming rate during distillation, when being raised to-15 DEG C, again cooling to-20 DEG C and keeps after 1 hour, continue to heat up.When products temperature reaches 30 DEG C, be incubated about 1.5 hours, total head plug outlet.
Positive beneficial effect of the present invention
1., after amikacin sulfate for injection production technology level improves, reduce lamp inspection percent defective, improve raw material availability;
2. every assay all conforms with the regulations, and product quality is more stable, and production cost declines, and the market competitiveness is stronger;
3. technological process is simple, and convenient operation, is more suitable for workshop large-scale production.
Original production process product information slip
As can be seen from the table, 20 batch data pH values of statistics and content all conform with the regulations, but lamp inspection percent defective meansigma methods is 2.79%, obviously exceed the lamp inspection percent defective (other kind percent defectives are generally about 1.0%) of other kinds.
New technology experimental result statistical table:
| Lot number | Lamp inspection number (propping up) | The number of rejects (propping up) | Lamp inspection percent defective % |
| 1206281 | 5000 | 33 | 0.66 |
| 1206282 | 5000 | 27 | 0.54 |
| 1207011 | 5000 | 30 | 0.60 |
| 1207012 | 5000 | 31 | 0.62 |
| 1209071 | 5000 | 28 | 0.56 |
| 1209072 | 5000 | 25 | 0.50 |
| 1209091 | 5000 | 19 | 0.38 |
| 1209092 | 5000 | 20 | 0.60 |
| 1211121 | 5000 | 25 | 0.50 |
| 1211122 | 5000 | 22 | 0.44 |
As can be seen from the table, after performing new technology, lamp inspection percent defective is down to less than 0.66%,
Meansigma methods is 0.54%, reduces 2.26% than the lamp inspection percent defective of former technique.
Four, detailed description of the invention
Be different from a freeze-dry process for the amikacin sulfate for injection of traditional handicraft, its concrete grammar is:
Pre-freeze cools to-35 DEG C, and then the cold insulation time was increased to 60 minutes by 30 minutes, and rear cabinet freezes, evacuation, controls programming rate during distillation, when being raised to-15 DEG C, again cooling to-20 DEG C and keeps after 1 hour, continue to heat up.When products temperature reaches 30 DEG C, be incubated about 1.5 hours, total head plug outlet.
Claims (1)
1. an amikacin sulfate for injection lyophilizing new technology, its concrete grammar is:
(1) products temperature is down to-35 DEG C, then cold insulation 60 minutes, ensures goods fully charge.
(2) when being evacuated to about 20Pa, open electrical heating, during distillation, control programming rate liter per hour 1 DEG C, when being raised to-15 DEG C, again cooling to-20 DEG C and keep after 1 hour, continue to heat up.
(3) when products temperature reaches 30 DEG C, about 1.5 hours are incubated, total head plug outlet under pressure is 6Mpa state.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310541029.6A CN104622814A (en) | 2013-11-06 | 2013-11-06 | New freeze-drying technology of amikacin sulfate for injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310541029.6A CN104622814A (en) | 2013-11-06 | 2013-11-06 | New freeze-drying technology of amikacin sulfate for injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN104622814A true CN104622814A (en) | 2015-05-20 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310541029.6A Pending CN104622814A (en) | 2013-11-06 | 2013-11-06 | New freeze-drying technology of amikacin sulfate for injection |
Country Status (1)
| Country | Link |
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| CN (1) | CN104622814A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113340064A (en) * | 2021-05-27 | 2021-09-03 | 广东金城金素制药有限公司 | Erythromycin lactobionate freeze dryer and freeze drying process thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101129383A (en) * | 2006-08-25 | 2008-02-27 | 天津和美生物技术有限公司 | Antibiotic compound containing aminoglycoside antibiotic |
| CN101584658A (en) * | 2009-07-03 | 2009-11-25 | 上海恒丰强动物药业有限公司 | Preparation method of amikacin sulfate injection |
| CN103181890A (en) * | 2011-12-27 | 2013-07-03 | 四川科伦药物研究有限公司 | Amikacin sulphate injection and preparation method for same |
-
2013
- 2013-11-06 CN CN201310541029.6A patent/CN104622814A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101129383A (en) * | 2006-08-25 | 2008-02-27 | 天津和美生物技术有限公司 | Antibiotic compound containing aminoglycoside antibiotic |
| CN101584658A (en) * | 2009-07-03 | 2009-11-25 | 上海恒丰强动物药业有限公司 | Preparation method of amikacin sulfate injection |
| CN103181890A (en) * | 2011-12-27 | 2013-07-03 | 四川科伦药物研究有限公司 | Amikacin sulphate injection and preparation method for same |
Non-Patent Citations (1)
| Title |
|---|
| 张强等: "《药剂学》", 31 January 2005 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113340064A (en) * | 2021-05-27 | 2021-09-03 | 广东金城金素制药有限公司 | Erythromycin lactobionate freeze dryer and freeze drying process thereof |
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Application publication date: 20150520 |