CN101559287B - Method for drying hydrocortisone sodium succinate asepsis powder - Google Patents
Method for drying hydrocortisone sodium succinate asepsis powder Download PDFInfo
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- CN101559287B CN101559287B CN2009100688896A CN200910068889A CN101559287B CN 101559287 B CN101559287 B CN 101559287B CN 2009100688896 A CN2009100688896 A CN 2009100688896A CN 200910068889 A CN200910068889 A CN 200910068889A CN 101559287 B CN101559287 B CN 101559287B
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- sodium succinate
- hydrocortisone sodium
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Abstract
The invention discloses a method for drying hydrocortisone sodium succinate asepsis powder, which comprises the following steps: delivering filtered hydrocortisone sodium succinate water solution intoa temperature control tank, delivering the water solution after passing through a second precision filter into a spray drying tower, atomizing the water solution through an atomizer, and contacting t he water solution with hot aseptic air to be dried. The top inside the spray drying tower is provided with a hot air distributor which comprises an inner pipe and an air deflector, the lower part of the air deflector is bent to one side, the outer surface of the tower wall of the spray drying tower is provided with a tower wall shaking device, one end of a dust discharge pipe is connected with an air hammer chamber, the other end of the dust discharge pipe is arranged outside a sterile room, the air hammer chamber is hermetically connected with the tower wall of the spray drying tower, and thedried hydrocortisone sodium succinate asepsis powder is discharged from a discharge hole at the bottom of the spray drying tower and collected by a cyclone separator. The method strictly ensures asep sis of liquid medicine, ensures even drying of materials, avoids dust pollution, and strictly ensures the cleanliness of the sterile room.
Description
Technical field
The invention belongs to the preparation field of chemicals, relate to a kind of drying means of hydrocortisone sodium succinate asepsis powder specifically.
Background technology
The hydrocortisone sodium succinate aqueous solution through the chemical synthesis process preparation can be prepared into hydrocortisone sodium succinate asepsis powder by several method.As vacuum freeze-drying method, this method is to obtain the hydrocortisone sodium succinate of solid block after the freeze drying of certain density hydrocortisone sodium succinate soup process earlier, and crushing and screening just can obtain powder product again.There is following shortcoming in process of production in the method: the powerful freezing equipment of (1) production process needs is lowered the temperature to the soup in the household freezer, power consumption is big, production cost is high, and drying time is long, drying efficiency is low, (2) because the loss on drying requirement of hydrocortisone sodium succinate own is≤1%, and hygroscopicity is bigger, the phenomenon that crushing process can cause moisture to raise, and easily microbiological contamination, be difficult to guarantee aseptic, apyrogeneity, therefore quite strict to environmental requirement, requirement must have the extremely low gnotobasis guarantee of humidity.(3) secondary is pulverized processing, uses mechanical power transmission can cause related substances to increase, and cause deterioration in quality, and whole process of production is discontinuous.Have also that to adopt the vacuum drying oven seasoning that hydrocortisone sodium succinate is carried out dry, but hydrocortisone sodium succinate is responsive to temperature, the method material is toasted for a long time, and product quality is affected easily.Existing spray drying process has advantages such as continuity, low power consuming and labour intensity are low.At present, spray drying device is mainly used to produce, processes lower food and the Chinese medicinal granule preparation of microbiological indicator requirement, also is applied to itself have the antibiotic manufacturing field of antibacterial effect, uses less in the manufacturing field of non-antibiotic aseptic powder.
Because hydrocortisone sodium succinate belongs to the glucocorticoid medicine of steroidal class, very easily microbiological contamination itself, produce pyrogen, this product except that the requirement that will satisfy injection sterile powder, itself also have specification requirement of related substances index and loss on drying to be lower than 1% control, use the existing spray drying device that can produce the powder-injection medicine and prepare this product, owing to quality problems, do not reach the quality requirement of injection sterile powder.
When the aseptic medicine of spray-drying, exist some not enough at present, the one, material is before entering atomizer, and initial material filtered through early stage, and material is subject to the influence of environment temperature in the filter process, causes the instability of physicochemical properties.The 2nd, the wind deflector of the hot-air distributor of general spray drying tower is straight plate setting, this wind deflector can cause the heat in the hot blast to concentrate, the hot-spot that can occur material causes part coking phenomenon, also exists the portioned product moisture to exceed standard simultaneously, influences product quality.The 3rd, the pneumatic hammer chamber of the tower wall Rapping apparatus that drying tower is outer is connected with the tower wall, when pneumatic hammer beats the tower wall in the indoor swing of pneumatic hammer, the air stream that forms drives the iron filings dust that falls that shakes and permeates in the desinfection chamber by the venthole between pneumatic hammer chamber and the tower wall, the sterile production environment is caused dust pollution, cause the reduction of gnotobasis cleanliness factor.
Summary of the invention
The objective of the invention is to overcome deficiency of the prior art, a kind of drying means of hydrocortisone sodium succinate asepsis powder is provided.
Technical scheme of the present invention is summarized as follows:
A kind of drying means of hydrocortisone sodium succinate asepsis powder, comprise the steps: with concentration to be that the hydrocortisone sodium succinate aqueous solution of 100g/L-200g/L is imported the temperature control jar after filtering, again through in the input spray drying tower behind second fine filter, after atomizer atomizing, contact and carry out drying with hot filtrated air, the top of described spray drying tower inside is provided with hot-air distributor, pipe and wind deflector in described hot-air distributor comprises, the bottom of described wind deflector is to the bent setting of a lateral bending, the outer surface of described spray-drying Tata wall is provided with tower wall Rapping apparatus, described tower wall Rapping apparatus comprises the pneumatic hammer chamber and is connected with the pneumatic hammer of aseptic compressed air pipeline, one end of dust discharge pipeline is connected with described pneumatic hammer chamber, the other end of described dust discharge pipeline is arranged on outside the desinfection chamber, being connected to of tower wall of described pneumatic hammer chamber and described spray drying tower is tightly connected, dried hydrocortisone sodium succinate asepsis powder is discharged from the bottom discharge mouth of described spray drying tower, collects through cyclone separator to obtain.
Filter through coarse filter, primary filter and first fine filter successively before the hydrocortisone sodium succinate aqueous solution input temperature control jar.
The filter membrane aperture of described coarse filter is 1.0 μ m.
The filter membrane aperture of described primary filter is 0.45 μ m.
The filter membrane aperture of described first fine filter is 0.22 μ m.
Temperature in the described temperature control jar is 15 ℃-20 ℃.
The filter membrane aperture of described second fine filter is 0.22 μ m.
Described wind deflector lower knuckle angle is 15 °-30 °.
The temperature that hot filtrated air in the described spray drying tower advances described tower is 135～170 ℃, and the temperature of tower bottom discharging one's intention as revealed in what one says is 95～120 ℃, and the tower internal pressure is 300～500Pa.
The present invention has the following advantages: the setting of (one) temperature control jar, solved and filtered the initial unsettled difficult problem of material physicochemical properties in back in earlier stage, guaranteed that material enters the stability, the particularly setting of second fine filter of various technical indicators before the atomizer, strict guarantee soup aseptic; (2) the reclinate setting of hot-air distributor wind deflector, it is more even that hot blast is distributed, and can produce mild swirling eddy, efficiently solve the problem of material heat damage, stop the coking phenomenon that localized hyperthermia causes, made full use of heat energy, guaranteed the homogeneous drying of material, product moisture is stable and strict controlled, and product quality is largely increased; (3) the pneumatic hammer chamber of tower wall Rapping apparatus and tower wall airtight is connected and the setting of dust discharge pipeline, stopped the dust pollution of sterile production environment, the cleanliness factor of strict guarantee desinfection chamber.The invention solves and utilize spray drying process to be difficult to produce technical barrier aseptic, thermal sensitivity non-antibiotic medicine, the hydrocortisone sodium succinate asepsis powder content of preparation reaches more than 99%, related substances≤2%, moisture≤1%, aseptic, apyrogeneity, product quality meet the " requirement of the injection sterile powder of 2005 editions regulations of Chinese pharmacopoeia, and reach " British Pharmacopoeia ", " American Pharmacopeia " level.
Description of drawings
Fig. 1 is the process chart of method of the present invention.
Fig. 2 is the tower wall Rapping apparatus and the tower wall connection diagram of spray drying tower.
Fig. 3 is the structural representation of the hot-air distributor of the spray drying tower of the present invention's employing.
The specific embodiment
The present invention is further illustrated below in conjunction with accompanying drawing.
As shown in Figure 1, a kind of drying means of hydrocortisone sodium succinate asepsis powder, comprise the steps: with concentration to be that the hydrocortisone sodium succinate aqueous solution of 100g/L-200g/L is imported in the temperature control jar 4 after filtering, again through in second fine filter, the 5 back input spray drying towers 8, after atomizer 6 atomizing, contact and carry out drying with hot filtrated air, hot filtrated air is input in the spray drying tower from air inlet pipe 13, the top of spray drying tower inside is provided with hot-air distributor 7, pipe 17 and wind deflector 16 in hot-air distributor comprises, the bottom of wind deflector is to the bent setting of a lateral bending, the outer surface of spray-drying Tata wall is provided with tower wall Rapping apparatus, tower wall Rapping apparatus comprises pneumatic hammer chamber 29 and is connected with the pneumatic hammer 14 of aseptic compressed air pipeline 10, one end of dust discharge pipeline 11 is connected with described pneumatic hammer chamber, the other end of dust discharge pipeline is arranged on outside the desinfection chamber, being connected to of tower wall 15 of pneumatic hammer chamber and described spray drying tower is tightly connected, dried hydrocortisone sodium succinate asepsis powder is discharged from the bottom discharge mouth 12 of described spray drying tower, collects through cyclone separator to obtain.
The filter plant of process is followed successively by coarse filter 1, primary filter 2 and first fine filter 3 before the hydrocortisone sodium succinate aqueous solution input temperature control jar.
Filter membrane aperture in the coarse filter is 1.0 μ m.
Filter membrane aperture in the primary filter is 0.45 μ m.
The filter membrane aperture of first fine filter is 0.22 μ m.
Temperature in the temperature control jar is 15 ℃-20 ℃.
Filter membrane aperture in second fine filter is 0.22 μ m.
Wind deflector lower knuckle angle is preferably 15 °-30 °.
The temperature that hot filtrated air in the spray drying tower advances described tower is controlled at 135～170 ℃, and the temperature of tower bottom discharging one's intention as revealed in what one says is 95～120 ℃, and the tower internal pressure is 300～500Pa.
Because the physicochemical properties of hydrocortisone sodium succinate are active, responsive to temperature, the too high meeting of temperature causes related substances to increase, and influences product quality; Temperature is crossed the low appearance that can cause the material gelatin phenomenon, causes producing carrying out.After the material of product filtered through early stage, material was subject to the influence of environment temperature, therefore is provided with the temperature control jar especially, had guaranteed that material enters the stability of the preceding various technical indicators of atomizer.The particularly setting of second fine filter, strict guarantee soup aseptic.
Being tightly connected and the setting of dust discharge pipeline of pneumatic hammer chamber and tower wall in the tower wall Rapping apparatus can be beaten the iron filings dust that produces in the process with the shake of tower wall and be drained into outside the desinfection chamber, stopped the dust pollution of sterile production environment, guaranteed the cleanliness factor of desinfection chamber.
The bottom of wind deflector is provided with to a lateral bending song and can makes the hot blast distribution more even, and can produce mild swirling eddy, the coking phenomenon of effectively having stopped localized hyperthermia and having produced, and solved because hot blast concentrates material to can not get a fully dry difficult problem, made full use of heat energy, guarantee the homogeneous drying of material, improved product quality.
The hydrocortisone sodium succinate asepsis powder content of the present invention's preparation reaches more than 99%, related substances≤2%, moisture≤1%, aseptic, apyrogeneity, product quality meets the " requirement of the injection sterile powder of 2005 editions regulations of Chinese pharmacopoeia, and reach " British Pharmacopoeia ", " American Pharmacopeia " level.
Claims (9)
1. the drying means of a hydrocortisone sodium succinate asepsis powder, it is that the hydrocortisone sodium succinate aqueous solution of 100g/L-200g/L is imported the temperature control jar after filtering that its feature comprises the steps: concentration, again through in the input spray drying tower behind second fine filter, after atomizer atomizing, contact and carry out drying with hot filtrated air, the top of described spray drying tower inside is provided with hot-air distributor, pipe and wind deflector in described hot-air distributor comprises, the bottom of described wind deflector is to the bent setting of a lateral bending, the outer surface of described spray-drying Tata wall is provided with tower wall Rapping apparatus, described tower wall Rapping apparatus comprises the pneumatic hammer chamber and is connected with the pneumatic hammer of aseptic compressed air pipeline, one end of dust discharge pipeline is connected with described pneumatic hammer chamber, the other end of described dust discharge pipeline is arranged on outside the desinfection chamber, being connected to of tower wall of described pneumatic hammer chamber and described spray drying tower is tightly connected, dried hydrocortisone sodium succinate asepsis powder is discharged from the bottom discharge mouth of described spray drying tower, collects through cyclone separator to obtain.
2. the drying means of a kind of hydrocortisone sodium succinate asepsis powder according to claim 1 is characterized in that filtering through coarse filter, primary filter and first fine filter successively before the hydrocortisone sodium succinate aqueous solution input temperature control jar.
3. the drying means of a kind of hydrocortisone sodium succinate asepsis powder according to claim 2, the filter membrane aperture that it is characterized in that described coarse filter is 1.0 μ m.
4. the drying means of a kind of hydrocortisone sodium succinate asepsis powder according to claim 2, the filter membrane aperture that it is characterized in that described primary filter is 0.45 μ m.
5. the drying means of a kind of hydrocortisone sodium succinate asepsis powder according to claim 2, the filter membrane aperture that it is characterized in that described first fine filter is 0.22 μ m.
6. the drying means of a kind of hydrocortisone sodium succinate asepsis powder according to claim 1 is characterized in that the temperature in the described temperature control jar is 15 ℃-20 ℃.
7. the drying means of a kind of hydrocortisone sodium succinate asepsis powder according to claim 1, the filter membrane aperture that it is characterized in that described second fine filter is 0.22 μ m.
8. the drying means of a kind of hydrocortisone sodium succinate asepsis powder according to claim 1 is characterized in that described wind deflector lower knuckle angle is 15 °-30 °.
9. the drying means of a kind of hydrocortisone sodium succinate asepsis powder according to claim 1, it is characterized in that the temperature that hot filtrated air in the described spray drying tower advances described tower is 135～170 ℃, the temperature of tower bottom discharging one's intention as revealed in what one says is 95～120 ℃, and the tower internal pressure is 300～500Pa.
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| CN2009100688896A CN101559287B (en) | 2009-05-15 | 2009-05-15 | Method for drying hydrocortisone sodium succinate asepsis powder |
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| CN2009100688896A CN101559287B (en) | 2009-05-15 | 2009-05-15 | Method for drying hydrocortisone sodium succinate asepsis powder |
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| CN101559287B true CN101559287B (en) | 2010-10-13 |
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| CN103724383B (en) * | 2012-10-10 | 2016-02-03 | 河南利华制药有限公司 | Drying process in a kind of hydrocortisone sodium succinate production |
| CN106831926B (en) * | 2017-01-24 | 2020-01-21 | 山东轻工职业学院 | Drying method of rocuronium bromide bulk drug for injection |
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| CN1214947A (en) * | 1998-10-13 | 1999-04-28 | 苏州工业园区永达化工有限公司 | High-speed centrifugal spray-drying method for sodium glycinate |
| CN2503958Y (en) * | 2001-08-15 | 2002-08-07 | 卢顺从 | Freezing spray-drying solid-liquid separator |
| CN1726067A (en) * | 2002-12-02 | 2006-01-25 | 阿尔卡特公司 | Games console adaptor unit |
| CN101050229A (en) * | 2007-05-11 | 2007-10-10 | 天津市生物化学制药厂 | Method for preparing hydrocortisone sodium succinate |
| CN201059840Y (en) * | 2007-06-28 | 2008-05-14 | 张和明 | Sponging drying machine used for drying powder injection medicaments |
| CN101327378A (en) * | 2008-07-09 | 2008-12-24 | 史祖法 | Method for preparing powder by sponging drying method for superheated liquid |
-
2009
- 2009-05-15 CN CN2009100688896A patent/CN101559287B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1214947A (en) * | 1998-10-13 | 1999-04-28 | 苏州工业园区永达化工有限公司 | High-speed centrifugal spray-drying method for sodium glycinate |
| CN2503958Y (en) * | 2001-08-15 | 2002-08-07 | 卢顺从 | Freezing spray-drying solid-liquid separator |
| CN1726067A (en) * | 2002-12-02 | 2006-01-25 | 阿尔卡特公司 | Games console adaptor unit |
| CN101050229A (en) * | 2007-05-11 | 2007-10-10 | 天津市生物化学制药厂 | Method for preparing hydrocortisone sodium succinate |
| CN201059840Y (en) * | 2007-06-28 | 2008-05-14 | 张和明 | Sponging drying machine used for drying powder injection medicaments |
| CN101327378A (en) * | 2008-07-09 | 2008-12-24 | 史祖法 | Method for preparing powder by sponging drying method for superheated liquid |
Non-Patent Citations (1)
| Title |
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| JP特开2006-348253A 2006.12.28 |
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Address after: 300308 No. 269 South River Road, Tianjin Airport Economic Zone Patentee after: Tianjin Biochem Pharmaceutical Co., Ltd. Address before: 300308 No. 269 South River Road, Tianjin Airport Logistics Processing Zone Patentee before: Tianjin Biochem Pharmaceutical Co., Ltd. |