CN102631290A - Synthetic method for producing suppositories - Google Patents
Synthetic method for producing suppositories Download PDFInfo
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- CN102631290A CN102631290A CN2012100970704A CN201210097070A CN102631290A CN 102631290 A CN102631290 A CN 102631290A CN 2012100970704 A CN2012100970704 A CN 2012100970704A CN 201210097070 A CN201210097070 A CN 201210097070A CN 102631290 A CN102631290 A CN 102631290A
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- suppository
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Abstract
The invention discloses a synthetic method for producing suppositories. The synthetic method includes steps of adding bulk drug and auxiliary materials into heated and melted matrix and circularly grinding to obtain a uniform liquid mixed material; performing spray granulation for the liquid mixed material to obtain uniform fine materials; and finally pressing the fine materials to prepare the suppositories by a high-speed suppository forming machine. Drug raw materials are in spray granulation by an improved traditional hot melting method, so that drug is granular before being pressed to form the suppositories, the grains are pressed into the suppositories by the high-speed suppository forming machine, high-speed suppository preparation is feasible, a production cycle is greatly shortened, and production cost is lowered. Besides, the grain size of the suppository drug prepared by the method is small, the suppositories can be absorbed by human bodies more easily, and accordingly the internal quality of the suppositories is improved.
Description
Technical field
The present invention relates to the pharmaceutical technology field, specifically refer to a kind of synthetic method of producing suppository.
Background technology
At present, the method for producing suppository in the prior art has two kinds, both hot melt and pressing.
Hot melt be with crude drug and other adjuvant earlier through pulverizing, sieving, again the fine powder of crushing screening gained is joined in the substrate of heat fused, this liquid material is produced required suppository through the suppository automatic assembly line.Hot melt is the main way of the current production suppository that generally adopts both at home and abroad; Because liquid material need be cast in earlier in the suppository mould; Wait it to solidify then, take out the liquid material cast of carrying out next group again, more time-consuming; The speed of production that this method is the highest is per hour 30,000, and manual the completion mainly leaned in outer package.
Pressing is earlier substrate to be rasped to powder; To make smooth with a file thin substrate and crude drug and other auxiliary materials and mixing of crushing screening then; Press bolt with suppository press at last; This method is loaded down with trivial details because of the operation that substrate is rasped to powder, difficulty big, can't realize machinery automation processing, can only lean on manual completion, causes production efficiency low, is eliminated at present.
Summary of the invention
The objective of the invention is to overcome the defective of existing suppository method for preparing inefficiency, a kind of synthetic method of producing suppository efficiently is provided, make its prepared suppository good absorbing effect and suppository quality controllability good.
For realizing above-mentioned purpose, the synthetic method of the production suppository that the present invention designed the steps include:
(1) crude drug and adjuvant are added in the substrate of heat fused, and circular grinding obtains uniform liquefied mixture material;
(2) the liquefied mixture material is carried out mist projection granulating, obtain uniform fine;
(3) fine is utilized high speed suppository press compacting suppository.
Preferably, the process of the liquefied mixture material being carried out mist projection granulating in the said step (2) is: keep liquefied mixture material temperature to be 40～50 ℃ and be delivered to and carry out mist projection granulating in the scraper-type spraying apparatus, and the ambient temperature during mist projection granulating is 10～20 ℃.Liquid material is incubated in the material-storage jar of spraying apparatus to keep its liquid condition, and when spraying into aerosol can, temperature is below 20 ℃ in the aerosol can, can make spray particles solidify rapidly.
Preferably, the ambient temperature during the pressure bolt in the said step (3) is below 20 ℃.
Preferably, the fineness of said liquefied mixture material is for passing through 24 mesh sieves.
Alternatively, said substrate is water-soluble base or fat-soluble substrate.
Alternatively, said suppository is bullet type, torpedo or Duckbill type suppository.
Alternatively, the fine in the said step (3) also passes through the pelletizing machine granulate before pressing bolt.
Need to prove, when the fine of above-mentioned spraying gained has the phenomenon of sticking glutinous drift during suppository in compacting, can in fine, add lubricant, commonly used have Pulvis Talci, a magnesium stearate etc., is this area common technology means, do not give unnecessary details.
Above-mentioned, the fine of gained occurs the not enough situation of viscosity in compacting during suppository, can in fine, add binding agent, and commonly used have starch, CMCNa, a hydroxypropyl emthylcellulose etc., is this area common technology means, do not give unnecessary details.
At present, the speed of domestic system bolt machine is up to per hour 30,000, should make the bolt machine relatively, and the mature technology of domestic existing production high speed tablet press per hour can be produced the tablet more than 1,000,000.When adopting synthetic method of the present invention to prepare suppository, no longer be liquid condition before the medicine compacting, but solid powdery can transform high speed tablet press fully a little, become the high speed suppository press, this improvement will increase substantially the production efficiency of suppository.Its reforming mode can for: change system into and need the suppository shape of compacting to be complementary the shape of the last low punch of high speed tablet press; And because the volume ratio tablet of suppository is big; Thickness is also higher, and the height that dashes in the corresponding increase of needs is so that the more granule materials of the internal energy entering of drift.After transforming, the speed of production of the high speed suppository press of gained depends on the drift number of suppository press and the rotating speed of suppository press, can reach the speed of production of per hour producing 30～400,000 suppositorys through test.
Above-mentioned, the fine of gained can be controlled the hardness of suppository and melt when compacting suppository and become the time limit through the pressure of adjustment high speed suppository press.Prepared suppository needs to store at place, the cool place below 30 ℃.
In addition, with reference to the plastic-aluminum heat seal packing of tablet, the suppository of high speed suppository press compacting can adopt plastic-aluminum heat seal packing, mechanization, the automatization that can realize the suppository packing equally.Further, shortened the production time of suppository.
Beneficial effect of the present invention: through improving traditional hot melt, medicine material is carried out mist projection granulating, make medicine before pressing bolt, be graininess; Thereby can prepare suppository through pressing, it is feasible that high speed production suppository is become, and shortened the production cycle significantly; Reduced production cost; And the suppository diameter of aspirin particle by this method preparation is little, is absorbed by body more easily, thereby has improved the inherent quality of suppository.
Description of drawings
Fig. 1 is the particulate Electronic Speculum figure of diclofenac sodium suppository Chinese medicine of prior art for preparing.
Fig. 2 is the particulate Electronic Speculum figure of diclofenac sodium suppository Chinese medicine of the synthetic method preparation of production suppository of the present invention.
The specific embodiment
Below in conjunction with accompanying drawing and specific embodiment the present invention is made further detailed description.
Embodiment 1
Get 36 type mixed fatty glycerides 10500g as substrate, place melting pot, in 55 ℃ with its fusing after change in the colloid mill; Open colloid mill, the substrate that makes fusing circular grinding and add diclofenac sodium 500g in colloid mill, continue circular grinding after 20 minutes discharging change in the material-storage jar of scraper-type spraying apparatus; Obtain the liquefied mixture material 45 ℃ of insulations with constantly stirring down, utilize the shower nozzle of scraper-type spraying apparatus the liquefied mixture material evenly to be sprayed onto on the inwall of aerosol can of scraper-type spraying apparatus the formation fine; By the scraper plate machine this fine is collected in the material storage barrel, behind the pelletizing machine granulate, by the high speed suppository press; Be pressed into bullet type diclofenac sodium suppository 1, every 1.1g contains diclofenac sodium 50mg; After quality inspection is qualified, can carry out plastic-aluminum heat seal packing.
Embodiment 2
Get 38 type mixed fatty glycerides 15588g, lanoline 860g, paraffin 860g as substrate, place melting pot, in 50 ℃ with its fusing after change in the colloid mill; Open colloid mill, the substrate that makes fusing circular grinding and add metronidazole 2000g, clotrimazole 1600g, chlorhexidine acetate 80g in colloid mill, continue circular grinding after 25 minutes discharging change in the material-storage jar of scraper-type spraying apparatus; Obtain the liquefied mixture material 40 ℃ of insulations with constantly stirring down, utilize the shower nozzle of scraper-type spraying apparatus the liquefied mixture material evenly to be sprayed onto on the inwall of aerosol can of scraper-type spraying apparatus the formation fine; By the scraper plate machine this fine is collected in the material storage barrel; Behind the pelletizing machine granulate,, be pressed into torpedo metronidazole,clotrimazole and chlorhexidine acetate suppositories 2 by the high speed suppository press; Every 2.1g; Contain metronidazole 0.2g, clotrimazole 0.16g, chlorhexidine acetate 8mg, after quality inspection is qualified, can carry out plastic-aluminum heat seal packing.
Embodiment 3
Get 38 type mixed fatty glycerides 7000g as substrate, place melting pot, in 50 ℃ with its fusing after change in the colloid mill; Open colloid mill, the substrate that makes fusing circular grinding and add metronidazole 5000g in colloid mill, continue circular grinding after 20 minutes discharging change in the material-storage jar of scraper-type spraying apparatus; Obtain the liquefied mixture material 45 ℃ of insulations with constantly stirring down, utilize the shower nozzle of scraper-type spraying apparatus the liquefied mixture material evenly to be sprayed onto on the inwall of aerosol can of scraper-type spraying apparatus the formation fine; By the scraper plate machine this fine is collected in the material storage barrel, behind the pelletizing machine granulate, by the high speed suppository press; Be pressed into torpedo metronidazole suppository 3, every 1.2g contains metronidazole 0.5g; After quality inspection is qualified, can carry out plastic-aluminum heat seal packing.
Embodiment 4
Get glycerin gelatine 10200g as substrate, place melting pot, in 65 ℃ with its fusing after change in the colloid mill; Open colloid mill, the substrate that makes fusing circular grinding and add clotrimazole 11500g, microcrystalline Cellulose 300g in colloid mill, continue circular grinding after 25 minutes discharging change in the material-storage jar of scraper-type spraying apparatus; Obtain the liquefied mixture material 45 ℃ of insulations with constantly stirring down, utilize the shower nozzle of scraper-type spraying apparatus the liquefied mixture material evenly to be sprayed onto on the inwall of aerosol can of scraper-type spraying apparatus the formation fine; By the scraper plate machine this fine is collected in the material storage barrel, behind the pelletizing machine granulate, by the high speed suppository press; Be pressed into Duckbill type clotrimazole bolt 4, every 1.5g contains clotrimazole 0.15g; After quality inspection is qualified, can carry out plastic-aluminum heat seal packing.
Embodiment 5
Get 38 type mixed fatty glycerides 10265g as substrate, place melting pot, in 50 ℃ with its fusing after change in the colloid mill; Open colloid mill, the substrate that makes fusing circular grinding and add econazole nitrate 500g, Oleum Curcumae 2100mL in colloid mill, continue circular grinding after 25 minutes discharging change in the material-storage jar of scraper-type spraying apparatus; Obtain the liquefied mixture material 45 ℃ of insulations with constantly stirring down, utilize the shower nozzle of scraper-type spraying apparatus the liquefied mixture material evenly to be sprayed onto on the inwall of aerosol can of scraper-type spraying apparatus the formation fine; By the scraper plate machine this fine is collected in the material storage barrel, added hydroxypropyl emthylcellulose 1585g, behind the mixer mixing; By the high speed suppository press; Be pressed into Duckbill type suppository 5, every 1.4g contains econazole nitrate 50mg, Oleum Curcumae 0.2mL; After quality inspection is qualified, can carry out plastic-aluminum heat seal packing.
Embodiment 6
Get polyoxyethylene monostearate 10900g as substrate, place melting pot, in 60 ℃ with its fusing after change in the colloid mill; Open colloid mill, the substrate that makes fusing circular grinding and add bisacodyl 100g in colloid mill, continue circular grinding after 25 minutes discharging change in the material-storage jar of scraper-type spraying apparatus; Obtain the liquefied mixture material 45 ℃ of insulations with constantly stirring down, utilize the shower nozzle of scraper-type spraying apparatus the liquefied mixture material evenly to be sprayed onto on the inwall of aerosol can of scraper-type spraying apparatus the formation fine; By the scraper plate machine this fine is collected in the material storage barrel, behind the pelletizing machine granulate, by the high speed suppository press; Be pressed into bullet type suppository 6, every 1.1g contains bisacodyl 10mg; After quality inspection is qualified, can carry out plastic-aluminum heat seal packing.
Embodiment 7
Taking polyethylene glycol 1000 (PEG1000) 7200g and Macrogol 4000 (PEG4000) 2800g place melting pot as substrate, in 60 ℃ with its fusing after change in the colloid mill; Open colloid mill, the substrate that makes fusing circular grinding and add ofloxacin 2500g in colloid mill, continue circular grinding after 20 minutes discharging change in the material-storage jar of scraper-type spraying apparatus; Obtain the liquefied mixture material 45 ℃ of insulations with constantly stirring down, utilize the shower nozzle of scraper-type spraying apparatus the liquefied mixture material evenly to be sprayed onto on the inwall of aerosol can of scraper-type spraying apparatus the formation fine; By the scraper plate machine this fine is collected in the material storage barrel, behind the pelletizing machine granulate, by the high speed suppository press; Be pressed into bullet type ofloxacin bolt 1, every 1.1g contains ofloxacin 250mg; After quality inspection is qualified, can carry out plastic-aluminum heat seal packing.
Mean diameter through detecting the diclofenac sodium in the diclofenac sodium suppository among the embodiment 1 is 60 μ m (Fig. 2); And the mean diameter of the diclofenac sodium in the commercially available diclofenac sodium suppository is 240 μ m (Fig. 1); This has explained method refinement provided by the present invention particle diameter of drug particles; Help suppository and after administration, absorbed, improved the inherent quality of suppository by body.
Diameter of aspirin particle in the foregoing description is between 55～65 μ m.Need to prove; Through the circular grinding time and adjustment roll flute distance of control colloid mill; Can obtain the drug particles of different-grain diameter; The drug particles that milling time is looked more is more little, and it is the drug particles of 4 μ m that I obtains particle diameter, and the personnel of embodiment of the present invention can adjust milling time and mill distance according to actual needs.
Claims (7)
1. a synthetic method of producing suppository the steps include:
(1) crude drug and adjuvant are added in the substrate of heat fused, and circular grinding obtains uniform liquefied mixture material;
(2) the liquefied mixture material is carried out mist projection granulating, obtain uniform fine;
(3) fine is utilized high speed suppository press compacting suppository.
2. the synthetic method of production suppository according to claim 1; It is characterized in that: the process of the liquefied mixture material being carried out mist projection granulating in the said step (2) is: keep liquefied mixture material temperature to be 40～50 ℃ and be delivered to and carry out mist projection granulating in the scraper-type spraying apparatus, and the ambient temperature during mist projection granulating is below 20 ℃.
3. the synthetic method of production suppository according to claim 1 is characterized in that: the ambient temperature during pressure bolt in the said step (3) is below 20 ℃.
4. the synthetic method of production suppository according to claim 1 is characterized in that: the fineness of said fine is for passing through 24 mesh sieves.
5. the synthetic method of production suppository according to claim 1 is characterized in that: said substrate is water-soluble base or fat-soluble substrate.
6. the synthetic method of production suppository according to claim 1 is characterized in that: said suppository is bullet type, torpedo or Duckbill type suppository.
7. according to the synthetic method of each described production suppository of claim 1～6, it is characterized in that: the fine in the said step (3) also passes through the pelletizing machine granulate before pressing bolt.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100970704A CN102631290A (en) | 2012-04-05 | 2012-04-05 | Synthetic method for producing suppositories |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2012100970704A CN102631290A (en) | 2012-04-05 | 2012-04-05 | Synthetic method for producing suppositories |
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| CN102631290A true CN102631290A (en) | 2012-08-15 |
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| CN2012100970704A Pending CN102631290A (en) | 2012-04-05 | 2012-04-05 | Synthetic method for producing suppositories |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104970973A (en) * | 2014-04-02 | 2015-10-14 | 江苏宇通干燥工程有限公司 | Suppository manufacturing method and suppository manufacturing equipment |
Citations (6)
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| CN87103195A (en) * | 1986-04-22 | 1987-11-18 | 武田药品工业株式会社 | Produce the method for seasoning composition |
| CN1704045A (en) * | 2003-03-30 | 2005-12-07 | 丛繁滋 | Supported suppository adapted for drug administering to cavity and its preparation method |
| CN1951424A (en) * | 2006-11-15 | 2007-04-25 | 上海慈瑞医药科技有限公司 | Pharmaceutical composition for treating gynecological inflammation and preparation method thereof |
| CN101060862A (en) * | 2002-02-15 | 2007-10-24 | Ltp脂质技术供应股份公司 | Composition for oral or rectal administration |
| JP2011225550A (en) * | 2010-03-30 | 2011-11-10 | Cci Corp | Matrix metalloprotease production suppressing and elastase activity inhibiting agent |
| CN102274264A (en) * | 2011-08-08 | 2011-12-14 | 黑龙江省中医研究院 | Application of platycodon root total saponin to medicaments for treating and preventing mycoplasma pneumoniae infectious diseases |
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2012
- 2012-04-05 CN CN2012100970704A patent/CN102631290A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN87103195A (en) * | 1986-04-22 | 1987-11-18 | 武田药品工业株式会社 | Produce the method for seasoning composition |
| CN101060862A (en) * | 2002-02-15 | 2007-10-24 | Ltp脂质技术供应股份公司 | Composition for oral or rectal administration |
| CN1704045A (en) * | 2003-03-30 | 2005-12-07 | 丛繁滋 | Supported suppository adapted for drug administering to cavity and its preparation method |
| CN1951424A (en) * | 2006-11-15 | 2007-04-25 | 上海慈瑞医药科技有限公司 | Pharmaceutical composition for treating gynecological inflammation and preparation method thereof |
| JP2011225550A (en) * | 2010-03-30 | 2011-11-10 | Cci Corp | Matrix metalloprotease production suppressing and elastase activity inhibiting agent |
| CN102274264A (en) * | 2011-08-08 | 2011-12-14 | 黑龙江省中医研究院 | Application of platycodon root total saponin to medicaments for treating and preventing mycoplasma pneumoniae infectious diseases |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104970973A (en) * | 2014-04-02 | 2015-10-14 | 江苏宇通干燥工程有限公司 | Suppository manufacturing method and suppository manufacturing equipment |
| CN104970973B (en) * | 2014-04-02 | 2018-09-07 | 江苏宇通干燥工程有限公司 | Suppository manufacturing method and suppository manufacturing equipment |
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Application publication date: 20120815 |