CN104688690B - A kind of oxyamyli tectus aldehydum wet granular agent and its manufacture method - Google Patents
A kind of oxyamyli tectus aldehydum wet granular agent and its manufacture method Download PDFInfo
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Abstract
The present invention relates to a kind of oxyamyli tectus aldehydum formulation and its manufacture method and products thereof.Oxyamyli tectus aldehydum wet granular agent manufacture method, raw material is done with starch, add periodate and carry out oxidation reaction as oxidant, obtain intermediate product dialdehyde starch；Then coating is carried out to dialdehyde starch, then by separation of solid and liquid, granulation, selective dry, packaging, just obtains oxyamyli tectus aldehydum wet granular agent (hereinafter referred to as wet granular agent)；Characterized in that, described wet granular agent moisture content is 13%~80%.Oxyamyli tectus aldehydum wet granular agent made from the above method, described wet granular agent moisture content are 13%~80%.It is an advantage of the current invention that wet granular agent overcomes the defects of dry particl agent, medicine is substantially increased in vivo to the adsorption capacity of urea, raising evident in efficacy, and reduces the pain of patient's medication.
Description
Technical field
The present invention relates to a kind of oxyamyli tectus aldehydum formulation and its manufacture method.
Background technology
Oxyamyli tectus aldehydum is that one kind treats uremic medicine, and its curative effect is embodied by interior absorption.Oxyamyli tectus aldehydum quilt
After patient is oral, do not dissolve, do not absorbed in vivo yet, aldehyde radical is contained in its molecule, aldehyde radical can be with the urine in patient's enteron aisle
Element combines generation schiff bases, excretes.So, oxyamyli tectus aldehydum can reduce haemodialysis time with the renal function of compensation of patient
Number, the lighter patient of partial symptoms even can stop haemodialysis.
Referring to Fig. 1, the production technology of original oxyamyli tectus aldehydum is：Raw material is done with starch, oxidant is made with periodate
Oxidation reaction is carried out, starch is oxidized generation dialdehyde starch, and then carrying out coating to dialdehyde starch obtains oxyamyli tectus aldehydum, then passes through
Centrifugation, granulation, drying, packaging are crossed, just obtains commercially available oxyamyli tectus aldehydum powdery granule agent (hereinafter referred to as dry particl agent),
Provided according to national drug standard, dry particl agent moisture content 8%~12% (percentage by weight, similarly hereinafter), therefore, it is necessary to which drying reaches
Can to the standard.
Oxyamyli tectus aldehydum obtains state approval in 1987 and listed at home.The clinical practice of more than 20 years, many diseases are helped
People mitigates slight illness, and some patients obtain rehabilitation.But by clinical practice for many years, the deficiency of oxyamyli tectus aldehydum dry particl agent
Part also gradually shows：Because particle is especially hard, take with warm water to specifications, particle can not be swelled softening, Bing Rennan
To swallow, feel when oral " grains of sand in one's mouth ", severe patient can cause reflex vomiting, and pain is brought to patient.It is particularly big
Most patients need long-term to take oxyamyli tectus aldehydum, therefore reduce the compliance of patient, cause medicine not play a role.
It is being difficult still to be swelled in patient body, or even sent out in the stool of some patients' discharge after even if dry particl agent is taken with warm water
Now a large amount of white particles without swelling.So, absorption of the medicine to urea in enteron aisle certainly will be influenceed.
The content of the invention
In order to solve the major defect of the existing dry particl formulation of oxyamyli tectus aldehydum, it is wet that the present invention provides a kind of oxyamyli tectus aldehydum
Granule and its manufacture method.
The present invention is realized by the following technical programs：
Oxyamyli tectus aldehydum wet granular agent manufacture method, raw material is done with starch, add periodate and carry out oxygen as oxidant
Change reaction, obtain intermediate product dialdehyde starch；Then coating is carried out to dialdehyde starch, then by separation of solid and liquid, granulation, selectivity
Dry, packaging, just obtain oxyamyli tectus aldehydum wet granular agent (hereinafter referred to as wet granular agent)；Characterized in that, described wet granular
Agent moisture content is 13%~80%.Described wet granular agent moisture content is preferably 25%~65%.
Oxyamyli tectus aldehydum wet granular agent made from the above method, described wet granular agent moisture content are 13%~80%.
Oxyamyli tectus aldehydum wet granular agent made from the above method, described wet granular agent moisture content are 20%~65%.
Described selectivity, which is dried, to be referred to, when deisgn product moisture content is more than 50%, controls the intensity of separation of solid and liquid i.e.
It can reach the moisture content of design, it is not necessary to which obtained particle is dried；When deisgn product moisture content is less than 50%, it is difficult to only
The moisture content just designed merely with control separation of solid and liquid intensity is, it is necessary to which obtained particle is dried.
It is an advantage of the current invention that wet granular agent overcomes the defects of dry particl agent, it is right in vivo to substantially increase medicine
The adsorption capacity of urea, raising evident in efficacy, and reduce the pain of patient's medication.
Brief description of the drawings
Fig. 1 is the production technological process of original oxyamyli tectus aldehydum.
Fig. 2 is the production technological process of oxyamyli tectus aldehydum of the present invention.
Embodiment
The production technology of wet granular agent such as Fig. 2, oxyamyli tectus aldehydum wet granular agent manufacture method, raw material is done with starch, is added
Periodate carries out oxidation reaction as oxidant, obtains intermediate product dialdehyde starch；Then coating is carried out to dialdehyde starch, obtained
To oxyamyli tectus aldehydum slurries.Concrete operations are exemplified below：
Oxidation reaction：Into 5 liters of four mouthfuls of vials plus 3 liters of purified waters, opening stirring, 140 grams of sodium metaperiodates of input are carried out
Dissolving, after all dissolving, is rapidly added 225 grams of starch.Kept for 50 ± 5 DEG C, continue stirring reaction 1 hour, discharging, with suction filtration side
Method carries out separation of solid and liquid, obtains dialdehyde starch filter cake.The filter cake separated crosses 20 mesh sieves and is put into the four mouthfuls of glass reinstalled
In glass bottle, 2 liters of purified waters are added, 50 ± 5 DEG C is warming up to, agitator treating 30 minutes, discharges, filter, filter cake re-sieving granulation.Together
Quadrat method is washed 5 times.It is standby after dialdehyde starch sieving granulation after wash clean.
Coating：1 liter of purified water is added in 5 liters of four mouthfuls of vials, starts stirring, 18 grams of gelatin is added, is warming up to 45 ± 5
DEG C, 2 hours~4 hours, gelatin was completely dissolved, then added 2 liters of purified waters, added the dialdehyde starch of washes clean after oxidation
Grain, 45 ± 5 DEG C of keeping temperature, after stirring 2.5 hours, 650 milliliters of ethanol are added, continue stirring 30 minutes, feed liquid are released, with taking out
Filtering method carries out separation of solid and liquid, obtains oxyamyli tectus aldehydum filter cake.The filter cake separated crosses 20 mesh sieves and is put into what is reinstalled
In four mouthfuls of vials, 2 liters of purified waters are added, 45 ± 5 DEG C is warming up to, agitator treating 30 minutes, discharges, filter, filter cake re-sieving
Granulation.Same method washs 3 times, and the 3rd discharging is exactly oxyamyli tectus aldehydum slurries, standby.
Hereafter suction filtration separation of solid and liquid, if necessary granulation, increase drying steps and packaging takes different disposal condition,
Detailed in Example 1~6.
Described particle moisture content detection, using the MS-100 type infrared moistures of Shanghai Jia Shi Electronic Science and Technology Co., Ltd.s
Analyzer is carried out.Described vacuum packaging is using the DZ-800W pumping packing machines of the gloomy package packing machine Co., Ltd of Beijing Ostwald-Folin
Carry out.
Embodiment 1
Oxyamyli tectus aldehydum slurries are put into be placed in the Buchner funnel on bottle,suction and carry out separation of solid and liquid：Vavuum pump is opened to enter
Row filters, and when detecting filter cake moisture content 75.5%, stops filtering, takes out filter cake；Then pelletize：With 20 mesh stainless steel sieve series grains,
Wet granular agent is obtained, is well mixed, detection moisture content is 77.9%；Packed using aluminum plastic film vacuum packaging equipment.
Embodiment 2
Dialdehyde starch slurries are put into be placed in the Buchner funnel on bottle,suction and carry out separation of solid and liquid：Vavuum pump is opened to carry out
Filter, when detecting filter cake moisture content 62.2%, stop filtering, take out filter cake；Then pelletize：With 20 mesh stainless steel sieve series grains, mix
Close uniformly, obtain wet granular agent, detection moisture content is 65.8%；Packed using aluminum plastic film vacuum packaging equipment.
Embodiment 3
Dialdehyde starch slurries are put into be placed in the Buchner funnel on bottle,suction and carry out separation of solid and liquid：Vavuum pump is opened to carry out
Filter, when detecting filter cake moisture content 46.6%, stop filtering, take out filter cake；Then pelletize：With 20 mesh stainless steel sieve series grains, mix
Close uniformly, obtain wet granular agent, detection moisture content is 50.2%；Packed using aluminum plastic film vacuum packaging equipment.
Embodiment 4
Dialdehyde starch slurries are put into be placed in the Buchner funnel on bottle,suction and carry out separation of solid and liquid：Vavuum pump is opened to carry out
Filter, when detecting cake moisture 47.3%, stop filtering, take out filter cake；Then pelletize：With 20 mesh stainless steel sieve series grains, mix
Closing uniformly, obtain wet granular agent, detection moisture content is 52.4%, is put into infrared drying oven, and control temperature is toasted no more than 45 DEG C,
Taken out when detecting moisture content 40.8%, cool to room temperature, it is 39.6% to be well mixed detection moisture content；Using aluminum plastic film vacuum packet
Fill equipment package.
Embodiment 5
Dialdehyde starch slurries, it is put into be placed in the Buchner funnel on bottle,suction and carries out separation of solid and liquid：Vavuum pump is opened to enter
Row filters, and when detecting filter cake moisture content 45.8%, stops filtering, takes out filter cake, then pelletize：With 20 mesh stainless steel sieve series grains,
It is well mixed, wet granular agent is obtained, detection water content is 49.1%, is put into infrared drying oven, no more than the 45 DEG C bakings of control temperature
It is roasting, taken out when detecting moisture content 21.3%, cool to room temperature, it is 20.5% to be well mixed detection moisture content.With aluminum plastic film vacuum
Packaging.
Embodiment 6
Dialdehyde starch slurries, it is put into be placed in the Buchner funnel on bottle,suction and carries out separation of solid and liquid：Vavuum pump is opened to enter
Row filters, and when detecting filter cake moisture content 49.5%, stops filtering, takes out filter cake；Then pelletize：With 20 mesh stainless steel sieve series grains,
It is well mixed, wet granular agent is obtained, detection moisture content is 53.6%, is put into infrared drying oven, no more than the 45 DEG C bakings of control temperature
It is roasting, taken out when detecting water content 13.7%, cool to room temperature, it is 13.1% to be well mixed detection moisture content.With aluminum plastic film vacuum
Packaging.
The wet granular agent and commercially available dry particl agent manufactured in aforementioned manners is compareed, and absorption urea is carried out in laboratory
The experiment of (molecular weight 60).1.5g urea is taken, is dissolved in 1000ml distilled water, obtains urea liquid.Use the good real electronics in Shanghai
The MS-100 type infrared moisture meters of Science and Technology Ltd., the moisture content of wet granular agent and commercially available dry particl agent is determined respectively.
Urea liquid is accurately taken with pipette, every part of 50ml, 2.500g wet granulars agent and commercially available dry is separately added into every part of urea liquid
Granule (is calculated) by dry weight.Vibration absorption 24h, after centrifugation, takes supernatant liquor to survey in 37 DEG C of microbiological incubators
Determine nitrogen content and calculate adsorption rate.
Nitrogen analysis：Carried out according to two annex XIID n2 methods (annex 47) methods of Chinese Pharmacopoeia 2010 edition.
Adsorption rate calculates：
N：Adsorption rate, per unit weight butt granular absorption weight of urea, mg/g
C0：Prepare urea concentration, mg/L
C：Clear liquid urea concentration after adsorbing separation, mg/L
W：Particle butt weight, g
The wet granular agent of different moisture content and commercially available dry particl agent are listed in table 1 to Absorption for Urea rate data.
The adsorption rate of the wet granular agent of table 1 and dry particl agent to urea
| Sequence number | 1 | 2 | 3 | 4 | 5 | 6 | 7* |
| Water content (%) | 13.1 | 20.5 | 39.6 | 50.2 | 65.8 | 77.9 | 11.8 |
| Adsorption rate (mg/g) | 2.1 | 4.0 | 4.0 | 4.3 | 4.6 | 4.7 | 1.7 |
* commercially available prod
It is vacuum-packed using aluminum plastic film, wet granular agent has preferable stability.Wet granular agent and dry particl agent simultaneously
Preserved in Chinese Pharmacopoeia regulation shady place, the different holding times carry out microorganism detection and Absorption for Urea rate detected, microorganism
Detection method is carried out according to 2010 editions annex XI J microbial decolorizations of Chinese Pharmacopoeia, and Absorption for Urea rate is detected according to preceding
Literary method is carried out, and detection data are listed in table 2.
The stability test result of table 2
* commercially available prod
The main distinction of wet granular agent and dry particl agent：
1st, wet granular agent do not need after granulation drying process or only need it is partially dried make its moisture content reach 13~
80%；Dry particl agent, which has to pass through drying process, makes its moisture content reach 8%~12%.
2nd, wet granular agent is soft particle, is easily swelled in warm water；Dry particl agent is fine and close particle, hardly
It is swelled in warm water.
3rd, mouthfeel is soft when wet granular agent is oral, no feeling of grittiness；Mouthfeel is very poor when dry particl agent is oral, there is the strong grains of sand
Sense.
4th, combine not close between the intragranular oxyamyli tectus aldehydum particulate of wet granular agent, thus particle internal void is flourishing, than
Surface area is larger, strong to the adsorption capacity of urea；It is tightly combined between the intragranular oxyamyli tectus aldehydum particulate of dry particl agent, thus
Grain internal void is undeveloped, and specific surface area is smaller, poor to the adsorption capacity of urea.
Claims (4)
1. oxyamyli tectus aldehydum wet granular agent manufacture method, raw material is done with starch, add periodate and aoxidized as oxidant
Reaction, obtains intermediate product dialdehyde starch；Then coating is carried out to dialdehyde starch, then it is dry by separation of solid and liquid, granulation, selectivity
Dry, packaging, just obtains oxyamyli tectus aldehydum wet granular agent；Characterized in that, described wet granular agent moisture content is 13%~80%.
2. oxyamyli tectus aldehydum wet granular agent manufacture method according to claim 1, described wet granular agent moisture content are
20%~65%.
3. oxyamyli tectus aldehydum wet granular agent, it is characterised in that be made using the method for claim 1, described wet granular agent
Moisture content is 13%~80%.
4. oxyamyli tectus aldehydum wet granular agent according to claim 3, it is characterised in that using the method for claim 2
It is made, described wet granular agent moisture content is in 20%-65%.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1083715A (en) * | 1993-05-28 | 1994-03-16 | 天津大学 | The capsule oral agent of efficient absorption blood urea nitrogen |
| CN103012607A (en) * | 2012-12-07 | 2013-04-03 | 天津大学 | Preparation method of porous dialdehyde starch with high urea adsorption |
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- 2013-12-07 CN CN201310687176.4A patent/CN104688690B/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1083715A (en) * | 1993-05-28 | 1994-03-16 | 天津大学 | The capsule oral agent of efficient absorption blood urea nitrogen |
| CN103012607A (en) * | 2012-12-07 | 2013-04-03 | 天津大学 | Preparation method of porous dialdehyde starch with high urea adsorption |
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