CN104997754A - Analgesic-antipyretic aspirin composition capsule - Google Patents
Analgesic-antipyretic aspirin composition capsule Download PDFInfo
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- CN104997754A CN104997754A CN201510471738.0A CN201510471738A CN104997754A CN 104997754 A CN104997754 A CN 104997754A CN 201510471738 A CN201510471738 A CN 201510471738A CN 104997754 A CN104997754 A CN 104997754A
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Abstract
The invention discloses an analgesic-antipyretic aspirin composition capsule, and belongs to the technical field of medicine. The composition is prepared from aspirin, carboxypolymethylene, microcrystalline cellulose, L-tartaric acid, analgesic K30, 95% ethyl alcohol and talcum powder. The aspirin is a novel crystalline compound, an X-ray powder diffraction pattern which is obtained through measurement by using a Cu-K alpha ray is showed in Figure 1, the aspirin is different from aspirin reported in an existing technology, it is proved in experiments that the capsule prepared from the novel aspirin crystalline compound is high in dissolution rate, the stability is good, the content of free salicylic acid is lower, increasing of the content of the free salicylic acid of the capsule is not obvious when the storage time is prolonged, and gastrointestinal adverse reactions are greatly reduced.
Description
Technical field
The invention belongs to medical art, relate to a kind of antipyretic analgesic aspirin composition capsule.
Background technology
Aspirin (aspirin), have another name called aspirin, one of three large classical medicines in history, as the time-honored antipyretic analgesic of one, its effectiveness is obviously cheap, so far remain most widely used antipyretic-antalgic anti-inflammatory agent, and be the standard preparation comparing and evaluate other drug.Since the 60's of 20th century, pharmacological research shows, aspirin persistency deactivation COX-1 is active, suppress platelet function, without dosage dependent interaction, extremely low concentration (nmol/L) can reach inhibitory action rapidly, namely has clear and definite blood coagulation resisting function, thus can as the medicine of pre-preventing thrombosis." Chinese Consensus of experts " suggestion aspirin prolonged application dosage in primary prevention was 75-100mg/ days, and was 75-150mg/ day at the prolonged application dosage of secondary prevention.
Mainly there is two problems in the Genprin of existing use: facile hydrolysis produces salicylic acid and causes gastrointestinal hemorrhage.Salicylic acid is the hydrolyzate of aspirin, is the principal element that aspirin causes digestive tract to stimulate simultaneously, and the height of its content is one of important indicator evaluating Genprin quality.In pharmacopeia, in regulation aspirin, salicylic content must not more than 1.5%.
The maximum toxic and side effects of aspirin is exactly very easily cause rotten to the corn, hemorrhage and ulcer of gastrointestinal tract mucosa etc.Except analgesia, antipyretic except, all need Long-term taking medicine when aspirin is used for the treatment of the diseases such as rheumatic fever, arthritis, antithrombotic, further increase the incidence rate of toxic and side effects.Although people have carried out improving dosage form, as added suppository, avoid medicine and gastrointestinal tract to touch, medication is extremely inconvenient; And for example make enteric coated preparation, although decrease the incidence rate of toxic and side effects to a certain extent, have part Seepage can occur under one's belt, stimulation can be caused to stomach like this, damage is caused to gastric mucosa; If the content of free salicylic acid is high in enteric coated capsule, salicylism can be caused to react, still do not tackle the problem at its root.
Therefore, reduce aspirin capsule middle reaches to have very important significance from salicylic acid content.
Summary of the invention
Goal of the invention of the present invention is to provide a kind of antipyretic analgesic aspirin composition capsule.
In order to complete object of the present invention, the technical scheme of employing is:
A kind of antipyretic analgesic aspirin composition capsule, described compositions is made up of aspirin, carbopol, microcrystalline Cellulose, L-TARTARIC ACID, PVP K30,95% ethanol, Pulvis Talci; Described aspirin is crystal, and the X-ray powder diffraction pattern that the measurement of use Cu-K alpha ray obtains as shown in Figure 1.
Preferably, with parts by weight, described compositions is made up of the aspirin of 5 weight portions, the carbopol of 8-12 weight portion, the microcrystalline Cellulose of 38-40 weight portion, the L-TARTARIC ACID of 0.03-0.07 weight portion, the PVP K30 of 0.1-0.3 weight portion, 95% ethanol of 3.5-4.1 weight portion, the Pulvis Talci of 2.5-3.5 weight portion.
Preferably, with parts by weight, described compositions is made up of the aspirin of 5 weight portions, the carbopol of 10 weight portions, the microcrystalline Cellulose of 39 weight portions, the L-TARTARIC ACID of 0.05 weight portion, the PVP K30 of 0.2 weight portion, 95% ethanol of 3.8 weight portions, the Pulvis Talci of 3 weight portions.
The preparation method of described compositions comprises the following steps:
1) weigh according to technology preparation;
2) premixing: the aspirin raw material of recipe quantity and carbopol are mixed with equal increments method, then adds microcrystalline Cellulose with equal increments method;
3) prepare PVP K30 ethanol: 95% ethanol of recipe quantity is placed in stainless steel cask, adds the PVP K30 of recipe quantity while stirring, be stirred to all dissolvings for subsequent use;
4) mixing granulation: the L-TARTARIC ACID of the aspirin of premixing, carbopol, microcrystalline Cellulose and recipe quantity is added in wet mixing pelletizer, open stirring motor and be dry mixed 5 minutes, add the PVP K30 solution prepared, wet mixing 90-120 soft material second, 24 order nylon wires are arranged in oscillating granulator granulates;
5) dry: arranging boiling drier inlet temperature is 60 DEG C, is dried to moisture < 2.0%, select 20 order nylon wires to be arranged on granulate in oscillating granulator after dry;
6) always mix: the dry granule after granulate and Pulvis Talci are joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) select enteric glue shell, use capsule filling machine fill, content uniformity conforms with the regulations;
8) pack.
The preparation method of the crystal of described aspirin comprises the following steps:
By aspirin dissolution of solid in the volume of 30 DEG C be in the chloroform soln of aspirin weight 4 times; First with the speed of 4ml/min add 8 times that volume total amount is aspirin weight methyl acetone, water, isopropyl alcohol mixed solvent, the volume ratio of methyl acetone, water, isopropyl alcohol is 1:5:1, and limit edged stirs, control temperature 30 DEG C, growing the grain 0.5 hour; And then with the speed of 3ml/min add 12 times that volume total amount is aspirin weight methyl acetone, water, isopropyl alcohol mixed solvent, the volume ratio of methyl acetone, water, isopropyl alcohol is 1:3:0.5, growing the grain is after 3 hours, be cooled to 0 DEG C with the speed of 10 DEG C/h, then keep mixing speed 90 revs/min of stirring and crystallizing, growing the grain 2 hours; Filter, drying under reduced pressure obtains aspirin crystalline compounds.
Below technical scheme of the present invention is made further explanation:
The present invention is by the precise controlling to crystallization condition, and prepared a kind of aspirin novel crystal forms unlike the prior art, the X-ray powder diffraction pattern of this aspirin crystal unlike the prior art.Simultaneously due to the ins and outs of this crystal formation, find through test, capsule dissolubility prepared by this aspirin crystal compound is high, good stability, not only there is lower free salicylic acid content, and along with period of storage its free salicylic acid content of prolongation increase not obvious, greatly reduce medicine gastrointestinal side effect.
Accompanying drawing explanation
Fig. 1 is the X-ray powder diffraction that the aspirin crystal of the embodiment of the present invention 1 preparation uses the measurement of Cu-K alpha ray to obtain.
Detailed description of the invention
Below by specific embodiment, summary of the invention of the present invention is described in further detail, but does not therefore limit content of the present invention.
embodiment 1:the preparation of aspirin crystal
By aspirin dissolution of solid in the volume of 30 DEG C be in the chloroform soln of aspirin weight 4 times; First with the speed of 4ml/min add 8 times that volume total amount is aspirin weight methyl acetone, water, isopropyl alcohol mixed solvent, the volume ratio of methyl acetone, water, isopropyl alcohol is 1:5:1, and limit edged stirs, control temperature 30 DEG C, growing the grain 0.5 hour; And then with the speed of 3ml/min add 12 times that volume total amount is aspirin weight methyl acetone, water, isopropyl alcohol mixed solvent, the volume ratio of methyl acetone, water, isopropyl alcohol is 1:3:0.5, growing the grain is after 3 hours, be cooled to 0 DEG C with the speed of 10 DEG C/h, then keep mixing speed 90 revs/min of stirring and crystallizing, growing the grain 2 hours; Filter, drying under reduced pressure obtains aspirin crystalline compounds.
As shown in Figure 1, its purity of high-performance liquid chromatogram determination is 99.9% to the X-ray powder diffraction pattern that the aspirin crystal prepared uses the measurement of Cu-K alpha ray to obtain.
embodiment 2:the preparation of aspirin capsule, step is as follows:
Prescription: with parts by weight as table 1
Table 1 aspirin composition prescription
Preparation method:
1) weigh according to technology preparation;
2) premixing: the aspirin raw material of recipe quantity and carbopol are mixed with equal increments method, then adds microcrystalline Cellulose with equal increments method;
3) prepare PVP K30 ethanol: 95% ethanol of recipe quantity is placed in stainless steel cask, adds the PVP K30 of recipe quantity while stirring, be stirred to all dissolvings for subsequent use;
4) mixing granulation: the L-TARTARIC ACID of the aspirin of premixing, carbopol, microcrystalline Cellulose and recipe quantity is added in wet mixing pelletizer, open stirring motor and be dry mixed 5 minutes, add the PVP K30 solution prepared, wet mixing 90-120 soft material second, 24 order nylon wires are arranged in oscillating granulator granulates;
5) dry: arranging boiling drier inlet temperature is 60 DEG C, is dried to moisture < 2.0%, select 20 order nylon wires to be arranged on granulate in oscillating granulator after dry;
6) always mix: the dry granule after granulate and Pulvis Talci are joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) select enteric glue shell, use capsule filling machine fill, content uniformity conforms with the regulations;
8) pack.
embodiment 3:the preparation of aspirin capsule, step is as follows:
Prescription: with parts by weight as table 2
Table 2 aspirin composition prescription
Preparation method:
1) weigh according to technology preparation;
2) premixing: the aspirin raw material of recipe quantity and carbopol are mixed with equal increments method, then adds microcrystalline Cellulose with equal increments method;
3) prepare PVP K30 ethanol: 95% ethanol of recipe quantity is placed in stainless steel cask, adds the PVP K30 of recipe quantity while stirring, be stirred to all dissolvings for subsequent use;
4) mixing granulation: the L-TARTARIC ACID of the aspirin of premixing, carbopol, microcrystalline Cellulose and recipe quantity is added in wet mixing pelletizer, open stirring motor and be dry mixed 5 minutes, add the PVP K30 solution prepared, wet mixing 90-120 soft material second, 24 order nylon wires are arranged in oscillating granulator granulates;
5) dry: arranging boiling drier inlet temperature is 60 DEG C, is dried to moisture < 2.0%, select 20 order nylon wires to be arranged on granulate in oscillating granulator after dry;
6) always mix: the dry granule after granulate and Pulvis Talci are joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) select enteric glue shell, use capsule filling machine fill, content uniformity conforms with the regulations;
8) pack.
embodiment 4:the preparation of aspirin capsule, step is as follows:
Prescription: with parts by weight as table 3
Table 3 aspirin composition prescription
Preparation method:
1) weigh according to technology preparation;
2) premixing: the aspirin raw material of recipe quantity and carbopol are mixed with equal increments method, then adds microcrystalline Cellulose with equal increments method;
3) prepare PVP K30 ethanol: 95% ethanol of recipe quantity is placed in stainless steel cask, adds the PVP K30 of recipe quantity while stirring, be stirred to all dissolvings for subsequent use;
4) mixing granulation: the L-TARTARIC ACID of the aspirin of premixing, carbopol, microcrystalline Cellulose and recipe quantity is added in wet mixing pelletizer, open stirring motor and be dry mixed 5 minutes, add the PVP K30 solution prepared, wet mixing 90-120 soft material second, 24 order nylon wires are arranged in oscillating granulator granulates;
5) dry: arranging boiling drier inlet temperature is 60 DEG C, is dried to moisture < 2.0%, select 20 order nylon wires to be arranged on granulate in oscillating granulator after dry;
6) always mix: the dry granule after granulate and Pulvis Talci are joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) select enteric glue shell, use capsule filling machine fill, content uniformity conforms with the regulations;
8) pack.
test example:aspirin capsule release and the experiment of free salicylic acid assay
1, burst size
Burst size in acid: the capsule of Example 2 preparation respectively and commercially available enteric coated capsule sample, according to drug release determination method (annex I D second method method 1), adopt dissolution method first method device, with the hydrochloric acid solution 600ml of 0.lmol/L for dissolution medium, rotating speed is 100 turns per minute, operates in accordance with the law, constantly little through 2, get solution 10ml, filter, get subsequent filtrate as need testing solution; Get aspirin reference substance, accurately weighed, acetate methanol solubilize on the rocks also dilutes the solution made containing 4.25 μ g in every lml, product solution in contrast.Measure according to the method under assay item.The burst size of aspirin in meter grate every, limit should be less than 10% of aspirin labelled amount.
Burst size in buffer: the solution for continuous in acid under burst size check item adds the 0.2mol/L sodium radio-phosphate,P-32 solution of 37 DEG C, mixing, pH value to 6.8 ± 0.05 of solution is regulated with 2mol/L hydrochloric acid solution or 2mol/L sodium hydroxide solution, continue stripping 15 minutes, get solution 10ml, filter, get subsequent filtrate as need testing solution; It is appropriate that another precision takes aspirin reference substance, accurately weighed, also dilutes the solution made containing 22 μ g in every 1ml, as aspirin reference substance solution with glacial acetic acid dissolve with methanol solution; Separately get salicylic acid reference substance, accurately weighed, add 1% glacial acetic acid dissolve with methanol solution and dilute the solution made containing 1.7 μ g in every lml, as salicylic acid reference substance solution.According to the chromatographic condition under assay item; precision measures each 10 μ l Fen Do of need testing solution, aspirin reference substance solution and salicylic acid reference substance solution and notes people's chromatograph of liquid; record chromatogram; aspirin and salicylic content in calculating every by external standard method, after salicylic acid content is multiplied by 1.304, is added with aspirin content and obtains burst size in often buffer; limit is 70% of labelled amount, should conform with the regulations.
2, free salicylic acid content
Capsule prepared by difference Example 2 and commercially available enteric coated capsule sample appropriate (being about equivalent to aspirin 0.lg), wear into fine powder, accurately weighed, put in 100ml measuring bottle, the methanol solution jolting adding 1% glacial acetic acid makes aspirin dissolve, and is diluted to scale, shakes up, filter membrane filters, and gets subsequent filtrate as need testing solution (facing by brand-new); Get salicylic acid reference substance and be about 15mg, accurately weighed, put in 50ml measuring bottle, add the dissolve with methanol solution of 1% glacial acetic acid and be diluted to scale, shake up, precision measures 5ml, puts in 100ml measuring bottle, be diluted to scale with the methanol solution of 1% glacial acetic acid, shake up, in contrast product solution.Measure according to the method under aspirin free salicylic acid item, by external standard method with calculated by peak area, 0.5% of labelled amount must not be crossed.
The measurement result (0 day) of table 4 aspirin capsule release, free salicylic acid
Release after table 5 accelerated test, free salicylic acid measurement result (6 months, 40 DEG C of 75%RH)
As can be seen from the result of the test of table 4 and table 5, the aspirin capsule prepared of the embodiment of the present invention 2 before acceleration after in acid burst size be 0 substantially, discharge completely in buffer, free salicylic acid is substantially constant; And in acid, burst size will much larger than embodiment 2 in commercially available enteric coated capsule, in buffer, burst size is much smaller than embodiment 2,
Free salicylic acid increases obviously.
Identical test is carried out to other embodiments, has obtained analog result.
Claims (5)
1. an antipyretic analgesic aspirin composition capsule, is characterized in that: described compositions is made up of aspirin, carbopol, microcrystalline Cellulose, L-TARTARIC ACID, PVP K30,95% ethanol, Pulvis Talci; Described aspirin is crystal, and the X-ray powder diffraction pattern that the measurement of use Cu-K alpha ray obtains as shown in Figure 1.
2. antipyretic analgesic aspirin composition capsule according to claim 1, it is characterized in that: with parts by weight, described compositions is made up of the aspirin of 5 weight portions, the carbopol of 8-12 weight portion, the microcrystalline Cellulose of 38-40 weight portion, the L-TARTARIC ACID of 0.03-0.07 weight portion, the PVP K30 of 0.1-0.3 weight portion, 95% ethanol of 3.5-4.1 weight portion, the Pulvis Talci of 2.5-3.5 weight portion.
3. antipyretic analgesic aspirin composition capsule according to claim 2, it is characterized in that: with parts by weight, described compositions is made up of the aspirin of 5 weight portions, the carbopol of 10 weight portions, the microcrystalline Cellulose of 39 weight portions, the L-TARTARIC ACID of 0.05 weight portion, the PVP K30 of 0.2 weight portion, 95% ethanol of 3.8 weight portions, the Pulvis Talci of 3 weight portions.
4., according to the arbitrary described antipyretic analgesic aspirin composition capsule of claim 1-3, it is characterized in that, the preparation method of described composition capsule comprises the following steps:
1) weigh according to technology preparation;
2) premixing: the aspirin raw material of recipe quantity and carbopol are mixed with equal increments method, then adds microcrystalline Cellulose with equal increments method;
3) prepare PVP K30 ethanol: 95% ethanol of recipe quantity is placed in stainless steel cask, adds the PVP K30 of recipe quantity while stirring, be stirred to all dissolvings for subsequent use;
4) mixing granulation: the L-TARTARIC ACID of the aspirin of premixing, carbopol, microcrystalline Cellulose and recipe quantity is added in wet mixing pelletizer, open stirring motor and be dry mixed 5 minutes, add the PVP K30 solution prepared, wet mixing 90-120 soft material second, 24 order nylon wires are arranged in oscillating granulator granulates;
5) dry: arranging boiling drier inlet temperature is 60 DEG C, is dried to moisture < 2.0%, select 20 order nylon wires to be arranged on granulate in oscillating granulator after dry;
6) always mix: the dry granule after granulate and Pulvis Talci are joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
7) select enteric glue shell, use capsule filling machine fill, content uniformity conforms with the regulations;
8) pack.
5. antipyretic analgesic aspirin composition capsule according to claim 1, it is characterized in that, the preparation method of the crystal of described aspirin comprises the following steps:
By aspirin dissolution of solid in the volume of 30 DEG C be in the chloroform soln of aspirin weight 4 times; First with the speed of 4ml/min add 8 times that volume total amount is aspirin weight methyl acetone, water, isopropyl alcohol mixed solvent, the volume ratio of methyl acetone, water, isopropyl alcohol is 1:5:1, and limit edged stirs, control temperature 30 DEG C, growing the grain 0.5 hour; And then with the speed of 3ml/min add 12 times that volume total amount is aspirin weight methyl acetone, water, isopropyl alcohol mixed solvent, the volume ratio of methyl acetone, water, isopropyl alcohol is 1:3:0.5, growing the grain is after 3 hours, be cooled to 0 DEG C with the speed of 10 DEG C/h, then keep mixing speed 90 revs/min of stirring and crystallizing, growing the grain 2 hours; Filter, drying under reduced pressure obtains aspirin crystalline compounds.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106822197A (en) * | 2015-12-03 | 2017-06-13 | 黄小兵 | A kind of analgesic-antipyretic aspirin combination medicine |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB798633A (en) * | 1956-02-29 | 1958-07-23 | Monsanto Chemicals | Aspirin |
| CN1442145A (en) * | 2003-01-10 | 2003-09-17 | 郑州市协和制药厂 | Aspilrin slow release tablet |
| WO2007080362A1 (en) * | 2006-01-14 | 2007-07-19 | Pliva Hrvatska D.O.O. | Pharmaceutically acceptable co-crystalline forms of sildenafil |
| CN101596166A (en) * | 2008-06-04 | 2009-12-09 | 永信药品工业(昆山)有限公司 | Aspirin Intestine-soluble micro-pill |
| CN102803199A (en) * | 2009-06-25 | 2012-11-28 | 泰特拉有限公司 | Novel acetylsalicylic acid salts |
| CN104151163A (en) * | 2014-07-14 | 2014-11-19 | 西安交通大学 | Crystal form of aspirin as well as preparation method and application thereof |
-
2015
- 2015-08-05 CN CN201510471738.0A patent/CN104997754A/en not_active Withdrawn
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB798633A (en) * | 1956-02-29 | 1958-07-23 | Monsanto Chemicals | Aspirin |
| CN1442145A (en) * | 2003-01-10 | 2003-09-17 | 郑州市协和制药厂 | Aspilrin slow release tablet |
| WO2007080362A1 (en) * | 2006-01-14 | 2007-07-19 | Pliva Hrvatska D.O.O. | Pharmaceutically acceptable co-crystalline forms of sildenafil |
| CN101596166A (en) * | 2008-06-04 | 2009-12-09 | 永信药品工业(昆山)有限公司 | Aspirin Intestine-soluble micro-pill |
| CN102803199A (en) * | 2009-06-25 | 2012-11-28 | 泰特拉有限公司 | Novel acetylsalicylic acid salts |
| CN104151163A (en) * | 2014-07-14 | 2014-11-19 | 西安交通大学 | Crystal form of aspirin as well as preparation method and application thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106822197A (en) * | 2015-12-03 | 2017-06-13 | 黄小兵 | A kind of analgesic-antipyretic aspirin combination medicine |
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