CN105021559A - Establishment method of release curve of rabeprazole sodium enteric-coated micro-pill capsule in acidic medium - Google Patents
Establishment method of release curve of rabeprazole sodium enteric-coated micro-pill capsule in acidic medium Download PDFInfo
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Abstract
The invention discloses an establishment method of a release curve of a rabeprazole sodium enteric-coated micro-pill capsule in an acidic medium. The method comprises the steps: taking the rabeprazole sodium enteric-coated micro-pill capsule, adopting an oar-method device, taking the acidic medium as a release medium, respectively taking solutions at different rotation speeds and time points, filtering, measuring to take the dissolution filtrate, carrying out appropriate treatment, and then taking the treated filtrate as a test sample solution; additionally taking a rabeprazole sodium reference substance, adding the acidic medium, carrying out appropriate treatment, and thus obtaining a reference substance solution; and measuring the absorbance by using an ultraviolet-visible spectrophotometry, calculating the release degree and drawing the release curve. The method overcomes the defects that rabeprazole sodium is easy to degrade in the acidic medium and is difficult to effectively detect by high performance liquid chromatography, and enteric-coated accessories seriously interfere determination results in ultraviolet-visible spectrophotometry, innovatively adopts simple acid addition precipitation centrifugation to remove accessory interference, detects degradation products of rabeprazole sodium, indirectly detects the rabeprazole sodium release degree, and has the advantages of being simple, quick and accurate.
Description
Technical field
The invention belongs to pharmaceutical formulations and analyze detection field, more specifically, the present invention relates to the method for building up of a kind of Rabeprazole sodium enteric-coated micro-pellet capsule release profiles in acid medium.
Background technology
RABEPRAZOLE SODIUM dissociation constant is larger, it is the reversible H+/K+-ATP enzyme inhibitor of a kind of part, spinoff is less, and have in conjunction with target spot more, the advantage faster compared with other drug effect, relieving haperacidity intensity is stronger, is mainly used in gastric ulcer, duodenal ulcer, reflux esophagitis, Zhuo-Ai (Zollinger-Ellison) syndrome (gastrinoma).
The existing sodium rabeprazole enteric-coated preparation of bibliographical information burst size in pH6.8 phosphate buffer can adopt UV-VIS spectrophotometry to detect in 282nm place mensuration absorbance at present; But the method is carried out under disturbing negligible situation based on pharmaceutical adjunct.
Sodium rabeprazole enteric-coated capsule (
sprinkle
tM) content product, the major auxiliary burden in prescription is diacetyl monoglyceride, ethyl cellulose, L-HPC, hypromellose phthalate, carragheen etc.This product bulk drug is very easy to degraded in acid medium, be difficult to effectively detect at high performance liquid chromatograph, all there is chromophoric group in catabolite and bulk drug structure, have absorption in ultraviolet region, therefore effectively detect by UV-VIS spectrophotometry.But this product enteric material hypromellose phthalate also has strong absorption in ultraviolet region, just dissolves at more than pH5.5, can separate out at below pH5.5, according to UV-VIS spectrophotometry, enteric accessory severe jamming measurement result.Therefore, under pH6.0 phosphate buffer and pH6.8 phosphate buffer acid medium condition, all adopt acid adding to separate out pelleting centrifugation and remove hypromellose phthalate, get supernatant as need testing solution, thus the interference of enteric material can be got rid of, adopt UV-VIS spectrophotometry effectively to detect.
Summary of the invention
Based on this, in order to overcome the defect of above-mentioned prior art, the invention provides the burst size of a kind of Rabeprazole sodium enteric-coated micro-pellet capsule in acid medium, and then setting up the method for its release profiles.
In order to realize foregoing invention object, this invention takes following technical scheme:
A method for building up for Rabeprazole sodium enteric-coated micro-pellet capsule release profiles in acid medium, comprises the following steps:
(1), the preparation of need testing solution
Get Rabeprazole sodium enteric-coated micro-pellet capsule, adopt paddle method device, with 0.1mol/L hydrochloric acid solution for release medium, under the rotating speed of 50 ~ 100rpm, get solution respectively in the time of 5 ~ 120min, filter, filtrate is need testing solution; Or
Get Rabeprazole sodium enteric-coated micro-pellet capsule, adopt paddle method device, with pH6.0 phosphate buffer for release medium, under the rotating speed of 50 ~ 100rpm, solution is got respectively in the time of 5 ~ 120min, filter, filtrate, in 37.0 DEG C ± 0.5 DEG C Water Under bath 1 ± 0.5 hour, is got filtrate and is added acid, leave standstill 15 ~ 60min, centrifugal 5 ~ the 20min of 3000 ~ 5000rpm, supernatant is need testing solution, and described filtrate is 9:0.5 ~ 2.0 with adding sour volume ratio; Or
Get Rabeprazole sodium enteric-coated micro-pellet capsule, adopt paddle method device, with pH6.8 phosphate buffer for release medium, under the rotating speed of 50 ~ 100rpm, get solution respectively in the time of 5 ~ 120min, filter, get filtrate and add acid, leave standstill the centrifugal 5 ~ 20min of 15 ~ 60min, 3000 ~ 5000rpm, supernatant is need testing solution, and described filtrate is 9:0.5 ~ 2.0 with adding sour volume ratio;
(3), the preparation of reference substance solution
When release medium is 0.1mol/L hydrochloric acid solution, get RABEPRAZOLE SODIUM reference substance, add 0.1mol/L hydrochloric acid solution, make and be about equivalent to the reference substance solution that Rabeprazole sodium content is 1.3 μ g/ml; Or
When release medium is pH6.0 phosphate buffer, get RABEPRAZOLE SODIUM reference substance, add methyl alcohol to dissolve and the solution making 0.5mg/ml, make with pH6.0 phosphate buffer again and be about equivalent to the solution that Rabeprazole sodium content is 10 μ g/ml, in 37.0 DEG C ± 0.5 DEG C Water Under bath 1 ± 0.5 hour, get solution and add acid, leave standstill 15 ~ 60min, be reference substance solution, described solution is 9:0.5 ~ 2.0 with adding sour volume ratio;
When release medium is pH6.8 phosphate buffer, get RABEPRAZOLE SODIUM reference substance, add pH6.8 phosphate buffer to make and be about equivalent to the solution that Rabeprazole sodium content is 10 μ g/ml, add acid, leave standstill 15 ~ 60min, be reference substance solution, described solution is 9:0.5 ~ 2.0 with adding sour volume ratio;
(3), detect
When release medium is 0.1mol/L hydrochloric acid solution, with 0.1mol/L hydrochloric acid solution for blank solvent; Or
When release medium is pH6.0 phosphate buffer, be that the pH6.0 phosphate buffer-1mol/L hydrochloric acid solution of 9:0.5 ~ 2.0 is blank solvent with volume ratio; Or
When release medium is pH6.8 phosphate buffer, be that the pH6.8 phosphate buffer-1mol/L hydrochloric acid solution of 9:0.5 ~ 2.0 is blank solvent with volume ratio;
Adopt UV-VIS spectrophotometry, light path is 1cm ~ 3cm, gets the need testing solution of step (1) and the reference substance solution of step (2), measures absorbance in 280nm ~ 320nm wavelength, calculates release, draws release profiles.
Wherein in some embodiments, the rotating speed described in step (1) is 60 ~ 75rpm.
Wherein in some embodiments, described in step (1) and step (2), acid is selected from 0.9 ~ 1.1mol/L hydrochloric acid solution, 0.9 ~ 1.1mol/L sulfuric acid solution or 0.9 ~ 1.1mol/L phosphoric acid solution.
Wherein in an embodiment, described in step (1) and step (2), acid is 1mol/L hydrochloric acid solution.
Wherein in some embodiments, when release medium is pH6.0 phosphate buffer, filtrate described in step (1) and step (2) is 9:1 with the volume ratio adding acid.
Wherein in some embodiments, when release medium is pH6.8 phosphate buffer, filtrate described in step (1) and step (2) is 9:1.2 with the volume ratio adding acid.
Wherein in some embodiments, leave standstill 25 ~ 35min in step (1), centrifugal rotational speed is 4000 ~ 4200rpm, and centrifugation time is 10 ~ 15min.
Wherein in some embodiments, described in step (1), light path is 2 ~ 3cm; Described determined wavelength is 290 ~ 305nm, is preferably 298nm ± 2nm, is more preferably 298nm.
Wherein in an embodiment, described determined wavelength is 298 ± 2nm.
Compared with prior art, the present invention has following beneficial effect:
1, the method for building up of release profiles of the present invention is by after adopting a series of process to dissolution fluid, UV-VIS spectrophotometry is used to detect Rabeprazole sodium enteric-coated micro-pellet release profiles in acid medium, overcome Rabeprazole sodium enteric-coated micro-pellet easily to degrade in acid medium, effective detection is difficult at high performance liquid chromatograph, the shortcoming of auxiliary material severe jamming in UV-VIS spectrophotometry, and creative use simple acid adding pelleting centrifugation removing enteric material is main auxiliary material interference, can indirect detection RABEPRAZOLE SODIUM burst size situation, have fast, advantage accurately,
2, the method for building up of release profiles of the present invention is accurate, operation feasible, and favorable reproducibility is highly sensitive, practical at work.
Accompanying drawing explanation
Fig. 1 is the stability spectrogram of reference substance solution under 0.1mol/L hydrochloric acid solution in the embodiment of the present invention 1;
Fig. 2 is the stability spectrogram of reference substance solution under pH6.0 phosphate buffer in the embodiment of the present invention 2,298nm place from top to bottom the first and second spectrum lines is place the room temperature 0h of 30min and the spectrum line of 1h in 37.0 DEG C of water-baths, other spectrum lines be place 0 in 37.0 DEG C of water-baths, 60,90, the room temperature 0h of 120min and the spectrum line of 1h;
Fig. 3 is the stability spectrogram of reference substance solution under pH6.8 phosphate buffer in the embodiment of the present invention 3;
Fig. 4 is the releasing curve diagram of the embodiment of the present invention 4 in 0.1mol/L hydrochloric acid solution;
Fig. 5 is the releasing curve diagram of the embodiment of the present invention 5 in pH6.0 phosphate buffer;
Fig. 6 is the releasing curve diagram of the embodiment of the present invention 6 in pH6.8 phosphate buffer.
Embodiment
Be below specific embodiments of the invention, technical scheme of the present invention is further described, but protection scope of the present invention is not limited to these implementation columns.Every do not deviate from the present invention's design change or equivalent substituting include within protection scope of the present invention.
Unless otherwise indicated, the raw material used in following examples and reagent are commercially available.
Embodiment 1.
Precision takes RABEPRAZOLE SODIUM reference substance 10mg, add 0.1mol/L dissolve with hydrochloric acid solution and dilute the solution made containing 1 μ g in every 1ml, put in 37.0 DEG C ± 0.5 DEG C water-bath, respectively at 0,30,60,90,120min time get appropriate solution, be chilled to room temperature, according to UV-VIS spectrophotometry, scan under 200 ~ 400nm wavelength respectively at the different time.Under 0.1mol/L hydrochloric acid solution, the stability spectrogram of reference substance solution is shown in Fig. 1.Each solution ultraviolet spectrogram has stable absorbance in 298nm place.
Embodiment 2.
Precision takes RABEPRAZOLE SODIUM reference substance 10mg, add pH6.0 phosphate buffer dissolve and be diluted to the solution containing 10 μ g in every 1ml, put in 37.0 DEG C ± 0.5 DEG C water-bath, respectively at 0,30,60,90,120min time get appropriate solution, be chilled to room temperature, precision measures 9ml precision and adds 1ml 1mol/L hydrochloric acid solution respectively, according to UV-VIS spectrophotometry, scans under 200 ~ 400nm wavelength respectively at the different time.Under pH6.0 phosphate buffer, the stability spectrogram of reference substance solution is shown in Fig. 2.In Fig. 2 298nm place from top to bottom the first and second spectrum lines be place the room temperature 0h of 30min and the spectrum line of 1h in 37.0 DEG C of water-baths, except placing 30min in 37.0 DEG C of water-baths, the ultraviolet spectrogram of other each solution has stable absorbance in 298nm place.Therefore in pH6.0 phosphate-buffered liquid medium, dissolution fluid and reference substance solution place 1h in 37.0 DEG C of water-baths is necessary.
Embodiment 3.
Precision takes RABEPRAZOLE SODIUM reference substance 10mg, add pH6.8 phosphate buffer dissolve and be diluted to the solution containing 10 μ g in every 1ml, put in 37.0 DEG C ± 0.5 DEG C water-bath, respectively at 0,30,60,90,120min time get appropriate solution, be chilled to room temperature, precision measures 9ml precision and adds 1.2ml 1mol/L hydrochloric acid solution respectively, according to UV-VIS spectrophotometry, scans under 200 ~ 400nm wavelength respectively at the different time.Under pH6.8 phosphate buffer, the stability spectrogram of reference substance solution is shown in Fig. 3.Each solution ultraviolet spectrogram has stable absorbance in 298nm place.
The method for building up of the release profiles of embodiment 4. Rabeprazole sodium enteric-coated micro-pellet capsule in 0.1mol/L hydrochloric acid solution
Key instrument: RC806 type stripping experiment instrument, UV-2450 type ultraviolet spectrophotometer.
Comprise the following steps:
(1) preparation of sample solution
Get three batches of Rabeprazole sodium enteric-coated micro-pellet capsules respectively, adopt according to drug release determination method (Chinese Pharmacopoeia version in 2010 two annex X D second methods), adopt dissolution method (Chinese Pharmacopoeia version in 2010 two annex X C second methods) device, with 0.1mol/L hydrochloric acid solution 750ml for release medium, rotating speed is 75rpm, through 5,10,15,30,45,60,90,120min, get solution 10ml respectively, filter, and instant supplementary release medium 10ml, measuring subsequent filtrate is need testing solution;
(2) preparation of reference substance solution
It is appropriate that another precision takes RABEPRAZOLE SODIUM reference substance, adds the solution product solution in contrast that 0.1mol/L hydrochloric acid solution makes every 1ml about 1.3 μ g.
(3) measure
By UV-VIS spectrophotometry, light path is 3cm, with 0.1mol/L hydrochloric acid solution for blank solvent, measures absorbance in 298nm place.Calculate release (representing with mean value ± SD).The stripping curve figure of Rabeprazole sodium enteric-coated micro-pellet capsule in 0.1mol/L hydrochloric acid solution is shown in accompanying drawing 4, and release the results are shown in Table 1.
Table 1 Rabeprazole sodium enteric-coated micro-pellet capsule is release result (n=6) in 0.1mol/L hydrochloric acid solution
The method of the present embodiment detects that the burst size of each preparation unit 5 ~ 120min in 0.1mol/L hydrochloric acid solution medium should be 0% ~ 10% of labelled amount indirectly.
The method for building up of the release profiles of embodiment 5. Rabeprazole sodium enteric-coated micro-pellet capsule in pH6.0 phosphate buffer
Key instrument: RC806 type stripping experiment instrument, UV-2450 type ultraviolet spectrophotometer.
Comprise the following steps:
(1) preparation of sample solution
Get three batches of Rabeprazole sodium enteric-coated micro-pellet capsules respectively, adopt according to drug release determination method (Chinese Pharmacopoeia version in 2010 two annex X D second methods), adopt dissolution method (Chinese Pharmacopoeia version in 2010 two annex X C second methods) device, with pH6.0 phosphate buffer 1 000ml for release medium, rotating speed is 75rpm, through 20, 30, 35, 40, 45, 50, 60, 70min, get solution 10ml respectively, filter, and instant supplementary release medium 10ml, get subsequent filtrate and place 1h in 37.0 DEG C ± 0.5 DEG C water-bath, precision measures 9ml precision and adds 1mol/L hydrochloric acid solution 1ml, shake up, after leaving standstill 30min, centrifugal (4000rpm, 10min), supernatant is need testing solution.
(2) preparation of reference substance solution
It is appropriate that another precision takes RABEPRAZOLE SODIUM reference substance, add methyl alcohol dissolve and make the solution that every 1ml is about 0.5mg, the solution of every 1ml about 10 μ g is made again with the dilution of pH6.0 phosphate buffer, 1h is placed in 37.0 DEG C ± 0.5 DEG C water-bath, precision measures 9ml precision and adds 1mol/L hydrochloric acid solution 1ml, shake up, leave standstill 30min, in contrast product solution.
(3) measure
By UV-VIS spectrophotometry, light path is 3cm, with pH6.0 phosphate buffer-1mol/L hydrochloric acid solution (9:1) for blank solvent, measures absorbance in 298nm place.Calculate release (representing with mean value ± SD).The stripping curve figure of Rabeprazole sodium enteric-coated micro-pellet capsule in pH6.0 phosphate buffer is shown in accompanying drawing 5, and burst size the results are shown in Table 2.
Table 2 Rabeprazole sodium enteric-coated micro-pellet capsule is release result (n=6) in pH6.0 phosphate buffer
The method of the present embodiment indirectly detect each preparation unit in pH6.0 phosphate-buffered liquid medium 35,45, the release of 60min should be 20% ~ 30%, 75% ~ 85%, 85% ~ 95% of labelled amount.
The method for building up of the release profiles of embodiment 6. Rabeprazole sodium enteric-coated micro-pellet capsule in pH6.8 phosphate buffer
Key instrument: RC806 type stripping experiment instrument, UV-2450 type ultraviolet spectrophotometer.
Comprise the following steps:
(1) preparation of sample solution
Get three batches of Rabeprazole sodium enteric-coated micro-pellet capsules respectively, according to drug release determination method (Chinese Pharmacopoeia version in 2010 two annex X D second methods), adopt dissolution method (Chinese Pharmacopoeia version in 2010 two annex X C second methods) device, with 0.1mol/L hydrochloric acid solution 750ml for acid medium, rotating speed is 75rpm, after 2h, add 250ml 0.2mol/L sodium radio-phosphate,P-32 solution, make to become pH6.8 phosphate buffer (0.05mol/L), rotating speed is 60rpm, through 10, 15, 20, 25, 30, 45min, get solution 10ml respectively, filter, and instant supplementary release medium 10ml, precision measures 9ml precision and adds 1mol/L hydrochloric acid solution 1.2ml, shake up, after leaving standstill 30min, centrifugal (4000rpm, 10min), supernatant is need testing solution.
(2) preparation of reference substance solution
It is appropriate that another precision takes RABEPRAZOLE SODIUM reference substance, and add the solution that pH6.8 phosphate buffer makes every 1ml about 10 μ g, precision measures 9ml precision and adds 1mol/L hydrochloric acid solution 1.2ml, shakes up, and leaves standstill 30min, in contrast product solution.
(3) measure
By UV-VIS spectrophotometry, light path is 3cm, with pH6.8 phosphate buffer-1mol/L hydrochloric acid solution (9:1.2) for blank solvent, measures absorbance in 298nm place.Calculate release (representing with mean value ± SD).The stripping curve figure of Rabeprazole sodium enteric-coated micro-pellet capsule in pH6.8 phosphate buffer is shown in accompanying drawing 6, and burst size the results are shown in Table 3.
Table 3 Rabeprazole sodium enteric-coated micro-pellet capsule is release result (n=6) in pH6.8 phosphate buffer
The method of the present embodiment indirectly detect each preparation unit in pH6.8 phosphate-buffered liquid medium 15,20,25, the burst size of 45min should be respectively 35% ~ 45%, 60% ~ 70%, 75% ~ 85%, 85% ~ 95% of labelled amount.
The above embodiment only have expressed several embodiment of the present invention, and it describes comparatively concrete and detailed, but therefore can not be interpreted as the restriction to the scope of the claims of the present invention.It should be pointed out that for the person of ordinary skill of the art, without departing from the inventive concept of the premise, can also make some distortion and improvement, these all belong to protection scope of the present invention.Therefore, the protection domain of patent of the present invention should be as the criterion with claims.
Claims (9)
1. a method for building up for Rabeprazole sodium enteric-coated micro-pellet capsule release profiles in acid medium, is characterized in that, comprise the following steps:
(1), the preparation of need testing solution
Get Rabeprazole sodium enteric-coated micro-pellet capsule, adopt paddle method device, with 0.1mol/L hydrochloric acid solution for release medium, paddle, under the rotating speed of 50 ~ 100rpm, gets solution respectively in the time of 5 ~ 120min, and filter, filtrate is need testing solution; Or
Get Rabeprazole sodium enteric-coated micro-pellet capsule, adopt paddle method device, with pH6.0 phosphate buffer for release medium, under the rotating speed of 50 ~ 100rpm, solution is got respectively in the time of 5 ~ 120min, filter, filtrate, in 37.0 DEG C ± 0.5 DEG C Water Under bath 1 ± 0.5 hour, is got filtrate and is added acid, leave standstill 15 ~ 60min, centrifugal 5 ~ the 20min of 3000 ~ 5000rpm, supernatant is need testing solution, and described filtrate is 9:0.5 ~ 2.0 with adding sour volume ratio; Or
Get Rabeprazole sodium enteric-coated micro-pellet capsule, adopt paddle method device, with pH6.8 phosphate buffer for release medium, under the rotating speed of 50 ~ 100rpm, get solution respectively in the time of 5 ~ 120min, filter, get filtrate and add acid, leave standstill the centrifugal 5 ~ 20min of 15 ~ 60min, 3000 ~ 5000rpm, supernatant is need testing solution, and described filtrate is 9:0.5 ~ 2.0 with adding sour volume ratio;
(2), the preparation of reference substance solution
When release medium is 0.1mol/L hydrochloric acid solution, get RABEPRAZOLE SODIUM reference substance, add 0.1mol/L hydrochloric acid solution, make and be about equivalent to the reference substance solution that Rabeprazole sodium content is 1.3 μ g/ml; Or
When release medium is pH6.0 phosphate buffer, get RABEPRAZOLE SODIUM reference substance, add methyl alcohol to dissolve and the solution making 0.5mg/ml, make with pH6.0 phosphate buffer again and be about equivalent to the solution that Rabeprazole sodium content is 10 μ g/ml, in 37.0 DEG C ± 0.5 DEG C Water Under bath 1 ± 0.5 hour, get solution and add acid, leave standstill 15 ~ 60min, be reference substance solution, described solution is 9:0.5 ~ 2.0 with adding sour volume ratio;
When release medium is pH6.8 phosphate buffer, get RABEPRAZOLE SODIUM reference substance, add pH6.8 phosphate buffer to make and be about equivalent to the solution that Rabeprazole sodium content is 10 μ g/ml, add acid, leave standstill 15 ~ 60min, be reference substance solution, described solution is 9:0.5 ~ 2.0 with adding sour volume ratio;
(3), detect
When release medium is 0.1mol/L hydrochloric acid solution, with 0.1mol/L hydrochloric acid solution for blank solvent; Or
When release medium is pH6.0 phosphate buffer, be that the pH6.0 phosphate buffer-1mol/L hydrochloric acid solution of 9:0.5 ~ 2.0 is blank solvent with volume ratio; Or
When release medium is pH6.8 phosphate buffer, be that the pH6.8 phosphate buffer-1mol/L hydrochloric acid solution of 9:0.5 ~ 2.0 is blank solvent with volume ratio;
Adopt UV-VIS spectrophotometry, light path is 1cm ~ 3cm, gets the need testing solution of step (1) and the reference substance solution of step (2), measures absorbance in 280nm ~ 320nm wavelength, calculates burst size, draws release profiles.
2. the method for building up of Rabeprazole sodium enteric-coated micro-pellet capsule according to claim 1 release profiles in acid medium, it is characterized in that, described in step (1) and step (2), acid is selected from 0.9 ~ 1.1mol/L hydrochloric acid solution, 0.9 ~ 1.1mol/L sulfuric acid solution or 0.9 ~ 1.1mol/L phosphoric acid solution.
3. the method for building up of Rabeprazole sodium enteric-coated micro-pellet capsule according to claim 2 release profiles in acid medium, is characterized in that, described in step (1) and step (2), acid is 1mol/L hydrochloric acid solution.
4. the method for building up of Rabeprazole sodium enteric-coated micro-pellet capsule according to claim 1 release profiles in acid medium, it is characterized in that, when release medium is pH6.0 phosphate buffer, filtrate/solution described in step (1) and step (2) is 9:1 with the volume ratio adding acid.
5. the method for building up of Rabeprazole sodium enteric-coated micro-pellet capsule according to claim 1 release profiles in acid medium, it is characterized in that, when release medium is pH6.8 phosphate buffer, filtrate/solution described in step (1) and step (2) is 9:1.2 with the volume ratio adding acid.
6. the method for building up of Rabeprazole sodium enteric-coated micro-pellet capsule according to claim 1 release profiles in acid medium, it is characterized in that, leave standstill 25 ~ 35min in step (1), centrifugal rotational speed is 4000 ~ 4200rpm, and centrifugation time is 10 ~ 15min.
7. the method for building up of Rabeprazole sodium enteric-coated micro-pellet capsule according to claim 1 release profiles in acid medium, is characterized in that, described in step (1), light path is 2 ~ 3cm; Described determined wavelength is 290 ~ 305nm.
8. the method for building up of Rabeprazole sodium enteric-coated micro-pellet capsule according to claim 7 release profiles in acid medium, is characterized in that, described determined wavelength is 298 ± 2nm.
9. the method for building up of Rabeprazole sodium enteric-coated micro-pellet capsule according to claim 1 release profiles in acid medium, is characterized in that, the rotating speed described in step (1) is 60 ~ 75rpm.
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| CN112697688A (en) * | 2020-12-18 | 2021-04-23 | 正大制药（青岛）有限公司 | Acid resistance measuring method of omeprazole chewable tablets |
| CN113624702A (en) * | 2021-08-18 | 2021-11-09 | 丽珠集团丽珠制药厂 | Dissolution curve determination method of rabeprazole sodium enteric-coated tablets |
| CN118311216A (en) * | 2024-06-07 | 2024-07-09 | 湖南明瑞制药股份有限公司 | Rapid determination method for dissolution rate of sodium rabeprazole enteric-coated tablets |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112697688A (en) * | 2020-12-18 | 2021-04-23 | 正大制药（青岛）有限公司 | Acid resistance measuring method of omeprazole chewable tablets |
| CN113624702A (en) * | 2021-08-18 | 2021-11-09 | 丽珠集团丽珠制药厂 | Dissolution curve determination method of rabeprazole sodium enteric-coated tablets |
| CN113624702B (en) * | 2021-08-18 | 2023-12-22 | 丽珠集团丽珠制药厂 | Dissolution curve determination method of rabeprazole sodium enteric-coated tablet |
| CN118311216A (en) * | 2024-06-07 | 2024-07-09 | 湖南明瑞制药股份有限公司 | Rapid determination method for dissolution rate of sodium rabeprazole enteric-coated tablets |
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