CN101278916A - Quality control method of orally disintegrating tablet - Google Patents
Quality control method of orally disintegrating tablet Download PDFInfo
- Publication number
- CN101278916A CN101278916A CNA2007100616615A CN200710061661A CN101278916A CN 101278916 A CN101278916 A CN 101278916A CN A2007100616615 A CNA2007100616615 A CN A2007100616615A CN 200710061661 A CN200710061661 A CN 200710061661A CN 101278916 A CN101278916 A CN 101278916A
- Authority
- CN
- China
- Prior art keywords
- disintegration
- tablet
- oral cavity
- hanging basket
- screen cloth
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention relates to a quality control method for orally disintegrating tablets; the method adopts an elevation typed disintegration apparatus stipulated in 'Chinese pharmacopoeia 2005 edition' without making an additional monitoring equipment, has the advantages of simple and easy operation, and conforms to the habit of people to detect disintegration time limited, thereby being convenient for relevant departments to standardize detection operation on the disintegration time limited of the orally disintegrating tablets uniformly.
Description
Technical field
The invention belongs to medical solid quality of the pharmaceutical preparations control method, relate to the oral cavity disintegration tablet mensuration of external disintegration.
Background technology
Oral cavity disintegration tablet is a kind of newer solid preparation, not needing to be characterized in water, need not to chew, and tablet places lingual surface, meets rapid disintegrate of saliva or dissolving, borrows and swallows power, and medicine can be gone into the stomach onset.Rapid disintegrate is fine particle or dissolved characteristics in the oral cavity because oral cavity disintegration tablet has; thereby avoid too high in the gastrointestinal local drug concentration; reduced medicine to esophagus and gastrointestinal stimulation, this new method of administration is particularly useful for the patient of old man, children's, dysphagia and the inconvenient person that fetches water takes medicine.Oral cavity disintegration tablet is applicable to onset rapidly, and valid density and poisoning concentration differ bigger medicine, and some war wound emergency treatment medicines, NSAID (non-steroidal anti-inflammatory drug), spasmolytic Bendectin and analgesic etc. all relatively are fit to make oral cavity disintegration tablet.
The characteristics of taking at oral cavity disintegration tablet require delicate mouthfeel pleasant, no grittiness, so the mensuration of disintegration is oral cavity disintegration tablet important quality control project.The disintegration time mensuration method and the physiology of oral cavity environment of conventional tablet fall far short, be not suitable for the mensuration of disintegration time of orally disintegrating tablets, for making external disintegration testing result can reflect preferably that medicine is at intraoral practical situation, in " formulation characteristic of oral cavity disintegration tablet and the quality control meeting summary " at national drug evaluation center to having determined the gross control point disintegration of oral cavity disintegration tablet: disintegration time is in one minute, the first-selected water of medium, consumption should be less than 2ml, temperature is 37 ℃, adopt static method, granularity control project (should less than the 710um of dispersible tablet) should be arranged in addition, in order to determine feasible method, suggestion designs SOME METHODS simultaneously and comes comparison, also to do volunteer's human body compatibility test simultaneously, in conjunction with the concrete physiological environment in oral cavity, by comprehensive test, consider repeatability, resolution, dependency and operability factor are studied, work out and unification.To adopting which kind of assay method not have concrete regulation, people adopt mostly in the human oral cavity that settled process, filter paper draw wet method, digestion instrument improved method in disintegration time mensuration method, the 2ml water at present, and are as follows to various assay method divisions in the meeting summary:
1, disintegration time mensuration method in the human oral cavity
Volunteer oral's test method(s) is the most direct disintegration time assay method.Select 10 healthy volunteers, tablet is placed in the oral cavity, allowing tongue to do slightly moves up and down, with no obvious bulk thing is complete disintegrate, with the stopwatch record used time of disintegration of tablet, be disintegration time with its meansigma methods, the defective of this method is that the healthy volunteer relatively is difficult to find, volunteer's individual variation also can make result's poor reproducibility, and the operability in actual production is relatively poor.
2, settled process in the 2ml water
Oral cavity disintegration tablet being placed the graduated cylinder that fills 37 ℃ of 2ml ± 1 ℃ of water, leave standstill, is the disintegrate deadline with the whole avalanches of tablet, writes down the used time of its disintegrate with stopwatch.Measuring 10 respectively, is disintegration time with its meansigma methods.Although 37 ℃ of water temperatures more approach the physiology of oral cavity environment in this method since with whole avalanches as terminal point, lack so disintegration time is compared with the used time of disintegrate in the human oral cavity slightly.Whether really in addition, because after the tablet avalanche, most of granule still flocks together, terminal point is not easy to observe, can't judge tablet disintegrate fully.
3, filter paper draws wet method
Add an amount of 37 ℃ ± 1 ℃ water in the 200ml beaker, with another 50ml small beaker back-off wherein, the water yield is advisable to surpass 50ml beaker height.With a folded filter paper is four layers, is positioned over 50ml small beaker top, presses small beaker, filter paper is fully soaked after, unclamp and make small beaker come-up.Tablet is placed on the filter paper, after the whole moistenings of observation tablet, cut, should not have hard core with A4 paper.With the stopwatch record tablet used time of moistening, measure 10 respectively, be disintegration time with its meansigma methods.This method approaches tablet in intraoral wet processes, but since this method by bottom moistening tablet, so the thickness of testing result and tablet is closely related, can not be general.
4, digestion instrument improved method
On the basis of existing dissolution test system, slightly adjust self-control disintegrate device.Tablet is placed hanging basket, be put in 750ml37 ℃ ± 1 ℃ the water, the rotating speed of stirring arm is 50r/min.Entering liquid level from hanging basket and pick up counting, collapse with stopwatch record tablet and loose and all by the used time of screen cloth, measure 10 respectively, is disintegration time with its meansigma methods.Because of this method has stirring, differ bigger with the physiology of oral cavity environment, so its testing result also with the oral cavity in the test differ far away.
At the present disintegration that does not still have standard method to detect oral cavity disintegration tablet, and the versatility of above-mentioned several method and oral cavity simulated environment are all undesirable; Chinese patent ZL200420115932.2 and Chinese patent application 200510070951.7,200510070950.2 all adopt home-made contrivance to measure the external disintegration of oral cavity disintegration tablet, because of the special experimental provision of needs, make troubles for scientific research and testing and actual production.Therefore it is a kind of good with the intraoral disintegration temporal correlation to seek, and the good external disintegration time mensuration method of versatility is very important to the development of oral cavity disintegration tablet.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art, a kind of method of quality control of easy general oral cavity disintegration tablet is provided, the object of the present invention is to provide a kind of method that adopts the lift disintegration tester to measure disintegration time of orally disintegrating tablets.
The present invention realizes by following steps:
(1) the lift disintegration tester that adopts existing Chinese Pharmacopoeia to stipulate injects water in its 1000ml beaker.
(2) the hanging basket screen cloth position of adjusting lift disintegration tester makes the hanging basket screen cloth be positioned at transfixion under the liquid level.
(3) medicine to be measured is placed the glass tubing of step 2 hanging basket, leave standstill, collapse with stopwatch record medicine and loose and all by the used time of screen cloth, the mensuration stipulated number is a disintegration time with its meansigma methods.
Screen cloth in above-mentioned (2) is positioned at 0.35-0.55cm place under the liquid level.
The invention has the advantages that this method meets the use habit that people measure disintegration, utilize existing apparatus in the pharmacopeia, easy and simple to handle, versatility is good, does not need the special installation just can be effectively to carrying out quality control the disintegration of oral cavity disintegration tablet.
When the invention has the advantages that the disintegration of detecting oral cavity disintegration tablet, tablet is in the water about 2ml and leaves standstill, and more approaches the human oral cavity physiological environment; After granule is all by screen cloth, be disintegrate and finish, terminal point is easy to observe, and data reappearance is good.
The specific embodiment
Embodiment 1
In the 1000ml of lift disintegration tester beaker, fill the 500ml temperature and be 37 ℃ ± 1 ℃ water, regulate the hanging basket position, make the hanging basket screen cloth be positioned at 0.35cm place under the liquid level, the simvastatin oral cavity disintegration tablet is placed the glass tubing of above-mentioned hanging basket, leave standstill, collapse all used time of 28 order stainless steel meshs bottom hanging basket of loosing also, measure 10 disintegration time respectively with stopwatch record tablet, with its meansigma methods is disintegration time, result such as following table.
Embodiment 2
In the 1000ml of lift disintegration tester beaker, fill the 800ml temperature and be 37 ℃ ± 1 ℃ water, regulate the hanging basket position, make the hanging basket screen cloth be positioned at 0.45cm place under the liquid level, cefixime oral disintegration tablet is placed the glass tubing of above-mentioned hanging basket, leave standstill, collapsing all used time of 28 order stainless steel meshs bottom hanging basket of loosing also with stopwatch record tablet, measure 10 disintegration time respectively, is disintegration time with its meansigma methods.
Embodiment 3
In the 1000ml of lift disintegration tester beaker, fill the 400ml temperature and be 37 ℃ ± 1 ℃ water, regulate the hanging basket position, make the hanging basket screen cloth be positioned at 0.55cm place under the liquid level, the ranitidine oral cavity disintegration tablet is placed the glass tubing of above-mentioned hanging basket, leave standstill, collapsing all used time of 28 order stainless steel meshs bottom hanging basket of loosing also with stopwatch record tablet, measure 10 disintegration time respectively, is disintegration time with its meansigma methods.
Claims (2)
1. the method for quality control of an oral cavity disintegration tablet is characterized in that adopting the lift disintegration tester to measure the disintegration of oral cavity disintegration tablet, and its operating procedure is as follows:
(1) the lift disintegration tester that adopts existing Chinese Pharmacopoeia to stipulate injects water in its 1000ml beaker.
(2) the hanging basket screen cloth position of adjusting lift disintegration tester makes the hanging basket screen cloth be positioned at transfixion under the liquid level.
(3) medicine to be measured is placed the glass tubing of above-mentioned (2) hanging basket, leave standstill, collapse with stopwatch record medicine and loose and all by the used time of screen cloth, the mensuration stipulated number is a disintegration time with its meansigma methods.
2. as claim 1 described method of quality control, it is characterized in that the screen cloth in the step 2 is positioned at 0.35-0.55cm place under the liquid level.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100616615A CN101278916A (en) | 2007-04-04 | 2007-04-04 | Quality control method of orally disintegrating tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100616615A CN101278916A (en) | 2007-04-04 | 2007-04-04 | Quality control method of orally disintegrating tablet |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101278916A true CN101278916A (en) | 2008-10-08 |
Family
ID=40011706
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2007100616615A Pending CN101278916A (en) | 2007-04-04 | 2007-04-04 | Quality control method of orally disintegrating tablet |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101278916A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102192971A (en) * | 2011-03-18 | 2011-09-21 | 辽宁省计量科学研究院 | Disintegration time limit testing standard substance and preparation method thereof |
| CN104422755A (en) * | 2013-09-09 | 2015-03-18 | 北京量子高科制药科技有限公司 | Method for detecting disintegration time of quick disintegration preparation |
-
2007
- 2007-04-04 CN CNA2007100616615A patent/CN101278916A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102192971A (en) * | 2011-03-18 | 2011-09-21 | 辽宁省计量科学研究院 | Disintegration time limit testing standard substance and preparation method thereof |
| CN102192971B (en) * | 2011-03-18 | 2013-09-04 | 辽宁省计量科学研究院 | Disintegration time limit testing standard substance and preparation method thereof |
| CN104422755A (en) * | 2013-09-09 | 2015-03-18 | 北京量子高科制药科技有限公司 | Method for detecting disintegration time of quick disintegration preparation |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Wasilewska et al. | How to assess orodispersible film quality? A review of applied methods and their modifications | |
| Mahar et al. | Gastric pH and gastric residence time in fasted and fed conscious beagle dogs using the Bravo® pH system | |
| CA2648937A1 (en) | Apparatus and method for detecting gastroesophageal reflux disease (gerd) | |
| Kulshrestha et al. | Some clinical pharmacological studies with terfenadine, a new antihistamine drug. | |
| CN101695443A (en) | Oral drug compliance monitoring using magnetic-field sensors | |
| CN108231188A (en) | Contactless and minimal-contact monitoring for the quality of life parameter assessed and intervened | |
| CN101128736A (en) | Method for monitoring patient or subject compliance with medical prescriptions, and formulation for use in the method | |
| JP2015100382A (en) | Swallowing ability examination device | |
| CN101991495A (en) | Multi-function bedside nursing work station | |
| Bartley et al. | Normal adult values, diurnal variation, and repeatability of nasal nitric oxide measurement | |
| CN103654858A (en) | Portable stroke early-warning monitor | |
| Orenstein et al. | Scintigraphy versus pH probe for quantification of pediatric gastroesophageal reflux: a study using concurrent multiplexed data and acid feedings | |
| CN101278916A (en) | Quality control method of orally disintegrating tablet | |
| Feng et al. | A study to draw a normative database of laryngopharynx pH profile in Chinese | |
| CN105560199A (en) | Infantile domperidone orally disintegrating tablet and preparation method thereof | |
| Freedman et al. | Miniature hygrometric hot flash recorder | |
| Rutkove et al. | A methodology for the real-time measurement of distal extremity temperature | |
| Dhiman et al. | Formulation and In-Vitro evaluation of fast dissolving tablets of telmisartan. | |
| CN109010322A (en) | A kind of orodispersible film and preparation method thereof comprising Oxcarbazepine | |
| CN108888602A (en) | A kind of montelukast preparation of sodium and preparation method thereof | |
| CN101632644A (en) | Avapro dispersible tablet and preparation method thereof | |
| CN107550884B (en) | A kind of Doneppezil Hydrochloride capsule and preparation method thereof | |
| Zhao et al. | [Retracted] Updated Pharmacological Effects of Total Phenolic Acid on the Meningeal Microcirculation in Mice | |
| CN106124498A (en) | Occult blood detection kit and application thereof | |
| Bamigbola | Correlation of in vitro dissolution profiles with in vivo pharmacokinetic parameters of some commercial brands of aspirin tablets marketed in Nigeria |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20081008 |