CN103439214A - Method for testing water vapor penetration rate of medicament preparation film coat - Google Patents
Method for testing water vapor penetration rate of medicament preparation film coat Download PDFInfo
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- CN103439214A CN103439214A CN2013103948923A CN201310394892A CN103439214A CN 103439214 A CN103439214 A CN 103439214A CN 2013103948923 A CN2013103948923 A CN 2013103948923A CN 201310394892 A CN201310394892 A CN 201310394892A CN 103439214 A CN103439214 A CN 103439214A
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- film
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- coating
- water vapor
- pick
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Abstract
The invention provides a method for testing water vapor penetration rate of a medicament preparation film coat. The damp-proof capability of a film coat is evaluated by testing the water vapor penetration rate of the film coat, and no coating tablets are needed to be prepared, so that the method is simple and convenient, and capable of meeting the requirements in testing the water vapor penetration rate of the film coat.
Description
Technical field
The invention belongs to the pharmaceutical production technical field, relate to a kind of method of detection of drugs preparation film-coating water vapor transmittance.
Background technology
At present, the existing method of detection of drugs preparation film-coating water vapor transmittance is: with coating solution to be measured, pharmaceutical preparation is carried out to film coating, then coating tablet is put into to climatic chamber, carry out the investigation of water vapor transmittance.It is loaded down with trivial details that it prepares the coating tablet process, and the production cycle is long.
Summary of the invention
In order to solve problems of the prior art, the invention provides a kind of method of detection of drugs preparation film-coating water vapor transmittance, estimate the moistureproof ability of film-coating by the water vapor transmittance of measuring film-coating, do not need to prepare coating tablet, simply, conveniently, can meet again the requirement that detects the film-coating water vapor transmittance.
In order to realize purpose of the present invention, the technical scheme of employing is summarized as follows:
A kind of method of detection of drugs preparation film-coating water vapor transmittance, is characterized in that, the flow process of described detection method is: prepare free film, with free film and measurement bottle, prepare pick-up unit, pick-up unit is placed to climatic chamber and detect, calculate transmitance.
The described free film for preparing, its concrete grammar is: get polyester sheet and be fixed on smooth operator's console, by coating solution all be sprayed on polyester sheet, make film-coating, after drying, film-coating and polyester sheet are peeled off, put into exsiccator standby.
Described with free film with measure bottle and prepare pick-up unit, its concrete grammar is: 1, get and measure bottle, measure bottleneck inner diameter R (cm), according to formula S=∏ (0.5R)
2(cm
2), calculate bottleneck area S, put into drying agent in bottle, drying, standby; 2, free film is cut into to test piece, measures and recording film thickness, cover the measurement bottle that adds drying agent, obtain.
Describedly pick-up unit is placed to climatic chamber detect, its concrete grammar is: the pick-up unit made is put into to exsiccator, and at room temperature dry, precise weighing, record numerical value, then device is put into to climatic chamber 48 hours, the weight of device for recording and detecting different standing times.
Described calculating transmitance, its concrete grammar is: 1, according to formula W=M
t-M
0(unit: g) calculate the steam transit dose; 2, according to the penetrating rate=W/ of formula steam (S*t) (unit: g/cm
2* h) calculate water vapor transmittance, wherein the T-test duration (h), S-weighing bottleneck inner headed face amasss (cm
2), M
t-determinator t hour quality (g).M
0-the determinator initial mass.
Compared with prior art, the good effect that the present invention has is:
1, do not need film-coating to be measured is made to coating tablet saving resource and time;
2, having avoided the detection error of bringing into because of the difference of tablet, is testing result is more accurate.
Embodiment
Below in conjunction with embodiment, the present invention is described further.
1. free film preparation:
1.1 polyester sheet is cut into to 15*15cm, the each point thickness deviation should<± 5um, the person is fixed on smooth operator's console to get the even thickness.
Add in the spray gun liquid storage cylinder 1.2 get coating solution, mix up spray pattern, by coating solution all be sprayed on polyester sheet, make the film-coating of thickness 40 ± 5um, after the film-coating drying, film-coating and polyester sheet are peeled off, it is standby that film-coating is put into exsiccator.
2 determinator preparations:
2.1 it is some to get the same specification measuring cup, with vernier caliper measurement bottleneck inner diameter R (cm), calculates bottleneck area S.
S=∏(0.5R)
2 (cm
2)
Take the drying agent (anhydrous silica gel) of identical weight in each device, be placed under 80 ℃ of conditions dry 2 hours, take out, put in exsiccator and be cooled to room temperature.
2.2 free film is cut into to a certain size test piece (internal diameter of the bottleneck+6mm), measure each point thickness deviation≤5um, recording each point thickness mean value is the sample thickness.With double faced adhesive tape, the bottleneck edge is twined one week, measuring cup weight is recorded in weighing, adds a certain amount of anhydrous silica gel.
2.3 the test piece cut out is covered to bottleneck, evens up, and the proving installation made is without breakage, film-coating and bottleneck are closely pasted.
3. test:
3.1 the determinator made is put into to exsiccator, at room temperature dry 2 hours.By electronic balance weighing determinator quality, record numerical value.Device is put into to climatic chamber, and test environment should keep 40 ± 2 ℃ of temperature, humidity 70 ± 5%.
3.2 record test device is in the quality of the 4th, 8,16,20,24,28,32,36,40,44 hours and test environment temperature, humidity.
4 data are processed:
4.1 steam transit dose: the steam transit dose of a period of time film-coating.Formula: W=M
t-M
0(unit: g)
4.2 the penetrating rate of steam: the unit interval, by the penetrating amount of steam of test area, is the evaluation index of clothing film water vapour permeability, formula: the penetrating rate=W/ of steam (S*t) (unit: g/cm
2* h)
T: test duration (h);
S: weighing bottleneck inner headed face amasss (cm
2);
M
t: determinator t hour quality (g);
M
0:the determinator initial mass.
Exemplary scenario described here is only the explanation to the principle of the invention, and preferred embodiment of the present invention, should by any way, not utilize top narration to limit the scope of the invention.The professional person of this area, can utilize principle of the present invention, designs various embodiment, and do not exceed scope of the present invention.
Claims (5)
1. the method for a detection of drugs preparation film-coating water vapor transmittance, is characterized in that, the flow process of described detection method is: prepare free film, with free film and measurement bottle, prepare pick-up unit, pick-up unit is placed to climatic chamber and detect, calculate transmitance.
2.
as claim 1the described free film for preparing, its concrete grammar is: get polyester sheet and be fixed on smooth operator's console, by coating solution all be sprayed on polyester sheet, make film-coating, after drying, film-coating and polyester sheet are peeled off, put into exsiccator standby.
3.
as claim 1described
'sprepare pick-up unit with free film and measurement bottle, its concrete grammar is: 1. get and measure bottle, measure bottleneck inner diameter R (cm), according to formula S=∏ (0.5R)
2(cm
2), calculate bottleneck area S, put into drying agent in bottle, drying, standby; 2. free film is cut into to test piece, measures and recording film thickness, cover the measurement bottle that adds drying agent, obtain.
4.
as claim 1describedly pick-up unit is placed to climatic chamber detect, its concrete grammar is: the pick-up unit made is put into to exsiccator, and at room temperature dry, precise weighing, record numerical value, then device is put into to climatic chamber 48 hours, the weight of device for recording and detecting different standing times.
5.
as claim 1described calculating transmitance, its concrete grammar is: 1. according to formula W=M
t-M
0(unit: g) calculate the steam transit dose; 2. according to the penetrating rate=W/ of formula steam (S*t) (unit: g/cm
2* h) calculate water vapor transmittance, wherein the T-test duration (h), S-weighing bottleneck inner headed face amasss (cm
2), M
t-determinator t hour quality (g), M
0-the determinator initial mass.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2013103948923A CN103439214A (en) | 2013-09-03 | 2013-09-03 | Method for testing water vapor penetration rate of medicament preparation film coat |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2013103948923A CN103439214A (en) | 2013-09-03 | 2013-09-03 | Method for testing water vapor penetration rate of medicament preparation film coat |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN103439214A true CN103439214A (en) | 2013-12-11 |
Family
ID=49692914
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2013103948923A Pending CN103439214A (en) | 2013-09-03 | 2013-09-03 | Method for testing water vapor penetration rate of medicament preparation film coat |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103439214A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106323801A (en) * | 2015-06-23 | 2017-01-11 | 大连瑞贤达塑胶有限公司 | Weight reducing method for measuring water steam penetrating performance of plastic film |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101852713A (en) * | 2009-04-06 | 2010-10-06 | 潍坊恒联玻璃纸有限公司 | Method for measuring water vapor penetrability of glass paper |
-
2013
- 2013-09-03 CN CN2013103948923A patent/CN103439214A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101852713A (en) * | 2009-04-06 | 2010-10-06 | 潍坊恒联玻璃纸有限公司 | Method for measuring water vapor penetrability of glass paper |
Non-Patent Citations (2)
| Title |
|---|
| 平其能等: "《现代药剂学》", 31 December 1998 * |
| 郎轶咏，李三鸣: "乙酸纤维素游离膜的吸湿性", 《膜科学与技术》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106323801A (en) * | 2015-06-23 | 2017-01-11 | 大连瑞贤达塑胶有限公司 | Weight reducing method for measuring water steam penetrating performance of plastic film |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
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| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20131211 |