CN110441302A - A kind of tulobuterol transdermal patch non-destructive quality control method - Google Patents
A kind of tulobuterol transdermal patch non-destructive quality control method Download PDFInfo
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- CN110441302A CN110441302A CN201810416389.6A CN201810416389A CN110441302A CN 110441302 A CN110441302 A CN 110441302A CN 201810416389 A CN201810416389 A CN 201810416389A CN 110441302 A CN110441302 A CN 110441302A
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- patch
- adhesive layer
- quality control
- tulobuterol
- control method
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/84—Systems specially adapted for particular applications
Abstract
The present invention relates to tulobuterol crystal reservoir devices transdermal patch non-destructive quality control methods.The quality control method can quickly detect size, shape and the distribution situation of medicine crystal in tulobuterol crystal reservoir devices transdermal patch adhesive layer.Specifically: the present invention is suitable for tulobuterol medicine crystal reservoir devices transdermal patch.The quality control method mainly includes that two steps: the first step remove opaque backing under the premise of not influencing medicine crystal physical presence state in patch adhesive layer, to shift patch adhesive layer on carrier；Second step, by medicine crystal situation and camera shooting in ordinary optical microscope observation adhesive layer, to assess the quality of the pharmaceutical preparations.Quality control method repeatability of the present invention is high, can significantly improve tulobuterol transdermal patch Quality Control level and non-destructive testing efficiency.
Description
Technical field
Medicine crystal existence is the Key Quality for guaranteeing patch curative effect in tulobuterol crystal depot transdermal patch
Factor.The present invention relates to tulobuterol crystal depot transdermal patch method of quality control.The quality control method can be true, complete
Size, shape and the distribution of medicine crystal in tulobuterol crystal depot transdermal patch adhesive layer is presented.
Background technique
Tulobuterol (Tulobuterol, TBR) is a kind of selectively acting in the retarding agent of sympathetic nerve beta 2 receptor, pine
Relaxation bronchial smooth muscle, the drug as diseases such as treatment bronchial asthma, chronic bronchitis.Round the clock based on asthma disease
Circadian changes develop tulobuterol percutaneous drug administration preparation.Tulobuterol percutaneous drug administration preparation, which has, avoids abdominal pain, appetite not
The advantages of side effects such as vibration, and effective blood drug concentration can be maintained up to for 24 hours.Slow releasing function is not only by as auxiliary material when its is long
High molecular material etc. influences, and closely related with tulobuterol medicine crystal store system in preparation.
As its key technology, the drug release behavior of patch is formed for the foundation of tulobuterol transdermal patch crystal store system
Medicine crystal situation control；Therefore, TBR crystallization is an important mass parameter.
To control effectively to patch quality, the release in vitro behavior of TBR is both needed to drug crystallization situation in adhesive layer
It is detected.It is consistent to the content of TBR in tulobuterol transdermal patch to generally use the destructive method of analysis such as chromatography
Property checked, it is this destructiveness evaluation method can not really reflect crystal situation in patch.
However, it is tired to think that the distribution for crystallizing tulobuterol using non-destructive method inspection has very big technology always in the past
It is difficult.Most importantly think, in not destroying patch adhesive layer under the premise of crystallizing system existence, the opaque backing of patch
It not can be removed, obstacle is caused to the direct observation of crystal in preparation.Researchers at home and abroad successively propose a variety of appropriate Luo Te immediately
Sieve transdermal patch lossless detection method, including near infrared spectrum imaging (NIRI), Terahertz Pulsed Spectroscopy
(TPS) and Terahertz Pulsed Imaging (TPI), micro-Raman spectroscopy and reflection method (MLRSM) etc..These
Lossless detection method has a common problem, be exactly in the preparation of display or simulation crystal image it is relatively fuzzy and most of
Fine crystals can not identify and show, i.e., cannot really show the physical presence state of crystal in preparation completely.In addition,
The cost is relatively high for these types of detection means, takes time and effort.
Summary of the invention
Object of the present invention is to: a kind of method is provided to significantly improve tulobuterol transdermal patch Quality Control level and lossless inspection
Survey efficiency.Quality Control technology of the present invention includes two steps: the first step removes opaque backing, and does not influence patch bonding
Crystal existence in layer, to shift adhesive layer on carrier；Second step observes adhesive layer Chinese medicine by ordinary optical microscope
Object crystal situation and camera shooting, to assess the quality of the pharmaceutical preparations.It is as follows that quality control method of the present invention implements detailed step: selection
Transfer vector (glass slide or polyester film), and to carrier surface washes of absolute alcohol to cleaning, throw off appropriate Luo Te to be detected
The protective layer material of sieve transdermal patch sticks in preparation is smooth on transfer vector, using the last item of 1000~2000g weight, comes
Rollback is pressed 3~10 times, and the bubble between interface is excluded, and adhesive layer is caused to come into full contact with transfer vector, enhancing adhesive layer and carrier
Adhesive force opens one jiao of patch, quickly throws off backing, so that patch adhesive layer rests on transfer vector；Again by common
Optical microscopy, which adjusts suitable multiple, can observe directly the size, shape and distribution situation of medicine crystal in adhesive layer.
Quality control method of the present invention repeatability is high, can significantly improve tulobuterol transdermal patch Quality Control level and lossless
Detection efficiency.
Detailed description of the invention
Fig. 1 is the resulting tulobuterol crystallographic microscope photo of this method
Fig. 2 is the tulobuterol crystallographic microscope photo that document provides
Fig. 3 is that picture is imaged in the tulobuterol crystal near infrared spectrum that document provides
Fig. 4 is the tulobuterol crystal terahertz pulse imaging that document provides
Fig. 5 is the tulobuterol crystal laser micro-raman spectrometry imaging that document provides
Specific embodiment
Embodiment
The protective layer material for throwing off tulobuterol transdermal patch to be detected sticks in preparation is smooth in clean glass slide,
It using the last item of 2000g weight, rolls 4 times back and forth, excludes the bubble between interface, adhesive layer is caused to come into full contact with transfer vector, increase
The adhesive force of strong tack coat and carrier, is securely pasted, and is opened one jiao of patch, is thrown off backing rapidly, so that patch adhesive layer stops
It stays on glass slide, realizes adhesive layer transfer；400 times, 1000 times are adjusted by ordinary optical microscope again, are observed in adhesive layer
Size, shape and the distribution situation of medicine crystal, are shown in Fig. 1.
Comparing embodiment 1
Hideo KATO etc. is in article " the Development of transdermal formulation of delivered
Tulobuterol for the treatment of bronchial asthma " in, about research tulobuterol transdermal patch
Releasing mechanism experiment, illustrates the microscope tulobuterol crystal picture in Fig. 2.
Comparing embodiment 2
Tomoaki Sakamoto etc. is in article " the Non-destructive analysis of delivered
tulobuterol crystal reservoir-type transdermal tapes using near infrared
Spectroscopy and imaging " in, it is appropriate using near infrared spectrum (NIRS) and near infrared spectrum imaging (NIRI) research
Fig. 3 is shown in the distribution of tulobuterol crystal in Luo Teluo transdermal patch, near infrared spectrum imaging.
Comparing embodiment 3
T.Sakamoto etc. is in article " the Detection of tulobuterol crystal in delivered
Transdermal patches using Terahertz pulsed spectroscopy and imaging " in, it has studied
Terahertz Pulsed Spectroscopy (TPS) and Terahertz Pulsed Imaging (TPI) is transdermal for detecting
Fig. 4 is shown in the case where tulobuterol crystal in patch, terahertz pulse imaging.
Comparing embodiment 4
T.Sakamoto etc. is in article " the Chemical mapping of tulobuterol in delivered
Transdermal tapes using Microscopic Laser Raman Spectroscopy " in, use micro laser
The distribution situation of crystal, micro laser in Raman spectroscopy and reflection method (MLRSM) technical research tulobuterol transdermal patch
Raman spectrum imaging is shown in Fig. 5.
Effect of the invention
The lossless detection method of the above comparing embodiment fails to find suitable means and removes patch backing, causes that there are one
A common problem is exactly that crystal image is relatively fuzzy in preparation, and the small crystals of drug can not be identified and be shown, i.e., cannot be complete
, there is the possibility misled to a certain extent in the physical presence state of crystal in complete true display preparation.In addition, these types detection
The cost is relatively high for means, takes time and effort.
Quality Control technology of the present invention, is to simplify, and directly returns initial problem, i.e., quick using appropriate means
Opaque backing is removed, and keeps the script existence of crystal in preparation adhesive layer, then direct by ordinary optical microscope
The physical presence state of observation or shooting crystal, crystal picture clarity is higher, and detection is quick, economy and facility.
It is worth noting that when carrying out medicine crystal observation to A meter Di original triturate using the method for the invention, hair
A small amount of drug crystallization occurs abnormal in existing sample, and crystal distribution is not visibly homogeneous, most of tulobuterol crystallization with
Tiny irregular non-particulate, interlaced, aggregation form have that (this is current other nondestructive technique institutes reported in the literature
The phenomenon that can not detecting), this actual phenomenon and the description of patent of invention (the ZL patent No. 96198929.7) have differences.Cause
This, the method for the invention can control for the quality of production of tulobuterol transdermal patch and provide technical support, more steady to provide
Fixed, safe and effective drug.
Claims (6)
1. a kind of patch non-destructive quality control method, which is characterized in that the technology implementation of the method for quality control can be divided into two
A step: the first step removes patch protective layer, sticks patch adhesive layer securely with transfer vector, then removes opaque back
Lining shifts adhesive layer on carrier；Second step by medicine crystal situation in ordinary optical microscope observation adhesive layer and is taken the photograph
Picture, to assess the quality of the pharmaceutical preparations.
2. patch non-destructive quality control method according to claim 1, which is characterized in that the carrier is a kind of transparent softwood
Material or hard material.
3. patch non-destructive quality control method according to claim 2, which is characterized in that the soft material is selected from transparent polyester
Film；Hard material is selected from glass slide.
4. patch non-destructive quality control method according to claim 1, which is characterized in that be so that patch adhesive layer and transfer carry
Body securely sticks, and after patch is affixed on carrier, need to use the last item of 1000~2000g weight, roll 3~10 times back and forth, row
Except the bubble between interface, adhesive layer is caused to come into full contact with transfer vector, enhances the adhesive force of adhesive layer and carrier, then tear-off backing
One jiao, it can quickly remove opaque backing.
5. patch non-destructive quality control method according to claim 1, which is characterized in that the adhesive layer quilt of the patch overwhelming majority
Lossless to be transferred on carrier, patch backing is removed, in the adhesive layer being transferred the spatial distribution of medicine crystal and each state with
Former patch is identical, can reach the Quality Control requirement of effectively assessment medicine crystal.
6. the described in any item patch non-destructive quality control methods of Claims 1 to 5, which is characterized in that the patch being transferred is viscous
It ties layer under the microscope, the size, shape and distribution of medicine crystal in adhesive layer, and adhesive layer and patch can really be presented
Backing reaches good separation, is transferred adhesive-less layer on the patch backing of part and remains.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810416389.6A CN110441302B (en) | 2018-05-03 | 2018-05-03 | Nondestructive quality control method for tulobuterol transdermal patch |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810416389.6A CN110441302B (en) | 2018-05-03 | 2018-05-03 | Nondestructive quality control method for tulobuterol transdermal patch |
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| CN110441302A true CN110441302A (en) | 2019-11-12 |
| CN110441302B CN110441302B (en) | 2021-12-07 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112707829A (en) * | 2020-12-25 | 2021-04-27 | 山东达因海洋生物制药股份有限公司 | Tulobuterol crystal form and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112707829A (en) * | 2020-12-25 | 2021-04-27 | 山东达因海洋生物制药股份有限公司 | Tulobuterol crystal form and preparation method thereof |
| CN112707829B (en) * | 2020-12-25 | 2023-07-21 | 山东达因海洋生物制药股份有限公司 | Toxolol crystal form and preparation method thereof |
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| Publication number | Publication date |
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| CN110441302B (en) | 2021-12-07 |
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