CN110133194A - A method of measurement Foradil Aerolizer formoterol fumarate Capsules Emptying Rate - Google Patents
A method of measurement Foradil Aerolizer formoterol fumarate Capsules Emptying Rate Download PDFInfo
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- CN110133194A CN110133194A CN201910445354.XA CN201910445354A CN110133194A CN 110133194 A CN110133194 A CN 110133194A CN 201910445354 A CN201910445354 A CN 201910445354A CN 110133194 A CN110133194 A CN 110133194A
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- Prior art keywords
- capsules
- emptying rate
- oil content
- capsule
- lubrication oil
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- 239000002775 capsule Substances 0.000 title claims abstract description 73
- 238000000034 method Methods 0.000 title claims abstract description 25
- OBRNDARFFFHCGE-QDSVTUBZSA-N arformoterol fumarate Chemical compound OC(=O)\C=C\C(O)=O.C1=CC(OC)=CC=C1C[C@@H](C)NC[C@H](O)C1=CC=C(O)C(NC=O)=C1.C1=CC(OC)=CC=C1C[C@@H](C)NC[C@H](O)C1=CC=C(O)C(NC=O)=C1 OBRNDARFFFHCGE-QDSVTUBZSA-N 0.000 title claims abstract description 24
- 238000005259 measurement Methods 0.000 title claims abstract description 15
- 229960000193 formoterol fumarate Drugs 0.000 title claims abstract description 12
- 239000003921 oil Substances 0.000 claims abstract description 34
- 238000005461 lubrication Methods 0.000 claims abstract description 30
- 239000010687 lubricating oil Substances 0.000 claims abstract description 11
- 238000004519 manufacturing process Methods 0.000 claims abstract description 8
- 238000000944 Soxhlet extraction Methods 0.000 claims description 3
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000012377 drug delivery Methods 0.000 description 2
- 238000000691 measurement method Methods 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- -1 Foradil Aerolizer formoterol fumarates Chemical class 0.000 description 1
- 229940112141 dry powder inhaler Drugs 0.000 description 1
- 229960002848 formoterol Drugs 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/0078—Testing material properties on manufactured objects
- G01N33/0081—Containers; Packages; Bottles
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Investigating Or Analysing Materials By Optical Means (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of methods for measuring Foradil Aerolizer formoterol fumarate Capsules Emptying Rate.Method includes the following steps: step 1, N parts of lubrication oil content for measuring the different same model Capsules of lubrication oil content；Step 2, N parts of Emptying Rate for measuring the different Capsules of lubrication oil content respectively；Step 3, the tables of data of model Capsules lubrication oil content and Emptying Rate is established；Step 4, for a batch of capsule of the model of same process production, the content of its lubricating oil is measured；Step 5, the tables of data that finding step 3 is established, finds out the Emptying Rate approximation of the capsule.This method increases the restriction to same model capsule on the basis of soxhlet type, controls influence of the difference to Emptying Rate of surface area, further improves the accuracy and rapidity of measurement.
Description
Technical field
The invention belongs to the detection technique fields of Capsules, specifically disclose a kind of hollow glue of measurement Foradil Aerolizer formoterol fumarate
The method of capsule Emptying Rate.
Background technique
In the manufacturing process of Capsules, the inner surface of Capsules can be coated with one layer of uniform lubrication oil coating.?
In the stowing operation of capsule, which can make capsule 's content be adhered on the inner surface of softgel shell.For general
Capsule preparations, which will not influence the release of content.But for the dry powder inhaler formulations of capsule-type, then can generate very
The interference of serious drug delivery system.Contained lubrication oil content is more on Capsules inner surface unit area, then moistens
Lubricating oil coating is thicker, then the medicinal powder adhered to will be more, it will be more serious to the interference of drug delivery system.
Due to production technology, the lubrication oil content of Capsules may be unstable.In order to control the phenomenon pair
The influence of final products needs to measure the Emptying Rate of Capsules.And the equipment that the measurement of Emptying Rate needs is more complex, while on
Hollow Emptying Rate and lubrication oil content are mentioned in face stronger correlation.
External some capsule companies can the lubrication oil content to Capsules determine a control standard, which is
Angle initialization based on safety.Adding for lubricating oil is mainly limited by the lubrication oil content of the Capsules of Unit Weight
Dosage indicates that adding a certain amount of lubricating oil not in Capsules influences its safety.But in such standard scale
Lubrication oil content, still can seriously affect the delivery process of the Foradil Aerolizer formoterol fumarate of capsule-type.And it measures mould oil
Method, only weigh the capsule of constant weight, then using the method for Soxhlet extractor or the principle of similitude, measure the weight
Capsule contained by lubrication oil content, the ratio of gained lubricants capacity and Capsules weight, the as lubrication of Capsules
Oil content numerical value.But there are certain deficiencies for above-mentioned measurement method, because of the capsule of same weight, probably due to the difference of model
It is different, and have very big difference in surface areas.Make different model capsule in the case where identical lubrication oil content, lube layer thickness
It is different.As a result cause lubrication oil content identical, the different situation of Emptying Rate occurs.
Summary of the invention
In view of the deficiencies of the prior art, the purpose of the present invention is to provide a kind of measurement Foradil Aerolizer formoterol fumarates is arranged with Capsules
The method of empty rate, this method increase the restriction to same model capsule, control surface area on the basis of soxhlet type
Influence of the difference to Emptying Rate further improves the accuracy and rapidity of measurement.
A method of measurement Foradil Aerolizer formoterol fumarate Capsules Emptying Rate, comprising the following steps:
Step 1, N parts of lubrication oil content for measuring the different same model Capsules of lubrication oil content；
Step 2, N parts of Emptying Rate for measuring the different Capsules of lubrication oil content respectively；
Step 3, the tables of data of model Capsules lubrication oil content and Emptying Rate is established；
Step 4, for a batch of capsule of the model of same process production, the content of its lubricating oil is measured；
Step 5, the tables of data that finding step 3 is established, finds out the emptying approximation of the capsule.
It is No. 3 Capsules of same model or No. 4 Capsules in step 1 as improved.
It is that described N parts is at least 4 parts as improved.
It is to lubricate the measurement of oil content in step 1 as improved, after capsule body cap is separated, shreds or shred respectively,
Lubrication oil content is measured with soxhlet extraction again.
The utility model has the advantages that
Compared with prior art, present invention has an advantage that
1, capsule model is controlled, guarantees that capsule surface product is consistent, ensure that the lubrication oil content of capsule can be used as capsule
Interior viscous powder situation；
2, the Emptying Rate data of the lubrication oil content of capsule and capsule are established into one-to-one tables of data, it can easy-to-look-up number
According to, reduce detection production line on personnel ability requirement；
3, with a batch of capsule, the influence of difference in surface areas is controlled, it is only necessary to which simple soxhlet extraction methods measure capsule
Lubricate oil content, so that it may the approximate Emptying Rate for knowing the capsule, without using Emptying Rate measurement method to measure numerical value.
Specific embodiment
Preferred embodiment of the present invention will be described with reference to embodiments, it should be understood that described herein preferred
Embodiment is only for the purpose of illustrating and explaining the present invention and is not intended to limit the present invention.
Embodiment 1
A method of measurement Foradil Aerolizer formoterol fumarate Capsules Emptying Rate, comprising the following steps:
Step 1, the lubrication oil content of No. 3 Capsules of N part is measured, the content of every part of lubricating oil is different, and numerical value is respectively
0.005g/10g, 0.01g/10g, 0.02g/10g, 0.03g/10g；
Step 2, the Emptying Rate of N No. 3 Capsules of part is measured, the numerical value measured is respectively 100%, 80% ... 50%, 30%；
Step 3, tables of data is established for the corresponding relationship of the lubricating oil of No. 3 Capsules 10g and Emptying Rate, it is as follows
Step 4, No. 3 capsules of a collection of same process production are selected, measuring lubrication oil content is 0.02g/10g；
Step 5, No. 3 capsule tables of data are looked into it is found that its Emptying Rate is 50%.
Embodiment 2
A method of measurement Foradil Aerolizer formoterol fumarate Capsules Emptying Rate, comprising the following steps:
Step 1, the lubrication oil content of No. 4 Capsules of N part is measured, the content of every part of lubricating oil is different, and numerical value is respectively
0.009g/10g, 0.015g/10g, 0.026g/10g, 0.04g/10g；
Step 2, the Emptying Rate of N No. 4 Capsules of part is measured, the numerical value measured is respectively 100%, 70% ... 60%, 45%；
Step 3, tables of data is established for the corresponding relationship of the lubricating oil of No. 4 Capsules 10g and Emptying Rate, it is as follows
Step 4, No. 4 capsules of a collection of same process production are selected, measuring lubrication oil content is 0.015g/10g；
Step 5, No. 3 capsule tables of data are looked into it is found that its Emptying Rate is 70%.
The foregoing is only a preferred embodiment of the present invention, the scope of protection of the present invention is not limited to this, it is any ripe
Know those skilled in the art within the technical scope of the present disclosure, the letter for the technical solution that can be become apparent to
Altered or equivalence replacement are fallen within the protection scope of the present invention.
Claims (4)
1. a kind of method for measuring Foradil Aerolizer formoterol fumarate Capsules Emptying Rate, which comprises the following steps: step 1,
N parts of lubrication oil content for measuring the different same model Capsules of lubrication oil content；Step 2, lubrication oil content is measured respectively
N parts of the Emptying Rate of different Capsules；Step 3, the tables of data of model Capsules lubrication oil content and Emptying Rate is established；
Step 4, for a batch of capsule of the model of same process production, the content of its lubricating oil is measured；Step 5, step is searched
Rapid 3 tables of data established, find out the Emptying Rate approximation of the capsule.
2. the method for measurement Foradil Aerolizer formoterol fumarate Capsules Emptying Rate according to claim 1, which is characterized in that step
No. 3 Capsules of same model or No. 4 Capsules in 1.
3. the method for measurement Foradil Aerolizer formoterol fumarate Capsules Emptying Rate according to claim 1, which is characterized in that described
N parts are at least 4 parts.
4. the method for measurement Foradil Aerolizer formoterol fumarate Capsules Emptying Rate according to claim 1, which is characterized in that step
The measurement that oil content is lubricated in 1 is shredded respectively or is shredded, then measure lubricating oil with soxhlet extraction after separating capsule body cap
Content.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910445354.XA CN110133194A (en) | 2019-05-27 | 2019-05-27 | A method of measurement Foradil Aerolizer formoterol fumarate Capsules Emptying Rate |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910445354.XA CN110133194A (en) | 2019-05-27 | 2019-05-27 | A method of measurement Foradil Aerolizer formoterol fumarate Capsules Emptying Rate |
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| Publication Number | Publication Date |
|---|---|
| CN110133194A true CN110133194A (en) | 2019-08-16 |
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| CN201910445354.XA Pending CN110133194A (en) | 2019-05-27 | 2019-05-27 | A method of measurement Foradil Aerolizer formoterol fumarate Capsules Emptying Rate |
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101433527A (en) * | 2007-11-13 | 2009-05-20 | 天津金耀集团有限公司 | Use of plant capsule in powder spray |
| CN102087249A (en) * | 2009-12-08 | 2011-06-08 | 国家纳米技术与工程研究院 | Quality control method for insulin inhalation powder |
| CN102133276A (en) * | 2011-03-04 | 2011-07-27 | 苏州大学 | Chinese globeflower flower extractive dry powder inhalant for treating respiratory tract infections and inflammations and preparation method thereof |
| CN103110612A (en) * | 2013-03-14 | 2013-05-22 | 苏州大学 | Tetrandrine dry powder inhalant and preparation method thereof |
| CN108143724A (en) * | 2018-03-05 | 2018-06-12 | 上海祺宇生物科技有限公司 | A kind of high oxygen-impermeable plant hollow capsule and preparation method thereof |
| CN108261407A (en) * | 2018-03-05 | 2018-07-10 | 上海祺宇生物科技有限公司 | A kind of hypromellose Capsules for being used to suck medicament |
-
2019
- 2019-05-27 CN CN201910445354.XA patent/CN110133194A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101433527A (en) * | 2007-11-13 | 2009-05-20 | 天津金耀集团有限公司 | Use of plant capsule in powder spray |
| CN102087249A (en) * | 2009-12-08 | 2011-06-08 | 国家纳米技术与工程研究院 | Quality control method for insulin inhalation powder |
| CN102133276A (en) * | 2011-03-04 | 2011-07-27 | 苏州大学 | Chinese globeflower flower extractive dry powder inhalant for treating respiratory tract infections and inflammations and preparation method thereof |
| CN103110612A (en) * | 2013-03-14 | 2013-05-22 | 苏州大学 | Tetrandrine dry powder inhalant and preparation method thereof |
| CN108143724A (en) * | 2018-03-05 | 2018-06-12 | 上海祺宇生物科技有限公司 | A kind of high oxygen-impermeable plant hollow capsule and preparation method thereof |
| CN108261407A (en) * | 2018-03-05 | 2018-07-10 | 上海祺宇生物科技有限公司 | A kind of hypromellose Capsules for being used to suck medicament |
Non-Patent Citations (4)
| Title |
|---|
| GUILLERMO AYALA ET AL.: "Statistical tools and control of internal lubricant content of inhalation grade HPMC capsules during manufacture", 《INTERNATIONAL JOURNAL OF PHARMACEUTICS》 * |
| SALEEM, I. Y. ET AL.: "Investigation on the aerosol performance of dry powder inhalation hypromellose capsules with different lubricant levels", 《INTERNATIONAL JOURNAL OF PHARMACEUTICS》 * |
| 李志平 等: "IFNα-2b 干粉吸入剂的制备及其药动学性质考察", 《中国药学杂志》 * |
| 赵陆华 等: "《中药高效液相色谱法应用》", 31 May 2005 * |
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| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20190816 |
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| RJ01 | Rejection of invention patent application after publication |