CN106606541A - Novel feeding method of Keteling capsule - Google Patents
Novel feeding method of Keteling capsule Download PDFInfo
- Publication number
- CN106606541A CN106606541A CN201710016801.0A CN201710016801A CN106606541A CN 106606541 A CN106606541 A CN 106606541A CN 201710016801 A CN201710016801 A CN 201710016801A CN 106606541 A CN106606541 A CN 106606541A
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- Prior art keywords
- capsule
- dry extract
- extractum
- keteling
- moisture
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16C—COMPUTATIONAL CHEMISTRY; CHEMOINFORMATICS; COMPUTATIONAL MATERIALS SCIENCE
- G16C20/00—Chemoinformatics, i.e. ICT specially adapted for the handling of physicochemical or structural data of chemical particles, elements, compounds or mixtures
- G16C20/50—Molecular design, e.g. of drugs
Abstract
A Keteling capsule is prepared from herba ficus dry extract and chlorpheniramine maleate. The invention discloses a novel feeding method of the Keteling capsule for the first time. The water content of the herba ficus dry extract, an extractive and a content determination item are taken as the indexes of uniform feeding, weights of detection items in a raw material quality standard are checked, and a raw material uniform feeding standard is made up by makeup of a calculation formula and industrial verification, thereby fulfilling the aim of achieving uniform and stable finished product quality and conforming to the requirements and concept of new-edition GMP (Good Manufacturing Practice). The prepared Keteling capsule has the effects of alleviating cough and asthma, diminishing inflammation and eliminating phlegm, and is used for treating cough with dyspnea and chronic bronchitis.
Description
Technical field
The present invention relates to a kind of new method that feeds intake of ketelin capsule, belongs to the technical field of pharmaceutical production charging technology.
Background technology
Ketelin capsule is recorded in 2015 editions《Chinese Pharmacopoeia》The Chinese medicine and western medicine compound preparation of one, main component is lobule
Banyan dry extract and Chlorphenamine Maleate.Folium fici microcarpae has antibacterial, analgesia, antiinflammatory and function of relieving cough and calming asthma, mainly contains three
The compositions such as terpenoid, flavonoid, acidic resins, tannin, are clinically usually used in controlling for various diseases such as cough, asthma, bronchitis
Treat.The preparation method of Foliole banyan dry extract：Foliole banyan dried leaves, add water to cook secondary, collecting decoction, and filtration, filtrate is concentrated into relatively
Density is the clear paste of 1.10-1.20 (80 DEG C), lets cool, and adds ethanol to make alcohol content up to 60%, stands more than 12 hours, filtration,
Filtrate recycling ethanol, is concentrated into the thick paste that relative density is 1.30 (50 DEG C), and less than 80 DEG C dry, pulverize into fine powder, obtain final product.
The extractum content difference that Folium fici microcarpae between difference batch is obtained is larger, reason one：Identical place of production different batches
The content difference of Folium fici microcarpae medical material itself is larger, reason its two：The difference of extraction conditions causes obtained Foliole banyan dry extract
Content difference is larger, although the difference of the above extracts moisture, extractum, apigenin-8-C-glucoside and the different Herba Viticis Cannabifoliae of the Foliole banyan dry extract for obtaining
Glycosides meets pharmacopoeial requirements, but because differences between batches are larger, causes the differences between batches of obtained ketelin capsule finished product larger.
To solve the problems, such as that content difference is big between single batch extractum batch, pharmaceutical factory can be by different batches in actual production process
Feed intake after being mutually mixed between secondary raw material, but most of producer's mixed material feedings do not have theoretical foundation, are only contained with single
The difference of item is determined in measurement carries out batch mixing, does not take into account the mixed measurement result of other indexs, causes after mixing except containing measurement
Other indicator differences beyond fixed are larger, still can not reach the purpose that homogenization feeds intake, and this is workshop actual production
A difficult problem urgently to be resolved hurrily in journey.
The content of the invention
The invention provides the new method that a kind of Chinese medicine and western medicine compound preparation ketelin capsule feeds intake.
The present invention proposes a kind of ketelin capsule and is made up of Foliole banyan dry extract and Chlorphenamine Maleate, its formula
By weight percentage it is Foliole banyan dry extract 50-90%, Chlorphenamine Maleate 0.20-0.35%.
The present invention contribution be：Propose first and batch mixed foundation for feeding intake and method are set up with multi objective, solve and cough
A difficult problem for mixed material feeding gear shaper without theoretical foundation between criticizing in the capsule actual production process of Trane, it is mixed to have filled up with single assay item
Close the technical deficiency of index.The invention is applied to after industrialization production, for batch between mixed material feeding theoretical foundation is provided, hence it is evident that carry
The high homogeneity of product, improves the result stability of each index of finished product, greatly improves the qualification rate of finished product, produces
Obvious good effect and industrial value, with significant novelty and technological progress.
According to the existing index of pharmacopeia, the Foliole banyan dry extract powder fed intake with reference to actual production and Chlorphenamine Maleate
Each index, formulates internal control quality standard.The higher batch of content need to be relatively low with content batch mixed material feeding, it is every after mixing
The requirement of index conformance with standard, reaches the purpose of end product quality stable homogeneous, and the high-quality ketelin capsule for meeting GMP requirements is obtained.
A kind of heretofore described ketelin capsule feeds intake in new method, with the moisture of Foliole banyan dry extract, extractum,
Assay item etc. for the homogenization that feeds intake index, to each detection
Appraise and decide weight, formulate computing formula, obtain raw material and feed intake homogenization standard.
The Foliole banyan dry extract of table 1 feed intake homogenization index selection
The computational methods of Foliole banyan dry extract inventory
The Foliole banyan dry extract of table 2 feed intake homogenization calculating
It is as follows with the computing formula that moisture calculates inventory X by taking a recipe quantity as an example：
X1=XRecipe quantity(PRequire moisture-PMoisture 2)/(PMoisture 1-PMoisture 2)
X2=XRecipe quantity(PRequire moisture-PMoisture 1)/(PMoisture 2-PMoisture 1)
In the same manner the content with extractum, apigenin-8-C-glucoside and Saponaretin is as index, after calculating each Testing index inventory,
Again according to assigning, score value calculates A batches extractum and B batches extractum difference inventory is as follows：
A batch extractum inventorys：
XA inventorys=(FMoisture×X1+FExtractum×X3+FApigenin-8-C-glucoside and Saponaretin×X5)/10
B batch extractum inventorys：
XB inventorys=(FMoisture×X2+FExtractum×X4+FApigenin-8-C-glucoside and Saponaretin×X6)/10
Therefore, the inventory of Foliole banyan extractum is XFoliole banyan extractum inventory=XA inventorys+XB inventorys
Specific embodiment
Case study on implementation
The computational methods that feed intake of Foliole banyan dry extract
The Foliole banyan dry extract of table 3 feed intake homogenization calculating
It is as follows with the computing formula that moisture calculates inventory X by taking a recipe quantity as an example：
X1=XRecipe quantity(PRequire moisture-PMoisture 2)/(PMoisture 1-PMoisture 2)=360* (5.0-7.7)/(3.5-7.7)=231.42g
X2=XRecipe quantity(PRequire moisture-PMoisture 1)/(PMoisture 2-PMoisture 1)=360* (5.0-3.5)/(7.7-3.5)=128.58g
It is as follows with the computing formula that extractum calculates inventory X：
X3=XRecipe quantity(PRequire extractum-PExtractum 2)/(PExtractum 1-PExtractum 2)=360* (60.0-69.0)/(58.0-69.0)=
294.54g
X4=XRecipe quantity(PRequire extractum-PExtractum 1)/(PExtractum 2-PExtractum 1)=360* (60.0-58.0)/(69.0-58.0)=
65.46g is as follows with the computing formula that assay calculates inventory X：
X5=XRecipe quantity(PRequire assay-PAssay 2)/(PAssay 1-PAssay 2)=360* (1.3-1.0)/(1.4-1.0)=
270g
X6=XRecipe quantity(PRequire assay-PAssay 1)/(PAssay 2-PAssay 1)=360* (1.3-1.4)/(1.0-1.4)=90g
After calculating each Testing index inventory, then score value calculates A batches extractum and B batch extractum is thrown respectively according to assigning
Doses is as follows：
A batch extractum inventorys：
XA inventorys=(FMoisture×X1+FExtractum×X3+FApigenin-8-C-glucoside and Saponaretin×X5)/10=(1*231.42g+2*294.54g+7*
270g)/10=271.05g
B batch extractum inventorys：
XB inventorys=(FMoisture×X2+FExtractum×X4+FApigenin-8-C-glucoside and Saponaretin×X6)/10=(1*128.58g+2*65.46g+7*
90g)/10=88.95g
Therefore, the inventory of Foliole banyan extractum is：A batch extractum 271.05g, B batch extractum 88.95g.
Practical measurement result after merging is as follows：
Table 4 contrast is predicted the outcome and practical measurement analysis of results table using former feeding method, new feeding method
Interpretation and discussion：It is respectively according to former feeding method carry out the feeding intake moisture of Foliole banyan extractum
3.5% and 7.7%, extractum is respectively 58.0% and 69.0%, and the content of apigenin-8-C-glucoside and Saponaretin is respectively 1.40mg/g
And 1.00mg/g, the differences between batches that two batches raw material feeds intake respectively are larger.According to the mixed moisture predictive value of new feeding method batch
For 5.0%, extract prediction value is 60.0%, and the prediction content of apigenin-8-C-glucoside and Saponaretin is 1.30mg/g, according to the invention
Computational methods batch it is mixed after sample moisture actual measured value be 4.71% (error between predictive value is 6.20%),
Extractum practical measurement result is containing for 61.25% (error between predictive value is 2.08%), apigenin-8-C-glucoside and Saponaretin
Amount practical measurement result is 1.31mg/g (error between predictive value is 0.77%).Analyzed by experimental data
Know：It is controllable with each mixed index expection measured value of raw material after the new feeding method batch, it is that end product quality stably provides reliability
Theoretical foundation.
Claims (3)
1. a kind of ketelin capsule, it is characterised in that：It is made up of Foliole banyan dry extract and Chlorphenamine Maleate, its formula is by weight
Amount percentage ratio is Foliole banyan dry extract 50-90%, Chlorphenamine Maleate 0.20-0.35%.
2. a kind of ketelin capsule according to claim 1, it is characterised in that：Foliole banyan dry extract is taken, maleic acid is added
Granule is made in chlorphenamine and right amount of auxiliary materials, mixing, loads capsule, obtains final product.
3. a kind of ketelin capsule according to claim 1, it is characterised in that：With the moisture of Foliole banyan dry extract, leach
Thing and assay item etc. are the index of the homogenization that feeds intake, and weight is appraised and decided to each detection, formulate computing formula, obtain raw material
The homogenization that feeds intake standard.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710016801.0A CN106606541B (en) | 2017-01-10 | 2017-01-10 | Novel feeding method of Keteling capsules |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710016801.0A CN106606541B (en) | 2017-01-10 | 2017-01-10 | Novel feeding method of Keteling capsules |
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| Publication Number | Publication Date |
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| CN106606541A true CN106606541A (en) | 2017-05-03 |
| CN106606541B CN106606541B (en) | 2020-02-14 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201710016801.0A Active CN106606541B (en) | 2017-01-10 | 2017-01-10 | Novel feeding method of Keteling capsules |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109125400A (en) * | 2018-09-12 | 2019-01-04 | 广东罗浮山药业有限公司 | Four coloured particles ketelin capsules of one kind and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102342977A (en) * | 2011-07-15 | 2012-02-08 | 吉林敖东集团大连药业股份有限公司 | Keteling capsule and preparation method thereof |
-
2017
- 2017-01-10 CN CN201710016801.0A patent/CN106606541B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102342977A (en) * | 2011-07-15 | 2012-02-08 | 吉林敖东集团大连药业股份有限公司 | Keteling capsule and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 国家药典委员会: "《中华人民共和国药典：2015年版.一部》", 30 June 2015, 中国医药科技出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109125400A (en) * | 2018-09-12 | 2019-01-04 | 广东罗浮山药业有限公司 | Four coloured particles ketelin capsules of one kind and preparation method thereof |
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| Publication number | Publication date |
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| CN106606541B (en) | 2020-02-14 |
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