CN1631425A - Lozenge for treating its pharyngitis and preparation process thereof - Google Patents
Lozenge for treating its pharyngitis and preparation process thereof Download PDFInfo
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- CN1631425A CN1631425A CN 200410101027 CN200410101027A CN1631425A CN 1631425 A CN1631425 A CN 1631425A CN 200410101027 CN200410101027 CN 200410101027 CN 200410101027 A CN200410101027 A CN 200410101027A CN 1631425 A CN1631425 A CN 1631425A
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- pharyngitis
- buccal tablets
- water
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- wetting agent
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Abstract
The invention relates to a buccal tablet for treating pharyngitis and its preparing process, wherein the buccal tablet comprises reactive component, medicinal excipient and thin film dressing. The tablet has the advantages of quick absorption and easy administration.
Description
Technical field
The present invention relates to a kind of pharyngitis buccal tablets and preparation method thereof.
Background technology
Yanyan slice is made up of 12 flavor medicines such as Radix Scrophulariae, has nourishing YIN and clearing away lung-heat, heat-clearing and toxic substances removing, and effect such as clearing throat, antitussive are antipruritic is mainly used in and treats the dry pharynx that chronic pharyngitis causes, itching throat, the treatment of diseases such as irritable cough, clinical effectiveness is better.
The Yanyan slice quality standard records in second in " Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation, and prescription and preparation technology are as follows:
Prescription: the Radix Scrophulariae 120g Radix Stemonae (system) 90g Radix Asparagi 90g
90g Cortex Moutan 90g Flos Farfarae Radix Ophiopogonis (system) 90g
Radix Rehmanniae 30g Semen Oroxyli 90g Periostracum Cicadae 30g
Fructus Canarii 90g Radix Isatidis 150g Oleum menthae 0.3g
Method for making: above 12 flavors, except that Oleum menthae, Flos Farfarae is ground into fine powder, sieves; Ten flavors such as all the other Radix Scrophulariaes decoct with water secondary, and 3 hours for the first time, 2 hours for the second time, collecting decoction left standstill 24 hours, get supernatant, be condensed into thick paste, mix with Common Coltsfoot Flower, drying is made granule, spray is with Oleum menthae, and mixing is pressed into 1000, sugar coating, promptly.
The dosage form of Yanyan slice is a coated tablet at present, and the coated tablet instructions of taking is oral, be absorbed as the gastrointestinal mucosal absorption and play a role, so onset is slow, and production cost is higher.
Consider that Yanyan slice can not satisfy patient's medication needs fully.In order to expand the range of application of Yanyan slice, make things convenient for the patient to use, we consider to be made into buccal tablets.
Summary of the invention
The objective of the invention is to overcome the shortcoming of existing dosage form, solve the imperfection of Chinese medicine buccal tablets technology, thereby a kind of new pharyngitis buccal tablets and preparation method thereof is provided.
Pharyngitis buccal tablets of the present invention prepares label by active component and pharmaceutically acceptable excipient, the bag film-coat.Wherein label active component and preparation technology are with recording in second Yanyan slice quality standard of " Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation, and pharmaceutically acceptable excipient is made up of water-soluble filler, wetting agent, correctives and lubricant.Active component, selected adjuvant and film-coat material weight share prescription in the gross weight shared ratio as follows:
Active component 45～72%
Water-soluble filler 20～48%
Correctives 0.1～0.7%
Wetting agent 2～6%
Lubricant 0.5～1.5%
Stomach dissolution type coating powder 4～8%
Filler is selected the good mannitol of water solublity, maltodextrin or other water solublity adjuvant preferably for use, or the mixture of above two kinds of materials.
Lubricant can be selected magnesium stearate or Pulvis Talci for use, or the mixture of above two kinds of materials.
The optional water of wetting agent, ethanol, ethanol water.
Correctives is selected from aspartame or Sucralose.
This dosage form adopts wet granulation technology, can use conventional tablet pharmaceutical equipment to produce.
Pharyngitis buccal tablets preparation technology: above 12 flavors, except that Oleum menthae, Flos Farfarae is ground into fine powder, sieves; Ten flavors such as all the other Radix Scrophulariaes decoct with water secondary, 3 hours for the first time, add 9 times of amounts of water, 2 hours for the second time, add 7 times of amounts of water, collecting decoction left standstill 24 hours, get supernatant, be condensed into the thick paste of relative density 1.40 (50 ℃), with Flos Farfarae fine powder and water solublity implant, correctives mix homogeneously, add an amount of wetting agent, make granule, drying, spray adds lubricant, mix homogeneously with Oleum menthae, compacting is wrapped film-coat, promptly in flakes.
Pharyngitis buccal tablets active component mostly is water soluble ingredient, has very strong to draw moistly, and it is very fast to be exposed in the air moisture absorption, therefore in former dosage form Yanyan slice, adopts sugar coating to avoid the moisture absorption.In this buccal tablets prescription, for the buccal tablets label,, multiple pharmaceutic adjuvant carries out proportioning by being carried out different proportion, carry out pharyngitis buccal tablets prescription screening.Show through repetition test, in view of the pharyngitis buccal tablets active component moisture absorption very easily, therefore need select for use specific adjuvant as the buccal tablets implant, also find under study for action, in selected adjuvant, the different proportionings of adjuvant, preparation process there is very big influence, therefore in this prescription, must polarize selected adjuvant between certain proportional band in, selected adjuvant total amount and active component total amount between certain proportional band in, could guarantee that the water absorption rate of label can remain in certain scope, thereby guarantee the quality of label.We adopt barrier material that buccal tablets is carried out coating simultaneously, thereby have solved the problems referred to above effectively.Through the screening of test of many times, in prescription, we adopt the very little novel adjuvant of hygroscopicity (mannitol, maltodextrin etc.) as filler, to adopt certain ratio to mix with active component, make label; Adopt barrier material that buccal tablets is carried out coating simultaneously.
The pharyngitis buccal tablets is little sweet in cool taste, can slowly dissolve after running into saliva in the oral cavity, directly acts on the affected part and plays a role.The present invention has following advantage:
1, model of action aspect
Yanyan slice is the table sugar garment piece, is oral formulations, mainly relies on intestines and stomach mucosa absorption performance throat therapeutical effect; The pharyngitis buccal tablets mainly relies on oral cavity and pharyngeal mucosa to absorb for containing chemical preparation, and medicine directly acts on the patient affected part, and the local concentration height is rapid-action, so pharyngitis buccal tablets curative effect obviously is better than Yanyan slice.
2, infiltration rate aspect
I. the pharyngitis buccal tablets is a Film coated tablets, and film-coat all adopts hydrophilic material, adds water soluble adjuvants such as mannitol, lactose in the plain tablet recipe, oral cavity melting speed 5-15 minute; And Yanyan slice is the table sugar garment piece, and in the plain tablet recipe, does not add any adjuvant, so disintegration time is grown (45-60 minute).
II. after Yanyan slice needs gastrointestinal mucosal to be absorbed into blood, play a role, and the pharyngitis buccal tablets is to absorb by oral cavity and pharyngeal mucosa to directly act on the affected part by general action.
III. Yanyan slice is oral, and pharyngitis buccal tablets buccal, oral mucosa 5-15 action time minute.
3, medication is convenient
Yanyan slice is a coated tablet, needs to use water delivery service; Therefore the pharyngitis buccal tablets need not to use water delivery service for containing oral dosage form, can take whenever and wherever possible, and inconvenient patient provides a great convenience condition in order to be busy with one's work, to fetch water.
4, medication acceptance level
The pharyngitis buccal tablets adds filleies such as mannitol, lactose in prescription, the sweet correctives that waits of A Siba has good mouthfeel, is easier to people and receives.
The generation of above-mentioned effect is because it is described: mannitol and maltodextrin are the comparatively ideal water-soluble filler of tablet, and flowability, cohesive are all good, no hygroscopicity, and the tablet that is pressed into is bright and clean attractive in appearance.A Siba is sweet to be the novel sweetener of white mealy crystal, and stable in properties is soluble in water, nonhygroscopic, is suitable for the correctives as medicine; Oleum menthae is major ingredient composition in the prescription, because of its have local anesthetic action shelter for bitterness also effective, so with it and A Siba is sweet share as correctives to reach the flavoring effect; Magnesium stearate is white, fine and smooth, light powder, and lubricity is strong, and is unilateral bright and clean attractive in appearance, most widely used behind the tabletting.Simultaneously, this product film-coat material adopts hydrophobicity stomach dissolution type coating powder, can effectively prevent the sheet wicking absorbent, guarantees the quality of buccal tablets.
The specific embodiment
Pharyngitis buccal tablets of the present invention prepares label by active component, water-soluble filler, correctives, wetting agent and lubricant, and the bag film-coat is formed.The main materials and auxiliary materials weight share prescription in the gross weight shared preferred proportion as follows:
Active component 48～65%
Water-soluble filler 25～45%
Correctives 0.2～0.6%
Wetting agent 2～6%
Lubricant 0.7～13%
Stomach dissolution type coating powder 4～8%
Preferred mannitol of water-soluble filler and maltodextrin.
Preferred A Siba is sweet for correctives.
The preferred magnesium stearate of lubricant.
Wetting agent preferred alcohol solution (95%).
With following embodiment the present invention is described.
Embodiment 1:
Prescription:
| Content | Gram number (g) | Percentage ratio (%) |
| Pharyngitis buccal tablets active component | 416.5 | ?64.1 |
| Mannitol | 190.0 | ?29.2 |
| Maltodextrin | 34.4 | ?5.3 |
| Aspartame | 2.6 | ?0.4 |
| Magnesium stearate | 6.5 | ?1.0 |
Gross weight: 650 milligrams
Preparation technology:
Take by weighing pharyngitis buccal tablets active component, mannitol, maltodextrin, aspartame by recipe quantity, behind above-mentioned supplementary material mix homogeneously, pulverized 100 sieves, add 95% alcoholic solution as wetting agent, stirred 5 minutes, granulate with 40 mesh sieves, 50 ℃ ± 5 ℃ aeration-dryings, dried granule is crossed 40 mesh sieve granulate, and particle weight done in record, and calculate with this and to add adjuvant magnesium stearate consumption, by amount of calculation take by weighing add adjuvant and the abundant mix homogeneously of dried granule after, sample examination, qualified back tabletting, the bag film-coat, the aluminum-plastic packaged and dress box in the qualified back of finished product detection.
Embodiment 2:
Prescription:
| Content | Gram number (g) | Percentage ratio (%) |
| Pharyngitis buccal tablets active component | 416.5 | ?61.3 |
| Mannitol | 253.98 | ?37.4 |
| Aspartame | 2.7 | ?0.4 |
| Magnesium stearate | 6.8 | ?1.0 |
Gross weight: 680 milligrams
Preparation technology:
Take by weighing pharyngitis buccal tablets active component, mannitol, aspartame by recipe quantity, behind above-mentioned supplementary material mix homogeneously, pulverized 100 sieves, add 95% alcoholic solution as wetting agent, stirred 5 minutes, granulate with 40 mesh sieves, 50 ℃ ± 5 ℃ aeration-dryings, dried granule is crossed 40 mesh sieve granulate, and particle weight done in record, and calculate with this and to add adjuvant magnesium stearate consumption, by amount of calculation take by weighing add adjuvant and the abundant mix homogeneously of dried granule after, sample examination, qualified back tabletting, the bag film-coat, the aluminum-plastic packaged and dress box in the qualified back of finished product detection.
Embodiment 3:
Prescription:
| Content | Gram number (g) | Percentage ratio (%) |
| Pharyngitis buccal tablets active component | 416.5 | ?59.5 |
| Mannitol | 220.0 | ?31.4 |
| Maltodextrin | 53.7 | ?7.7 |
| Aspartame | 2.8 | ?0.4 |
| Magnesium stearate | 7.0 | ?1.0 |
Gross weight: 700 milligrams
Preparation technology:
Take by weighing pharyngitis buccal tablets active component, mannitol, maltodextrin, aspartame by recipe quantity, behind above-mentioned supplementary material mix homogeneously, pulverized 100 sieves, add 95% alcoholic solution as wetting agent, stirred 5 minutes, granulate with 40 mesh sieves, 50 ℃ ± 5 ℃ aeration-dryings, dried granule is crossed 40 mesh sieve granulate, and particle weight done in record, and calculates with this and to add adjuvant magnesium stearate consumption, by amount of calculation take by weighing add adjuvant and the abundant mix homogeneously of dried granule after, sample examination, qualified back tabletting, the aluminum-plastic packaged and dress box in the qualified back of finished product detection.
Embodiment 4:
Prescription:
| Content | Gram number (g) | Percentage ratio (%) |
| Pharyngitis buccal tablets active component | 416.5 | ?59.5 |
| Mannitol | 226.0 | ?32.3 |
| Maltodextrin | 47.7 | ?6.8 |
| Aspartame | 2.8 | ?0.4 |
| Magnesium stearate | 7.0 | ?1.0 |
Gross weight: 700 milligrams
Preparation technology:
Take by weighing pharyngitis buccal tablets active component, mannitol, maltodextrin, aspartame by recipe quantity, behind above-mentioned supplementary material mix homogeneously, pulverized 100 sieves, add 95% alcoholic solution as wetting agent, stirred 5 minutes, granulate with 40 mesh sieves, 50 ℃ ± 5 ℃ aeration-dryings, dried granule is crossed 40 mesh sieve granulate, and particle weight done in record, and calculates with this and to add adjuvant magnesium stearate consumption, by amount of calculation take by weighing add adjuvant and the abundant mix homogeneously of dried granule after, sample examination, qualified back tabletting, the aluminum-plastic packaged and dress box in the qualified back of finished product detection.
Embodiment 5:
Prescription:
| Content | Gram number (g) | Percentage ratio (%) |
| Pharyngitis buccal tablets active component | 416.5 | ?57.8 |
| Mannitol | 216.0 | ?30.0 |
| Maltodextrin | 45.0 | ?6.3 |
| Erythritol | 32.4 | ?4.5 |
| Aspartame | 2.9 | ?0.4 |
| Magnesium stearate | 7.2 | ?1.0 |
Gross weight: 720 milligrams
Preparation technology:
Take by weighing pharyngitis buccal tablets active component, mannitol, maltodextrin, aspartame by recipe quantity, behind above-mentioned supplementary material mix homogeneously, pulverized 100 sieves, add 95% alcoholic solution as wetting agent, stirred 5 minutes, granulate with 40 mesh sieves, 50 ℃ ± 5 ℃ aeration-dryings, dried granule is crossed 40 mesh sieve granulate, and particle weight done in record, and calculates with this and to add adjuvant magnesium stearate consumption, by amount of calculation take by weighing add adjuvant and the abundant mix homogeneously of dried granule after, sample examination, qualified back tabletting, the aluminum-plastic packaged and dress box in the qualified back of finished product detection.
Embodiment 6:
Prescription:
| Content | Gram number (g) | Percentage ratio (%) |
| Pharyngitis buccal tablets active component | 416.5 | ?55.5 |
| Mannitol | 260.0 | ?34.7 |
| Maltodextrin | 63.0 | ?9.0 |
| Aspartame | 3.0 | ?0.4 |
| Magnesium stearate | 7.5 | ?1.0 |
Gross weight: 750 milligrams
Preparation technology:
Take by weighing pharyngitis buccal tablets active component, mannitol, maltodextrin, aspartame by recipe quantity, behind above-mentioned supplementary material mix homogeneously, pulverized 100 sieves, add 95% alcoholic solution as wetting agent, stirred 5 minutes, granulate with 40 mesh sieves, 50 ℃ ± 5 ℃ aeration-dryings, dried granule is crossed 40 mesh sieve granulate, and particle weight done in record, and calculate the amount that adds the adjuvant magnesium stearate with this, by amount of calculation take by weighing add adjuvant and the abundant mix homogeneously of dried granule after, sample examination, qualified back tabletting, the bag film-coat, the aluminum-plastic packaged and dress box in the qualified back of finished product detection.
Embodiment 7:
Prescription:
| Content | Gram number (g) | Percentage ratio (%) |
| Pharyngitis buccal tablets active component | 416.5 | ?52.1 |
| Mannitol | 290.0 | ?36.3 |
| Maltodextrin | 82.3 | ?10.3 |
| Aspartame | 3.2 | ?0.4 |
| Magnesium stearate | 8.0 | ?1.0 |
Gross weight: 800 milligrams
Preparation technology:
Take by weighing pharyngitis buccal tablets active component, mannitol, maltodextrin, aspartame by recipe quantity, behind above-mentioned supplementary material mix homogeneously, pulverized 100 sieves, add 95% alcoholic solution as wetting agent, stirred 5 minutes, granulate with 40 mesh sieves, 50 ℃ ± 5 ℃ aeration-dryings, dried granule is crossed 40 mesh sieve granulate, and particle weight done in record, and calculate with this and to add adjuvant magnesium stearate consumption, by amount of calculation take by weighing add adjuvant and the abundant mix homogeneously of dried granule after, sample examination, qualified back tabletting, the bag film-coat, the aluminum-plastic packaged and dress box in the qualified back of finished product detection.
Claims (9)
1, a kind of pharyngitis buccal tablets, it is characterized in that being made up of active component, pharmaceutically acceptable excipient and film-coat, wherein active component is with recording in second Yanyan slice quality standard of " Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation about extraction of active ingredients.
2,, it is characterized in that pharmaceutically acceptable excipient is made up of water-soluble filler, wetting agent, correctives and lubricant according to the described pharyngitis buccal tablets of claim 1.
3, according to claim 1 or 2 described pharyngitis buccal tabletses, it is characterized in that each composition weight share prescription in the gross weight shared ratio as follows:
Active component 45～72%
Water-soluble filler 20～48%
Correctives 0.1～0.7%
Wetting agent 2～6%
Lubricant 0.5～1.5%
Stomach dissolution type coating powder 4～8%.
4, according to the described pharyngitis buccal tablets of claim 3, it is characterized in that each composition weight share prescription in the gross weight shared ratio as follows:
Active component 48～65%
Water-soluble filler 25～45%
Correctives 0.2～0.6%
Wetting agent 2～6%
Lubricant 0.7～1.3%
Stomach dissolution type coating powder 4～8%.
5, according to the described pharyngitis buccal tablets of claim 2, it is characterized in that water-soluble filler selects mannitol or maltodextrin for use, or the mixture of above two kinds of materials.
6, according to the described pharyngitis buccal tablets of claim 2, it is characterized in that lubricant selects magnesium stearate or Pulvis Talci for use, or the mixture of above two kinds of materials.
7,, it is characterized in that wetting agent selects water, ethanol or ethanol water for use according to the described pharyngitis buccal tablets of claim 2.
8,, it is characterized in that correctives selects aspartame or Sucralose for use according to the described pharyngitis buccal tablets of claim 2.
9, a kind of preparation method of pharyngitis buccal tablets is characterized in that according to second Yanyan slice quality standard of " Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation, extracts active component, with water solublity implant, correctives mix homogeneously, add an amount of wetting agent, make granule, drying, spray is with Oleum menthae, add lubricant, mix homogeneously, compacting is in flakes, the bag film-coat, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410101027 CN1631425A (en) | 2004-12-02 | 2004-12-02 | Lozenge for treating its pharyngitis and preparation process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410101027 CN1631425A (en) | 2004-12-02 | 2004-12-02 | Lozenge for treating its pharyngitis and preparation process thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1631425A true CN1631425A (en) | 2005-06-29 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410101027 Pending CN1631425A (en) | 2004-12-02 | 2004-12-02 | Lozenge for treating its pharyngitis and preparation process thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1631425A (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103656415A (en) * | 2013-12-20 | 2014-03-26 | 青岛琴诚医药技术有限公司 | Application of anti-pharyngitis tablet and preparation method thereof |
| CN104127659A (en) * | 2014-08-26 | 2014-11-05 | 淄博夸克医药技术有限公司 | Traditional Chinese medicine for treating chronic pharyngitis |
| CN104622946A (en) * | 2015-01-12 | 2015-05-20 | 福建农林大学 | Gynura bicolor heat-clearing buccal tablet and preparation method thereof |
| CN107496789A (en) * | 2017-07-27 | 2017-12-22 | 刘道鹏 | A kind for the treatment of pharyngitis capsule and preparation method thereof |
| CN107744554A (en) * | 2017-11-30 | 2018-03-02 | 海南金香远药业科技有限公司 | A kind of pharyngitis mouth-sucking tablet and preparation method thereof |
| CN111450211A (en) * | 2020-04-15 | 2020-07-28 | 伊春药业有限公司 | Pharyngitis tablet and preparation method thereof |
-
2004
- 2004-12-02 CN CN 200410101027 patent/CN1631425A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103656415A (en) * | 2013-12-20 | 2014-03-26 | 青岛琴诚医药技术有限公司 | Application of anti-pharyngitis tablet and preparation method thereof |
| CN104127659A (en) * | 2014-08-26 | 2014-11-05 | 淄博夸克医药技术有限公司 | Traditional Chinese medicine for treating chronic pharyngitis |
| CN104622946A (en) * | 2015-01-12 | 2015-05-20 | 福建农林大学 | Gynura bicolor heat-clearing buccal tablet and preparation method thereof |
| CN107496789A (en) * | 2017-07-27 | 2017-12-22 | 刘道鹏 | A kind for the treatment of pharyngitis capsule and preparation method thereof |
| CN107744554A (en) * | 2017-11-30 | 2018-03-02 | 海南金香远药业科技有限公司 | A kind of pharyngitis mouth-sucking tablet and preparation method thereof |
| CN111450211A (en) * | 2020-04-15 | 2020-07-28 | 伊春药业有限公司 | Pharyngitis tablet and preparation method thereof |
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