CN101904850A - Medicament for relieving cough and removing sputum and preparation method for syrup thereof - Google Patents
Medicament for relieving cough and removing sputum and preparation method for syrup thereof Download PDFInfo
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- 206010011224 Cough Diseases 0.000 title claims abstract description 30
- 239000006188 syrup Substances 0.000 title claims abstract description 30
- 235000020357 syrup Nutrition 0.000 title claims abstract description 30
- 239000003814 drug Substances 0.000 title claims abstract description 25
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 206010036790 Productive cough Diseases 0.000 title abstract description 5
- 208000024794 sputum Diseases 0.000 title abstract 3
- 210000003802 sputum Anatomy 0.000 title abstract 3
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- 238000005303 weighing Methods 0.000 claims abstract description 17
- YQSHYGCCYVPRDI-UHFFFAOYSA-N (4-propan-2-ylphenyl)methanamine Chemical compound CC(C)C1=CC=C(CN)C=C1 YQSHYGCCYVPRDI-UHFFFAOYSA-N 0.000 claims abstract description 16
- 229960003782 dextromethorphan hydrobromide Drugs 0.000 claims abstract description 16
- HSRJKNPTNIJEKV-UHFFFAOYSA-N Guaifenesin Chemical compound COC1=CC=CC=C1OCC(O)CO HSRJKNPTNIJEKV-UHFFFAOYSA-N 0.000 claims abstract description 13
- 229930006000 Sucrose Natural products 0.000 claims abstract description 13
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 13
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- 235000010233 benzoic acid Nutrition 0.000 claims abstract description 12
- 239000007788 liquid Substances 0.000 claims abstract description 11
- 238000009835 boiling Methods 0.000 claims abstract description 9
- 238000005516 engineering process Methods 0.000 claims abstract description 8
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- 206010062717 Increased upper airway secretion Diseases 0.000 claims description 18
- 208000026435 phlegm Diseases 0.000 claims description 18
- 150000001875 compounds Chemical class 0.000 claims description 14
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- 239000000940 FEMA 2235 Substances 0.000 claims description 10
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- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 abstract 2
- MIDXCONKKJTLDX-UHFFFAOYSA-N 3,5-dimethylcyclopentane-1,2-dione Chemical compound CC1CC(C)C(=O)C1=O MIDXCONKKJTLDX-UHFFFAOYSA-N 0.000 abstract 2
- 235000013736 caramel Nutrition 0.000 abstract 2
- 239000003086 colorant Substances 0.000 abstract 2
- 229940041616 menthol Drugs 0.000 abstract 2
- DNIAPMSPPWPWGF-GSVOUGTGSA-N (R)-(-)-Propylene glycol Chemical compound C[C@@H](O)CO DNIAPMSPPWPWGF-GSVOUGTGSA-N 0.000 abstract 1
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- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 description 6
- BELBBZDIHDAJOR-UHFFFAOYSA-N Phenolsulfonephthalein Chemical compound C1=CC(O)=CC=C1C1(C=2C=CC(O)=CC=2)C2=CC=CC=C2S(=O)(=O)O1 BELBBZDIHDAJOR-UHFFFAOYSA-N 0.000 description 5
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- 239000003172 expectorant agent Substances 0.000 description 5
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- 210000003437 trachea Anatomy 0.000 description 5
- OROGSEYTTFOCAN-DNJOTXNNSA-N codeine Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)=C[C@H](O)[C@@H]1OC1=C2C3=CC=C1OC OROGSEYTTFOCAN-DNJOTXNNSA-N 0.000 description 4
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- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 description 2
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 description 2
- VHUUQVKOLVNVRT-UHFFFAOYSA-N Ammonium hydroxide Chemical compound [NH4+].[OH-] VHUUQVKOLVNVRT-UHFFFAOYSA-N 0.000 description 2
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- QNVKOSLOVOTXKF-UHFFFAOYSA-N 4-[(2-amino-3,5-dibromophenyl)methylamino]cyclohexan-1-ol;hydron;chloride Chemical compound Cl.NC1=C(Br)C=C(Br)C=C1CNC1CCC(O)CC1 QNVKOSLOVOTXKF-UHFFFAOYSA-N 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention discloses a medicament for relieving cough and removing sputum and a preparation method for syrup thereof. The medicament consists of 1 to 6g of dextromethorphan hydrobromide, 10 to 30g of guaiamar, 500 to 800g of saccharose, 50 to 150ml of 1,2-propanediol, 1 to 3g of benzoic acid, 0.1 to 0.3g of menthol, 1 to 8ml of essence, 10 to 20ml of ethanol and 1 to 5ml of caramel colorant. The preparation method comprises the following steps of: weighing the saccharose, adding purified water, boiling to dissolve the saccharose, adding the caramel colorant, boiling, filtering, and cooling to the temperature of between 40 and 60 DEG C; weighing the dextromethorphan hydrobromide, the guaiamar, the menthol, the benzoic acid and the ethanol, stirring to dissolve, adding water with the temperature of between 70 and 90 DEG C, fully stirring to fully dissolve in a clear state, filtering, and adding filter liquor into the syrup; making the relative density of the liquid medicine between 1.08 and 1.48; weighing the 1,2-propanedio and the essence, filtering in turn, and adding into the syrup; adding a proper amount of boiling water, uniformly stirring, inspecting after the liquid medicine is cooled to below 50 DEG C, filtering the qualified product, and obtaining the filter liquor, namely the syrup for relieving cough and removing sputum. The preparation method has the advantages of adopting the advanced film coating and ultrafiltration technology, solving the problems of sedimentation and crystal precipitation of the medicament for a long term, ensuring controllable quality and high stability, and having simple process; and the product has the advantages of easy absorption, exact treatment effect, safety, and capacity of better meeting the clinical needs.
Description
Technical field:
The present invention relates to the technical field of the processing technology of a kind of medicine of relieving cough and expelling phlegm and syrup thereof, relate in particular to the preparation method of compound recipe dextromethorphan hydrobromide oral formulations.
Background knowledge:
Flu is the upper respiratory tract infection that is caused by multiple virus, is commonly called as " cold ", is all generable common respiratory tract diseases of the four seasons.Untimely control has popularity and infectiousness widely, if can lead to complications as viral pneumonia, myocarditis etc., serious harm human health.Flu is divided into common cold and influenza clinically again.Bronchitis is the commonly encountered diseases of middle-aged and elderly people in winter.How in time to cure transformation because of acute bronchitis forms.According to statistics, China more than 50 years old the middle-aged and elderly people sickness rate be about 15%～30%.Often show as cough, expectoration clinically, or with breathing hard, pant etc., severe patient can concurrent emphysema, pulmonary heart disease etc., have had a strong impact on people's work and life.
Flu and bronchitic symptom are cardinal symptom to cough, to cough up phlegm mostly.Cough is a kind of defensive reflex activity that respiratory system is produced when being upset, and expectorant is the product of respiratory inflammation, can stimulate respiratory mucosa to cause cough, and increases the weight of to infect.Therefore, must use antisussive and expectorant agent with mitigate the disease.
Be used for antitussive at present or the expectorant medicine is a lot, in the clinical practices such as dextromethorphan hydrobromide capsule and mucosolvan, these medicines are difficult to reach the effect of treatment simultaneously only at antitussive with a kind of symptom in eliminating the phlegm.Also have some clinical line medicines to have bigger former of drug dependence and side effect thereby can not satisfy the requirement in market.
The compound recipe Suppress develops at above two kinds of cardinal symptoms specially, its dextromethorphan hydrobromide is a central antitussive, suppress the oblongata coughing centre and the generation effect, antitussive effect equates with codeine, but there is not analgesic effect, a little less than addiction and the toleration, therapeutic dose can not suppress to breathe.Guaifenesin is a nauseous expectorant, and oral back stimulates gastric mucosa, causes that reflexive the bronchus secretion increases, the viscosity of reduction expectorant and produce phlegm-dispelling functions.
Summary of the invention:
The objective of the invention is to: the preparation method that a kind of medicine and syrup thereof of relieving cough and expelling phlegm are provided, adopt advanced filming and hyperfiltration technique, solve medicine precipitation and crystallization for a long time and separate out problem, to guarantee the controlled and stable enhancing of its quality, technology is simple, is easy to absorb determined curative effect, safety meets clinical needs better.
The object of the present invention is achieved like this:
1, the preparation method of the medicine of this relieving cough and expelling phlegm and syrup thereof comprises the steps:
1.1 the medicine of compound recipe DM Cough agent is formed:
Dextromethorphan hydrobromide 1～6g guaifenesin 10～30g sucrose 500～800g
1,2-propylene glycol 50～150ml benzoic acid 1～3g Mentholum 0.1～0.3g
Essence 1～8ml ethanol 10～20ml caramel color 1～5ml
Make 1000ml altogether
1.2 the medicine of optimum formula is formed:
Dextromethorphan hydrobromide 3g guaifenesin 20g sucrose 650g
1,2-propylene glycol 100ml benzoic acid 2g Mentholum 0.1g
Essence 4ml ethanol 14ml caramel color 2ml
Make 1000ml altogether
2, the preparation technology of relieving cough and expelling phlegm syrup:
Take by weighing sucrose, add purified water, boil make dissolving after, add caramel color and boil, filter, put and be chilled to 40～60 ℃; Take by weighing dextromethorphan hydrobromide, guaifenesin, Mentholum, benzoic acid, ethanol, stirring and dissolving adds 70～90 ℃ water and fully stirs to make and be dissolved to clear and bright after-filtration fully, and filtrate adds in the above-mentioned syrup; Make the relative density 1.08～1.48 of medicinal liquid; Measure 1,2-propylene glycol, essence are filtered in the above-mentioned syrup successively; Add proper amount of boiling water, stir evenly, treat that fluid temperature is chilled to the after-filtration that is up to the standards below 50 ℃, filtrate is the relieving cough and expelling phlegm syrup.In whole process of production, equipment container that directly contacts with medicinal liquid etc. has all adopted and has been coated with membrane technology, avoid directly contacting with metal, simultaneously all adopt the lucifuge operation on the automatic production line haveing suffered, in the final filter operation, we adopt advanced nanometer scale selectivity filtration technology, and these all are in order to ensure drug quality better and stability.
Below be the result of main pharmacodynamics test of the present invention, clinical trial and quality research:
1, the study of pharmacy that has the compound recipe DM Cough agent of Antitussive and Expectorant Effect:
The mice strong aqua ammonia is caused the antitussive action of coughing
55 of mices, male and female are respectively 27,28, body weight 20～25g, be divided into 5 groups at random, be blank group (normal saline group), codeine (0.05g/kg) positive controls, compound recipe DM Cough height (17ml/kg), in (4.4ml/kg), low dosage (1.0ml/kg) group, 11 every group.Wherein middle dosage group (4.4ml/kg) is equivalent to the clinical patient dosage.The continuous gastric infusion of animal 3 times, every day 1 time, the last administration is after 60 minutes, mice is put respectively in the airtight glass bell jar of people, sprayed into 25 strong aqua ammonia 20 seconds, after spraying stops with ultrasound atomizer, take out mice immediately, write down cough number of times and the incubation period of mice in 2 minutes.The result shows, all obviously resists the caused cough effect of ammonia after compound recipe DM Cough height, the administration of middle dosage group, and obviously prolongs the incubation period that cough takes place.
Influence to the phenol red excretion of mice trachea
55 of mices, body weight 20～25g is divided into 5 groups at random, the normal saline matched group, ammonium chloride (0.18g/kg) positive controls, compound recipe DM Cough height (17ml/kg), in (4.4ml/kg), low (1.0ml/kg) dosage group.Gastric infusion is tested fasting in preceding 24 hours and be can't help water for three days on end.After the last administration 30 minutes, lumbar injection 5 phenol red normal saline 500g/kg injected back 30 minutes, put to death animal.Back fixation, separation trachea are got one section of trachea (preferably trachea equal in length between the group) and are put into 1ml normal saline small beaker vibration 30 minutes.Solution is sucked in vitro, add the 1mol/LNaOH of 0.1ml, make flushing liquor be alkalescence, in wavelength 546nm colorimetric.Colorimetric numerical value and phenol red standard curve are compared, convert out phenol red content.The result shows that phenol red secretion has slight short secretory action to the compound recipe DM Cough to the mice trachea, but compares no significant difference with the normal saline group.
2, the clinical research that has the compound recipe DM Cough agent of Antitussive and Expectorant Effect:
Employing randomized controlled test, the infant of the middle severe cough that the light disease pneumonia of 88 examples are caused is treated, test group 44 examples, matched group 44 examples by age give different oral doses, serve as the contrast medicine with the dextromethorphan hydrobromide oral liquid.Observe the variation of experimenter's cough, amount of expectoration, nasal obstruction.The result all has remarkable clinical efficacy for two groups, the 4th day course of treatment test group clinical effective rate 81.7%, matched group effective percentage 33.9%, difference has statistical significance (P＜0.05).The compound recipe DM Cough is not found untoward reaction.
3, we by long-term 36 months to preparation of the present invention, quickened 6 months and pilot project such as destructiveness is carried out specific aim and investigated, find that its clarity, color and the fluctuation of main component content are very little, thereby the quality that can draw the compound recipe DM Cough agent with Antitussive and Expectorant Effect is highly stable and controlled.
The specific embodiment:
Embodiment 1
Take by weighing 500g sucrose, add the 500ml purified water, boil make dissolving after, add caramel color 1ml and boil, filter, put and be chilled to 40 ℃; Take by weighing dextromethorphan hydrobromide, 10g guaifenesin, 0.1g Mentholum, the 1g benzoic acid of 1g, ethanol stirring and dissolving with 10ml, add 70 ℃ water and fully stir to make and be dissolved to clear and bright after-filtration fully, filtrate adds in the above-mentioned syrup, makes the relative density 1.08～1.48 of medicinal liquid; Measure 1 respectively, 2-propylene glycol 50ml, essence 1ml are filtered in the above-mentioned syrup successively; Add proper amount of boiling water, stir evenly, treat that fluid temperature is chilled to the after-filtration that is up to the standards below 50 ℃, filtrate is the relieving cough and expelling phlegm syrup.
Embodiment 2
Take by weighing 800g sucrose, add the 800ml purified water, boil make dissolving after, add caramel color 5ml and boil, filter, put and be chilled to 60 ℃; Take by weighing dextromethorphan hydrobromide, 30g guaifenesin, 0.1g Mentholum, the 3g benzoic acid of 6g, ethanol stirring and dissolving with 20ml, add 90 ℃ water and fully stir to make and be dissolved to clear and bright after-filtration fully, filtrate adds in the above-mentioned syrup, makes the relative density 1.08～1.48 of medicinal liquid; Measure 1 respectively, 2-propylene glycol 150ml, essence 8ml are filtered in the above-mentioned syrup successively; Add proper amount of boiling water, stir evenly, treat that fluid temperature is chilled to the after-filtration that is up to the standards below 50 ℃, filtrate is the relieving cough and expelling phlegm syrup.
Embodiment 3
Take by weighing 650g sucrose, add the 650ml purified water, boil make dissolving after, add caramel color 2ml and boil, filter, put and be chilled to 50 ℃; Take by weighing dextromethorphan hydrobromide, 0.1g Mentholum, the 2g benzoic acid of 3g, ethanol stirring and dissolving with 14ml, adding 80 ℃ water fully stirs to make and is dissolved to clear and bright after-filtration fully, filtrate adds in the above-mentioned syrup, the water that takes by weighing 80 ℃ of 20g guaifenesin addings fully stirs to make and is dissolved to clear and bright after-filtration fully, filtrate adds in the above-mentioned syrup, makes the relative density 1.08～1.48 of medicinal liquid; Measure 1 respectively, 2-propylene glycol 100ml, essence 4ml are filtered in the above-mentioned syrup successively; Add proper amount of boiling water, stir evenly, treat that fluid temperature is chilled to the after-filtration that is up to the standards below 50 ℃, filtrate is the relieving cough and expelling phlegm syrup.
Claims (5)
1. the medicine of a relieving cough and expelling phlegm.It is characterized in that: described medicine is formed dextromethorphan hydrobromide 1～6g guaifenesin 10～30g sucrose 500～800g 1,2-propylene glycol 50～150ml benzoic acid 1～3g Mentholum 0.1～0.3g essence 1～8ml ethanol 10～20ml caramel color 1～5ml.
2. according to the agent of the described medicaments compound DM Cough of claim 1, it is characterized in that: the medicine of optimum formula is formed: dextromethorphan hydrobromide 3g guaifenesin 20g sucrose 650g 1,2-propylene glycol 100ml benzoic acid 2g Mentholum 0.1g essence 4ml ethanol 14ml caramel color 2ml.
3. form according to the described cough-relieving and phlegm-eliminating medicine of claim 1, it is characterized in that: the preparation method of this preparation, take by weighing sucrose, add purified water, boil make dissolving after, add caramel color and boil, filter, put and be chilled to 40～60 ℃; Take by weighing dextromethorphan hydrobromide, guaifenesin, Mentholum, benzoic acid, ethanol, stirring and dissolving adds 70～90 ℃ water and fully stirs to make and be dissolved to clear and bright after-filtration fully, and filtrate adds in the above-mentioned syrup; Make the relative density 1.08～1.48 of medicinal liquid; Measure 1,2-propylene glycol, essence are filtered in the above-mentioned syrup successively; Add proper amount of boiling water, stir evenly, treat that fluid temperature is chilled to the after-filtration that is up to the standards below 50 ℃, filtrate is the relieving cough and expelling phlegm syrup.
4. according to claim 1 and 3 described cough-relieving and phlegm-eliminating medicine compound recipe DM Cough agent, it is characterized in that: the best preparation method of this preparation takes by weighing 650g sucrose, add the 650ml purified water, boil make dissolving after, add caramel color 2ml and boil, filter, put and be chilled to 50 ℃; Take by weighing dextromethorphan hydrobromide, 0.1g Mentholum, the 2g benzoic acid of 3g, ethanol stirring and dissolving with 14ml, adding 80 ℃ water fully stirs to make and is dissolved to clear and bright after-filtration fully, filtrate adds in the above-mentioned syrup, the water that takes by weighing 80 ℃ of 20g guaifenesin addings fully stirs to make and is dissolved to clear and bright after-filtration fully, filtrate adds in the above-mentioned syrup, makes the relative density 1.08～1.48 of medicinal liquid; Measure 1 respectively, 2-propylene glycol 100ml, essence 4ml are filtered in the above-mentioned syrup successively; Add proper amount of boiling water, stir evenly, treat that fluid temperature is chilled to the after-filtration that is up to the standards below 50 ℃, filtrate is the relieving cough and expelling phlegm syrup.
5. according to claim 1 and 3 described cough-relieving and phlegm-eliminating medicine compound recipe DM Cough agent, it is characterized in that: the haveing suffered in the preparation process of this preparation, all adopted with equipment container inwall that medicinal liquid directly contacts and to be coated with membrane technology, simultaneously all adopt the lucifuge operation on the automatic production line haveing suffered, in the final filter operation, adopt advanced nanometer scale selectivity to filter technology.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010258583A CN101904850B (en) | 2010-08-17 | 2010-08-17 | Medicament for relieving cough and removing sputum and preparation method for syrup thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010258583A CN101904850B (en) | 2010-08-17 | 2010-08-17 | Medicament for relieving cough and removing sputum and preparation method for syrup thereof |
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| Publication Number | Publication Date |
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| CN101904850A true CN101904850A (en) | 2010-12-08 |
| CN101904850B CN101904850B (en) | 2012-10-17 |
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| CN (1) | CN101904850B (en) |
Cited By (5)
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| CN102600210A (en) * | 2012-04-10 | 2012-07-25 | 湖北凤凰白云山药业有限公司 | Compound dextromethorphan hydrobromide syrup and preparation method for same |
| CN103191116A (en) * | 2013-04-12 | 2013-07-10 | 上海理工大学 | Dextromethorphan hydrobromide and guaiacol glycerin ether oral liquid and preparation method thereof |
| EP2845606A1 (en) * | 2014-07-10 | 2015-03-11 | Symrise AG | Medicament for the prevention, curing or abating cough and inflammations of the respiratory system |
| CN105769908A (en) * | 2016-05-06 | 2016-07-20 | 湖北凤凰白云山药业有限公司 | Medicine for resolving phlegm and relieving cough and preparation method thereof |
| CN109700758A (en) * | 2019-01-28 | 2019-05-03 | 上海美优制药有限公司 | DM Cough and preparation method thereof |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102600210A (en) * | 2012-04-10 | 2012-07-25 | 湖北凤凰白云山药业有限公司 | Compound dextromethorphan hydrobromide syrup and preparation method for same |
| CN102600210B (en) * | 2012-04-10 | 2018-11-02 | 湖北凤凰白云山药业有限公司 | A kind of compound DM Cough agent and preparation method thereof |
| CN103191116A (en) * | 2013-04-12 | 2013-07-10 | 上海理工大学 | Dextromethorphan hydrobromide and guaiacol glycerin ether oral liquid and preparation method thereof |
| EP2845606A1 (en) * | 2014-07-10 | 2015-03-11 | Symrise AG | Medicament for the prevention, curing or abating cough and inflammations of the respiratory system |
| WO2016005213A1 (en) * | 2014-07-10 | 2016-01-14 | Symrise Ag | Medicament |
| US10028967B2 (en) | 2014-07-10 | 2018-07-24 | Symrise Ag | Medicament |
| CN105769908A (en) * | 2016-05-06 | 2016-07-20 | 湖北凤凰白云山药业有限公司 | Medicine for resolving phlegm and relieving cough and preparation method thereof |
| CN105769908B (en) * | 2016-05-06 | 2019-03-01 | 湖北凤凰白云山药业有限公司 | A kind of drug of preventing phlegm from forming and stopping coughing and preparation method thereof |
| CN109700758A (en) * | 2019-01-28 | 2019-05-03 | 上海美优制药有限公司 | DM Cough and preparation method thereof |
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|---|---|
| CN101904850B (en) | 2012-10-17 |
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