CN101036719B - Sirup agent for curing cough for children and the preparing method - Google Patents
Sirup agent for curing cough for children and the preparing method Download PDFInfo
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- CN101036719B CN101036719B CN2007102004628A CN200710200462A CN101036719B CN 101036719 B CN101036719 B CN 101036719B CN 2007102004628 A CN2007102004628 A CN 2007102004628A CN 200710200462 A CN200710200462 A CN 200710200462A CN 101036719 B CN101036719 B CN 101036719B
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Abstract
The invention discloses a syrup for treating cough in children which is formed by materials of 50-400 ml licorice fluidextract, 10-60 ml balloonflower root fluidextract, 2-20 g ammonium chloride, 10-40 ml orange tincture, 200-500 g saccharose and 3-7 g sodium benzoate, and a method for preparing the same. Compared with the existing technology, the syrup of the invention can not only eliminate phlegm and relieve cough with exact curative effect for cough caused by cold of children, but also can reduce content of saccharose in the preparation to solve problem that it is too sweet of the syrup for treating cough in children to be taken for part patients, thus the syrup is more convenient for being taken for children, as well as can avoid anxiety, lack of concentration, hyper-sensitive in children which may be caused by increasing of children epinephrine level due to too much saccharose content.
Description
Technical field: the present invention relates to a kind of syrup for the treatment of infantile cough and preparation method thereof, belong to field of pharmaceutical technology.
Background technology: cough is one of cardinal symptom of lung pattern disease, no matter diseases caused by exogenous pathogenic factor or internal injury, and all lung qi that causes lose in Xuan Suzhe, all can cough.The child cough preparation is total to four Chinese medicine by Radix Glycyrrhizae fluidextract, Radix Platycodonis fluidextract, ammonium chloride, Pericarpium Citri junoris tincture and forms; Have eliminate the phlegm, the effect of antitussive, the cough that causes for infantile common cold has definite curative effect.Wherein " XIAOER ZHIKE TANGJIANG " rises GB Chinese patent medicine part internal medicine liver and gall fascicle at the 5th of Chinese medicine ministry standard and national terrestrial reference and all records, but through discovering, medicine according to the preparation of the method in the initial quality standard does not reach best therapeutic effect, even can cause other diseases.Syrup should be accepted dosage form for children's, contains the sucrose amount in the existing standard up to 65%, and the medical science report is eaten too much sugar can make high diabetes, the hyperlipidemia easily suffered from of blood glucose, can also cause fat, the child eats too much sugar and causes that easily digestive function descends, inappetence, and the malnutrition influence is grown.Sugar can make child's epinephrine level increase to cause anxiety, and is absent minded, makes child's tetchiness.World Health Organization (WHO) is investigated, and 23 countries think that eating too much sugar is to cause one of dead reason.The consumption rising that is directly proportional of people's death curve and sugar, modern medicine think that the intake of sucrose should suitably control otherwise be unfavorable for health.Therefore, the problem that must consider of the sugar content that the reduces syrup person that is the drug research.If but sugar content is very few in the medicine, not only can influence taste of medicine, also can influence stability of drug, so how effectively to control the sugar content of XIAOER ZHIKE TANGJIANG, the quality of guaranteeing medicine is the problem that the inventor considers for a long time.
Summary of the invention:
The objective of the invention is to: a kind of syrup for the treatment of infantile cough and preparation method thereof is provided, the present invention is directed to the existing too high problem of XIAOER ZHIKE TANGJIANG sugar content, consumption to sucrose has carried out the test investigation, simultaneously cane sugar content is changed the back detailed research has been carried out in the influence of aspects such as principal agent drug effect, preparation stability.
The present invention constitutes like this: a kind of syrup for the treatment of infantile cough, make by Radix Glycyrrhizae fluidextract 50-400ml, Radix Platycodonis fluidextract 10-60ml, ammonium chloride 2-20g, Pericarpium Citri junoris tincture 10-40ml and sucrose 200-500g, sodium benzoate 3-7g.
Say that accurately it is made by Radix Glycyrrhizae fluidextract 150ml, Radix Platycodonis fluidextract 30ml, ammonium chloride 10g, Pericarpium Citri junoris tincture 20ml and sucrose 460g, sodium benzoate 5g.
The preparation method of the syrup of treatment infantile cough of the present invention is: get sucrose, it is an amount of to add water, after boiling dissolving, filter, put coldly, filtrate is with Radix Glycyrrhizae fluidextract, Radix Platycodonis fluidextract, Pericarpium Citri junoris tincture, ammonium chloride and the sodium benzoate crossed with water dissolution, stir evenly, filter, medicinal liquid adds water and makes 1000ml, promptly.
In order effectively to control the sugar content of XIAOER ZHIKE TANGJIANG, the applicant has carried out a series of experimental study, and is specific as follows:
Experimental example 1: the sucrose consumption is selected research
Get sucrose and medicine respectively, prepare 5 duplicate samples by preparation method of the present invention, sugar-containing concentration is respectively 20%, 30%, 40%, 50%, 60%.Situations such as the character of sample, mouthfeel, discriminating, relative density, ammonium chloride content in the preparation of investigation variable concentrations sugar content.The results are shown in following table.
| Project | 20％ | 30％ | 40％ | 50％ | 60％ |
| Character | The translucent thick liquid of rufous | The translucent thick liquid of rufous | The translucent thick liquid of rufous | The translucent thick liquid of rufous | The translucent thick liquid of rufous |
| Mouthfeel | Slightly sweet | Slightly sweet | Sweet | Sweet | Cross sweet |
| Differentiate | Be positive reaction | Be positive reaction | Be positive reaction | Be positive reaction | Be positive reaction |
| Relative density | 1.02 | 1.07 | 1.13 | 1.18 | 1.24 |
| Content (%) | 99.7 | 101.2 | 100.7 | 98.9 | 99.3 |
According to above experimental result as can be known, except that relative density changed with the variation of sugar content, all the other all were not subjected to the influence of sugar content.As everyone knows, sugar content is too high, and World Health Organization (WHO) clearly advocates people's " low sugar diet " no matter be to be to have fraud not have profit for the child or for the adult, so selection sucrose amount ranges is 20%-50%; Consider that the child likes sweet food, the low slightly medicine of sugar content is difficult for accepting, " point out factors such as " contain the sucrose amount and should be not less than 45% (g/ml) " in first appendix of Chinese pharmacopoeia version in 2005, selecting best sucrose consumption is 46% simultaneously.
Experimental example 2: different sugar content is to the influence of growth of microorganism
Sucrose in syrup as correctives, and the sugar of high concentration can suppress microbial growth, but has increased production cost, and the polyphagia imapirment of the spleen and stomach, more harm than good to child and diabetics, now the growth of microorganism situation of sample is investigated with regard to different sugar content.
Experimental group: get sucrose and medicine respectively, prepare 5 duplicate samples (not adding sodium benzoate) by preparation method of the present invention, sugar-containing concentration is respectively 20%, 30%, 40%, 50%, 60%, the syrup of variable concentrations is further divided into two parts, bottling is numbered A, B, C, D, E and A ', B ', C ', D ', E '.Be used separately as microorganism culturing and reserved sample observing.
Matched group: get sucrose and medicine respectively, prepare 5 duplicate samples by preparation method of the present invention, sugar-containing concentration is respectively 20%, 30%, 40%, 50%, 60%, and the syrup of variable concentrations is further divided into two parts, bottling is numbered H, I, J, K, L and H ', I ', J ', K ', L '.Be used separately as microorganism culturing and reserved sample observing.The result is as follows:
Limit test of microbe
Limit test of microbe is the result show, experimental group is under the condition of adding preservative agent not, its antibacterial, mycete, yeast all have growth in various degree, but the difference that various bacterium numbers increase between variable concentrations is little, as seen what of sugar content have certain influence to microbial growth and breeding in the syrup, but influence is little; Matched group is after adding stabilizing agent, and its microbial limit is up to specification, and visible sugar content is little with interior microbial growth and syrup sugar content relation 60%.
Reserved sample observing (room temperature was deposited 6 months)
The reserved sample observing experimental result shows, experimental group is placed after 6 months under normal temperature environment, mouldy, fermentation, foaming in various degree all arranged and play phenomenon such as drum, and matched group does not all have above-mentioned phenomenon, as seen the going mouldy of syrup, fermentation and syrup sugar-containing concentration relation are little, but relevant with syrup sanitary condition, anti-corrosion measure, sterilization and holding conditions etc. in process of production.
Experimental example 3: stability study:
According to preparation method of the present invention, the preparation sugar content is totally 3 batches of 46% XIAOER ZHIKE TANGJIANG, and every batch two duplicate samples is made the stability that accelerated test and long term test are investigated medicine respectively.
One, stability test research method:
Adopt accelerated stability and long-time stability to carry out stability test.
1. sample: by the XIAOER ZHIKE TANGJIANG sample of preparation method preparation of the present invention, plastic bottle.Specification: 90ml/ bottle, sample lot number: Sy-601, Sy-602, Sy-603.
2. instrument:
Biochemistry incubator LRH-150B Guangdong Medical Apparatus and Instruments Factory
Horizontal laminar flow clean work station CJ type Suzhou clean technology institute intelligence disintegration tester
3. reagent:
Dilute hydrochloric acid, ammonia, sodium hydroxide, boric acid, C.I. 13020., bromocresol green, sulphuric acid are analytical pure.
4. test method:
(1) accelerated stability test: get above-mentioned three batch samples by the listing packing,, place under the condition of relative humidity 75% ± 5%, once investigate in 1st month, 2 months, 3 months, 6 samplings at the end of month of duration of test respectively 40 ℃ ± 2 ℃ of temperature.
(2) long-term stable experiment: get above-mentioned three batch samples by the listing packing, at room temperature storage is investigated three batch samples by " requirement of new Chinese medicine stability test ".
Two, study on the stability project: character, discriminating, relative density, assay, limit test of microbe.
Three, result: a that sees the following form, b, c, d, e, f.
The XIAOER ZHIKE TANGJIANG accelerated stability test is table as a result
Table a: lot number Sy-601
Table b: lot number Sy-602
Table c: lot number Sy-603
The XIAOER ZHIKE TANGJIANG long-term stable experiment is table as a result
Table d: lot number Sy-601
Table e: lot number Sy-602
Table f: lot number Sy-603
Four, conclusion:
From table, can find out, the XIAOER ZHIKE TANGJIANG of the present invention's preparation is being placed half a year by the sample of listing packing under the accelerated test condition He under the room temperature condition, quicken and the long-term investigation result from 0 month, January, February, March, June, each investigation project all loses unusually, ammonium chloride content does not change yet, and all meets the quality standard requirement.Illustrate that XIAOER ZHIKE TANGJIANG of the present invention has good stability, the sucrose amount that reduces in the prescription does not influence stability.
Experimental example 4: relative density research:
Because syrup sugar content of the present invention reduces, find that its relative density changes to some extent when investigating the sample of different cane sugar contents, so preparing sugar content according to preparation method of the present invention is totally 10 batches of 46% syrups, investigates the situation of change of relative density, the results are shown in following table:
Sucrose consumption during the result writes out a prescription as can be seen from table reduces, and relative density decreases, but stable in the finite concentration scope.
Experimental example 5: preparation cough-relieving of the present invention, reduce phlegm, relieving asthma and immunization research:
One, material:
1, medicine: XIAOER ZHIKE TANGJIANG: the method preparation of the patent " cough stopping formulation and preparation technology thereof " of having applied for according to the inventor.
Preparation of the present invention: prepare according to the method for the invention.
2, animal: mice, provide by Guiyang Medical College, body weight 26-30g counts 60.
Two, experimental technique and result
1, antitussive experiment: get 30 of mices, male and female half and half are divided into 3 groups at random, are respectively matched group, XIAOER ZHIKE TANGJIANG, preparation group of the present invention.Each administration group is gastric infusion 20ml/kg according to dosage, and matched group gives the equal-volume normal saline, and every Mus is drawn with strong aqua ammonia 0.1ml spraying and coughs after 1 hour, with the cough phase be index, observe medicine to the preclinical reaction of mouse cough.The result sees following table for details.
Cough-relieving rate %=(administration group cough response time/matched group cough response time) * 100%
| Group | Dosage C/mlkg -1 | Cough latent period t/s | Cough-relieving rate % |
| Matched group | - | 19.23±3.68 | - |
| The XIAOER ZHIKE TANGJIANG group | 20 | 35.41±13.55 | 184.1 |
| Preparation group of the present invention | 20 | 37.86±14.63 | 196.9 |
Preparation group of the present invention is compared P＜0.01 with matched group and XIAOER ZHIKE TANGJIANG group; As seen, compare preparation group mouse cough of the present invention long, the also corresponding rising of cough-relieving rate incubation period with the XIAOER ZHIKE TANGJIANG group.
2, the experiment of eliminating the phlegm: the phenol red excretion amount experiment of mice trachea, get 30 of mices, male and female half and half are divided into 3 groups at random, are respectively matched group, XIAOER ZHIKE TANGJIANG, preparation group of the present invention.Water 12h is can't help in fasting before each group experiment, gastric infusion, the administration volume is 0.2ml/10g, the blank group gives the equal-volume distilled water, after 30 minutes, the phenol red 0.1ml of lumbar injection (5mg)/10g body weight takes off cervical vertebra and puts to death mice after half an hour, it is fixing to face upward the position, cut off neck middle part skin, isolate trachea, cut one section trachea down to the trachea bifurcation from thyroid cartilage, put in the test tube that fills the 2ml normal saline, add 0.1mlNaOH again, measure trap at the 545nm place, calculate the phenol red excretion amount in mouse breathing road according to standard curve with 721 type spectrophotometers, with the phenol red excretion amount of matched group is 100%, respectively organizes mice trachea phenol red output.The results are shown in following table.
| Group | Dosage (mlkg -1) | Phenol red excretion amount (μ g/ml) | The P value |
| Matched group | - | 1.78±0.62 | - |
| The XIAOER ZHIKE TANGJIANG group | 20 | 4.33±1.32 | ＜0.05 |
| Preparation group of the present invention | 20 | 4.80±1.46 | ＜0.01 |
Preparation group of the present invention is compared with matched group, P＜0.01; Compare P＜0.05 with the XIAOER ZHIKE TANGJIANG group; As seen, preparation group of the present invention is compared with the XIAOER ZHIKE TANGJIANG group, and the sputum secretory volume of mice significantly increases.
More than experiment shows, preparation of the present invention and XIAOER ZHIKE TANGJIANG relatively more can prolong the incubation period of strong aqua ammonia inducing mouse cough, increases mice expectoration amount.
Compared with prior art, syrup provided by the invention not only have better eliminate the phlegm, the antitussive effect, the cough that infantile common cold is caused has definite curative effect, and reduced the content of sucrose in the preparation, it is sweet excessively to have solved the XIAOER ZHIKE TANGJIANG mouthfeel, insufferable situation when part patient takes, convenient children taking, the child's epinephrine level that can avoid simultaneously causing because of the sucrose amount is too high increases, thereby cause anxiety, absent minded, make the generation of situations such as child's tetchiness.
The specific embodiment:
Embodiments of the invention 1: Radix Glycyrrhizae fluidextract 150ml, Radix Platycodonis fluidextract 30ml, ammonium chloride 10g, Pericarpium Citri junoris tincture 20ml, sucrose 460g, sodium benzoate 5g
Preparation technology is: get sucrose, it is an amount of to add water, boil dissolving after, filter, put coldly, filtrate stirs evenly with Radix Glycyrrhizae fluidextract, Radix Platycodonis fluidextract, Pericarpium Citri junoris tincture, ammonium chloride and sodium benzoate (dissolving with suitable quantity of water), filter, medicinal liquid adds water and makes 1000ml, promptly gets syrup of the present invention.Said preparation is oral, and 2-5 year 5ml takes the circumstances into consideration below 2 years old to successively decrease, and 5 years old with last 5-10ml, 3-4 time on the one.
Embodiments of the invention 2: Radix Glycyrrhizae fluidextract 50ml, Radix Platycodonis fluidextract 10ml, ammonium chloride 2g, Pericarpium Citri junoris tincture 10ml, sucrose 200g, sodium benzoate 3g
Preparation technology is with embodiment 1.
Embodiments of the invention 3: Radix Glycyrrhizae fluidextract 400ml, Radix Platycodonis fluidextract 60ml, ammonium chloride 20g, Pericarpium Citri junoris tincture 40ml, sucrose 500g, sodium benzoate 7g
Preparation technology is with embodiment 1.
Embodiments of the invention 4: Radix Glycyrrhizae fluidextract 50ml, Radix Platycodonis fluidextract 60ml, ammonium chloride 2g, Pericarpium Citri junoris tincture 40ml, sucrose 300g, sodium benzoate 4g
Preparation technology is with embodiment 1.
Embodiments of the invention 5: Radix Glycyrrhizae fluidextract 200ml, Radix Platycodonis fluidextract 40ml, ammonium chloride 8g, Pericarpium Citri junoris tincture 30ml, sucrose 420g, sodium benzoate 6g
Preparation technology is with embodiment 1.
Claims (2)
1. syrup for the treatment of infantile cough, it is characterized in that: it is made by Radix Glycyrrhizae fluidextract 150ml, Radix Platycodonis fluidextract 30ml, ammonium chloride 10g, Pericarpium Citri junoris tincture 20ml, sucrose 460g and sodium benzoate 5g.
2. treat the preparation method of the syrup of infantile cough according to claim 1, it is characterized in that: get sucrose, it is an amount of to add water, boil dissolving after, filter, put cold, filtrate stirs evenly with Radix Glycyrrhizae fluidextract, Radix Platycodonis fluidextract, Pericarpium Citri junoris tincture, ammonium chloride and with the sodium benzoate that water dissolution is crossed, and filters, medicinal liquid adds water and makes 1000ml, promptly.
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| CN103988947B (en) * | 2014-06-04 | 2016-01-20 | 河南中医学院 | Health protection tea of a kind of supplemental treatment throat disease and preparation method thereof |
| CN104198619B (en) * | 2014-09-23 | 2016-01-13 | 华润三九（郴州）制药有限公司 | A kind of quality determining method of P-Cymene |
| CN107854428A (en) * | 2016-12-20 | 2018-03-30 | 成都医学院 | A kind of Pyridostigmine Bromide syrup and preparation method thereof |
| CN108371680A (en) * | 2018-04-26 | 2018-08-07 | 江苏四环生物制药有限公司 | A kind of preparation method of P-Cymene |
| CN110522810A (en) * | 2018-05-23 | 2019-12-03 | 北京盈科瑞创新药物研究有限公司 | A kind of sucking child cough pharmaceutical solutions and preparation method thereof |
| CN111437250B (en) * | 2020-04-23 | 2022-05-03 | 合肥医工医药股份有限公司 | Stable mefenanamine ammonium oral solution and preparation method thereof |
| CN116999496B (en) * | 2023-09-21 | 2024-04-02 | 黑龙江中桂制药有限公司 | Concentrated alcohol-free children cough syrup and preparation process thereof |
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