CN100584316C - Sugar-free type red tangerine peel oral liquor for treating productive cough - Google Patents
Sugar-free type red tangerine peel oral liquor for treating productive cough Download PDFInfo
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- CN100584316C CN100584316C CN200610099307A CN200610099307A CN100584316C CN 100584316 C CN100584316 C CN 100584316C CN 200610099307 A CN200610099307 A CN 200610099307A CN 200610099307 A CN200610099307 A CN 200610099307A CN 100584316 C CN100584316 C CN 100584316C
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Abstract
The sugar-free red tangerine peel oral liquid for treating productive cough is prepared with red tangerine peel, sessile stemona root, almond, white swallowwort, tuckahoe and other Chinese medicinal materials. It is used to treat cough, asthma with abundant phlegm, cold, bronchitis and laryngopharyngitis. The oral liquid includes also supplementary material maltitol and corrective, which is selected from proteoglycan, sweetener and stevioside and is preferably stevioside,.
Description
Technical field:
The present invention relates to a kind of activating QI to eliminate phlegm, the nourishing the lung to arrest cough oral liquid particularly relates to the oral liquid of being made up of flavour of a drug such as Exocarpium Citri Grandis, the Radix Stemonae, Semen Armeniacae Amarum, Rhizoma Cynanchi Stauntonii, Poria, Rhizoma Pinelliae Preparata, Fructus Schisandrae Chinensis, Radix Glycyrrhizaes, can be used for cough, asthma abundant expectoration clinically; Flu bronchitis, pharyngolaryngitis.
Background technology:
The product red tangerine peel oral liquor for treating productive cough prescription that has gone on the market comes from the 18 the 199th page of Chinese drug standard, its prescription " also record in Juhong Tanke liquid for 2005 editions one one 657 pages by Chinese pharmacopoeia, form by flavour of a drug such as Exocarpium Citri Grandis, the Radix Stemonae, Semen Armeniacae Amarum, Rhizoma Cynanchi Stauntonii, Poria, Rhizoma Pinelliae Preparata, Fructus Schisandrae Chinensis, Radix Glycyrrhizaes, function cures mainly and is activating QI to eliminate phlegm, nourishing the lung to arrest cough.Be used for cough, asthma abundant expectoration due to the turbid phlegm obstructing in the lung; Flu bronchitis, pharyngolaryngitis are seen above-mentioned patient.
Juhong Tanke liquid in the market all be with sucrose as correctives because the easy moisture absorption of sucrose, viscosity is big, the solution instability owing to contain a large amount of sucrose (accounting for 42%) in its adjuvant, all is not suitable for diabetes, obesity, cardiovascular and cerebrovascular vessel patient in addition.For a change above-mentioned defective, the present invention is through having selected a kind of novel correctives place of sucrose, add compositions such as maltose alcohol simultaneously, make preparation of the present invention highly stable, good mouthfeel, obtained beyond thought effect, simultaneously because the variation of prescription needs new method of quality control that it is detected, so the present invention also provides new method of quality control.
Summary of the invention:
Chinese medicine oral liquid of the present invention, its prescriptions of Chinese medicine is composed as follows:
The Exocarpium Citri Grandis 150-600g Radix Stemonae (sweet moxibustion) 15-60g Semen Armeniacae Amarum 50-200g Poria 15-60g
Rhizoma Pinelliae Preparata 15-60g Fructus Schisandrae Chinensis 10-40g Rhizoma Cynanchi Stauntonii 25-100g Radix Glycyrrhizae 5-20g
Preferably:
The Exocarpium Citri Grandis 200-400g Radix Stemonae (sweet moxibustion) 20-40g Semen Armeniacae Amarum 75-150g Poria 20-40g
Rhizoma Pinelliae Preparata 20-40g Fructus Schisandrae Chinensis 15-25g Rhizoma Cynanchi Stauntonii 40-60g Radix Glycyrrhizae 8-12g
Most preferably:
The Exocarpium Citri Grandis 300g Radix Stemonae (sweet moxibustion) 30g Semen Armeniacae Amarum 100g Poria 30g
Rhizoma Pinelliae Preparata 30g Fructus Schisandrae Chinensis 20g Rhizoma Cynanchi Stauntonii 50g Radix Glycyrrhizae 10g
Above recipe quantity calculates with the crude drug amount, can be made into medicine oral liquid 500-2000ml.
Oral liquid of the present invention wherein also comprises adjunct ingredient, and described adjunct ingredient is: maltose alcohol and correctives, correctives are selected from protein sugar, cyclamate, steviosin, most preferably steviosin.Also can add auxiliary elements such as sodium benzoate, ethyl hydroxybenzoate, Mentholum, essence as required in addition.
Oral liquid of the present invention, wherein the consumption of adjunct ingredient is:
Maltose alcohol 90-360g, steviosin 2-8g,
Preferably:
Maltose alcohol 150-210g, steviosin 3-5g,
Most preferably:
Maltose alcohol 180g, steviosin 4g,
Other compositions such as sodium benzoate, ethyl hydroxybenzoate, Mentholum, essence are an amount of, described is according to the selected addition of galenic pharmacy routine techniques in right amount, at this to make marks in right amount.Sodium benzoate 3g preferably, ethyl hydroxybenzoate 0.3g, essence and Mentholum are an amount of, make 1000ml.
Described essence can be the essence of any odor type.
Above adjuvant amount is corresponding with above-mentioned prescriptions of Chinese medicine, can be made into medicine oral liquid 500-2000ml with Chinese medicine, preferably makes 1000ml.
Oral liquid of the present invention, its preparation method is as follows:
More than eight the flavor, Exocarpium Citri Grandis, the Semen Armeniacae Amarum vapor distillation, collect distillate 80ml, Six-elements such as medicinal residues and all the other Radixs Stemonae decoct with water secondary, each 2 hours, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.25-1.35 (80 ℃), adding ethanol makes the alcohol amount of containing reach 75%-80%, left standstill 24 hours, and got supernatant, reclaim ethanol and be concentrated into the clear paste that relative density is 1.18-1.20 (80 ℃), this clear paste and above-mentioned distillate (volatile oil), forming pharmaceutically active substance of the present invention together, is raw material with this pharmaceutically active substance, adds the adjunct ingredient that the present invention's screening obtains, through preparation method of the present invention, promptly get oral liquid of the present invention.
For oral liquid of the present invention, can adopt following method preparation:
Promptly get the Juhong Tanke clear paste 65g of recipe quantity, add the volatile oil distillate, steviosin 4g, maltose alcohol 180g, sodium benzoate 3g, this ethyl ester of hydroxyl 0.3g, stirring makes dissolving, and mixing filters, and puts cold, add essence and Mentholum is an amount of, add water to 1000ml, stir evenly, promptly.
Prescription of the present invention and technology obtain through screening, and screening process is as follows:
The clear paste of getting four recipe quantities designs four different pharmaceutical formulations and compares experiment from above-mentioned adjuvant.The results are shown in Table 1.With mouthfeel, clarification property, safety, price serves as that the examination evaluation index compares test, as a result table 2
Table 1 preparation experimental formula
The different pharmaceutical formulations of table 2 are the fruit comparative result
The above results shows: 2 mouthfeels of filling a prescription are suitable, and clarity is fine, and cost of supplementary product is low, safety.So this product pharmaceutical formulation optimization formula 2.
The present invention also comprises the method for quality control of oral liquid of the present invention, and this method may further comprise the steps:
To character, differentiate, check steps such as assay.
Concrete steps are:
[character] this product is a brown liquid; Gas fragrance, sweet, little hardship of distinguishing the flavor of.
This product 5ml is got in [discriminating] (1), adds ethyl acetate 15ml jolting and extracts, and divides and gets acetic acid ethyl fluid, and evaporate to dryness, residue add dehydrated alcohol 1ml makes dissolving, as need testing solution.Other gets Exocarpium Citri Grandis control medicinal material 0.3g, adds methanol 10ml and puts in the water-bath reflux 20 minutes, filters, and filtrate evaporate to dryness, residue add dehydrated alcohol 1ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (appendix VI method) test, draw each 6 μ l of above-mentioned two kinds of solution,, put respectively on same silica gel g thin-layer plate, (2: 3: 0.3: 0.3) upper solution was developing solvent, launched, and took out, and dried with toluene-ethyl acetate-formic acid-water.Spray is with the aluminum chloride alcoholic solution.Put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph, should show the speckle of same color.
(2) get this product 6ml, add strong ammonia solution and transfer more than the PH to 10, add chloroform and extract three times, (15ml, 10ml, 10ml), combined chloroform solution, evaporate to dryness, residue add 90% ethanol 1ml makes dissolving, as need testing solution.Other gets radix stemonae tuberosae control medicinal material 1g, adds 90% ethanol 20ml and 2% hydrochloric acid 1ml mixed liquor, refluxes 20 minutes, placement is spent the night, and filters evaporate to dryness, residue adds water 3ml, makes dissolving, adds strong ammonia solution and transfers more than the PH to 10, adding chloroform extracts three times, (15ml, 10ml, 10ml), combined chloroform solution, evaporate to dryness, residue adds 90% ethanol 1ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (appendix VI method) test, draw each 6 μ l of need testing solution and control medicinal material solution, put respectively on same silica gel g thin-layer plate, be developing solvent with chloroform-methanol (8: 0.6), launch, take out, to dry, spray is with rare bismuth potassium iodide test solution.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph, should show the speckle of 1-2 same color.
[inspection] relative density should be not less than 1.05 (appendix VIIA)
PH value should be 4.0～6.0 (appendix VIIG)
Other should meet every regulation relevant under the mixture item (appendix I J)
[assay] measured according to high performance liquid chromatography (appendix VID).
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile-0.1% phosphoric acid water (21: 79) is a mobile phase; The detection wavelength is 283nm, and theoretical cam curve should be not less than 2000 by the naringin peak.
The preparation of reference substance solution: it is an amount of that precision takes by weighing 110 ℃ of naringin reference substances that are dried to constant weight, adds methanol and make the solution that every 1ml contains 70 μ g, promptly.
The preparation of need testing solution: precision is measured this product 1.0ml, puts in the 25ml measuring bottle, adds 50% methanol and is diluted to scale, shakes up, and filters through microporous filter membrane (0.45 μ m), promptly.
Algoscopy: accurate respectively need testing solution and each 10 μ l of reference substance solution of drawing, inject chromatograph of liquid, measure, promptly.
The every 1ml of this product contains Exocarpium Citri Grandis with naringin (C
10H
10O
4) meter, must not be less than 1.1mg.Oral liquid of the present invention has been carried out stability experiment, and the result is as follows:
With lot number be: 030301,030303,030306 three batch samples, simulation production medication terms of packing, be that inner packing is that vial adds and exposes aluminium lid (containing the latex pad), outer package is a carton, place 0,1,2,3,6,12,18,24 month different times in room temperature, examine or check by Juhong Tanke liquid (Sugarless type) quality standard.
Investigate content:
According to quality standard to character, discriminating, inspection: relative density, pH value,, content uniformity, the content of naringin, microbial limit: antibacterial, mycete, escherichia coli are investigated respectively.
Conclusion:
More than three batch samples through the investigation that keeps sample of the room temperature of 24 months different times, it is all up to specification that every index is investigated the result.
Technological operation of the present invention is convenient, steady quality, and equipment adapts to, and can be used for big production.
The specific embodiment:
Further specify the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1
The preparation of active component
Prescription
The Exocarpium Citri Grandis 300g Radix Stemonae (sweet moxibustion) 30g Semen Armeniacae Amarum 100g Poria 30g
Rhizoma Pinelliae Preparata 30g Fructus Schisandrae Chinensis 20g Rhizoma Cynanchi Stauntonii 50g Radix Glycyrrhizae 10g
More than eight the flavor, Exocarpium Citri Grandis, Semen Armeniacae Amarum vapor distillation, the collection distillate, Six-elements such as medicinal residues and all the other Rhizoma Pinelliae Preparata decoct with water secondary, each 2 hours, collecting decoction, filter, filtrate is concentrated into the thick paste shape, adds ethanol and makes and contain the alcohol amount and reach 75-80%, leave standstill, get supernatant and reclaim ethanol and be concentrated in right amount, obtain extractum, this extractum is formed pharmaceutically active substance of the present invention with Semen Armeniacae Amarum distillate (volatile oil).
Embodiment 2
The preparation of oral liquid
Promptly get the Juhong Tanke clear paste of embodiment 1, add the volatile oil distillate, steviosin 4g, maltose alcohol 180g, sodium benzoate 3g, this ethyl ester of hydroxyl 0.3g stirs and makes dissolving, and mixing filters, and puts coldly, adds essence and Mentholum is an amount of, adds water to 1000ml, stirs evenly, promptly.
Embodiment 3
The preparation of active component
Prescription
The Exocarpium Citri Grandis 150g Radix Stemonae (sweet moxibustion) 15g Semen Armeniacae Amarum 50g Poria 15g
Rhizoma Pinelliae Preparata 15g Fructus Schisandrae Chinensis 10g Rhizoma Cynanchi Stauntonii 25g Radix Glycyrrhizae 5g
Preparation method is with embodiment 1
Embodiment 4
The preparation of active component
Prescription
The Exocarpium Citri Grandis 600g Radix Stemonae (sweet moxibustion) 60g Semen Armeniacae Amarum 200g Poria 60g
100g Radix Glycyrrhizae 20g before the Rhizoma Pinelliae Preparata 60g Fructus Schisandrae Chinensis 40g
Preparation method is with embodiment 1
Embodiment 5
The preparation of active component
Prescription
The Exocarpium Citri Grandis 200g Radix Stemonae (sweet moxibustion) 20g Semen Armeniacae Amarum 75g Poria 20g
Rhizoma Pinelliae Preparata 20g Fructus Schisandrae Chinensis 15g Rhizoma Cynanchi Stauntonii 40g Radix Glycyrrhizae 8g
Preparation method is with embodiment 1
Embodiment 6
The preparation of active component
Prescription
The Exocarpium Citri Grandis 400g Radix Stemonae (sweet moxibustion) 40g Semen Armeniacae Amarum 150g Poria 40g
Rhizoma Pinelliae Preparata 40g Fructus Schisandrae Chinensis 25g Rhizoma Cynanchi Stauntonii 60g Radix Glycyrrhizae 12g
Preparation method is with embodiment 1
Embodiment 7
The preparation of oral liquid
Promptly get the Juhong Tanke clear paste of embodiment 2, add the volatile oil distillate, steviosin 8g, maltose alcohol 360g, sodium benzoate 3g, this ethyl ester of hydroxyl 0.3g stirs and makes dissolving, and mixing filters, and puts coldly, adds essence and Mentholum is an amount of, adds water to 1000ml, stirs evenly, promptly.
Embodiment 8
The preparation of oral liquid
Promptly get the Juhong Tanke clear paste of embodiment 3, add the volatile oil distillate, protein sugar 2g, maltose alcohol 180g, sodium benzoate 3g, this ethyl ester of hydroxyl 0.3g stirs and makes dissolving, and mixing filters, and puts coldly, adds essence and Mentholum is an amount of, adds water to 1000ml, stirs evenly, promptly.
Embodiment 9
The preparation of oral liquid
Promptly get the Juhong Tanke clear paste of embodiment 4, add the volatile oil distillate, cyclamate 3g, maltose alcohol 150g, sodium benzoate 3g, this ethyl ester of hydroxyl 0.3g stirs and makes dissolving, and mixing filters, and puts coldly, adds essence and Mentholum is an amount of, adds water to 1000ml, stirs evenly, promptly.
Embodiment 10
The preparation of oral liquid
Promptly get the Juhong Tanke clear paste of embodiment 3, add the volatile oil distillate, steviosin 5g, maltose alcohol 210g, sodium benzoate 3g, this ethyl ester of hydroxyl 0.3g stirs and makes dissolving, and mixing filters, and puts coldly, adds essence and Mentholum is an amount of, adds water to 1000ml, stirs evenly, promptly.
Claims (3)
1, a kind of sugar-free type red tangerine peel oral liquor for treating productive cough is characterized in that, the prescription of used raw material of Chinese medicine is as follows: Exocarpium Citri Grandis 300g, Radix Stemonae 30g, Semen Armeniacae Amarum 100g, Poria 30g, Rhizoma Pinelliae Preparata 30g, Fructus Schisandrae Chinensis, 20g Rhizoma Cynanchi Stauntonii 50g, Radix Glycyrrhizae 10g, with Juhong Tanke extractum and the maltose alcohol 180g that this prescription makes, steviosin 4g, sodium benzoate 3g, ethyl hydroxybenzoate 0.3g, Mentholum, essence are an amount of, add water and obtain the 1000ml sugar-free type red tangerine peel oral liquor for treating productive cough.
2, the preparation method of the oral liquid of claim 1 is characterized in that, process following steps: Exocarpium Citri Grandis, the Semen Armeniacae Amarum vapor distillation, collect distillate 80ml, medicinal residues and all the other Six-elements decoct with water secondary, each 2 hours, collecting decoction filtered, filtrate is concentrated into the clear paste that relative density is 1.25-1.35, add ethanol and make and contain alcohol amount and reach 75%-80%, left standstill 24 hours, get supernatant, reclaim ethanol and be concentrated into the clear paste that relative density is 1.18-1.20, qinghuo reagent 65g adds the volatile oil distillate, steviosin 4g, maltose alcohol 180g, sodium benzoate 3g, this ethyl ester of hydroxyl 0.3g stirs and makes dissolving, mixing, filter, put coldly, add essence and Mentholum is an amount of, add water to 1000ml, stir evenly, promptly.
3, the content assaying method of naringin in the oral liquid of claim 1 is characterized in that, may further comprise the steps:
Assay: according to high effective liquid chromatography for measuring;
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile-0.1% phosphoric acid water is a mobile phase; The detection wavelength is 283nm, and theoretical cam curve should be not less than 2000 by the naringin peak;
The preparation of reference substance solution: it is an amount of that precision takes by weighing 110 ℃ of naringin reference substances that are dried to constant weight, adds methanol and make the solution that every 1ml contains 70 μ g, promptly;
The preparation of need testing solution: precision is measured this product 1.0ml, puts in the 25ml measuring bottle, adds 50% methanol and is diluted to scale, shakes up, and filters through microporous filter membrane, promptly;
Algoscopy: accurate respectively need testing solution and each 10 μ l of reference substance solution of drawing, inject chromatograph of liquid, measure, promptly.
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| CN200610099307A CN100584316C (en) | 2006-07-13 | 2006-07-13 | Sugar-free type red tangerine peel oral liquor for treating productive cough |
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| CN200610099307A CN100584316C (en) | 2006-07-13 | 2006-07-13 | Sugar-free type red tangerine peel oral liquor for treating productive cough |
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| CN100584316C true CN100584316C (en) | 2010-01-27 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103494934B (en) * | 2013-10-15 | 2015-08-26 | 广西盈康药业有限责任公司 | A kind of Sugarless type blood-nourishing oral liquid with nine ingredients and preparation method thereof |
| CN108426955A (en) * | 2018-03-11 | 2018-08-21 | 安徽省食品药品检验研究院 | The discrimination method of tuber of stemona genunie medicinal materials |
| CN115919756A (en) * | 2022-10-19 | 2023-04-07 | 梅州市珍宝金柚实业有限公司 | Golden pomelo raw pulp oral liquid and preparation method and application thereof |
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Non-Patent Citations (4)
| Title |
|---|
| 中华人民共和国药典一部. 中华人民共和国药典委员会，657. 2005 |
| 中华人民共和国药典一部. 中华人民共和国药典委员会，657. 2005 * |
| 无糖型清咽消炎冲剂的研制. 黎新荣等.中国医院药学杂志，第16卷第11期. 1996 |
| 无糖型清咽消炎冲剂的研制. 黎新荣等.中国医院药学杂志，第16卷第11期. 1996 * |
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