CN102940856B - Method for preparing anti-viral oral liquid and product thereof - Google Patents
Method for preparing anti-viral oral liquid and product thereof Download PDFInfo
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Abstract
The invention discloses a method for preparing anti-viral oral liquid and a product thereof. The method is characterized in that the pH value of the oral liquid is stabilized at 5.5 to 6; and preferably, the pH value is stabilized in the range by adding a buffer salt. The preparation method for the product is completed, and the effect of the product is improved; and the clarity of the oral liquid can be effectively kept for a long term, and the pH value of the oral liquid and the stability of the forsythin content are effectively improved.
Description
Technical field
The present invention relates to a kind of modified model antivirus oral liquid preparation method and products thereof, belong to field of medicaments.
Background technology
Antivirus oral liquid is market application Chinese medicine preparation very widely, the clinical treatment that is mainly used in anemopyretic cold and influenza.In pharmacopeia, the formulation and technology of antivirus oral liquid is as follows:
[prescription] Radix Isatidis 129g Gypsum Fibrosum 57g Rhizoma Phragmitis 61g Radix Rehmanniae 32g Radix Curcumae 25g Rhizoma Anemarrhenae 25g Rhizoma Acori Graminei 25g Herba Pogostemonis 29g Fructus Forsythiae 46g;
[method for making] above nine tastes, decoct with water secondary, and 3 hours for the first time, collect volatile oil, use HYDROXYPROPYL BETA-CYCLODEXTRIN enclose, or 1.5 hours for the first time (collecting volatile oil and volatile oil emulsion) simultaneously; 1 hour 20 minutes for the second time, filter, filtrate merges, be concentrated into appropriate, add more than 85% ethanol and make to be 70% containing alcohol amount, standing, filter, filtrate recycling ethanol is also concentrated in right amount, adds volatile oil clathrate compound and proper honey, sucrose, flavoring orange essence, sodium cyclamate or adds volatile oil, volatile oil emulsion and proper honey, sucrose; Add water to 1000ml, mix, filtration, embedding, sterilizing, obtain.And in the working standard of pharmacopeia, the pH value of regulation antivirus oral liquid should remain between 4.0-6.0.
Domestic manufacturer is a lot, and what most of enterprise produced is sugar-containing type antivirus oral liquid, in finished product, contains a large amount of Mel and sucrose as correctives; What also have the production of fraction enterprise is sugar-free resisting virus oral liquid, uses super sweeting agent if steviosin, aspartame etc. are as correctives.Existing commercially available prod is analyzed, studied, and result shows that the product of producing by working standard exists following problem: 1, the preparation method of existing antivirus oral liquid is not perfect, and pH value given range is too large, causes the effect of product to differ greatly; 2, pH value poor stability; Existing sugar-containing type antivirus oral liquid, after placing 3 months, sample pH value presents significantly downward trend, and Determination of forsythin declines more than 10%; There is precipitation in solution after placing 1 year.The commercially available sample of sugar-free resisting virus oral liquid, solution has obvious sediment, and place sample pH value after 3 months and present significantly downward trend,, precipitation capacity significantly increases, and Determination of forsythin declines more than 10%.Therefore, antivirus oral liquid be sugar-containing type antivirus oral liquid or sugar-free resisting virus oral liquid all exist pH value unstable, do not clarify and the unsettled problem of Determination of forsythin.Clarity declines, and can become muddy brown solution, affects the outward appearance of product; And Determination of forsythin directly affects the effect of antivirus oral liquid, Determination of forsythin declines the effect obviously mean this antivirus oral liquid after long-time standing, also can obviously decline.Therefore there is the problem that effect quality is unstable, easily cause doctor-patient dispute in existing antivirus oral liquid.
Summary of the invention
Technical problem to be solved by this invention is, a kind of antivirus oral liquid preparation method and products thereof is provided.Product preparation method that the present invention is perfect, has determined rational pH value scope, and has improved the stability of pH value; The present invention can permanently effective maintenance oral liquid clarity, and effectively improve the stability of Determination of forsythin and the drug effect of oral liquid.
For solving the problems of the technologies described above, the present invention adopts following technical scheme: a kind of preparation method of antivirus oral liquid, is stabilized in 5.5-6 by the pH value of this oral liquid.
In the preparation method of above-mentioned antivirus oral liquid, by adding buffer salt to stablize pH value.
In the preparation method of aforesaid antivirus oral liquid, described buffer salt is sodium dihydrogen phosphate or potassium dihydrogen phosphate.
In the preparation method of aforesaid antivirus oral liquid, the concrete steps of this preparation method are, take Radix Isatidis 129g, Gypsum Fibrosum 57g, Rhizoma Phragmitis 61g, Radix Rehmanniae 32g, Radix Curcumae 25g, Rhizoma Anemarrhenae 25g, Rhizoma Acori Graminei 25g, Herba Pogostemonis 29g, Fructus Forsythiae 46g nine taste medical materials, decoct with water secondary; Decoct for the first time 1.5 hours, decoct for the second time 1 hour 20 minutes, filter, filtrate merges, and is concentrated into 200ml, adds 95% ethanol and makes to be 70% containing alcohol amount, standing, filters, and filtrate recycling ethanol is also concentrated into appropriate, adds volatile oil, volatile oil emulsion, antibacterial; Add buffer salt 1-10g, then add pH adjusting agent regulator solution pH value to 5.5-6; Finally add water to 1000ml, mix, filtration, embedding, sterilizing, obtain antivirus oral liquid.
In antivirus oral liquid prepared by preceding method, this oral liquid is mainly made by Radix Isatidis 129g, Gypsum Fibrosum 57g, Rhizoma Phragmitis 61g, Radix Rehmanniae 32g, Radix Curcumae 25g, Rhizoma Anemarrhenae 25g, Rhizoma Acori Graminei 25g, Herba Pogostemonis 29g, Fructus Forsythiae 46g and buffer salt 1-10g; Described buffer salt is sodium dihydrogen phosphate or potassium dihydrogen phosphate.
Compared with prior art, applicant is by analyzing the preparation method of existing antivirus oral liquid and research, and numerous factors such as the component in this preparation method process and proportion relation thereof, method step, temperature, pH value are tested, compare, screen, summed up, find when existing antivirus oral liquid pH value is during at 5.5-6, within rational service time, the constant product quality outside this pH value scope in existing pH value standard is good.
Applicant is through further test, even pH value is in the scope of 5.5-6 while finding the dispatching from the factory of existing antivirus oral liquid, no matter be sugar-containing type antivirus oral liquid, or Sugarless type oral liquid, after long-time placement, effect still can decline, such as the keeping life of existing antivirus oral liquid is generally 2 years, but placed after 1 year at product, although product is complete failure not, but there will be pH value to decline, solution generates precipitation, the problem that the clarity of product declines, and Determination of forsythin is declined, and and then cause the decline of product efficacy.
Therefore, the preparation method of applicant's product is optimized, and antivirus oral liquid pH value is determined at 5.5-6, and taked to stablize with buffer salt the measure of pH value.For this reason, applicant repeatedly tests, contrasts, sums up, concludes from numerous buffer salts, finally screening obtains sodium dihydrogen phosphate or these two kinds of buffer salts of potassium dihydrogen phosphate, add antivirus oral liquid after sodium dihydrogen phosphate or potassium dihydrogen phosphate within reaching the keeping life of 2 years, for a long time, stably to keep pH value, also stability simultaneously that guaranteed to stick up glycosides content, the clarity that has effectively kept oral liquid, has solved the problem that existing product exists, and has obtained unforeseeable effect.It is below applicant's experimentation.
Table one: the impact of antivirus oral liquid pH on stability of solution.
Experimental technique: 2010 editions pharmacopeia regulation antivirus oral liquid pH scopes are 4.0-6.0, and we are divided into 5 parts by same antivirus oral liquid solution, regulate different pH with sodium hydroxide and hydrochloric acid, after embedding sterilizing, under 40 degree conditions, place, observe the indices of solution, result is as follows:
From table one, pH value is that 4.0-5.0 solution is placed 10 days under 40 degree conditions, solution easily has Precipitation, the content of phillyrin declines obviously, when therefore antiviral solution is within the scope of pH value is 4.0-5.0, quality stability will change in a short time, and the content that produces precipitation and phillyrin obviously declines.And the antivirus oral liquid solution that pH value is 5.5-6.0 is placed 10 days under 40 degree conditions, solution is clarified substantially, and effectively keep Determination of forsythin, the drug effect that keeps oral liquid, be the clarity of antiviral oral administration solution, the content of phillyrin is relevant with pH, this is also the key factor that keeps the drug effect of oral liquid.Yet the antivirus oral liquid solution that pH value is 5.5-6.0 is placed 1 month under 40 degree conditions, still can cause pH value obviously to decline, and make solution occur a small amount of precipitation, and the obvious decline of Determination of forsythin.
Table two: the stablizing effect test of sodium dihydrogen phosphate and potassium dihydrogen phosphate.
Experimental technique: will be divided into N part with a antiviral solution, and add sodium dihydrogen phosphate or potassium dihydrogen phosphate, and be mixed with the solution of different pH value, and after embedding sterilizing, place 6 months in 40 degree proof boxs, and observe the indices of solution:
From table two, add after sodium dihydrogen phosphate or potassium dihydrogen phosphate, pH is within the scope of 5.5-6.0 time, under 40 degree conditions, place and within 6 months, can effectively keep solution clarification and keep Determination of forsythin, and solution is placed 6 months at 40 degree, being equivalent to room temperature places 2 years, this has surpassed the effect duration that this product is drafted, therefore in the scope that is 5.5-6.0 at pH and add after the buffer salt that applicant preferably obtains, can be long-term within reaching the keeping life of 2 years, stably keep pH value, also stability simultaneously that guaranteed to stick up glycosides content, the clarity that has effectively kept oral liquid, solved the problem that existing product exists, obtained unforeseeable effect.
The specific embodiment
Below in conjunction with embodiment, the present invention is further illustrated.
Embodiment 1:
A preparation method for antivirus oral liquid, this preparation method is in solution, to add sodium dihydrogen phosphate buffer salt, regulates after pH, makes the pH value of oral liquid finished product be stabilized in 5.5.
The concrete preparation method of above-mentioned antivirus oral liquid is: take Radix Isatidis 129g, Gypsum Fibrosum 57g, Rhizoma Phragmitis 61g, Radix Rehmanniae 32g, Radix Curcumae 25g, Rhizoma Anemarrhenae 25g, Rhizoma Acori Graminei 25g, Herba Pogostemonis 29g, Fructus Forsythiae 46g nine taste medical materials, decoct with water secondary; Decoct for the first time 1.5 hours, decoct for the second time 1 hour 20 minutes, filter, filtrate merges, be concentrated into 200ml, add 95% ethanol and make to be 70% containing alcohol amount, standing, filter, filtrate recycling ethanol is also concentrated into appropriate, adds volatile oil, volatile oil emulsion, antibacterial, correctives appropriate; Add again sodium dihydrogen phosphate buffer salt 5g gram, add pH adjusting agent regulator solution pH value to 5.7, add water to 1000ml, mix, filtration, embedding, sterilizing, obtain antivirus oral liquid, after sterilizing, pH value of solution is down to 5.5, and buffer salt can make solution pH value in depositing process maintain 5.5.
By said method, prepare the antivirus oral liquid obtaining, mainly by Radix Isatidis 129g, Gypsum Fibrosum 57g, Rhizoma Phragmitis 61g, Radix Rehmanniae 32g, Radix Curcumae 25g, Rhizoma Anemarrhenae 25g, Rhizoma Acori Graminei 25g, Herba Pogostemonis 29g, Fructus Forsythiae 46g and sodium dihydrogen phosphate 5g, made.
Embodiment 2:
A preparation method for antivirus oral liquid, this preparation method is to add potassium dihydrogen phosphate buffer salt, regulates after pH, makes the pH value of oral liquid be stabilized in 6.0.
The concrete preparation method of above-mentioned antivirus oral liquid is: take Radix Isatidis 129g, Gypsum Fibrosum 57g, Rhizoma Phragmitis 61g, Radix Rehmanniae 32g, Radix Curcumae 25g, Rhizoma Anemarrhenae 25g, Rhizoma Acori Graminei 25g, Herba Pogostemonis 29g, Fructus Forsythiae 46g nine taste medical materials, decoct with water secondary; Decoct for the first time 1.5 hours, decoct for the second time 1 hour 20 minutes, filter, filtrate merges, be concentrated into 200ml, add 95% ethanol and make to be 70% containing alcohol amount, standing, filter, filtrate recycling ethanol is also concentrated into appropriate, adds volatile oil, volatile oil emulsion, antibacterial, correctives appropriate; Add potassium dihydrogen phosphate buffer salt 8g gram; Add pH adjusting agent regulator solution pH value to 6.3, add water to 1000ml, mix, filtration, embedding, sterilizing, obtain antivirus oral liquid, after sterilizing, pH value of solution is 6.0, and potassium dihydrogen phosphate buffer salt can make solution deposit pH value in process and maintain 6.0.
By said method, prepare the antivirus oral liquid obtaining, mainly by Radix Isatidis 129g, Gypsum Fibrosum 57g, Rhizoma Phragmitis 61g, Radix Rehmanniae 32g, Radix Curcumae 25g, Rhizoma Anemarrhenae 25g, Rhizoma Acori Graminei 25g, Herba Pogostemonis 29g, Fructus Forsythiae 46g and potassium dihydrogen phosphate 8g, made.
Embodiment 3:
A preparation method for antivirus oral liquid, this preparation method is to add potassium dihydrogen phosphate buffer salt, regulates after pH, makes the pH value of oral liquid be stabilized in 5.8.
The concrete preparation method of above-mentioned antivirus oral liquid is: take Radix Isatidis 129g, Gypsum Fibrosum 57g, Rhizoma Phragmitis 61g, Radix Rehmanniae 32g, Radix Curcumae 25g, Rhizoma Anemarrhenae 25g, Rhizoma Acori Graminei 25g, Herba Pogostemonis 29g, Fructus Forsythiae 46g nine taste medical materials, decoct with water secondary; Decoct for the first time 1.5 hours, decoct for the second time 1 hour 20 minutes, filter, filtrate merges, be concentrated into 200ml, add 95% ethanol and make to be 70% containing alcohol amount, standing, filter, filtrate recycling ethanol is also concentrated into appropriate, adds volatile oil, volatile oil emulsion, antibacterial, correctives appropriate; Add potassium dihydrogen phosphate buffer salt 5g gram; Add pH adjusting agent regulator solution pH value to 6.0, add water to 1000ml, mix, filtration, embedding, sterilizing, obtain antivirus oral liquid, after sterilizing, pH value of solution is 5.8, and potassium dihydrogen phosphate buffer salt can make solution deposit pH value in process and maintain 5.8.
By said method, prepare the antivirus oral liquid obtaining, mainly by Radix Isatidis 129g, Gypsum Fibrosum 57g, Rhizoma Phragmitis 61g, Radix Rehmanniae 32g, Radix Curcumae 25g, Rhizoma Anemarrhenae 25g, Rhizoma Acori Graminei 25g, Herba Pogostemonis 29g, Fructus Forsythiae 46g and potassium dihydrogen phosphate 5g, made.
Claims (1)
1. a preparation method for antivirus oral liquid, is characterized in that: the pH value of this oral liquid is stabilized in to 5.52-5.98; By adding buffer salt, stablize pH value; Described buffer salt is sodium dihydrogen phosphate or potassium dihydrogen phosphate; The concrete steps of the preparation method of this oral liquid are, take Radix Isatidis 129g, Gypsum Fibrosum 57g, Rhizoma Phragmitis 61g, Radix Rehmanniae 32g, Radix Curcumae 25g, Rhizoma Anemarrhenae 25g, Rhizoma Acori Graminei 25g, Herba Pogostemonis 29g, Fructus Forsythiae 46g nine taste medical materials, decoct with water secondary; Decoct for the first time 1.5 hours, decoct for the second time 1 hour 20 minutes, filter, filtrate merges, and is concentrated into 200ml, adds 95% ethanol and makes to be 70% containing alcohol amount, standing, filters, and filtrate recycling ethanol is also concentrated into appropriate, adds volatile oil, volatile oil emulsion, antibacterial; Add buffer salt 1-10g, then add pH adjusting agent regulator solution pH value to 5.52-5.98; Finally add water to 1000ml, mix, filtration, embedding, sterilizing, obtain antivirus oral liquid.
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| CN103245737A (en) * | 2013-04-17 | 2013-08-14 | 杭州老桐君制药有限公司 | Detection method of anti-viral oral liquid |
| CN106975045A (en) * | 2016-01-15 | 2017-07-25 | 北京盈科瑞药物研究院有限公司 | A kind of antiviral Neulized inhalation pharmaceutical solutions and preparation method thereof |
| CN109985095A (en) * | 2017-12-29 | 2019-07-09 | 瑞普（天津）生物药业有限公司 | A method of preparing Shuanghuanglian oral liquid for livestock clarification preparation |
| CN109985096A (en) * | 2017-12-29 | 2019-07-09 | 瑞普（天津）生物药业有限公司 | A method of promoting Shuanghuanglian oral liquid preparation clear stable |
| CN109498778B (en) * | 2018-11-20 | 2021-07-27 | 安徽东盛友邦制药有限公司 | Antiviral oral liquid with good taste and production process thereof |
| CN109224072B (en) * | 2018-11-20 | 2022-05-03 | 安徽东盛友邦制药有限公司 | Antiviral oral liquid for enhancing immunity and preparation method thereof |
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| CN1308021C (en) * | 2002-08-13 | 2007-04-04 | 吴圣楣 | Antivirus oral liquid |
| CN1939525B (en) * | 2006-09-27 | 2010-05-12 | 广州市香雪制药股份有限公司 | Production of antiviral oral liquid |
| CN102764405A (en) * | 2011-04-30 | 2012-11-07 | 顾建光 | Preparation method of antiviral oral liquid |
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