CN102940856A - 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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- CN102940856A CN102940856A CN2012105360485A CN201210536048A CN102940856A CN 102940856 A CN102940856 A CN 102940856A CN 2012105360485 A CN2012105360485 A CN 2012105360485A CN 201210536048 A CN201210536048 A CN 201210536048A CN 102940856 A CN102940856 A CN 102940856A
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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 that very widely Chinese medicine preparation, the clinical treatment that is mainly used in anemopyretic cold and influenza are used in market.The formulation and technology of antivirus oral liquid is as follows in pharmacopeia:
[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 flavors decoct with water secondary, 3 hours for the first time, collect volatile oil, use the HYDROXYPROPYL BETA-CYCLODEXTRIN enclose, or the first time 1.5 hours (collecting simultaneously volatile oil and volatile oil emulsion); 1 hour 20 minutes for the second time, filter, filtrate merges, be concentrated into an amount of, add ethanol more than 85% and make that to contain the alcohol amount be 70%, leave standstill, filter, filtrate recycling ethanol also is 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, mixing, filtration, embedding, sterilization, and get final product.And the pH value of regulation antivirus oral liquid should remain between the 4.0-6.0 in the working standard of pharmacopeia.
Domestic manufacturer is a lot, and what most of enterprise produced is the sugar-containing type antivirus oral liquid, namely contains a large amount of Mel and sucrose as correctives in finished product; What also have the production of fraction enterprise is the sugar-free resisting virus oral liquid, namely uses super sweeting agent such as steviosin, aspartame etc. as correctives.Existing commercially available prod is analyzed, studied, and the result shows that there is following problem in the product by working standard production: 1, the preparation method of existing antivirus oral liquid is not perfect, and the 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, the sample P H-number presents significant downward trend, and Determination of forsythin descends more than 10%; Precipitation appears in solution after placing 1 year.The commercially available sample of sugar-free resisting virus oral liquid, solution has obvious sediment, places that sample P H presents significant downward trend after 3 months,, precipitation capacity significantly increases, and Determination of forsythin descends 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 descends, and can become muddy brown solution, affects the outward appearance of product; And Determination of forsythin directly affects the effect of antivirus oral liquid, and the effect that Determination of forsythin decline obviously means this antivirus oral liquid also can obviously descend after leaving standstill for a long time.Therefore, existing antivirus oral liquid exist the effect quality unstable, cause the problem of doctor-patient dispute easily.
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 been determined rational pH value scope, and has improved the stability of pH value; The present invention can permanently effective maintenance oral liquid clarity, and the drug effect of the stability of Effective Raise Determination of forsythin and 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 with the pH value of this oral liquid.
In the preparation method of above-mentioned antivirus oral liquid, stablize pH value by adding buffer salt.
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 by weighing 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 flavor medical materials, decoct with water secondary; Decocted 1.5 hours for the first time, decocted 1 hour 20 minutes for the second time, filter, filtrate merges, and is concentrated into 200ml, adds 95% ethanol and makes that to contain the alcohol amount be 70%, leaves standstill, and filters, and filtrate recycling ethanol also is concentrated into an amount of, adds volatile oil, volatile oil emulsion, antibacterial; Add buffer salt 1-10g, add again PH regulator regulator solution pH value to 5.5-6; Add water at last 1000ml, mixing, filtration, embedding, sterilization obtain antivirus oral liquid.
In the antivirus oral liquid of preceding method preparation, 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, the applicant is by analyzing and study the preparation method of existing antivirus oral liquid, 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, sum up, find when existing antivirus oral liquid pH value during at 5.5-6, in rational scope service time, the constant product quality in the existing pH value standard outside this pH value scope is good.
The applicant is through further test, even pH value is in the scope of 5.5-6 when finding the dispatching from the factory of existing antivirus oral liquid, no matter be the sugar-containing type antivirus oral liquid, or Sugarless type oral liquid, effect still can descend after long-time the placement, keeping life such as existing antivirus oral liquid is generally 2 years, but after product has been placed 1 year, although product is complete failure not, descend but pH value can occur, solution generates precipitation, the problem that the clarity of product descends, and Determination of forsythin is descended, and and then cause the decline of product efficacy.
Therefore, the preparation method of applicant's product is optimized, and the 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, the applicant repeatedly tests, contrasts, sums up, concludes from numerous buffer salts, at last screening obtains sodium dihydrogen phosphate or these two kinds of buffer salts of potassium dihydrogen phosphate, add antivirus oral liquid behind sodium dihydrogen phosphate or the potassium dihydrogen phosphate and can within reaching the keeping life in 2 years, for a long time, stably keep pH value, the stability that has simultaneously also 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 below is applicant's experimentation.
Table one: antivirus oral liquid solution pH value is on the impact of 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 with same antivirus oral liquid solution, regulate different PH with sodium hydroxide with hydrochloric acid, after the embedding sterilization, place under 40 degree conditions, observe the indices of solution, the result is as follows:
From table one as can be known, pH value is that 4.0-5.0 solution was placed 10 days under 40 degree conditions, solution easily has Precipitation, the content decrease of phillyrin is obvious, when therefore antiviral solution is in pH value is the 4.0-5.0 scope, quality stability will change in a short time, and the content that produces precipitation and phillyrin obviously descends.And being the antivirus oral liquid solution of 5.5-6.0, under 40 degree conditions, placed 10 days pH value, solution is clarified substantially, and effectively keep Determination of forsythin, the drug effect that keeps oral liquid, the content of clarity, phillyrin that is the antiviral oral administration solution is relevant with the solution pH value, and this also is the key factor that keeps the drug effect of oral liquid.Yet pH value is that the antivirus oral liquid solution of 5.5-6.0 was placed 1 month under 40 degree conditions, still can cause pH value obviously to descend, and makes solution a small amount of precipitation occur, 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, and after the embedding sterilization, in 40 degree proof boxs, place 6 months, and observe the indices of solution:
From table two as can be known, after adding sodium dihydrogen phosphate or potassium dihydrogen phosphate, the solution pH value is in the 5.5-6.0 scope time, under 40 degree conditions, place and effectively to keep the solution clarification in 6 months and keep Determination of forsythin, and solution was placed 6 months at 40 degree, being equivalent to room temperature placed 2 years, this has surpassed the effect duration that this product is drafted, therefore in the solution pH value is the scope of 5.5-6.0 and after adding the buffer salt that the applicant preferably obtains, can be long-term within reaching the keeping life in 2 years, stably keep pH value, the stability that has simultaneously also guaranteed to stick up glycosides content, the clarity that has effectively kept oral liquid, solve the problem that existing product exists, obtained unforeseeable effect.
The specific embodiment
The present invention is further illustrated below in conjunction with embodiment.
Embodiment 1:
A kind of preparation method of antivirus oral liquid, this preparation method are to add the sodium dihydrogen phosphate buffer salt in the solution, behind the adjusting PH, so that the pH value of oral liquid finished product is stabilized in 5.5.
The concrete preparation method of above-mentioned antivirus oral liquid is: take by weighing 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 flavor medical materials, decoct with water secondary; Decocted 1.5 hours for the first time, decocted 1 hour 20 minutes for the second time, filter, filtrate merges, be concentrated into 200ml, add 95% ethanol and make that to contain the alcohol amount be 70%, leave standstill, filter, filtrate recycling ethanol also is concentrated into an amount of, and it is an amount of to add volatile oil, volatile oil emulsion, antibacterial, correctives; Add again sodium dihydrogen phosphate buffer salt 5g gram, add PH regulator regulator solution pH value to 5.7, add water to 1000ml, mixing, filtration, embedding, sterilization, obtain antivirus oral liquid, solution PH is down to 5.5 after the sterilization, and buffer salt can make solution pH value in depositing process maintain 5.5.
By the antivirus oral liquid that the said method preparation obtains, 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 sodium dihydrogen phosphate 5g.
Embodiment 2:
A kind of preparation method of antivirus oral liquid, this preparation method are to add the potassium dihydrogen phosphate buffer salt, behind the adjusting PH, so that the pH value of oral liquid is stabilized in 6.0.
The concrete preparation method of above-mentioned antivirus oral liquid is: take by weighing 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 flavor medical materials, decoct with water secondary; Decocted 1.5 hours for the first time, decocted 1 hour 20 minutes for the second time, filter, filtrate merges, be concentrated into 200ml, add 95% ethanol and make that to contain the alcohol amount be 70%, leave standstill, filter, filtrate recycling ethanol also is concentrated into an amount of, and it is an amount of to add volatile oil, volatile oil emulsion, antibacterial, correctives; Add potassium dihydrogen phosphate buffer salt 8g gram; Add PH regulator regulator solution pH value to 6.3, add water to 1000ml, mixing, filtration, embedding, sterilization obtain antivirus oral liquid, and solution PH is 6.0 after the sterilization, and the potassium dihydrogen phosphate buffer salt can make solution deposit that pH value maintains 6.0 in the process.
By the antivirus oral liquid that the said method preparation obtains, 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 potassium dihydrogen phosphate 8g.
Embodiment 3:
A kind of preparation method of antivirus oral liquid, this preparation method are to add the potassium dihydrogen phosphate buffer salt, behind the adjusting PH, so that the pH value of oral liquid is stabilized in 5.8.
The concrete preparation method of above-mentioned antivirus oral liquid is: take by weighing 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 flavor medical materials, decoct with water secondary; Decocted 1.5 hours for the first time, decocted 1 hour 20 minutes for the second time, filter, filtrate merges, be concentrated into 200ml, add 95% ethanol and make that to contain the alcohol amount be 70%, leave standstill, filter, filtrate recycling ethanol also is concentrated into an amount of, and it is an amount of to add volatile oil, volatile oil emulsion, antibacterial, correctives; Add potassium dihydrogen phosphate buffer salt 5g gram; Add PH regulator regulator solution pH value to 6.0, add water to 1000ml, mixing, filtration, embedding, sterilization obtain antivirus oral liquid, and solution PH is 5.8 after the sterilization, and the potassium dihydrogen phosphate buffer salt can make solution deposit that pH value maintains 5.8 in the process.
By the antivirus oral liquid that the said method preparation obtains, 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 potassium dihydrogen phosphate 5g.
Claims (5)
1. the preparation method of an antivirus oral liquid is characterized in that: the pH value of this oral liquid is stabilized in 5.5-6.
2. the preparation method of antivirus oral liquid according to claim 1 is characterized in that: stablize pH value by adding buffer salt.
3. the preparation method of antivirus oral liquid according to claim 2, it is characterized in that: described buffer salt is sodium dihydrogen phosphate or potassium dihydrogen phosphate.
4. according to claim 1 to the preparation method of 3 each described antivirus oral liquids, it is characterized in that: the concrete steps of this preparation method are, take by weighing 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 flavor medical materials, decoct with water secondary; Decocted 1.5 hours for the first time, decocted 1 hour 20 minutes for the second time, filter, filtrate merges, and is concentrated into 200ml, adds 95% ethanol and makes that to contain the alcohol amount be 70%, leaves standstill, and filters, and filtrate recycling ethanol also is concentrated into an amount of, adds volatile oil, volatile oil emulsion, antibacterial; Add buffer salt 1-10g, add again PH regulator regulator solution pH value to 5.5-6; Add water at last 1000ml, mixing, filtration, embedding, sterilization obtain antivirus oral liquid.
5. the antivirus oral liquid of described method preparation according to claim 4, it is characterized in that: 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.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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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 |
| CN109224072A (en) * | 2018-11-20 | 2019-01-18 | 安徽东盛友邦制药有限公司 | A kind of antiviral oral liquor of strengthen immunity and preparation method thereof |
| 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 |
| 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 |
| 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 |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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| 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 |
| 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 |
| CN109224072A (en) * | 2018-11-20 | 2019-01-18 | 安徽东盛友邦制药有限公司 | A kind of antiviral oral liquor of strengthen immunity and preparation method thereof |
| 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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Address after: Hangzhou City, Zhejiang province 311500 an Tonglu Road Economic Development Zone No. 88 Patentee after: Hangzhou Huarun laotongjun Pharmaceutical Co., Ltd Address before: Hangzhou City, Zhejiang province 311512 an Tonglu Road Economic Development Zone No. 88 Patentee before: HANGZHOU L-TONJUN PHARMACEUTICAL Co.,Ltd. |