CN104784365B - A kind of preparation process of compound dandelion oral solution - Google Patents
A kind of preparation process of compound dandelion oral solution Download PDFInfo
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- CN104784365B CN104784365B CN201510219086.1A CN201510219086A CN104784365B CN 104784365 B CN104784365 B CN 104784365B CN 201510219086 A CN201510219086 A CN 201510219086A CN 104784365 B CN104784365 B CN 104784365B
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Abstract
The present invention provides a kind of preparation processes of compound dandelion oral solution, it is to be prepared by the following method: (1) weighing bulk pharmaceutical chemicals: dandelion, folium isatidis, viola mandshurica, Radix Glycyrrhizae；(2) it by above-mentioned raw materials medicine, adds water to cook；(3) decocting liquid filters, and it is 1.10~1.15 (60 DEG C) that filtrate, which is concentrated into relative density, adds ethyl alcohol to make alcohol content up to 65%, refrigerates, filtration；(4) filtrate tune pH value refrigerates, filtration to 8.3-8.5；(5) filtrate decompression is concentrated into no alcohol, adds purified water quantitative, adjusts pH value to 6.5-7.0, filtration, encapsulating, sterilizing to get.The present invention also provides the compound dandelion oral solutions that preceding method is prepared.Compound dandelion oral solution quality prepared by the present invention is stablized, and the indexs such as character, clarity and active constituent content meet the requirement of novel chiral synthon preparation after long-term placement, has practical application value.
Description
Technical field
The present invention relates to field of veterinary, and in particular to a kind of preparation process of veterinary drug oral solution.
Background technique
Pig febrile disease is common one of the disease in current pig farm, can clinically be divided into fever caused by infection and non-infectious hair
Heat, wherein fever caused by infection is most commonly seen, various pathogen (such as bacterium, virus, mycoplasma, Chlamydia, Richettsia, spirals
Body, fungi, helminth) can cause to generate heat, acute infectious disease accounts for critical role in fever caused by infection, as swine fever, brickpox,
The several frequently seen infectious disease such as Streptococcus suis, swine toxoplasmosis, swine eperythrozoonosis has high fever and different degrees of whole body
Symptom.Pig will lead to its appetite stimulator once falling ill, or even not feed.
Compound dandelion oral solution is the novel chiral synthon preparation developed for pig febrile disease, and prescription is by folium isatidis, Pu Gong
English, viola mandshurica, Radix Glycyrrhizae four traditional Chinese medicine material composition, it is extracted, concentration and purifying be made, for pig febrile disease it is fast, again, poor prognosis
The features such as, this product is prepared into oral liquid formulations, with the curative effect of fast onset drug, from facing with the trouble boiled medicine, application
Also more convenient, easily received for veterinary clinic using unit；But compound dandelion oral solution is there is also the FAQs of oral solution,
For example precipitating is also easy to produce after placing oral solution for a long time, phenomena such as clarity is poor, and active constituent content declines, how to improve multiple
The quality stability of square dandelion oral solution is a urgent problem.
Summary of the invention
It is an object of that present invention to provide a kind of preparation processes of compound dandelion oral solution, to improve dandelion oral solution
Quality stability.
The present invention provides a kind of preparation processes of compound dandelion oral solution, it includes the following steps:
(1) bulk pharmaceutical chemicals are weighed: dandelion, folium isatidis, viola mandshurica, Radix Glycyrrhizae；
(2) it by above-mentioned raw materials medicine, adds water to cook；
(3) decocting liquid filters, and it is 1.10~1.15 (60 DEG C) that filtrate, which is concentrated into relative density, and ethyl alcohol is added to reach alcohol content
65%, it refrigerates, filtration；
(4) filtrate tune pH value refrigerates, filtration to 8.3-8.5；
(5) filtrate decompression is concentrated into no alcohol, adds purified water quantitatively to adjust pH value to 6.5-7.0, filters, encapsulating, sterilizing, i.e.,
.
Wherein, in step (2), secondary, first time plus 30 times of amount water are added water to cook, second plus 20 times of amount water are pan-fried every time
It boils 2 hours.
Wherein, in step (3) and step (4), cold preservation time is 24 hours or more.
Wherein, in step (4), pH value 20%NaOH is adjusted.
Wherein, in step (5), preservative is added after adjusting pH value, then filter.
Further, the sorbic acid that preservative is final concentration of 0.2%.
" final concentration of 0.2% sorbic acid " refers to that sorbic acid is shared final concentration of in compound dandelion oral solution
0.2%.
Wherein, the proportion of bulk pharmaceutical chemicals are as follows: 30-120 parts of dandelion；15-60 parts of folium isatidis；15-60 parts of viola mandshurica；
5-20 parts of Radix Glycyrrhizae.
Further, the proportion of bulk pharmaceutical chemicals are as follows: 60 parts of dandelion；15 parts of folium isatidis；30 parts of viola mandshurica；5 parts of Radix Glycyrrhizae.
The present invention also provides the compound dandelion oral solutions that preceding method is prepared.
The present invention passes through the addition of the critical process steps such as alcohol filtrate alkali tune on the basis of conventional oral liquid preparing process
And state modulator, the compound dandelion oral solution final product quality that finally makes are stablized, and character, clarity and have after placing 2 years
The indexs such as effective component content meet the requirement of novel chiral synthon preparation, have practical application value.
Specific embodiment
It is described further below with embodiment, but the present invention is not limited to these embodiments.
The preparation of the compound dandelion oral solution of the present invention of embodiment 1
It takes: dandelion 600g, folium isatidis 150g, viola mandshurica 300g, Radix Glycyrrhizae 50g；
It by weighed four traditional Chinese medicine material, adds water to cook secondary, for the first time plus 30 times of amount water, adds 20 times of amount water second, every time
It decocts 2 hours, collecting decoction, filtration, it is 1.10~1.15 (60 DEG C) that filtrate, which is concentrated into relative density, and ethyl alcohol is added to reach alcohol content
65%, refrigeration 24 hours or more, filtration, filtrate 20%NaOH tune pH value to 8.3-8.5 refrigeration 24 hours or more, filtered, filter
Liquid is concentrated under reduced pressure into no alcohol, adds purified water to adjust total amount to 1000ml, adds 0.2% sorbic acid, stirring and dissolving, and adjust pH value to
6.5-7.0, filtration, encapsulating, sterilizing to get.
Beneficial effects of the present invention are illustrated below by way of test example.
The stability study of 1 compound dandelion oral solution difference preparation method of test example
1, test material
The compound dandelion oral solution (oral solution one) of this preparation process preparation: it is prepared according to 1 method of the embodiment of the present invention
It forms.
The compound dandelion oral solution (oral solution two) of common process preparation: preparation process is as follows: it takes: dandelion 600g,
Folium isatidis 150g, viola mandshurica 300g, Radix Glycyrrhizae 50g；By weighed four traditional Chinese medicine material, secondary, first time plus 30 times of amounts are added water to cook
Water, second plus 20 times of amount water, decoct 2 hours every time, collecting decoction, filtration, filtrate be concentrated into relative density for 1.10~
1.15 (60 DEG C) add ethyl alcohol to make alcohol content up to 65%, and refrigeration 24 hours or more, filtration, filtrate decompression was concentrated into no alcohol, adds purifying
Water adjusts total amount to 1000ml, adds 0.2% sorbic acid, stirring and dissolving, filtration, encapsulating, sterilizing to get.
2, stability test
Three batches of samples are prepared respectively by preparation process of the present invention and common process, under the conditions of quasi- listing finished product packing, are set
25 DEG C ± 2 DEG C of temperature, placed under the conditions of relative humidity 60% ± 10%, sampling in every 3 months is primary, respectively at 0,3,6,9,12,
18, it samples within 24 months, emphasis carries out three oral fluidity shape, clarity, effective component (aesculetin) assay indexs
Comparative experimental research.
Oral solution main indicator detection method:
(1) character
Oral solution sample 5ml is taken, is set in colorless and transparent test tube, oral fluidity shape is observed under white background, this product should be
Brown liquid.
(2) clarity
Oral solution sample is taken, is set in colorless and transparent beaker, jog is observed under white background, observe oral solution clarity
And precipitation status, this product should be clarified.
(3) content of Aesculetin measures
According to high effective liquid chromatography for measuring, in which:
Chromatographic condition and system suitability are tested: using octadecylsilane chemically bonded silica as filler；With methanol -0.6%
Glacial acetic acid aqueous solution (18:82) is mobile phase；Detection wavelength is 323nm.Number of theoretical plate should be not less than by the calculating of aesculetin peak
3000。
The preparation of reference substance solution: taking aesculetin reference substance appropriate, accurately weighed, adds methanol that every 1ml is made containing the bark of ash
The solution of 80 μ g of B prime to get.
The preparation of test solution: precision measures oral solution sample 3ml, sets in stuffed conical flask, precision plus methanol 22ml,
Close plug, weighed weight, ultrasonic treatment (power 200W, frequency 32kHz) 30 minutes let cool, then weighed weight, are supplied and subtracted with methanol
The weight of mistake, shakes up, filtration, take subsequent filtrate to get.
Measuring method: accurate absorption reference substance solution and each 10 μ l of test solution respectively, injection liquid chromatograph, measurement,
To obtain the final product.
The every 1ml of this product is containing viola mandshurica with aesculetin (C9H6O4) meter, 0.28mg must not be lacked.
3, test result
(1) character
Testing result is shown in Table 1.
1 character of table detects test data
Seen from table 1: the compound dandelion oral solution (oral solution one) and conventional fabrication process prepared by this preparation process
Oral liquid formulations (oral solution two) the appearance character observation no significant difference being prepared, is brown liquid.
(2) clarity
Testing result is shown in Table 2.
2 clarity of table detects test data
From table 2: routinely the compound dandelion oral liquid formulations (oral solution two) of preparation process preparation are extremely unstable,
Start to occur precipitating on a small quantity after placing 3 months, occur a large amount of precipitatings after placing 6 months, quality is against regulation；And use this
Compound dandelion oral solution (oral solution one) quality that preparation process is prepared is stablized, and freshly prepd after placing 24 months
Oral solution is compared, clarity no significant difference, illustrates that the oral solution clarity prepared by this preparation process meets regulation.
(3) content of Aesculetin measures
It the results are shown in Table 3.
Table 3 effective component (aesculetin) content balance test data (unit: mg/ml)
Seen from table 3: in the compound dandelion oral solution (oral solution two) being produced in conventional fashion under content of Aesculetin
Drop is more obvious, and after placing 12 months, content has been lower than 0.28mg/ml, against regulation, it may be possible to since precipitating generates, packet
It wraps up in caused by effective component；And according to content of Aesculetin in the compound dandelion oral solution (oral solution one) of this preparation process preparation
More stable, content does not decline substantially after placing 24 months, meets regulation.
In conclusion poor by the compound dandelion stability of Oral that traditional handicraft is prepared, long-term place is also easy to produce
Precipitating, and active constituent content loss is more obvious, technique has certain problems, and the present invention is on the basis of common process
On, the critical process of alcoholic solution alkali tune removal of impurities, and strict control technological parameter are added in preparation process, finally makes obtained multiple
Square dandelion oral solution clarity meets oral liquid formulations requirement, and active constituent content is stablized, and quality stability is promoted obviously,
Achieve good effect.
Claims (1)
1. a kind of preparation process of compound dandelion oral solution, it is characterised in that: it includes the following steps:
(1) bulk pharmaceutical chemicals are weighed: 60 parts of dandelion, 15 parts of folium isatidis, 30 parts of viola mandshurica, 5 parts of Radix Glycyrrhizae；
(2) by above-mentioned raw materials medicine, secondary, first time plus 30 times of amount water are added water to cook, second plus 20 times of amount water decoct 2 every time
Hour；
(3) decocting liquid filters, and it is 1.10~1.15 that filtrate, which is concentrated into relative density at 60 DEG C, and ethyl alcohol is added to make alcohol content up to 65%, cold
Hide 24 hours or more, filtration；
(4) filtrate 20%NaOH tune pH value to 8.3-8.5, refrigeration 24 hours or more, filtration；
(5) filtrate decompression is concentrated into no alcohol, adds purified water quantitative, 0.2% sorbic acid is added, and adjusts pH value to 6.5-7.0, filter
Cross, encapsulating, sterilizing to get.
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| CN104784365B true CN104784365B (en) | 2019-11-26 |
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| CN109771521A (en) * | 2019-03-11 | 2019-05-21 | 阜新登峰农牧有限公司 | The double yellow double essence arts of Chinese medicine for preventing and treating pig epidemic fever disease dissipate |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103285135A (en) * | 2013-06-20 | 2013-09-11 | 成都乾坤动物药业有限公司 | Preparation technology for increasing clarity of poplar flower injection |
| CN103285176A (en) * | 2013-06-27 | 2013-09-11 | 成都乾坤动物药业有限公司 | Micro-powder granules for treating fever disease of pigs and preparation process thereof |
| CN104155383A (en) * | 2014-08-27 | 2014-11-19 | 成都乾坤动物药业有限公司 | Detection method of dandelion and viola philippica granules |
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| JPWO2006008802A1 (en) * | 2004-07-20 | 2008-07-31 | 株式会社栃本天海堂 | Herbal medicine for domestic animals |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103285135A (en) * | 2013-06-20 | 2013-09-11 | 成都乾坤动物药业有限公司 | Preparation technology for increasing clarity of poplar flower injection |
| CN103285176A (en) * | 2013-06-27 | 2013-09-11 | 成都乾坤动物药业有限公司 | Micro-powder granules for treating fever disease of pigs and preparation process thereof |
| CN104155383A (en) * | 2014-08-27 | 2014-11-19 | 成都乾坤动物药业有限公司 | Detection method of dandelion and viola philippica granules |
Non-Patent Citations (1)
| Title |
|---|
| 消炎退热胶囊的质量标准研究;陈学松;《中成药》;20090731;第31卷(第7期);第1140-1142页 * |
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Address after: No. 259, Middle Section of Jinfu Road, Wenjiang District, Chengdu City, Sichuan Province, 611130 Patentee after: CHENGDU QIANKUN VETERINARY PHARMACEUTICAL CO.,LTD. Address before: 611130 no.259 Jinfu Road, Chengdu cross strait science and Technology Industrial Development Park, Wenjiang District, Chengdu City, Sichuan Province Patentee before: CHENGDU QIANKUN VETERINARY PHARMACEUTICAL Co.,Ltd. |
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