CN108295040A - Yuxintong capsules preparation method - Google Patents
Yuxintong capsules preparation method Download PDFInfo
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- CN108295040A CN108295040A CN201711162926.0A CN201711162926A CN108295040A CN 108295040 A CN108295040 A CN 108295040A CN 201711162926 A CN201711162926 A CN 201711162926A CN 108295040 A CN108295040 A CN 108295040A
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- ethyl alcohol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/66—Papaveraceae (Poppy family), e.g. bloodroot
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/55—Liquid-liquid separation; Phase separation
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Abstract
The invention discloses a kind of Yuxintong capsules preparation methods, red ginseng, Radix Notoginseng and corydalis tuber are extracted by continuous dynamic countercurrent respectively, and it is eluted by macroporous resin column, it is detached again through wide spectrum medicine target system of fingerprints, concentration, dry, crushing, by treated, powder mixes, and refills to obtain capsule preparations by liquid fluidized bed granulation.The Yuxintong capsules preparation method of the present invention discards the dross and selects the essential to active compound object using multinomial domestic forward position pharmaceutical technology, is finally reached the purpose for improving curative effect and reducing toxic side effect, and reduces the consumption of the energy in this course.
Description
Technical field
The present invention relates to a kind of Yuxintong capsules preparation methods.
Background technology
There are many kinds of the Chinese patent drugs for treating coronary heart diseases and angina pectoris, is broadly divided into two classes, first, single medicinal material or its extraction
Object, such as Danshen heart-benefiting piece（It is prepared by Salvia root P.E）, Kedaling（It is prepared by the alcohol extracting thing of corydalis tuber）；It is another
Class is compound preparation, such as：Researches on Oral Solution for Checking Heart Pain（It is made of Radix Astragali, Radix Ophiopogonis, Radix Salviae Miltiorrhizae etc.）, the first nourishing heart electuary of benefit（By Radix Astragali, Radix Salviae Miltiorrhizae
Deng composition）, heart pill（It is made of styrax, borneol, Radix Salviae Miltiorrhizae, Radix Notoginseng etc.）, nourishing heart blood circulation promoting ointment（By Radix Salviae Miltiorrhizae, Radix Astragali, Radix Angelicae Sinensis, ice
The compositions such as piece）Deng.Although these drugs have certain clinical efficacy for the treatment of coronary heart diseases and angina pectoris, in various degree
Presence treatment it is not definite enough, be unable to the defects for the treatment of both manifestation and root cause of disease.CN1297290C discloses a kind of coronary disease and angina pectoris for the treatment of
Pharmaceutical composition and preparation method thereof, pharmaceutical composition includes red ginseng, Radix Notoginseng and corydalis tuber, but preparation method compares biography
System, effect be not notable.
Invention content
The object of the present invention is to provide a kind of Yuxintong capsules preparation methods, using multinomial domestic forward position pharmaceutical technology to original
Drug is discarded the dross and selected the essential, and is finally reached the purpose for improving curative effect and reducing toxic side effect, and reduce disappearing for the energy in this course
Consumption.
Present invention technical solution used for the above purpose is：Yuxintong capsules preparation method, steps are as follows：1）
Ethyl alcohol infiltration is added in red ginseng, is then extracted by continuous dynamic countercurrent twice, merges extracting solution, then passes through macroporous absorbent resin
Column elutes, and ethanol eluate is detached by wide spectrum medicine target system of fingerprints, concentration, it is dry, smash it is spare；2）Radix Notoginseng powder at coarse powder,
Water continuous dynamic countercurrent is added to extract, by the way that using divinylbenzene as crosslinking agent, toluene, dimethylbenzene etc. are used as pore after extracting solution filtering
The resin absorbing column of agent, it is spare by the liquid of resin column；Resin column is eluted with ethyl alcohol, and ethanol eluate is distilled to recover second
Merge with above-mentioned liquid after alcohol, then detached by wide spectrum medicine target system of fingerprints, is concentrated, it is dry, it smashes spare；
3）Ethyl alcohol infiltration is added in corydalis tuber, and then continuous dynamic countercurrent extracts, and is eluted by large pore resin absorption column, ethanol elution
Liquid is detached by wide spectrum medicine target system of fingerprints, and concentration dry, pulverize spare；4）Above-mentioned 3 kinds of extract fine powders are mixed, are carried out
Capsule is filled.
Further, the step 4）After extract is pulverized and mixed, 1.5% pregelatinized starch and the stirring of 75% ethyl alcohol is added
Uniformly, particle is made using fluidized bed granulation technology, particle is added the magnesium stearate of total amount 0.5%, then carries out capsule charge.
Further, Yuxintong capsules preparation method is as follows：1）It is small that 8 times of amount ethyl alcohol infiltrations 3 are added in red ginseng
When after medicinal material together with infiltration ethanol continuous dynamic countercurrent extract 3.5 hours, filtration, decompression filtrate recycling ethanol is spare, the dregs of a decoction
It is spare；The red ginseng extraction dregs of a decoction add 6 times of amount water continuous dynamic countercurrents to extract 1.5 hours, and extracting solution filtration merges with above-mentioned alcohol extract,
By large pore resin absorption column, 2 retention volumes are first washed with water, then with 95% ethanol elution, 4 retention volumes, collect ethyl alcohol
Eluent recycles ethyl alcohol, and ethanol eluate is detached by wide spectrum medicine target system of fingerprints, and liquid concentrates after separation, and 75 DEG C of decompressions are dry
Dry, dried object powder is spare at fine powder；2）Radix Notoginseng powder at coarse powder, add 10 times of amount water infiltrations after 2 hours medicinal material it is continuous together with immersion fluid
Dynamic countercurrent extracts 2.5 hours, and extracting solution filtration, filtrate is by the way that using divinylbenzene as crosslinking agent, toluene, dimethylbenzene etc. are as cause
The resin absorbing column of hole agent, it is spare by the liquid of resin column；Resin column is eluted with 85% ethyl alcohol, ethanol eluate distillation
Merge with above-mentioned filtrate after recycling ethyl alcohol, merges liquid and detached by wide spectrum medicine target system of fingerprints, liquid concentrates after separation, 65 DEG C
It is dried under reduced pressure, dried object powder is at fine powder, spare；3）Medicinal material is together with infiltration ethyl alcohol after 8 times of amount ethyl alcohol of corydalis tuber addition infiltrate 4 hours
Liquid continuous dynamic countercurrent extracts 4.5 hours, and filtration, decompression filtrate recycling ethanol and by large pore resin absorption column is first washed with water 3
A retention volume collects ethanol eluate then with 95% ethanol elution, 6 retention volumes, recycles ethyl alcohol, and ethanol eluate is logical
Cross the separation of wide spectrum medicine target system of fingerprints, liquid concentrates after separation, 75 DEG C be dried under reduced pressure, dried object powder is at fine powder, spare.
Further, step 1）Middle large pore resin absorption column resin demand is 0.25 times of medicinal material amount.
Further, step 3）Middle large pore resin absorption column resin demand is 0.35 times of medicinal material amount.
Further, microwave sterilization processing is carried out before capsule filling.It is sterilized to product using microwave technology,
Sterilising temp is low, and the period is short, it is ensured that effective ingredient makes full use of and is unlikely to decompose, and energy consumption consumption is smaller.
Beneficial effects of the present invention are：The Yuxintong capsules preparation method of the present invention is extracted using advanced dynamic countercurrent
Technology extracts Chinese medicine, takes efficient, and purity is big, and saves energy consumption.It is extracted using macroporous adsorption resin technology
The purifying of object is refined, removes the impurity such as the tannin in active ingredient, discards the dross and selects the essential, make the further refining pure of effective ingredient
Change.It is sterilized to product using microwave technology, sterilising temp is low, and the period is short, it is ensured that effective ingredient makes full use of
And be unlikely to decompose, energy consumption consumption is smaller.It is granulated simultaneously using fluidized bed granulation technology, makes product mix, granulation, drying
It is disposable to complete, the time of contact of drug intermediate products and air is reduced, makes product not vulnerable to pollution, is easy to quality management and control.It adopts
The extract of traditional Chinese medicine further identify with wide spectrum medicine target system of fingerprints, is screened, separation, isolates and disease is risen directly
The component of therapeutic effect is connect, and is used as medicine, pharmaceutical effectiveness is made to be substantially improved, while reducing the dosage of patient, reaches Chinese patent drug height
Active low weight.
Description of the drawings
Fig. 1 is that treatment group compares block diagram to different degrees of curative effect to treat angina pectoris.
Fig. 2 is that two groups of ECG curative effects compare block diagram.
Specific implementation mode
Explanation is further explained to the present invention with reference to specific embodiment.
Yuxintong capsules preparation method, is as follows：
1）Red ginseng is added medicinal material after 8 times of amount ethyl alcohol infiltrate 3 hours and is extracted 3.5 hours together with infiltration ethanol continuous dynamic countercurrent,
Filtration, decompression filtrate recycling ethanol is spare, and the dregs of a decoction are spare.The red ginseng extraction dregs of a decoction add 6 times of amount water continuous dynamic countercurrent extractions 1.5 small
When, extracting solution filtration merges with above-mentioned alcohol extract, passes through large pore resin absorption column（Resin demand is 0.25 times of medicinal material amount）, first
2 retention volumes are washed with water, then with 95% ethanol elution, 4 retention volumes, collects ethanol eluate, recycles ethyl alcohol.Ethyl alcohol
Eluent is detached by wide spectrum medicine target system of fingerprints（System model Epic BT System-384）, liquid concentrates after separation, and 75
It DEG C is dried under reduced pressure, dried object powder is at fine powder, spare.
2）Radix Notoginseng powder at coarse powder, add 10 times of amount water infiltrations after 2 hours medicinal material together with immersion fluid continuous dynamic countercurrent extraction 2.5
Hour, extracting solution filtration, filtrate is by using divinylbenzene as crosslinking agent, the resin adsorption as pore-foaming agent such as toluene, dimethylbenzene
Column, it is spare by the liquid of resin column；Resin column is eluted with 85% ethyl alcohol, ethanol eluate be distilled to recover ethyl alcohol after with it is upper
Filtrate merging is stated, merges liquid and is detached by wide spectrum medicine target system of fingerprints（System model Epic BT System-386）, separation
Liquid concentrates afterwards, 65 DEG C be dried under reduced pressure, dried object powder is at fine powder, spare.
3）Corydalis tuber is added medicinal material after 8 times of amount ethyl alcohol infiltrate 4 hours and extracts 4.5 together with infiltration ethanol continuous dynamic countercurrent
Hour, filtration, decompression filtrate recycling ethanol simultaneously passes through large pore resin absorption column（Resin demand is 0.35 times of medicinal material amount）, first use
3 retention volumes are washed, then with 95% ethanol elution, 6 retention volumes, ethanol eluate is collected, recycles ethyl alcohol.Ethyl alcohol is washed
De- liquid is detached by wide spectrum medicine target system of fingerprints（System model Epic BT System-384）, liquid concentrates after separation, 75 DEG C
It is dried under reduced pressure, dried object powder is at fine powder, spare.
Wherein, the mass ratio of red ginseng, Radix Notoginseng and corydalis tuber is 155~165：155~165：210~230.
4）Above-mentioned 3 kinds of extract fine powders are mixed, the pregelatinized starch and 75% ethyl alcohol that total amount 1.5% is added stir evenly,
Particle is made using fluidized bed granulation technology, the magnesium stearate of total amount 0.5% is added in particle, carries out microwave disinfection processing, then into
Row capsule charge to obtain the final product.
Yuxintong capsules prepared by the process of the application are compared with existing process, significant effect：
Clinical test has been carried out to drug prepared by the application process, has observed case 415, wherein control group 100（It is existing
There is handicraft product）, treatment group 315（The application handicraft product）, clinical trial data is summarized as follows：
Curative effect determinate standard：Efficacy determination main project is angina pectoris and electrocardiogram.
Table 1 is severity extent and therapeutic effect explanation.
| Slightly | Moderate | Compared with severe | Severe | |
| It is effective | Symptom disappear or mostly disappear | Symptom disappear or mostly disappear | Symptom disappears or is relieved to the standard of " slight " substantially | Symptom disappears or is relieved to the standard of " moderate " substantially |
| Effectively | Panic attacks number, degree and duration have substantially reduced | Standard of the pain relief to " slight " | Standard of the pain relief to " moderate " | Symptom is relieved to below the mark " compared with severe " |
| In vain | Symptom is substantially identical with before treatment | Symptom is substantially identical as before treatment | Symptom is identical as before treatment | Symptom is identical as before treatment |
Treatment group compares different degrees of curative effect to treat angina pectoris（%）, such as Fig. 1.
Ridit examines X2=3.41 P ＞ 0.05, treatment group is to different degrees of patient with angina pectoris its curative effect without significant difference.
Treatment group's pretherapy and post-treatment curative effect of obstruction of qi in the chest individual event syndrome compares, such as table 2
Treatment group's tcm syndrome curative effect is compared with severity extent, such as table 3
Two groups of ECG curative effects compare, such as Fig. 2.
Examining 0.01 treatment groups of the P of U=3.21 ﹤ and control group through Ridit, there are significant differences in terms of electrocardiogram improvement.It controls
Treatment group is better than control group to the improvement of electrocardiogram.
Claims (6)
1. Yuxintong capsules preparation method, which is characterized in that steps are as follows：
1）Ethyl alcohol infiltration is added in red ginseng, is then extracted by continuous dynamic countercurrent twice, merges extracting solution, is then inhaled by macropore
The elution of attached resin column, ethanol eluate are detached by wide spectrum medicine target system of fingerprints, concentration, it is dry, smash it is spare；
2）Radix Notoginseng powder adds water continuous dynamic countercurrent to extract at coarse powder, by using divinylbenzene as crosslinking agent after extracting solution filtering, first
The resin absorbing column as pore-foaming agent such as benzene, dimethylbenzene, it is spare by the liquid of resin column；Resin column is eluted with ethyl alcohol,
Ethanol eluate merges after being distilled to recover ethyl alcohol with above-mentioned liquid, is then detached by wide spectrum medicine target system of fingerprints, concentrates, and does
It is dry, it smashes spare；
3）Ethyl alcohol infiltration is added in corydalis tuber, and then continuous dynamic countercurrent extracts, and is eluted by large pore resin absorption column, ethanol elution
Liquid is detached by wide spectrum medicine target system of fingerprints, and concentration dry, pulverize spare；
4）Above-mentioned 3 kinds of extract fine powders are mixed, capsule filling is carried out.
2. Yuxintong capsules preparation method according to claim 1, which is characterized in that the step 4）Extract crushes mixed
After conjunction, the pregelatinized starch and 75% ethyl alcohol that are added 1.5% stir evenly, and particle are made using fluidized bed granulation technology, particle adds
Enter the magnesium stearate of total amount 0.5%, then carries out capsule charge.
3. Yuxintong capsules preparation method according to claim 1 or 2, which is characterized in that be as follows：
1）Red ginseng is added medicinal material after 8 times of amount ethyl alcohol infiltrate 3 hours and is extracted 3.5 hours together with infiltration ethanol continuous dynamic countercurrent,
Filtration, decompression filtrate recycling ethanol is spare, and the dregs of a decoction are spare；The red ginseng extraction dregs of a decoction add 6 times of amount water continuous dynamic countercurrent extractions 1.5 small
When, extracting solution filtration merges with above-mentioned alcohol extract, by large pore resin absorption column, 2 retention volumes is first washed with water, then use
95% retention volume of ethanol elution 4 collects ethanol eluate, recycles ethyl alcohol, and ethanol eluate passes through wide spectrum medicine target fingerprint system
System separation, liquid concentrates after separation, 75 DEG C be dried under reduced pressure, dried object powder is at fine powder, spare；
2）Radix Notoginseng powder at coarse powder, add 10 times of amount water infiltrations after 2 hours medicinal material it is small together with the extraction 2.5 of immersion fluid continuous dynamic countercurrent
When, extracting solution filtration, filtrate is by using divinylbenzene as crosslinking agent, the resin absorbing column as pore-foaming agent such as toluene, dimethylbenzene,
It is spare by the liquid of resin column；Resin column is eluted with 85% ethyl alcohol, ethanol eluate be distilled to recover ethyl alcohol after with above-mentioned filter
Liquid merge, merge liquid by wide spectrum medicine target system of fingerprints detach, after separation liquid concentrate, 65 DEG C be dried under reduced pressure, dried object powder
It is spare at fine powder.
3）It is small together with infiltration ethanol continuous dynamic countercurrent extraction 4.5 that medicinal material after 8 times of amount ethyl alcohol infiltrate 4 hours is added in corydalis tuber
When, 3 retention volumes are first washed with water, then with 95% second in filtration, decompression filtrate recycling ethanol and by large pore resin absorption column
Alcohol elutes 6 retention volumes, collects ethanol eluate, recycles ethyl alcohol, and ethanol eluate is detached by wide spectrum medicine target system of fingerprints,
Liquid concentrates after separation, 75 DEG C be dried under reduced pressure, dried object powder is at fine powder, spare.
4. Yuxintong capsules preparation method according to claim 3, which is characterized in that step 1）Middle large pore resin absorption column
Resin demand is 0.25 times of medicinal material amount.
5. Yuxintong capsules preparation method according to claim 3, which is characterized in that step 3）Middle large pore resin absorption column
Resin demand is 0.35 times of medicinal material amount.
6. Yuxintong capsules preparation method according to claim 2, which is characterized in that carried out at microwave sterilization before filling
Reason.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201711162926.0A CN108295040A (en) | 2017-11-21 | 2017-11-21 | Yuxintong capsules preparation method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115068523A (en) * | 2022-07-08 | 2022-09-20 | 大连胜光药业集团股份有限公司 | New application of medicine for treating coronary heart disease and angina pectoris |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1686485A (en) * | 2005-05-23 | 2005-10-26 | 刘德胜 | Medicinal composition for treating coronary heart disease and stenocardia and its preparation method |
| CN102119964A (en) * | 2010-01-07 | 2011-07-13 | 天津天士力现代中药资源有限公司 | Extract of preventing and treating coronary heart disease and stenocardia and preparation method and application thereof |
-
2017
- 2017-11-21 CN CN201711162926.0A patent/CN108295040A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1686485A (en) * | 2005-05-23 | 2005-10-26 | 刘德胜 | Medicinal composition for treating coronary heart disease and stenocardia and its preparation method |
| CN102119964A (en) * | 2010-01-07 | 2011-07-13 | 天津天士力现代中药资源有限公司 | Extract of preventing and treating coronary heart disease and stenocardia and preparation method and application thereof |
Non-Patent Citations (3)
| Title |
|---|
| 李青山: "《现代药学实验技术第一卷》", 31 August 2006, 中国医药科技出版社 * |
| 王艳艳: "连续动态逆流提取技术及其设备研究", 《机电信息》 * |
| 谢秀琼: "《现代中药制剂新技术》", 30 June 2004, 化学工业出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115068523A (en) * | 2022-07-08 | 2022-09-20 | 大连胜光药业集团股份有限公司 | New application of medicine for treating coronary heart disease and angina pectoris |
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Application publication date: 20180720 |