CN108607017A - A kind of preparation method of ZAOREN ANSHEN YE - Google Patents
A kind of preparation method of ZAOREN ANSHEN YE Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/79—Schisandraceae (Schisandra family)
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- 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
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- 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
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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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
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
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Abstract
The invention discloses a kind of preparation methods of ZAOREN ANSHEN YE, this method uses form associated with a variety of separate modes, it is heavy that liquid cooling is concentrated by extraction, the modes such as external pressure ultrafiltration after centrifugation and addition oral solution auxiliary material, it realizes and retains to greatest extent in ZAOREN ANSHEN YE on the basis of active ingredient, improve clarity, realize that ZAOREN ANSHEN YE is continuously produced without alcoholization, avoid the introducing of impurity, with easy to operate, the advantages that at low cost, and the ZAOREN ANSHEN YE prepared by this method not only do not lose by active ingredient, and clarity is good, homogeneity is high, introducing without any impurity, therapeutic effect is good.
Description
Technical field
The present invention discloses the technical field for being related to traditional Chinese medicine oral liquid preparation more particularly to a kind of preparation side of ZAOREN ANSHEN YE
Method.
Background technology
There is ZAOREN ANSHEN YE bushing nourishing the liver, tranquilize the mind and promote the intelligence and other effects to be used for heart-liver blood deficiency, be lost caused by neurasthenia
Sleep it is forgetful, dizzy, headache etc. diseases, belong to traditional Chinese medicine oral liquid.Wherein, clarity is the important quality control index of traditional Chinese medicine oral liquid, it
Product stability is reflected, is the critical issue in oral liquid preparing process.Its quality of the usual good oral solution of clarity also compares
It is more excellent, the problem of therefore, how improving clarity, must be noted that when becoming current traditional Chinese medicine oral liquid production.
ZAOREN ANSHEN YE main component is frying spina date seed, Radix Salviae Miltiorrhizae and vinegar Fructus Schisandrae (processed) etc., due to the oral solution raw material
Middle there are the extracts of several kinds of Chinese medicinal materials, can influence its clarity.Currently, when most ZAOREN ANSHEN YE places one section on the market
Between after, can gather more precipitation in bottom of bottle and that shakes do not dissipate, it is muddy just to occur liquid during the storage of ZAOREN ANSHEN YE, deposits
The problems such as product homogeneity is poor.
To solve the above problems, those skilled in the art use alcohol precipitation process usually in ZAOREN ANSHEN YE preparation process,
But the medicament used during alcohol precipitation can be such that part active ingredient in extracting solution loses, and ethyl alcohol can not also recycle completely,
The problem of causing in the drug prepared containing a small amount of ethyl alcohol, harmful effect is generated to the effect of drug.In addition, the technique there is also
Consume big, of high cost, technological process length the disadvantage of alcohol amount.
Therefore, a kind of preparation method about ZAOREN ANSHEN YE how is researched and developed, product active ingredient and drug effect are not being influenced
Under the premise of, precipitation is led to the problem of during improving liquid storage, product clarity and homogeneity is improved, becomes people and urgently solve
Certainly the problem of.
Invention content
In consideration of it, the present disclosure provides a kind of preparation method of ZAOREN ANSHEN YE, at least to solve to use in the past
The ZAOREN ANSHEN YE that method prepares not only results in active ingredient loss, but also there are the clarity of ZAOREN ANSHEN YE
Difference, homogeneity are bad, the problems such as influencing therapeutic effect.
Technical solution provided by the invention, specifically, a kind of preparation method of ZAOREN ANSHEN YE, includes the following steps：
1) after mixing Semen Ziziphi Spinosae (parched), Radix Salviae Miltiorrhizae and vinegar Fructus Schisandrae (processed), 6~8 times of amount water are added, extraction is twice；
2) it extracting solution will mix, be concentrated under the conditions of 80 DEG C twice, density is 1.07~1.12g/cm3；
3) concentrate in step 2) is positioned over after being refrigerated 12 hours under 1 DEG C of environment, extract supernatant carry out tubular type from
Refining honey and water constant volume is added in the heart after centrifugation；
4) by after liquid agitation mixing after constant volume in step 3), heating is boiled 10 minutes, is stopped heating, is cooled to room temperature；
5) after liquid carries out initial filter after will be cooling in step 4), ultrafiltration membrane, finished product are crossed by the way of slipstream.
It is preferred that the extraction time in the step 1) twice is 2 hours.
Further preferably, after Semen Ziziphi Spinosae (parched), Radix Salviae Miltiorrhizae and vinegar Fructus Schisandrae (processed) being mixed in the step 1), be added 6~8 times
Water is measured, twice, specific extracting method is for extraction：
After Semen Ziziphi Spinosae (parched), Radix Salviae Miltiorrhizae and vinegar Fructus Schisandrae (processed) are mixed, 8 times of amount water are added, extracts 2 hours, adds 6 times of amounts
Water extracts 2 hours.
Further preferably, the centrifugal rotational speed that tubular type centrifuges in the step 3) is 16000r/min.
Further preferably, the density of refining honey is 1.36~1.38g/cm in the step 3)3。
Further preferably, ultrafiltration membrane is 100,000 molecular weight ultrafiltration membranes in the step 5).
Further preferably, the finished product density obtained in the step 5) is 1.20~1.30g/cm3, pH value be 3.8~
4.8。
In the preparation method of ZAOREN ANSHEN YE provided by the invention, using form associated with a variety of separate modes, by carrying
Concentration liquid cooling is taken to sink, modes, the realization such as external pressure ultrafiltration retain sedative jujube kernel to greatest extent after centrifugation and addition oral solution auxiliary material
In liquid on the basis of active ingredient, clarity is improved, realizes that ZAOREN ANSHEN YE is continuously produced without alcoholization, avoids the introducing of impurity,
The ZAOREN ANSHEN YE that the method provided through the invention prepares investigates 18 monthly nothings in accelerated 6 months with long-time stability
Precipitation generates, and clarity and homogeneity are higher.
The preparation method of ZAOREN ANSHEN YE provided by the invention, has many advantages, such as easy to operate, at low cost, and passes through this
The ZAOREN ANSHEN YE that method prepares not only do not lose by active ingredient, but also clarity is good, and homogeneity is high, no any impurity
It introduces, therapeutic effect is good.
Specific implementation mode
With specific embodiment, the present invention is further described in detail below, but is not limited to this hair
Bright protection domain.
Liquid muddiness is susceptible to during storage in view of existing ZAOREN ANSHEN YE, the clarity and homogeneity of product are poor,
After placing a period of time, it can gather more precipitation in bottom and that shakes do not dissipate, in order to not influence product active ingredient and drug effect
Under the premise of, precipitation is led to the problem of during improving liquid storage, improves product clarity and homogeneity, the present embodiment provides
A kind of sedative jujube kernel liquid preparing process of stabilization, is applicable to produce greatly, specifically comprises the following steps：
1) after mixing Semen Ziziphi Spinosae (parched), Radix Salviae Miltiorrhizae and vinegar Fructus Schisandrae (processed), 6~8 times of amount water are added, extraction is twice；
2) it extracting solution will mix, be concentrated under the conditions of 80 DEG C twice, density is 1.07~1.12g/cm3；
3) concentrate in step 2) is positioned over after being refrigerated 12 hours under 1 DEG C of environment, extracts supernatant and carries out 16000r/
The tubular type of min centrifuges, and a concentration of 1.36~1.38g/cm is added after centrifugation3Refining honey and water constant volume；
4) by after liquid agitation mixing after constant volume in step 3), heating is boiled 10 minutes, is stopped heating, is cooled to room temperature；
5) after liquid carries out initial filter after will be cooling in step 4), 100,000 molecular weight ultrafiltration membranes are crossed by the way of slipstream,
Finished product.
The embodiment above is sunk by extracting concentration liquid cooling, external pressure ultrafiltration etc. is square after centrifugation and addition oral solution auxiliary material
Formula is realized and is retained to greatest extent in ZAOREN ANSHEN YE on the basis of active ingredient, improves clarity, realizes that ZAOREN ANSHEN YE is continuous
It is produced without alcoholization, avoids the introducing of impurity, accelerated 6 months of the ZAOREN ANSHEN YE prepared by the above method and long-term steady
Qualitative investigation 18 is monthly to be generated without precipitation, and clarity and homogeneity are higher, it is not necessary that additional acid-base reagent is added, it is ensured that
Finished product density is in 1.20~1.30g/cm3, pH reaches 3.8~4.8.
In order to further increase the clarity and homogeneity that prepare ZAOREN ANSHEN YE, in step 1), extract every time
Time be 2 hours, and specifically, by Semen Ziziphi Spinosae (parched), Radix Salviae Miltiorrhizae and vinegar Fructus Schisandrae (processed) mix after, be added 8 times amount water, extraction
2 hours, 6 times of amount water are added, are extracted 2 hours.
The present invention is further described in detail with specific case study on implementation below.
Case study on implementation 1 (original process)
Semen Ziziphi Spinosae (parched) 250g, Radix Salviae Miltiorrhizae 50g, vinegar Fructus Schisandrae (processed) 50g extracting in waters, for the first time 8 times amount water, extract 2h, second
Secondary 6 times of amounts water, extracts 2h.It collects extracting solution twice to be concentrated under reduced pressure, refining honey and purifying is added after concentrate filtering
Water constant volume, makes density in 1.20~1.30g/cm3, embedding to obtain the final product.
Measure active constituent content Saponin A 0.068mg/ml, schizandrin 0.167mg/ml, danshinolic acid
1.42mg/ml.But there is muddiness after placing a period of time.
Case study on implementation 2
Semen Ziziphi Spinosae (parched) 250g, Radix Salviae Miltiorrhizae 50g, vinegar Fructus Schisandrae (processed) 50g extracting in waters, for the first time 8 times amount water, extract 2h, second
Secondary 6 times of amounts water, extracts 2h.Extracting solution twice is collected to be concentrated under reduced pressure.Concentrate injects cold-storage jar, after 1 DEG C refrigerates 12 hours
Supernatant is taken, the tubular type centrifugation of 16000r/min is carried out.A concentration of 1.36~1.38g/cm is added in liquid after gained centrifugation3's
Honey and purified water constant volume are refined, makes density in 1.20~1.30g/cm3.Heating is boiled to be cooled to room temperature after ten minutes.Using
The ultrafiltration membrane of 100,000 molecular weight is crossed in external-compression type ultrafiltration, and last embedding to obtain the final product.
Measure active constituent content Saponin A 0.067mg/ml, schizandrin 0.152mg/ml, danshinolic acid
1.61mg/ml, compared with original process, significant change does not occur for active constituent content, illustrates that the preparation method does not interfere with production
Product drug effect.And product is clarified after placing, and is not precipitated.
Case study on implementation 3
Semen Ziziphi Spinosae (parched) 250g, Radix Salviae Miltiorrhizae 50g, vinegar Fructus Schisandrae (processed) 50g extracting in waters, for the first time 8 times amount water, extract 2h, second
Secondary 6 times of amounts water, extracts 2h.Extracting solution twice is collected to be concentrated under reduced pressure.Concentrate injects cold-storage jar, after 1 DEG C refrigerates 12 hours
Supernatant is taken, is centrifuged.Refining honey and purified water constant volume is added in liquid after gained centrifugation, make density 1.20~
1.30g/cm3.Heating is boiled to be cooled to room temperature after ten minutes.Using external-compression type ultrafiltration, the ultrafiltration membrane of 500,000 molecular weight is crossed, finally
Embedding to obtain the final product.
Measure active constituent content Saponin A 0.054mg/ml, schizandrin 0.166mg/ml, danshinolic acid
1.31mg/ml, compared with the original process in case study on implementation 1, significant change does not occur for active constituent content, illustrates to use 500,000
The ultrafiltration preparation method of molecular weight does not interfere with product drug effect.But product precipitates after placing.
Case study on implementation 4
Semen Ziziphi Spinosae (parched) 250g, Radix Salviae Miltiorrhizae 50g, vinegar Fructus Schisandrae (processed) 50g extracting in waters, for the first time 8 times amount water, extract 2h, second
Secondary 6 times of amounts water, extracts 2h.Extracting solution twice is collected to be concentrated under reduced pressure.Concentrate injects cold-storage jar, after 1 DEG C refrigerates 12 hours
Supernatant is taken, the tubular type centrifugation of 16000r/min is carried out.A concentration of 1.36~1.38g/cm is added in liquid after gained centrifugation3's
Honey and purified water constant volume are refined, makes density in 1.20~1.30g/cm3.Heating is boiled to be cooled to room temperature after ten minutes.Using
The ultrafiltration membrane of 50,000 molecular weight is crossed in external-compression type ultrafiltration, and the rate of filtration is slow, is not suitable for producing greatly.
Case study on implementation 5
Semen Ziziphi Spinosae (parched) 250g, Radix Salviae Miltiorrhizae 50g, vinegar Fructus Schisandrae (processed) 50g extracting in waters, for the first time 8 times amount water, extract 2h, second
Secondary 6 times of amounts water, extracts 2h.Extracting solution twice is collected to be concentrated under reduced pressure.Concentrate injects cold-storage jar, after 1 DEG C refrigerates 48 hours
Supernatant is taken, the tubular type centrifugation centrifugation of 16000r/min is carried out.A concentration of 1.36~1.38g/ is added in liquid after gained centrifugation
cm3Refining honey and purified water constant volume, make density in 1.20~1.30g/cm3.Heating is boiled to be cooled to room temperature after ten minutes.
Using external-compression type ultrafiltration, cross the ultrafiltration membrane of 100,000 molecular weight, last embedding to obtain the final product.
Measure active constituent content Saponin A 0.054mg/ml, schizandrin 0.17mg/ml, danshinolic acid
1.76mg/ml, compared with the original process in case study on implementation 1, significant change does not occur for active constituent content, illustrates time of repose
Extension does not interfere with product drug effect.And product is clarified after placing, and is not precipitated.But time lengthening, that is, production cycle extends, and increases
Add production cost.
Case study on implementation 6
Semen Ziziphi Spinosae (parched) 250g, Radix Salviae Miltiorrhizae 50g, vinegar Fructus Schisandrae (processed) 50g extracting in waters, for the first time 8 times amount water, extract 2h, second
Secondary 6 times of amounts water, extracts 2h.Extracting solution twice is collected to be concentrated under reduced pressure.Liquid directly carries out the pipe of 16000r/min after concentration
Formula centrifuges.Refining honey and purified water constant volume is added in liquid after gained centrifugation, makes density in 1.20~1.30g/cm3.Heating
It boils and is cooled to room temperature after ten minutes.Using external-compression type ultrafiltration, cross the ultrafiltration membrane of 100,000 molecular weight, last embedding to obtain the final product.
Measure active constituent content Saponin A 0.050mg/ml, schizandrin 0.16mg/ml, danshinolic acid
1.56mg/ml, compared with original process, significant change does not occur for active constituent content, but is precipitated after product placement.Explanation
The impurity that refrigeration sedimentation removes is different from the impurity that 100,000 ultrafiltration membranes remove, and cannot by refrigerating the impurity part for settling and removing
It is removed by ultrafiltration membrane.
Those skilled in the art after considering the specification and implementing the invention disclosed here, will readily occur to its of the present invention
Its embodiment.This application is intended to cover the present invention any variations, uses, or adaptations, these modifications, purposes or
Person's adaptive change follows the general principle of the present invention and includes undocumented common knowledge in the art of the invention
Or conventional techniques.The description and examples are only to be considered as illustrative, and true scope and spirit of the invention are by following
Claim is pointed out.
It should be understood that the invention is not limited in content is described above, and can be without departing from the scope
It carry out various modifications and changes.The scope of the present invention is limited only by the attached claims.
Claims (7)
1. a kind of preparation method of ZAOREN ANSHEN YE, which is characterized in that include the following steps：
1) after mixing Semen Ziziphi Spinosae (parched), Radix Salviae Miltiorrhizae and vinegar Fructus Schisandrae (processed), 6~8 times of amount water are added, extraction is twice；
2) it extracting solution will mix, be concentrated under the conditions of 80 DEG C twice, density is 1.07~1.12g/cm3；
3) concentrate in step 2) is positioned over after being refrigerated 12 hours under 1 DEG C of environment, extracts supernatant and carries out tubular type centrifugation, from
Refining honey and water constant volume are added after the heart；
4) by after liquid agitation mixing after constant volume in step 3), heating is boiled 10 minutes, is stopped heating, is cooled to room temperature；
5) after liquid carries out initial filter after will be cooling in step 4), ultrafiltration membrane, finished product are crossed by the way of slipstream.
2. the preparation method of ZAOREN ANSHEN YE according to claim 1, which is characterized in that the extraction in the step 1) twice
Time is 2 hours.
3. the preparation method of ZAOREN ANSHEN YE according to claim 1, which is characterized in that wild jujube will be fried in the step 1)
After benevolence, Radix Salviae Miltiorrhizae and the mixing of vinegar Fructus Schisandrae (processed), 6~8 times of amount water are added, twice, specific extracting method is for extraction：
After Semen Ziziphi Spinosae (parched), Radix Salviae Miltiorrhizae and vinegar Fructus Schisandrae (processed) are mixed, 8 times of amount water are added, extract 2 hours, adds 6 times of amount water,
Extraction 2 hours.
4. the preparation method of ZAOREN ANSHEN YE according to claim 1, which is characterized in that tubular type centrifuges in the step 3)
Centrifugal rotational speed is 16000r/min.
5. the preparation method of ZAOREN ANSHEN YE according to claim 1, which is characterized in that refining honey in the step 3)
Density is 1.36~1.38g/cm3。
6. the preparation method of ZAOREN ANSHEN YE according to claim 1, which is characterized in that ultrafiltration membrane is 10 in the step 5)
Ten thousand molecular weight ultrafiltration membranes.
7. the preparation method of ZAOREN ANSHEN YE according to claim 1, which is characterized in that the finished product obtained in the step 5)
Density is 1.20~1.30g/cm3, pH value is 3.8~4.8.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109173422A (en) * | 2018-10-09 | 2019-01-11 | 飞潮（无锡）过滤技术有限公司 | The complete filtering technique of batch of process API medical fluid before a kind of medicine production transfer is brilliant |
| WO2021209667A1 (en) * | 2020-04-15 | 2021-10-21 | Euromed, S.A. | Method for obtaining a botanical extract |
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| CN1682918A (en) * | 2005-03-08 | 2005-10-19 | 北京正大绿洲医药科技有限公司 | Tranquilizing wild jujube seed dripping pill and its preparing method |
| CN101129429A (en) * | 2007-09-29 | 2008-02-27 | 黑龙江省智诚医药科技有限公司 | Technique of preparing traditional Chinese medicine xinkening formulated product |
| CN102125624A (en) * | 2010-01-13 | 2011-07-20 | 济南瑞安药业发展有限公司 | Modern preparation method for oral preparation of peach kernel and safflower four agents |
| CN103330761A (en) * | 2013-06-04 | 2013-10-02 | 江振鸣 | Preparation method for jujube kernel nerve-calming liquid |
| CN104083617A (en) * | 2014-07-30 | 2014-10-08 | 广州白云山星群(药业)股份有限公司 | Method for preparing child-strengthening digestion-promoting oral solution |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109173422A (en) * | 2018-10-09 | 2019-01-11 | 飞潮（无锡）过滤技术有限公司 | The complete filtering technique of batch of process API medical fluid before a kind of medicine production transfer is brilliant |
| WO2021209667A1 (en) * | 2020-04-15 | 2021-10-21 | Euromed, S.A. | Method for obtaining a botanical extract |
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