CN102824550A - Method for preparing compound gastrodia elata preparation - Google Patents

Method for preparing compound gastrodia elata preparation Download PDF

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Publication number
CN102824550A
CN102824550A CN2012103415074A CN201210341507A CN102824550A CN 102824550 A CN102824550 A CN 102824550A CN 2012103415074 A CN2012103415074 A CN 2012103415074A CN 201210341507 A CN201210341507 A CN 201210341507A CN 102824550 A CN102824550 A CN 102824550A
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ethanol
preparation
thick paste
dried cream
manufacture method
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CN2012103415074A
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Chinese (zh)
Inventor
陈正开
李华
唐禄丽
柯福锌
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SHAOTONG HUACHENG PHARMACEUTICAL CO Ltd
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SHAOTONG HUACHENG PHARMACEUTICAL CO Ltd
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Priority to CN2012103415074A priority Critical patent/CN102824550A/en
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Abstract

The invention discloses a method for preparing a compound gastrodia elata preparation. The method is used for preparing the compound gastrodia elata preparation taking gastrodia elata, schisandra chinensis and radix ophiopogonis to serve as effective components. The method comprises the following steps of: performing reflux extraction on the gastrodia elata and the schisandra chinensis by using ethanol according to given drug weight and component ratio; filtering ethanol extract of the gastrodia elata and the schisandra chinensis; recovering the ethanol in the ethanol extract under reduced pressure; concentrating the ethanol extract after the ethanol is extracted to obtain a first thick paste; drying the first thick paste to obtain a first dry paste; adding water and decocting the radix ophiopogonis; filtering decoction; concentrating the filtered decoction to obtain a second thick paste; drying the second thick paste to obtain a second dry paste; mixing the first dry paste and the second dry paste; and then crushing to prepare the compound gastrodia elata preparation. During a preparation process, the ethanol in the ethanol extract of the gastrodia elata and the schisandra chinensis is recovered by a reduced-pressure recovery method, so that gastrodin in the extract cannot be easily hydrolyzed, and further, the effective content of drugs is increased.

Description

The manufacture method of compound tall gastrodia tuber preparation
Technical field
The present invention relates to the field of Chinese medicines, particularly a kind of manufacture method of compound tall gastrodia tuber preparation.
Background technology
Common compound gastrodia elata medicine all is to form through extracting exquisiteness with the medical material of distinguishing the flavor of Rhizoma Gastrodiae, Fructus Schisandrae Chinensis, Radix Ophiopogonis three at present, and main effect is an invigorating brain and relieving mental uneasiness, is usually used in insomnia forgetfulness and neurastheniac.Common to produce process as shown in Figure 6, and comprising: step 601 is broken into coarse powder with Rhizoma Gastrodiae, Fructus Schisandrae Chinensis powder; Step 602, with 50% ethanol lixiviate three times, each extraction time is 24 hours, merges lixiviating solution, normal pressure reclaims the ethanol immersion, and is subsequent use; Step 603 will be extracted 2 times with water boil Radix Ophiopogonis, extracts 2 hours at every turn; Step 604 obtains decoction liquor Radix Ophiopogonis; Step 605, merge to reclaim behind the ethanol extracting solution and Radix Ophiopogonis decoction liquor; Step 606, the simmer down to fluid extract; Step 607 adds aqueous sodium glycerophosphate, sodium benzoate, sucrose and an amount of dextrin; Step 608, drying is put cold, sprays into Fructus Citri Limoniae essence; Step 609 is processed granule.
In the existing preparation method; The mode that ethanol in Rhizoma Gastrodiae, the Fructus Schisandrae Chinensis ethanol extract adopts normal pressure to reclaim; Make ethanol extract have higher temperature; Thereby cause effective ingredient gastrodine hydrolysis easily under higher temperature in the Rhizoma Gastrodiae, cause the decline of gastrodin content, influenced the curative effect of medicine.
Secondly; The ethanol extract of Rhizoma Gastrodiae, Fructus Schisandrae Chinensis and the water decoction of Radix Ophiopogonis are mixed into fluid extract, because gastrodine is a water-soluble substances, are easy to like this make that the gastrodine in the ethanol extract runs into aqueous extract Radix Ophiopogonis; And then hydrolysis, further caused the decline of gastrodin content.
In addition, mostly common this kind medicine is granule at present, and is the gastric solubility medicine; Effective ingredient gastrodine in the medicine is 4-methylol benzene-β-D-pyranglucoside semihydrate, in the process of taking; Medicine can pass through stomach, but owing to contain a large amount of gastric acid in the stomach, medicine is unstable under the gastric acid effect; The aglycon that causes constituting 4-methylol benzene-β-D-pyranglucoside is hydrolyzed to para hydroxybenzene ketone and D-Glucopyranose. easily, thereby loses activity, and then influences curative effect of medication.
And existing producing in the process also will add adjunct ingredients such as a large amount of sucrose and dextrin, is not suitable for hyperglycemic patients, and the crowd of taking receives serious restriction.
Summary of the invention
The manufacture method of compound tall gastrodia tuber preparation provided by the invention can reduce the hydrolysis of gastrodine in producing process.
Technical scheme of the present invention specifically is achieved in that
The manufacture method of compound tall gastrodia tuber preparation, be used for Rhizoma Gastrodiae, Fructus Schisandrae Chinensis, Radix Ophiopogonis be the compound tall gastrodia tuber preparation of effective ingredient, this method comprises:
According to given drug weight and ratio of component, Rhizoma Gastrodiae and Fructus Schisandrae Chinensis are used alcohol reflux, filter the ethanol extract of said Rhizoma Gastrodiae and Fructus Schisandrae Chinensis; Ethanol in the decompression recycling ethanol extracting solution; Concentrate and reclaim ethanol ethanol extract afterwards, obtain first thick paste and dry, obtain the first dried cream;
With decocte with water Radix Ophiopogonis, the filtered water decoction liquor, the water decoction behind the thickening filtration obtains second thick paste, and second thick paste is dry, obtains the second dried cream;
The said first dried cream and the second dried cream are mixed pulverizing afterwards, process preparation.
Preferably, said Rhizoma Gastrodiae and Fructus Schisandrae Chinensis are comprised with alcohol reflux:
The alcoholic acid amount that alcohol reflux adds is that 3-8 is doubly to the gross weight of said Rhizoma Gastrodiae and Fructus Schisandrae Chinensis.
Preferably, the time of said alcohol reflux is 3-6 hour.
Preferably, the extracting solution after the said concentrated recovery ethanol comprises: being concentrated into the filtrating after the said decompression recycling ethanol 60 ℃ of following relative densities is 1.25.
Preferably, said dry first thick paste comprises:
Under 60 ℃ of conditions, with said first thick paste drying under reduced pressure or the spray drying.
Preferably, said with decocte with water Radix Ophiopogonis, comprising: the amount that adds entry be 3-8 doubly to the weight of said Radix Ophiopogonis, decocting time is 4-8 hour.
Preferably, said filtered water decoction liquor comprises:
To be used to decoct the water filtration of Radix Ophiopogonis, obtain filtrating Radix Ophiopogonis;
Water decoction behind the thickening filtration comprises: being concentrated into filtrating Radix Ophiopogonis that obtains 60 ℃ of following relative densities is 1.30, and adds aqueous sodium glycerophosphate.
Preferably, said that second thick paste is dry, comprising: drying under reduced pressure second thick paste or spray drying second thick paste.
Preferably, the said preparation of processing comprises:
Add ethanol in the first dried cream of after said mixing, pulverizing and the second dried cream, obtain mixing ointment;
Said mixing ointment is processed granule, and dry;
In dried granule, add magnesium stearate and mixing;
The granule that is mixed with magnesium stearate is processed capsule preparations.
Preferably, the first dried cream of pulverizing after the said mixing and the second dried cream add ethanol and comprise:
The alcoholic acid amount of said adding is the doubly first dried cream of pulverizing and the weight of the second dried cream after mixing of 0.1-0.2.
Visible by above technical scheme, the manufacture method of compound tall gastrodia tuber preparation provided by the invention, leaching process simple and feasible; Have higher controllability, in the manufacturing process of this preparation, the ethanol extract of Rhizoma Gastrodiae and Fructus Schisandrae Chinensis reclaims the method that adopts reclaim under reduced pressure; Owing in the process of reclaim under reduced pressure, can reduce the pressure in the concentrate container, the gas in the container is extracted out; Thereby effectively reduced the temperature of ethanol extract; Reduce the hydrolysis of the effective ingredient gastrodine in the Rhizoma Gastrodiae, kept the biological activity of the active ingredient of each medical material in the prescription, improved the curative effect of medicine.
Simultaneously; Take to produce respectively Rhizoma Gastrodiae and the dried cream of Fructus Schisandrae Chinensis and Radix Ophiopogonis dried cream form; Can avoid traditional and produce in the flow process Rhizoma Gastrodiae and Fructus Schisandrae Chinensis ethanol extract and when Radix Ophiopogonis, water decoction was mixed into sulfur extractum; Gastrodine in Rhizoma Gastrodiae and the Fructus Schisandrae Chinensis ethanol extract is the shortcoming of hydrolysis in Radix Ophiopogonis extract easily, has further increased the effective content of medicine.
In addition, in medicine manufacturing process,, make the effective ingredient of compound gastrodia elata medicine not be vulnerable to the effect of gastric acid and hydrolysis when having guaranteed pharmaceutical effectiveness, is taken also convenient through processing capsule preparations.
Have, the present invention has deducted a large amount of adjuvants and the antiseptic that uses in the existing Technology again, and for example, sucrose, sodium benzoate etc. have improved the safety that medicine is taken, and has avoided hyperglycemic patients can not take the shortcoming of existing granules medicine.
Description of drawings:
Accompanying drawing 1 is that the compound tall gastrodia tuber preparation of the embodiment of the invention one is made flow chart.
Accompanying drawing 2 is the making flow chart of the first dried cream in the embodiment of the invention one.
Accompanying drawing 3 is the making flow chart of the second dried cream in the embodiment of the invention one.
Accompanying drawing 4 is for processing the making flow chart of preparation among the present invention.
Accompanying drawing 5 is that the compound tall gastrodia tuber preparation of the embodiment of the invention two is made flow chart.
Accompanying drawing 6 is the making flow chart of existing compound gastrodia elata granule.
The specific embodiment
For making the object of the invention, technical scheme and advantage clearer, below with reference to the accompanying drawing embodiment that develops simultaneously, to further explain of the present invention.
The manufacture method of the compound tall gastrodia tuber preparation of the embodiment of the invention one is as shown in Figure 1, comprises the steps:
Step 101 is produced the first dried cream.
According to given drug weight and ratio of component, Rhizoma Gastrodiae and Fructus Schisandrae Chinensis are used alcohol reflux, filter the ethanol extract of said Rhizoma Gastrodiae and Fructus Schisandrae Chinensis; Ethanol in the decompression recycling ethanol extracting solution; Concentrate and reclaim ethanol ethanol extract afterwards, obtain first thick paste and dry, obtain the first dried cream.
Step 102 is produced the second dried cream.
With decocte with water Radix Ophiopogonis, the filtered water decoction liquor, the water decoction behind the thickening filtration obtains second thick paste, and second thick paste is dry, obtains the second dried cream.
Step 103 is produced preparation.
The said first dried cream and the second dried cream are mixed pulverizing afterwards, process preparation.
As preferred embodiment, described step 101 is as shown in Figure 2, comprises the steps:
Step 201 is used alcohol reflux with Rhizoma Gastrodiae and Fructus Schisandrae Chinensis.
The alcohol reflux of Rhizoma Gastrodiae and Fructus Schisandrae Chinensis is meant, through having added Rhizoma Gastrodiae and Fructus Schisandrae Chinensis, is that the mixed liquor of solvent heats with ethanol; This moment, part ethanol volatilized after being heated; Evaporable gaseous state ethanol becomes liquid state again after receiving the condensing unit cooling, extract in the mixed liquor thereby be re-circulated to; As solvent, and then reach the effect of circulation extraction.In the step 201, adding concentration of alcohol is 50%, the alcoholic acid amount of adding be 3-8 doubly to the gross weight of Rhizoma Gastrodiae and Fructus Schisandrae Chinensis, extraction time is 3-6 hour.
Step 202, Rhizoma Gastrodiae and Fructus Schisandrae Chinensis ethanol extract in the filtration step 201.
In the step 202, the effective one-tenth major part in the medicine all is dissolved in the ethanol extract, so ethanol extract is filtered, discards after the filtering residue, can carry out subsequent operation to the ethanol extract after filtering.
Step 203, reclaim under reduced pressure step 202 is filtered the ethanol in the ethanol extract that obtains.
This step can be divided into two aspects, and on the one hand, because alcoholic acid cost is than higher, so can pass through reclaim under reduced pressure, in removal process, the part ethanol in the ethanol extract obtains collecting through the mode of reclaim under reduced pressure, stores afterwards subsequent use; On the other hand, the more condensed medicinal liquid that residue is contained medicine carries out subsequent operation;
Reclaim under reduced pressure is meant through the air that will contain in the extract container and finds time, and then causes the extract container to produce negative pressure, according to equation of gas state PV/T=nR; Wherein, R is that state is quantitative, and n is the amount of substance of gas; In the process of reclaim under reduced pressure, nR fixes in the container, and pressure P diminishes; The volume V of gas is constant, and then causes the internal tank temperature T to reduce, thereby can make the temperature of extracting solution also further reduce; So just reduce the hydrolysis of gastrodine in the medicine, better kept the curative effect of medicine.
Step 204, the extracting solution behind concentration step 203 decompression recycling ethanols obtains first thick paste.
In the step 204, the extracting solution after the reclaim under reduced pressure behind the ethanol contracts to being 1.25 60 ℃ of following relative densities, promptly obtains first thick paste.
Step 205, first thick paste that step 204 obtains is dry under 60 ℃, obtain the first dried cream.
In this step, under 60 ℃ of conditions, said first thick paste can obtain the first dried cream through drying under reduced pressure or spray-dired mode.
Drying under reduced pressure and spray drying can further prevent the hydrolysis of gastrodine, guarantee curative effect of medication.
Described step 102 is as shown in Figure 3, comprises the steps:
Step 301 is with decocte with water Radix Ophiopogonis.
In the step 301, in the decoction process, the water yield of adding be 3-8 doubly to weight Radix Ophiopogonis, decocting time is 4-8 hour.
Step 302, the filtered water decoction liquor.
Step 303, the water decoction behind the thickening filtration obtains second thick paste.
In step 303, the water decoction after the filtration contracts to being 1.30 60 ℃ of following relative densities.
Step 304 adds aqueous sodium glycerophosphate with second thick paste.
Sodium glycerophosphate is the common a kind of nutritional drugs of a kind of compound preparation, and its main effect is a supplementing the brain.
Step 305, dry second thick paste that adds aqueous sodium glycerophosphate obtains the second dried cream.
Second thick paste that adds aqueous sodium glycerophosphate is dry, obtain the second dried cream, wherein drying means can be drying under reduced pressure or spray drying.
Described step 301 is as shown in Figure 4, comprises the steps:
Pulverize after the second dried cream that step 401, first dried cream that step 205 is obtained and step 305 obtain mixes, obtain mixed powder.
Step 402, the mixed powder that step 401 is obtained adds ethanol, obtains mixing ointment.
The granulation that mixes ointment can add ethanol as wetting agent, just can convenient follow-up granulation operate, and in step 402, the ethanol of adding is 0.1-0.2 times of said mixed powder.
Step 403 is processed granule with said mixing ointment, and dry.
Step 404 is with adding magnesium stearate in the dried drug particles and mixing.
Magnesium stearate is a kind of lubricant common in a kind of compound medicine filling process; In order to guarantee the uniformity of medicine dress agent; Need in dried drug particles, add a certain amount of magnesium stearate, the magnesium stearate that adds usually accounts for the 0.3-0.8% of dry back drug particles quality.
Step 405 is processed capsule preparations with the granule that is mixed with magnesium stearate.
In this step, the granule that is mixed with magnesium stearate can be processed hard capsule or enteric coated capsule.
The manufacture method of the compound tall gastrodia tuber preparation of the embodiment of the invention two, as shown in Figure 5, comprising:
Step 501 is produced the second dried cream.
With decocte with water Radix Ophiopogonis, the filtered water decoction liquor, the water decoction behind the thickening filtration obtains first thick paste, and second thick paste is dry, obtains the second dried cream.
Step 502 is produced the first dried cream.
According to given drug weight and ratio of component, Rhizoma Gastrodiae and Fructus Schisandrae Chinensis are used alcohol reflux, filter the ethanol extract of said Rhizoma Gastrodiae and Fructus Schisandrae Chinensis; Ethanol in the decompression recycling ethanol extracting solution; Concentrate and reclaim ethanol ethanol extract afterwards, obtain first thick paste and dry, obtain the first dried cream.
Step 503 is produced preparation.
The second dried cream and the first dried cream are mixed pulverizing afterwards, process preparation.
Wherein step 102 is identical among the concrete operations of step 501 and the embodiment one; Step 101 is identical among the concrete operations of step 502 and the embodiment 1; Step 103 is identical among the concrete operations of step 503 and the embodiment 1, repeats no more here, in addition, produces the step of the first dried cream and the second dried cream and can carry out simultaneously also can carrying out according to random order, does not do concrete qualification in the embodiment of the invention.
The above is merely preferred embodiment of the present invention, and is in order to restriction the present invention, not all within spirit of the present invention and principle, any modification of being made, is equal to replacement, improvement etc., all should be included within the scope that the present invention protects.

Claims (10)

1. the manufacture method of compound tall gastrodia tuber preparation, be used for Rhizoma Gastrodiae, Fructus Schisandrae Chinensis, Radix Ophiopogonis be the compound tall gastrodia tuber preparation of effective ingredient, it is characterized in that this method comprises:
According to given drug weight and ratio of component, Rhizoma Gastrodiae and Fructus Schisandrae Chinensis are used alcohol reflux, filter the ethanol extract of said Rhizoma Gastrodiae and Fructus Schisandrae Chinensis; Ethanol in the decompression recycling ethanol extracting solution; Concentrate and reclaim ethanol ethanol extract afterwards, obtain first thick paste and dry, obtain the first dried cream;
With decocte with water Radix Ophiopogonis, the filtered water decoction liquor, the water decoction behind the thickening filtration obtains second thick paste, and second thick paste is dry, obtains the second dried cream;
The said first dried cream and the second dried cream are mixed pulverizing afterwards, process preparation.
2. the manufacture method of compound tall gastrodia tuber preparation as claimed in claim 1 is characterized in that, said Rhizoma Gastrodiae and Fructus Schisandrae Chinensis is comprised with alcohol reflux:
The alcoholic acid amount that alcohol reflux adds is that 3-8 is doubly to the gross weight of said Rhizoma Gastrodiae and Fructus Schisandrae Chinensis.
3. the manufacture method of compound tall gastrodia tuber preparation as claimed in claim 2 is characterized in that, and is said
The time of alcohol reflux is 3-6 hour.
4. the manufacture method of compound tall gastrodia tuber preparation as claimed in claim 1 is characterized in that, the extracting solution after the said concentrated recovery ethanol comprises: being concentrated into the filtrating after the said decompression recycling ethanol 60 ℃ of following relative densities is 1.25.
5. the manufacture method of compound tall gastrodia tuber preparation as claimed in claim 1 is characterized in that, said dry first thick paste comprises:
Under 60 ℃ of conditions, with said first thick paste drying under reduced pressure or the spray drying.
6. the manufacture method of compound tall gastrodia tuber preparation as claimed in claim 1 is characterized in that, and is said with decocte with water Radix Ophiopogonis, comprising: the amount that adds entry be 3-8 doubly to the weight of said Radix Ophiopogonis, decocting time is 4-8 hour.
7. the manufacture method of compound tall gastrodia tuber preparation as claimed in claim 1 is characterized in that, said filtered water decoction liquor comprises:
To be used to decoct the water filtration of Radix Ophiopogonis, obtain filtrating Radix Ophiopogonis;
Water decoction behind the thickening filtration comprises: being concentrated into filtrating Radix Ophiopogonis that obtains 60 ℃ of following relative densities is 1.30, and adds aqueous sodium glycerophosphate.
8. the manufacture method of compound tall gastrodia tuber preparation as claimed in claim 1 is characterized in that, and is said that second thick paste is dry, comprising: drying under reduced pressure second thick paste or spray drying second thick paste.
9. the manufacture method of compound tall gastrodia tuber preparation as claimed in claim 1 is characterized in that, the said preparation of processing comprises:
Add ethanol in the first dried cream of after said mixing, pulverizing and the second dried cream, obtain mixing ointment;
Said mixing ointment is processed granule, and dry;
In dried granule, add magnesium stearate and mixing;
The granule that is mixed with magnesium stearate is processed capsule preparations.
10. the manufacture method of compound tall gastrodia tuber preparation as claimed in claim 9 is characterized in that, the first dried cream of pulverizing after the said mixing and the second dried cream add ethanol and comprises:
The alcoholic acid amount of said adding is the doubly first dried cream of pulverizing and the weight of the second dried cream after mixing of 0.1-0.2.
CN2012103415074A 2012-09-14 2012-09-14 Method for preparing compound gastrodia elata preparation Pending CN102824550A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104258108A (en) * 2014-09-25 2015-01-07 昭通市骅成制药有限公司 Preparation method of compound gastrodia elata preparation and compound gastrodia elata preparation obtained by preparation method
CN108619401A (en) * 2018-07-25 2018-10-09 景雷 A kind of tranquilizing the mind patch with treatment insomnia function
CN113267005A (en) * 2021-05-14 2021-08-17 云南优源农业科技开发有限公司 High-efficiency drying method for gastrodia elata

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CN1562187A (en) * 2004-03-17 2005-01-12 北京奇源益德药物研究所 Compound prepration of gastrodia tuber and preparation technique

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104258108A (en) * 2014-09-25 2015-01-07 昭通市骅成制药有限公司 Preparation method of compound gastrodia elata preparation and compound gastrodia elata preparation obtained by preparation method
CN104258108B (en) * 2014-09-25 2016-01-13 昭通市骅成制药有限公司 A kind of preparation method of compound tall gastrodia tuber preparation and the compound tall gastrodia tuber preparation of acquisition
CN108619401A (en) * 2018-07-25 2018-10-09 景雷 A kind of tranquilizing the mind patch with treatment insomnia function
CN113267005A (en) * 2021-05-14 2021-08-17 云南优源农业科技开发有限公司 High-efficiency drying method for gastrodia elata

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Application publication date: 20121219