CN100400053C - Bupleurum root soft capsule and its preparation method - Google Patents
Bupleurum root soft capsule and its preparation method Download PDFInfo
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- CN100400053C CN100400053C CNB2005100570646A CN200510057064A CN100400053C CN 100400053 C CN100400053 C CN 100400053C CN B2005100570646 A CNB2005100570646 A CN B2005100570646A CN 200510057064 A CN200510057064 A CN 200510057064A CN 100400053 C CN100400053 C CN 100400053C
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- radix bupleuri
- bupleurum root
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Abstract
The present invention relates to a bupleurum root soft capsule which comprises bupleurum root volatile oil, bupleurum root extracts and a capsule casing. The bupleurum root soft capsule is characterized in that the capsule casing is mainly composed of gelatin and glycerol, wherein the weight proportion of the gelatin to the glycerol is 10: 3.5 to 7.5. The bupleurum root volatile oil is collected from vegetable oil. The bupleurum root extracts are bupleurum root dried extracts obtained by separating bupleurum root extracting solutions by using macroporous absorbing resin. The present invention also provides a preparation method for the bupleurum root soft capsule. The capsule casing is favorable in the external appearance and the hardness, and short in the disintegration time. The present invention solves the problems of extracting and sufficiently collecting the bupleurum root volatile oil, and also solves the problem that the collected amount of the extract is oversize in the extraction technology of the bupleurum root extracts, so that the present invention is suitable for the requirements of industrial production.
Description
Technical field
The present invention relates to a kind of bupleurum preparation, particularly a kind of bupleurum root soft capsule and preparation method thereof.
Background technology
As everyone knows, Radix Bupleuri is clearing away heat and expelling pathogen in the exterior class Chinese medicine, is mainly used in the treatment cold, fever clinically, alternate attack of chill and fever, and distending pain in the chest and hypochondrium etc., very good in particular for treatment cold, fever curative effect, the clinical practice history in existing thousands of years.Main effective ingredient in the Radix Bupleuri is Radix Bupleuri volatile oil and Radix Bupleuri total saponin.The existing analgesic composition of Radix Bupleuri that studies show that is mainly Radix Bupleuri volatile oil, and the saponin composition in the Radix Bupleuri also has refrigeration function, and antiinflammatory, analgesia and antitussive action are arranged.
Existing Radix Bupleuri medicine has only injection of Radix Bupleuri (aqueous solution of Radix Bupleuri volatile oil) and Radix Bupleuri oral liquid (mixed liquor of the aqueous extract of Radix Bupleuri volatile oil and Radix Bupleuri medical material).Because injection needs drug administration by injection, make troubles for clinical use; The Radix Bupleuri oral liquid dosage is big, each 10ml-20ml, and saikoside content wherein is low, the detection index of also not having Radix Bupleuri total saponin in the quality standard, and because of the moisture instability that causes in the preparation, thereby cause to carry and take inconvenience, product quality can not be effectively controlled, poor stability.The research worker of Chinese medicine circle attempts to prepare the bupleurum preparation of a kind of convenience, quality controllable system for many years.
Chinese patent literature CN1449794A once disclosed a kind of " Chaihu soft capsule formulations and preparation methods ", and wherein having introduced the gelatin of capsule shells of said preparation and the proportioning of glycerol is 10: 3.15～3.35.But the capsule shell viscosity of this proportioning is big, capsular formation difficulty, and the weight differential fluctuation is bigger when the system capsule.
Moreover the Radix Bupleuri volatile oil that above-mentioned patent application also discloses this preparation adopts steam distillation or carbon dioxide supercritical extraction method to extract.Wherein steam distillation is a kind of extracting method commonly used, and the collection of its volatile oil also is to adopt conventional oil-water separation to collect; The Radix Bupleuri volatile oil that carbon dioxide supercritical extraction method is extracted, the assay method of volatile oil trap in the employing Radix Bupleuri oral liquid (" 2000 editions one one of Chinese pharmacopoeia), under the volatile oil concentration of identical medical material, its trap does not reach the " requirement of Chinese pharmacopoeia Radix Bupleuri oral liquid, significant change has taken place in component that show the volatile oil gained that adopts this method extraction, its drug effect is not confirmed, result with document announcement is consistent (sees Li Xiuqin for this, Deng. the research of Radix Bupleuri volatile oil extracting method. Chinese Pharmaceutical Journal, 2004,39 (2): 103～105).Radix Bupleuri volatile oil as one of main component of Radix Bupleuri, its content in medical material is low, active high, water solublity is bigger, from above-mentioned introduction as can be known, adopting existing extracting method to be difficult to it is fully collected, all is the water solublity that utilizes Radix Bupleuri volatile oil bigger at present, adds cosolvent and directly makes the liquid preparation use.Because the content of Radix Bupleuri volatile oil own is few, adopt commonsense method to extract and collect, can make loss of volatile oil very big, can not reach clinical practice and industrial production requirement.
In addition, the Radix Bupleuri medicinal residues that above-mentioned patent application also discloses this preparation adopt conventional ethanol extraction method, find through experiment, Radix Bupleuri extractum yield height with this method extraction, reach more than 16% by medical material, wherein impurity content is very high for this, and active constituent content wherein is very low, this Radix Bupleuri extractum will be prepared into the bupleurum root soft capsule preparation, be equivalent to the adjuvant of extractum amount more than 1 times because of adding, if by in the above-mentioned patent every be equivalent to medical material 5g, the weight of every medicine is about 2g, actual being difficult to swallows in clinical use.And we also find under study for action, adopt the moisture absorption of dry extract of ethanol extraction extremely strong, and very easily conglomeration when the preparation soft capsule is difficult to finish the shaping work of soft capsule.
Summary of the invention
The object of the present invention is to provide steady quality, practical bupleurum root soft capsule clinically.
Another object of the present invention is to provide a kind of preparation method that is suitable for the bupleurum root soft capsule of suitability for industrialized production.
The object of the present invention is achieved like this: a kind of bupleurum root soft capsule, comprise Radix Bupleuri volatile oil, Radix Bupleuri extractum, capsule shells, and it is characterized in that: described capsule shells mainly is made up of gelatin and glycerol, and the weight proportion of gelatin and glycerol is 10: 3.5～7.5.
Also can add antiseptic in the above-mentioned capsule shells.
Above-mentioned Radix Bupleuri volatile oil is meant with vegetable oil collects the Radix Bupleuri volatile oil that obtains.
Above-mentioned Radix Bupleuri extractum is meant that the Radix Bupleuri extracting solution has been carried out macroporous adsorbent resin separates the dry extract that makes.
Above-mentioned bupleurum root soft capsule also comprises disperse medium, and described disperse medium is vegetable oil and suspending agent; Wherein vegetable oil is selected from one or more mixture of the edible or medicinal plant oil of soybean oil, Oleum Arachidis hypogaeae semen, Oleum sesami, Oleum Brassicae campestris; Suspending agent is selected one or more of Cera Flava, lecithin, glyceryl monostearate for use.
Above-mentioned vegetable oil: the ratio of suspending agent is 10: 0.3～3.0, by weight; Above-mentioned Radix Bupleuri extractum: the ratio of disperse medium is 10: 9～20, by weight.
In the above-mentioned bupleurum root soft capsule, the amount of Radix Bupleuri volatile oil is for using a great deal of of medical material.
Another object of the present invention is achieved in that a kind of preparation method of bupleurum root soft capsule, it is characterized in that:
A. the extraction of Radix Bupleuri volatile oil and collection: Radix Bupleuri is pulverized, adopted vapor distillation, distillate is collected volatile oil with vegetable oil, and the oil phase dehydration obtains containing the vegetable oil of Radix Bupleuri volatile oil;
B. the extraction separation of Radix Bupleuri extractum: the decocting liquid that extracts behind the Radix Bupleuri volatile oil filters standby; The medicinal residues alcohol reflux filters, and reclaims ethanol, and precipitation is filtered; With the solution absorption with macroporous adsorbent resin behind decocting liquid and the recovery ethanol, use ethanol elution again, reclaim ethanol; To reclaim liquid concentrates and precipitates common drying and obtain the Radix Bupleuri dry extract;
C. the Radix Bupleuri dry extract of gained is pulverized, with disperse medium, extract powder, contain the abundant mix homogeneously of vegetable oil of Radix Bupleuri volatile oil, made soft capsule and promptly get bupleurum root soft capsule.
Above-mentioned disperse medium, extract powder, the abundant mix homogeneously of vegetable oil that contains Radix Bupleuri volatile oil are preferably mixed disperse medium earlier with extract powder, adding contains the abundant mix homogeneously of vegetable oil of Radix Bupleuri volatile oil again.
Above-mentioned dewatering or employing centrifuge dehydration or anhydrous sodium sulfate dehydration; Above-mentioned macroporous adsorbent resin is nonpolar or the low pole macroporous adsorbent resin; The concentration of described eluant is 20～95% ethanol.
Above-mentioned macroporous adsorbent resin is D101, AB-8, S8, X-5 or NKA resin; The concentration of described eluant is 50～80% ethanol.
The prescription of the capsule shells that the present invention adopts, rubber easily forms, steady quality, outward appearance, the hardness of capsule shells are better, its disintegration (" appendix XIIA of Chinese pharmacopoeia version in 2000) less than 30 minutes.Why the present invention selects such proportioning, is because if glycerol content is low, in the production preparation of capsule shell the difficulty, content uniformity is big; Glycerol content is too high, and capsule is soft excessively, and is yielding.
The present invention adopts vegetable oil to collect Radix Bupleuri volatile oil, directly splash into the distillate of Radix Bupleuri volatile oil in the vegetable oil, utilize vegetable oil dissolution and the partition coefficient good to Radix Bupleuri volatile oil, Radix Bupleuri volatile oil is fully collected, distillate is after vegetable oil absorbs Radix Bupleuri volatile oil, do not absorb in the distillator of distillate inflow completely, proceed distillation again.Vegetable oil of the present invention has adopted edible and medicinal vegetable oil, itself is again the disperse medium in the soft capsule preparation, so the vegetable oil that contains Radix Bupleuri volatile oil can be directly used in the preparation soft capsule.Because the dissolubility of Radix Bupleuri volatile oil in vegetable oil is big, and the Radix Bupleuri volatile oil in the bupleurum root soft capsule of making can be remained in the medicine well, makes it not volatile, has guaranteed the steady quality of product.
The present invention will extract the decocting liquid behind the Radix Bupleuri volatile oil, carry out adsorbing separation with ethanol extract aqueous solution employing macroporous adsorbent resin of gained behind recovery ethanol of medicinal residues, the total recovery that makes the extraction of extractum is below 6.0%, and the rate of transform of Radix Bupleuri total saponin reaches more than 60%, and the content of saikoside is higher more than 4 times than Radix Bupleuri oral liquid among the present invention.Prepared product active constituent content height, dose is little, and is suitable for suitability for industrialized production.And inventor's research is learnt: the hygroscopicity of gained extractum is stronger, if extractum is bigger without its hygroscopicity of macroporous resin treatment; Used adjuvant and equipment container etc. should dewater or intensive drying in preparation process, even a spot of water also can cause extractum moisture absorption conglomeration, can not carry out soft capsule molding or content conglomeration in depositing, influence product quality, so the present invention is in the extraction of Radix Bupleuri volatile oil and Radix Bupleuri extractum, not only adopt macroporous resin adsorption to separate, but also adopted dehydration.
In a word, adopt the selected capsule shells prescription of product of the present invention, outward appearance, the hardness of its capsule shells are better, and disintegration time is short.The invention solves the extraction of Radix Bupleuri volatile oil and the problem of fully collecting, make it to be suitable for industrial production requirement.The present invention has also solved the excessive problem of extractum yield amount in the Radix Bupleuri extractum extraction process simultaneously, its separating technology is studied, the total recovery that makes Radix Bupleuri extractum is below 6.0%, and the rate of transform of saikoside is more than 60%, and makes it can meet suitability for industrialized production; By to the Radix Bupleuri volatile oil Study on extraction process, make the extracted amount of Radix Bupleuri volatile oil reach the regulation requirement, the volatile oil distillate employing ultraviolet spectrophotometry of its extraction (" appendix VA of Chinese pharmacopoeia version in 2000) measure at the 275nm-285nm place, trap is (every ml is equivalent to the distillate of 0.15 gram medical material) greater than 0.5, the rate of transform behind the extraction separation of Radix Bupleuri total saponin in medical material greater than 60%; The identical medical material amount with Radix Bupleuri oral liquid of the soft capsule that is prepared into compares, and its dose is the 2-4 grain, and the tolerant weight of every intragranular can reach below 0.7 gram.
The product of the present invention that adopts the method for the invention to make is used for animal experiment, and its refrigeration function is good, and toxicity is extremely low, and antiinflammatory, analgesic activity are better than Radix Bupleuri oral liquid.
The specific embodiment
Embodiment 1:
Prescription: Radix Bupleuri dry extract 220g (being equivalent to Radix Bupleuri medical material 5000g)
The Radix Bupleuri volatile oil a great deal of
Soybean oil 330g
Cera Flava 17g
Gelatin 110g
Glycerol 45g
Antiseptic is an amount of
Make 1000 altogether
Radix Bupleuri is pulverized or cut into chunks, add 5～10 times of medical material amounts of water, vapor distillation places the volatile oil receptor to collect the volatile oil of Radix Bupleuri distillate with the part of soybean oil in the prescription, divides oil-yielding stratum, dewaters, and must contain the soybean oil of Radix Bupleuri volatile oil, and is standby;
Decocting liquid behind the extraction Radix Bupleuri volatile oil filters, and is standby, and medicinal residues add 5～15 times of ethanol of medical material amount (ethanol content 50%～95%) reflux, extract, 1～3 time, filters, and reclaims ethanol, staticly settles filtration and collecting precipitation; The solution and the decocting liquid that reclaim behind the ethanol are crossed absorption with macroporous adsorbent resin, washing, reuse 70% ethanol elution, eluent reclaim concentrate behind the ethanol thick paste, common dry with precipitation, be ground into fine powder, standby;
Gelatin is soaked swelling, and glycerol adding and an amount of antiseptic heating mix homogeneously are as capsule shell material;
Cera Flava heating and melting with in remaining soybean oil in the prescription and the prescription adds extract powder by prescription again, crosses colloid mill, adds the vegetable oil that respective amount contains Radix Bupleuri volatile oil, and mix homogeneously is made bupleurum root soft capsule.
Embodiment 2～embodiment 14: the prescription according to the form below, all the other making steps are with embodiment 1.
Each component formula table that the present invention selects for use
(extractum makes 1000 altogether by 5000 gram Radix Bupleuri medical material preparations)
The inventor shows through test many times: uses existing eat or medicinal plant oil all has identical effect.
Claims (6)
1. the preparation method of a bupleurum root soft capsule, it is characterized in that: it comprises Radix Bupleuri volatile oil, Radix Bupleuri extractum, capsule shells; Described capsule shells mainly is made up of gelatin and glycerol, and the weight proportion of gelatin and glycerol is 10: 3.5～7.5; Described Radix Bupleuri volatile oil is meant with vegetable oil collects the Radix Bupleuri volatile oil that obtains; Described Radix Bupleuri extractum is meant that the Radix Bupleuri extracting solution has been carried out macroporous adsorbent resin separates the Radix Bupleuri dry extract that makes;
A. the extraction of Radix Bupleuri volatile oil and collection: Radix Bupleuri is pulverized, adopted vapor distillation, distillate is collected volatile oil with vegetable oil, and the oil phase dehydration obtains containing the vegetable oil of Radix Bupleuri volatile oil;
B. the extraction separation of Radix Bupleuri extractum: the decocting liquid that extracts behind the Radix Bupleuri volatile oil filters standby; The medicinal residues alcohol reflux filters, and reclaims ethanol, and precipitation is filtered; With the solution absorption with macroporous adsorbent resin behind decocting liquid and the recovery ethanol, use ethanol elution again, reclaim ethanol; To reclaim liquid concentrates and precipitates common drying and obtain the Radix Bupleuri dry extract;
C. the Radix Bupleuri dry extract of gained is pulverized, with disperse medium, extract powder, contain the abundant mix homogeneously of vegetable oil of Radix Bupleuri volatile oil, made soft capsule and promptly get bupleurum root soft capsule.
2. the preparation method of bupleurum root soft capsule as claimed in claim 1, it is characterized in that: described bupleurum root soft capsule also comprises disperse medium; Described disperse medium is vegetable oil and suspending agent, and wherein vegetable oil is selected from one or more mixture of the edible or medicinal plant oil of soybean oil, Oleum Arachidis hypogaeae semen, Oleum sesami, Oleum Brassicae campestris; Suspending agent is selected one or more of Cera Flava, lecithin, glyceryl monostearate for use.
3. the preparation method of bupleurum root soft capsule as claimed in claim 2, it is characterized in that: the vegetable oil in the described disperse medium: the ratio of suspending agent is 10: 0.3～3.0, by weight; Described Radix Bupleuri dry extract: the ratio of disperse medium is 10: 9～20, by weight.
4. the preparation method of bupleurum root soft capsule as claimed in claim 2, it is characterized in that: described disperse medium, extract powder, the abundant mix homogeneously of vegetable oil that contains Radix Bupleuri volatile oil are meant mixed disperse medium earlier with extract powder, adding contains the abundant mix homogeneously of vegetable oil of Radix Bupleuri volatile oil again.
5. the preparation method of bupleurum root soft capsule as claimed in claim 1 is characterized in that: described dewatering or employing centrifuge dehydration or anhydrous sodium sulfate dehydration; Described macroporous adsorbent resin is nonpolar or the low pole macroporous adsorbent resin; The concentration of described eluant is 20～95% ethanol.
6. the preparation method of bupleurum root soft capsule as claimed in claim 5, it is characterized in that: described macroporous adsorbent resin is D101, AB-8, S8, X-5 or NKA resin; The concentration of described eluant is 50～80% ethanol.
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| CNB2005100570646A CN100400053C (en) | 2005-05-17 | 2005-05-17 | Bupleurum root soft capsule and its preparation method |
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| CNB2005100570646A CN100400053C (en) | 2005-05-17 | 2005-05-17 | Bupleurum root soft capsule and its preparation method |
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| CN100400053C true CN100400053C (en) | 2008-07-09 |
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| CN103585187B (en) * | 2013-10-31 | 2015-08-26 | 吉林大学 | A kind of preparation method of wall tapestry extract |
| CN103585190B (en) * | 2013-10-31 | 2015-10-28 | 于淑娟 | Wall tapestry extract is preparing the application in medicines resistant to liver cancer |
| CN111714465B (en) * | 2020-07-22 | 2022-05-27 | 辽宁中医药大学 | Jiuwei Shuangjie soft capsule and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1449794A (en) * | 2003-04-16 | 2003-10-22 | 上海博泰医药科技有限公司 | Radix bupleuri soft capsule pharmaceutics and preparation process thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1449794A (en) * | 2003-04-16 | 2003-10-22 | 上海博泰医药科技有限公司 | Radix bupleuri soft capsule pharmaceutics and preparation process thereof |
Non-Patent Citations (2)
| Title |
|---|
| 柴胡挥发油提取方法的研究. 李秀琴，孙秀燕，何仲贵，毕开顺.中国药学杂志，第39卷第2期. 2004 |
| 柴胡挥发油提取方法的研究. 李秀琴，孙秀燕，何仲贵，毕开顺.中国药学杂志，第39卷第2期. 2004 * |
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