CN1259038C - Radix bupleuri soft capsule pharmaceutics and preparation process thereof - Google Patents
Radix bupleuri soft capsule pharmaceutics and preparation process thereof Download PDFInfo
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- CN1259038C CN1259038C CN 03116422 CN03116422A CN1259038C CN 1259038 C CN1259038 C CN 1259038C CN 03116422 CN03116422 CN 03116422 CN 03116422 A CN03116422 A CN 03116422A CN 1259038 C CN1259038 C CN 1259038C
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- radix bupleuri
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- volatile oil
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Abstract
The present invention relates to an oral medicine preparation of a soft capsule of bupleurum and a preparation technology thereof. The medicine liquid contains bupleurum extract, bupleurum volatile oil, solvent and stabilizing agent. The weight proportion of gelatin and glycerin in a capsule shell is 10: (3.15 to 3.35) and the preservative can be contained in the capsule shell. The soft capsule is prepared by the following steps: firstly, the bupleurum volatile oil is extracted; then, preparing the materials into the soft capsule by adopting a pressing method. Compared with the existing bupleurum dosage forms, the soft capsule of the present invention has the advantages of stable quality, convenient carrying and administration and quick dissolution of effective component.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of bupleurum root medicinal preparation,, the invention still further relates to the preparation method of said preparation simultaneously more specifically to a kind of bupleurum root soft capsule.
Background technology
The dry root of the medicinal umbelliferae bupleurum of Radix Bupleuri, Radix Bupleuri has the effect of " reconciling superficies and interior, soothing liver-QI, yang invigorating " on the Chinese medicine, is used for the treatment of cold, fever, alternate attack of chill and fever, sternal rib pain, diseases such as menoxenia.The preparation of Radix Bupleuri mainly contains injection and oral liquid clinically.The curative effect of injection can be affirmed, still has the shortcoming of medication inconvenience; Though oral liquid technology is simple, cost is low, and the quality instability is easy to generate precipitation, and carries transportation inconvenience.Saikoside in the Radix Bupleuri extract and Radix Bupleuri volatile oil all have the effect of antiinflammatory antipyretic, so need to utilize this two big active component in the preparation as far as possible, and this dosage form of soft capsule has satisfied such needs, and the bioavailability height absorbs fast simultaneously.
Summary of the invention
The object of the present invention is to provide a kind of bupleurum root soft capsule and production method thereof, the product oral form of administration, its steady quality, easy to use effective.
Bupleurum root soft capsule provided by the present invention is made up of medicinal liquid and softgel shell two parts.Its herb liquid contains active ingredient Radix Bupleuri volatile oil, Radix Bupleuri extract, also contains stabilizing agent, and active ingredient is dissolved in the solvent; Softgel shell mainly is made up of gelatin and glycerol, and the weight proportion of gelatin and glycerol is 10: 3.15～10: 3.35 parts, in addition, also contains an amount of antiseptic.
Solvent of the present invention can be one or more in liquid polyethylene glycol, isopropyl alcohol, tween 80, glycerol, propylene glycol, water and the vegetable oil (as Oleum Glycines, Oleum Arachidis hypogaeae semen, Oleum Camelliae etc.).
Antiseptic can be one or more in glycerol, propylene glycol, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, P-hydroxybenzoic acid phenyl ester, benzoic acid, the benzyl alcohol.
Stabilizing agent can be one or more in water, glycerol, tween 80, ethyoxyl castor oil hydrogenated, soybean lecithin, Cera Flava, aluminum monostearate, ethyl cellulose, the solid polyethylene glycol.
Among the present invention, the weight proportion of bupleurum root soft capsule herb liquid component is:
The component consumption
Radix Bupleuri extract 100
The Radix Bupleuri volatile oil corresponding amount extracted amount of volatile oil in the Radix Bupleuri of said extracted thing amount (promptly corresponding to)
Solvent 1.6～10
Stabilizing agent 0.3～1.2
Active ingredient in every capsules is fixed, and generally the content of its Radix Bupleuri extract is the 5-15g/ grain, and Radix Bupleuri volatile oil is a corresponding amount.
Gelatin, glycerol proportioning are difficult to grasp in the prescription of softgel shell.The amount of glycerol is too many, and softgel shell is softer, than being easier to extrusion; The amount of glycerol very little, softgel shell is harder, crisp, influences the quality stability and the disintegration time of soft capsule.Gelatin, glycerol proportioning to softgel shell have been carried out detailed experimental study, have obtained a proportioning preferably at last.
An amount of gelatin is added in the rustless steel glue pot, add suitable quantity of water again, airtight, 70 degree insulation 3hr, add glycerol, the antiseptic of test consumption more respectively, stir vacuumize degassing 2hr, put into gelatin heat-preserving container 70 degree insulation standing over night, second day moulding ball, drying at room temperature keeps sample and investigates 3 months, examination softgel shell outward appearance and physical property, found that gelatin and glycerol proportioning be 10: 3.15～3.35 o'clock the most suitable.The softgel shell prescription that is filtered out is applicable to the environment of warm moist.
The preparation technology of bupleurum root soft capsule may further comprise the steps:
Extract the volatile oil in the Radix Bupleuri earlier, can adopt steam distillation or carbon dioxide supercritical extraction method, preferred supercritical extraction.Collect and extract volatile oil and the medicinal residues that obtain, standby.The reuse conventional method is extracted Radix Bupleuri extract from medicinal residues.Specifically can add 95% ethanol to medicinal residues and decoct secondary, 2 hours for the first time, 1 hour for the second time, the filtrate gradation was filtered, and filtrate merging is evaporated to the thick paste shape, and drying can obtain Radix Bupleuri extract.
After Radix Bupleuri extract beaten powder and cross the 80-120 mesh sieve, feed intake by the prescription proportioning, earlier with the stabilizing agent thermosol in partial solvent, the thermosol thing is joined lentamente in the residual solvent that is preheated to 35～45 degree, the limit edged stirs, and adds solid and Radix Bupleuri volatile oil then again, it is moistening fully fully to mix assurance, cross colloid mill and pulverize the back pelleting, drying, promptly.
The invention provides a kind of bupleurum root soft capsule preparation and preparation technology thereof, product is an oral administered dosage form, can overcome the shortcoming of existing dosage form, and the bioavailability height satisfies the standard of such dosage form aspect outward appearance, hardness, disintegration etc. and physical and chemical stability.
The specific embodiment
The invention is further illustrated by the following examples.
Embodiment 1:
Component amount (gram/grain)
Radix Bupleuri extract is equivalent to crude drug 10g
The Radix Bupleuri volatile oil corresponding amount
PEG400 0.40g
Cera Flava 0.02
Glycerol 0.01
Water is an amount of
Capsule shells 0.22
Embodiment 2:
Component amount (gram/grain)
Radix Bupleuri extract is equivalent to crude drug 5g
The Radix Bupleuri volatile oil corresponding amount
Oleum Arachidis hypogaeae semen 0.26
Tween 80 0.01
Ethyl cellulose 0.02
Water is an amount of
Capsule shells 0.19
Embodiment 3:
Component amount (gram/grain)
Radix Bupleuri extract is equivalent to crude drug 15g
The Radix Bupleuri volatile oil corresponding amount
Isopropyl alcohol 0.40
Propylene glycol 0.10
Soybean lecithin 0.05
Capsule shells 0.25
The preparation technology of embodiment is as follows:
Take by weighing the Radix Bupleuri of recipe quantity, extract volatile oil wherein, can adopt steam distillation or carbon dioxide supercritical extraction method, the preferred supercritical extraction of method.Volatile oil that collection obtains and medicinal residues.Medicinal residues obtain Radix Bupleuri extract through following processing: medicinal residues add 95% ethanol and decoct secondary, and 2 hours for the first time, 1 hour for the second time, the filtrate gradation was filtered, and filtrate merging is evaporated to the thick paste shape, and drying can obtain Radix Bupleuri extract.
After Radix Bupleuri extract beaten powder and cross 100 mesh sieves, feed intake by the prescription proportioning, earlier with the stabilizing agent thermosol in partial solvent, the thermosol thing is joined lentamente in the residual solvent that is preheated to 45 degree, the limit edged stirs, and adds solid and Radix Bupleuri volatile oil then again, it is moistening fully fully to mix assurance, cross colloid mill and pulverize the back pelleting, drying, promptly.
Claims (6)
1, a kind of bupleurum root soft capsule is made up of medicinal liquid and softgel shell two parts, it is characterized in that medicinal liquid is made up of active ingredient Radix Bupleuri volatile oil, Radix Bupleuri extract basically, and contains stabilizing agent, and active ingredient is dissolved in the solvent; Softgel shell is made up of gelatin and glycerol basically, also contains an amount of antiseptic, and the weight proportion of gelatin and glycerol is 10: 3.15～10: 3.35; Radix Bupleuri volatile oil extracts by steam distillation or carbon dioxide supercritical extraction method and obtains, further extract the Radix Bupleuri medicinal residues of Radix Bupleuri extract after extracting volatile oil and obtain, its step is medicinal residues to be added 95% ethanol decoct 2 times, gradation is filtered, merging filtrate, be evaporated to the thick paste shape, drying.
2, bupleurum root soft capsule according to claim 1 is characterized in that solvent is one or more in liquid polyethylene glycol, isopropyl alcohol, tween 80, glycerol, propylene glycol, water and the vegetable oil.
3, bupleurum root soft capsule according to claim 1 is characterized in that antiseptic is one or more in glycerol, propylene glycol, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, P-hydroxybenzoic acid phenyl ester, benzoic acid, the benzyl alcohol.
4, bupleurum root soft capsule according to claim 1 is characterized in that the weight proportion of medicinal liquid component is:
The component consumption
Radix Bupleuri extract 100
The Radix Bupleuri volatile oil corresponding amount
Solvent 1.6～10
Stabilizing agent 0.3～1.2
Here, corresponding amount is meant the extracted amount corresponding to volatile oil in the Radix Bupleuri of above-mentioned Radix Bupleuri extract amount.
5, a kind of preparation method as one of claim 1-4 described bupleurum root soft capsule is characterized in that may further comprise the steps:
After Radix Bupleuri extract beaten powder and cross the 80-120 mesh sieve, feed intake by the prescription proportioning, earlier with the stabilizing agent thermosol in partial solvent, the thermosol thing is joined lentamente in the residual solvent that is preheated to 35～45 degree, the limit edged stirs, and adds Radix Bupleuri extract and Radix Bupleuri volatile oil then again, it is moistening fully fully to mix assurance, cross colloid mill and pulverize the back pelleting, drying, promptly.
6, bupleurum root soft capsule preparation method according to claim 5 is characterized in that adopting steam distillation or carbon dioxide supercritical extraction method to extract Radix Bupleuri volatile oil; The reuse conventional method extracts Radix Bupleuri extract from the Radix Bupleuri medicinal residues.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03116422 CN1259038C (en) | 2003-04-16 | 2003-04-16 | Radix bupleuri soft capsule pharmaceutics and preparation process thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03116422 CN1259038C (en) | 2003-04-16 | 2003-04-16 | Radix bupleuri soft capsule pharmaceutics and preparation process thereof |
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| CN1449794A CN1449794A (en) | 2003-10-22 |
| CN1259038C true CN1259038C (en) | 2006-06-14 |
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| CN 03116422 Expired - Fee Related CN1259038C (en) | 2003-04-16 | 2003-04-16 | Radix bupleuri soft capsule pharmaceutics and preparation process thereof |
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| CN100400053C (en) * | 2005-05-17 | 2008-07-09 | 重庆医药工业研究院有限责任公司 | Bupleurum root soft capsule and its preparation method |
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| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Yanzhou Hill Kangtai Pharmaceutical Co., Ltd. Assignor: Botai Medicine Science and Technology Co., Ltd., Shanghai Contract fulfillment period: 2008.12.29 to 2023.4.15 contract change Contract record no.: 2009370000078 Denomination of invention: Radix bupleuri soft capsule pharmaceutics and preparation process thereof Granted publication date: 20060614 License type: Exclusive license Record date: 2009.4.24 |
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Free format text: EXCLUSIVE LICENSE; TIME LIMIT OF IMPLEMENTING CONTACT: 2008.12.29 TO 2023.4.15; CHANGE OF CONTRACT Name of requester: YANZHOU HILL KANGTAI PHARMACEUTICAL CO., LTD. Effective date: 20090424 |
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Owner name: YANZHOU HILL KANGTAI PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: SHANGHAI BOTAI PHARMACEUTICAL TECHNOLOGY CO., LTD. Effective date: 20091023 |
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Effective date of registration: 20091023 Address after: Xin Yan Zhen private industrial park in Shandong city of Yanzhou Province Patentee after: Yanzhou Hill Kangtai Pharmaceutical Co., Ltd. Address before: Room 335, No. 3021, National Road, Shanghai, China Patentee before: Botai Medicine Science and Technology Co., Ltd., Shanghai |
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| C56 | Change in the name or address of the patentee |
Owner name: SHANDONG XI ER KANGTAI PHARMACEUTICAL CO., LTD. Free format text: FORMER NAME: YANZHOU XI ER KANGTAI PHARMACEUTICAL CO., LTD. |
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| CP01 | Change in the name or title of a patent holder |
Address after: Xin Yan Zhen Private Industrial Park 272100 Shandong city of Yanzhou Province Patentee after: SHANDONG XIER KANGTAI PHARMACEUTICAL CO., LTD. Address before: Xin Yan Zhen Private Industrial Park 272100 Shandong city of Yanzhou Province Patentee before: Yanzhou Hill Kangtai Pharmaceutical Co., Ltd. |
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