CN103830300A - traditional Chinese medicine fructus arctiie softgel preparation and preparation method thereof - Google Patents
traditional Chinese medicine fructus arctiie softgel preparation and preparation method thereof Download PDFInfo
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- CN103830300A CN103830300A CN201210478172.0A CN201210478172A CN103830300A CN 103830300 A CN103830300 A CN 103830300A CN 201210478172 A CN201210478172 A CN 201210478172A CN 103830300 A CN103830300 A CN 103830300A
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Abstract
The invention discloses a traditional Chinese medicine fructus arctiie softgel preparation and a preparation method thereof, the traditional Chinese medicine fructus arctiie softgel preparation comprises, by mass, 38.4% of drug extract powder, 59.2% of soybean oil and 2.4% of beeswax, and the prepared traditional Chinese medicine fructus arctiie softgel preparation has the advantages of accurate dose, small internal containing matter content, stable quality, high bioavailability, portability, convenient use, and suitability for the pharmaceutical and health care products field.
Description
Chinese medicine Fructus Arctii soft capsule preparation and preparation method thereof
Technical field
What the present invention relates to is preparation of a kind of Chinese medicine technical field and preparation method thereof, specifically a kind of Chinese medicine Fructus Arctii soft capsule preparation and preparation method thereof.
Background technology
Fructus Arctii, begins to be loaded in " Mingyi Bielu ", and original name is disliked real, and another name FRUCTUS ARCTII, Fructus Arctii, for the dry mature fruit of Compositae cattle potato platymiscium Niu Fen, all have distribution throughout the country.Fructus Arctii has dispelling wind and heat pathogens, lung qi dispersing rash, effect of resolving toxin and disinhibiting the throat.Modern pharmacology research finds, in Fructus Arctii contained total lignans compounds there is antitumor, antiviral, blood sugar lowering, control diabetic nephropathy, improve renal metabolism function, regulate immune, antibacterial, antioxidation, calcium antagonism and blood pressure lowering, to multiple physiologically actives such as platelet factor antagonisms.Because Fructus Arctii total lignans compounds belongs to low-polarity component, pure water soluble is poor, is prepared into solid orally ingestible artifact availability often undesirable.
Soft capsule is a kind of novel form that distinguishes over solid preparation, and its shell is to form with gelatin compacting, the aqueous medicinal liquid of parcel in softgel shell.Compared with other solid preparations, soft capsule has following characteristics: <1) substrate mostly is Vegetable oil lipoprotein in capsule, be conducive to and the mixing of low-polarity component; (2) loading amount is accurate, and content deviation is low, and bioavailability is high, rapid-action; (3) Nantural non-toxic, does not need to add the additives such as binding agent, forming agent.Capsule skin is made up of gelatin, glycerol and pure water, is edible natural product; (4) air-tightness is good, and content can stable for extended periods of time.
Research shows, soft capsule steady quality provided by the invention, and bioavailability is high, is easy to carry, and conveniently takes, and toxic and side effects is little, is particularly useful for needing the patient of long-term prescription.On domestic and international market, there is no like product at present.
Summary of the invention
The present invention is directed to prior art above shortcomings, a kind of Chinese medicine Fructus Arctii soft capsule preparation and preparation method thereof is provided, the soft capsule preparation technology who provides is easy, bioavailability and patient adaptability are high, be easy to carry, conveniently take, toxic and side effects is little, especially uses the patient who needs long-term prescription.
The present invention is achieved by the following technical solutions:
Component and the mass percent thereof of the Chinese medicine Fructus Arctii soft capsule preparation the present invention relates to are: 38.4% drug extract powder, 59.2% soybean oil and 2.4% Cera Flava.
Compared with prior art, the dissolution average that the present invention prepares gained Chinese medicine Fructus Arctii soft capsule preparation is 96.49 scholars 0.61, and the dissolution average of hard capsule preparation is 90.08 scholars 1.04, and the dissolution average of tablet is 83.57 scholars 4.67.The dissolution of soft capsule preparation is apparently higher than tablet and hard capsule.Meanwhile, the Chinese medicine Fructus Arctii soft capsule preparation of producing as stated above detects through ultraviolet spectrophotometry, and in per unit preparation, total lignans content is in aretigenin, between 15%-30%.Detect through high performance liquid chromatography, per unit preparation Arctiin and aretigenin content are respectively between 6-15% and 4-13%.
The specific embodiment
Below embodiments of the invention are elaborated, the present embodiment is implemented under take technical solution of the present invention as prerequisite, provided detailed embodiment and concrete operating process, but protection scope of the present invention is not limited to following embodiment.
embodiment 1
The first step, get Chinese medicine Fructus Arctii medicinal material coarse powder, by the ethanol pure water solution reflux, extract, of 90% volume ratio 4 times, after each 4 hours, filter with silk again, filtrate decompression concentration and recovery ethanol, obtains fluid extract;
Second step, add the pure water suspendible of 8 times of volumes of fluid extract; the petroleum ether extraction of 15 times of volumes for suspension; discard petroleum ether extraction liquid; pure water layer is added again to the ethyl acetate extraction of 12 times of volumes; the complete pure water solution that discards of extraction; concentrating under reduced pressure acetic acid ethyl acetate extract, is concentrated into thick paste, and 60 ℃ of vacuum dryings get dry extract;
The 3rd step, adopt mechanical means to pulverize dry cream, after 160 mesh sieves, make extract powder; Get extract powder 192g, Cera Flava 12g, soybean oil 296g, adds Cera Flava in soybean oil, and 80 ℃ of heating are placed and are cooled to room temperature; Then after extract powder being added to Cera Flava soybean oil, grind evenly, make pelleting filler.
The 4th step, by gelatin: glycerol: the ratio of pure water take volume ratio as 20:8:20 adds 0.5% Fe of gross mass after mixing
20
3be placed in glue pot, make film with 65 ℃ of heating glue pot 1h, adjust sprinkler body temperature to 48, adopt rotating mould platen press that pelleting filler and film are carried out to pelleting, make soft capsule, at 26 ℃, dry 24h under 30% damp condition is until surface dry, and hardness is suitable, obtains Chinese medicine Fructus Arctii soft capsule preparation.
Get the present embodiment and prepare gained Chinese medicine Fructus Arctii soft capsule preparation; according to dissolution method, take 0.5% sodium dodecyl sulfate solution 900mL as dissolution medium, rotating speed is per minute 100 to turn; operation in accordance with the law; through 4s timesharing, get solution smL, filter; precision measures subsequent filtrate 2mL; add 0.5% sodium dodecyl sulfate solution and be diluted to 1.0mL, shake up, as need testing solution; Separately get aretigenin 1.0mg, add dissolve with methanol and be diluted to 5.0mL, shake up, get 5mL, add 0.5% sodium dodecyl sulfate solution and be diluted to 50mL, shake up, in contrast product solution.Get above-mentioned two kinds of solution, measure absorbance according to ultraviolet visible spectrophotometry at 280nm wavelength place, calculate the stripping quantity of every.
Separately adopt and use the same method, the tablet that mensuration is made take Fructus Arctii total lignans as raw material and the dissolution of hard capsule.Measurement result is, the dissolution average of soft capsule preparation is 0.49, and the dissolution average of hard capsule preparation is 90.08, and the dissolution average of tablet is 83.57.
By the Fructus Arctii soft capsule preparation described in the present embodiment, adopt ultraviolet spectrophotometry, take aretigenin as external standard, measure the content of its Lignans in 280nm wavelength place, the corresponding percentage composition that draws other compositions in said preparation.Concrete operations are as follows:
1. the preparation of reference substance solution: it is appropriate that precision takes aretigenin reference substance, adds methanol and makes the solution of every mL containing 30ug, to obtain final product.
2. the preparation of need testing solution
Get approximately 10 mg of Fructus Arctii extract described in the present embodiment, accurately weighed, put in 25mL volumetric flask, add dissolve with methanol and be diluted to scale, shake up, filter, precision measures subsequent filtrate 1mL, puts in 1.0mL volumetric flask, adds methanol and is diluted to scale, shakes up, and to obtain final product.
3. assay
Get respectively reference substance and need testing solution, according to ultraviolet visible spectrophotometry, measure absorbance at 280nm wavelength place, calculate, to obtain final product.
Through assay, in the present embodiment, in per unit preparation, total lignans content is 22%.
Embodiment 2
By the Fructus Arctii soft capsule preparation described in the present embodiment, adopt high performance liquid chromatography, take Arctiin, aretigenin as external standard, by integral area ratio, measure the content of its aretigenin and Arctiin.Concrete operations are as follows:
1. chromatographic condition
1 .1 Arctiin
Chromatographic column: with octadecylsilane chemically bonded silica be filler, with methanol and pure water the ratio using volume ratio as 10:11 mix after as mobile phase; Detection wavelength is 280nm.Theoretical cam curve is calculated and should be not less than 15000 by Arctiin peak
1.2 aretigenin
Chromatographic column: with octadecylsilane chemically bonded silica be filler, ratio with methanol, acetonitrile and pure water using volume ratio as 20:20:60 mix after as mobile phase; Detection wavelength is 280nm.Theoretical cam curve is calculated and should be not less than 15000 by Arctiin peak
2. peparation
The preparation of 2.1 reference substance solution
Get Arctiin and aretigenin reference substance is appropriate, accurately weighed, add dissolve with methanol and make respectively every 1mL containing the solution of 0.52mg Arctiin, every 1mL the solution product storing solution in contrast containing the aretigenin of 0.66mg.Accurate this storing solution of absorption is appropriate, puts in 5mL measuring bottle, adds dissolve with methanol and is diluted to scale, obtains reference substance solution.
The preparation of 2.2 need testing solutions
Get the present embodiment and prepare 10 of gained Chinese medicine cattle potato soft capsule preparations, accurately weighed.Get the about 25mg of soft capsule content, accurately weighed, be placed in 10mL volumetric flask, precision adds methanol, weighs, and supersound process 30min, lets cool, then weighs, and supplies the weight of less loss with methanol, shakes up, and filters, and discards just filtrate, gets subsequent filtrate, to obtain final product.
3. assay
Get respectively the each 10uL of reference substance and need testing solution, according to high effective liquid chromatography for measuring.
Through assay, determine that in the present embodiment, per unit preparation Arctiin content is skilful %, aretigenin content is 13%.
The soft capsule dosage that the present embodiment provides is accurate, and content content difference is little, steady quality, and bioavailability is high, is easy to carry, and conveniently takes.The Chinese medicine Fructus Arctii soft capsule preparation of producing as stated above, is applicable to medicine and field of health care products.
Claims (7)
1. a Chinese medicine Fructus Arctii soft capsule preparation, is characterized in that, its component and mass percent thereof are: 38.4% drug extract powder, 59.2% soybean oil and 2.4% Cera Flava.
2. Chinese medicine Fructus Arctii soft capsule preparation according to claim 1, is characterized in that, described drug extract powder is: light yellow to yellow powder, be wherein more than or equal to 64.1% containing Fructus Arctii total lignans class content with UV spectrophotometry
A preparation method for Chinese medicine Fructus Arctii soft capsule preparation according to claim 1, is characterized in that, comprises the following steps:
The first step, get Chinese medicine Fructus Arctii medicinal material coarse powder, with after ethanol pure water solution reflux, extract,, filtrate is carried out to concentrating under reduced pressure to reclaim unnecessary alcohol, make fluid extract;
Second step, after being mixed with the pure water of 5-8 times of volume, fluid extract makes suspension; suspension is extracted to processing with the petroleum ether of 10-15 times of volume; then discard the petroleum ether of extract bottom; again to adding the ethyl acetate of 8-12 times of volume to carry out reextraction in the pure water layer of extract top; finally discard the pure water layer of extraction fluid and make thick paste by the extraction fluid of concentrating under reduced pressure remainder, thick paste being placed in to dried system under 60 ℃ of vacuum environments and getting dry extract;
The 3rd step, adopt mechanical means to pulverize dry cream, add the vegetable oil of 1.4-2.0 times of mass ratio after crossing 100-160 mesh sieve, and adopt mechanical means further to grind, obtain pelleting filler;
The 4th step, ratio by gelatin, glycerol and pure water take volume ratio as 20:8:20 add 0.5% Fe of gross mass after mixing
2o
3.
3. and be placed in glue pot, under 65 ℃ of environment, glue pot is heated to 1h and make film, then adjust temperature to 48 ℃ and adopt rotating mould platen press that film is carried out to pelleting processing, making soft capsule, will after described soft capsule dried, make Chinese medicine Fructus Arctii soft capsule preparation.
4. the preparation method of Chinese medicine Fructus Arctii soft capsule preparation according to claim 3, it is characterized in that, described reflux, extract, refers to: adopting concentration is ethanol pure water solution reflow treatment 2-4 time of 60-90% percent by volume, each return time is 2-4 hour, after refluxing, adopts silk to filter extraction.
5. the preparation method of Chinese medicine Fructus Arctii soft capsule preparation according to claim 3, is characterized in that, described concentrating under reduced pressure refers to: be 60 ℃ in temperature, and air pressure is-filtrate concentrated under the environment of 1.0Mpa, make fluid extract.
6. the preparation method of Chinese medicine Fructus Arctii soft capsule preparation according to claim 3, is characterized in that, described vegetable oil refers to the vegetable oil that contains 4% mass percent Cera Flava, and this vegetable oil refers to: the one in soybean oil, Oleum Ricini, Oleum Arachidis hypogaeae semen or Oleum sesami.
7. the preparation method of Chinese medicine Fructus Arctii soft capsule preparation according to claim 3, is characterized in that, described dried refers to that in temperature be 26 ℃, under the condition that humidity is 30%, after dry 22-26h, takes out soft capsule.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104957612A (en) * | 2015-06-22 | 2015-10-07 | 安庆市孝柱食品科技有限公司 | Oral soybean oil liquid |
| CN108743774A (en) * | 2018-08-14 | 2018-11-06 | 徐州大自然食品有限公司 | A kind of burdock extract composite soft capsule and preparation method thereof |
-
2012
- 2012-11-22 CN CN201210478172.0A patent/CN103830300A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104957612A (en) * | 2015-06-22 | 2015-10-07 | 安庆市孝柱食品科技有限公司 | Oral soybean oil liquid |
| CN108743774A (en) * | 2018-08-14 | 2018-11-06 | 徐州大自然食品有限公司 | A kind of burdock extract composite soft capsule and preparation method thereof |
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Application publication date: 20140604 |