CN1695649A - Soft capsule of extractive from active ingredient of jingangteng, and preparation method - Google Patents
Soft capsule of extractive from active ingredient of jingangteng, and preparation method Download PDFInfo
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- CN1695649A CN1695649A CN 200410022530 CN200410022530A CN1695649A CN 1695649 A CN1695649 A CN 1695649A CN 200410022530 CN200410022530 CN 200410022530 CN 200410022530 A CN200410022530 A CN 200410022530A CN 1695649 A CN1695649 A CN 1695649A
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- smilacis bockii
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Abstract
A bock greenbrier rhizome's extract in the form of capsule is prepared from said extract and solvent proportionally.
Description
Technical field
The present invention relates to a kind of anti-inflammation that has, be used for the treatment of Rhizoma Smilacis Bockii effective component extracts soft capsule of gynecological inflammation and preparation method thereof.
Background technology
Rhizoma Smilacis Bockii is a conventional Chinese medicine material among the people, has expelling wind and removing dampness, diuresis, detumescence poison, controls arthralgia, edema, furuncle etc.Bibliographical information " Rhizoma Smilacis Bockii " preparation has good efficacy to gynecological's adnexitis, gynecological's inflammatory mass etc.Pharmacological research shows that its water extract has anti-inflammatory and antalgic and antineoplastic action preferably.Rhizoma Smilacis Bockii is Rhizoma Smilacis Chinensis [Smilar chiaa L.], the main component that studies confirm that Rhizoma Smilacis Bockii treatment gynecological inflammation is the steroidal glycoside compounds, in addition, mainly to contain diosgenin be bioactive substances such as main saponin, alkaloid, organic acid, phenols to Rhizoma Smilacis Bockii.But the research of its bioactive substance still is in the starting stage at initial stage.The application of Rhizoma Smilacis Bockii in gynecological in recent years increases gradually, and curative effect obtains certainly.Existing preparation is the old dosage forms of tradition such as the syrup made with addition of pharmaceutic adjuvant with the decocting in water precipitate with ethanol extract of Rhizoma Smilacis Bockii, tablet, granule.Exist that preparation is coarse, defectives such as taking dose big (syrup: 20ml/ time, be equivalent to crude drug 30g), mouthfeel are poor, use inconvenience.Through consulting, the patent of invention of at present disclosed relevant Rhizoma Smilacis Bockii has: publication number is " nano medicine ' Jingangteng ' and preparation method thereof " of 01102399.6, this application discloses with steps such as microwave extracting, concentrating under reduced pressure, supersonic jet technology, spray dryinges and has made granularity at 1200～1500 orders, particle diameter 0.1～200nm, and most of particle diameters are the Rhizoma Smilacis Bockii nanometer and the preparation thereof of the high bioactivity of 100nm.Publication number is " a kind of granule of ' Jingangteng ' for the treatment of gynecological inflammation and preparation method thereof " of 03114644.9.Rhizoma Smilacis Bockii sheet four kind new medicines obtained the new drug certification in 2000.
Summary of the invention
Purpose of the present invention is exactly to solve the problems referred to above that the existing preparation of Rhizoma Smilacis Bockii exists, and provides that a kind of oral artifact utilization is better, stability of drug products is high, mouthfeel good, Rhizoma Smilacis Bockii effective component extracts soft capsule easy to use.
The present invention realizes by following technical proposal: a kind of Rhizoma Smilacis Bockii effective component extracts soft capsule, it is characterized in that every soft capsule contains Rhizoma Smilacis Bockii extract 75-200mg, and surplus is a solvent substrate.
Described Rhizoma Smilacis Bockii extract makes by following method: get Rhizoma Smilacis Bockii, it is broken into coarse powder, made it the 10-20 order, with the concentration of 6,5,5 times of amounts is that 40～80% ethanol extracts respectively, and concentration is preferably 55～70%, merges each time extracting solution, through concentrating, filter, D101 macroporous resin on the filtrate is received and is connect 45%～70% eluent, membrane filtration, concentrate, spray drying gets the micronization extract of particle diameter less than 20 μ m.
Dried as if membrane filtration liquid directly is concentrated into, the common oven drying method drying of reuse, then available comminution by gas stream or ball mill pulverizing carry out ultra fine, obtain the Rhizoma Smilacis Bockii extract micropowder of particle diameter less than 200 μ m.
Described Rhizoma Smilacis Bockii effective component extracts soft capsule makes by following processing method: Rhizoma Smilacis Bockii extract is carried out ultra fine with comminution by gas stream or ball mill pulverizing, make particle diameter less than 200 μ m, so that make stable emulsion, simultaneously can improve bioavailability, the Rhizoma Smilacis Bockii extract of super-refinement is added in the solvent substrate, fully stir, dissolve, filter, outgas, deliver in the jar of filling machine top, stand-by; Simultaneously gelatin is made the rubber gelatin solution, stand-by; Under the condition of 10,000 grades, 21-25 ℃, RH%:39-41%, start rotating mould press pelleting, the soft capsule of making is cleaned, 28 ± 2 ℃ dry 19-27 hour down, packing, packing get product.
Described solvent substrate is one or more plant edible foods or the medicinal oil in refine Testa oryzae oil, safflower oil, linoleic acid, alpha-linolenic acid, gamma-Linolenic acid, polyunsaturated fatty acid, Semen Tritici aestivi germ oil, Radix Oenotherae erythrosepalae oil, perilla oil, Oleum Hippophae, Semen Lini oil, bathypelagic fish oil, Semen Maydis oil, Oleum Vitis viniferae, Folium et Cacumen Artemisiae Halodendri seed oil, walnut oil, soybean oil, the Oleum Arachidis hypogaeae semen.
Can add edible or medicinal pigment in described solvent substrate or the rubber, perhaps edible or medicinal deodorant tune.
Bock greenbrier rhizome soft capsule provided by the invention is except that having good good outward appearance and stability, and it is fast also to have a stripping, the advantage that bioavailability is good.Because the effective ingredient of Rhizoma Smilacis Bockii is a glycosides compound, under normal conditions, all there is defect of bad in the bioavailability of glycosides compound, Just because of this, inventors of the present invention pass through countless experiments and concentrate on studies, and just draw the present invention's preparation method, promptly adopt the super-refinement technology, the specific surface area of the extract of Rhizoma Smilacis Bockii effective ingredient is increased, very easily contacts, thereby help improving bioavailability with the intestinal wall.
Bock greenbrier rhizome soft capsule with the present invention's preparation our experiments show that:
1, stability is high: Bock greenbrier rhizome soft capsule fibrauretin microcapsule was placed 2 years at normal temperatures, and product is reliable and stable, and every index is all qualified, meets the requirement of oral formulations and soft capsule fully;
2, color, smell and taste are complete: organoleptic examination shows, the Bock greenbrier rhizome soft capsule agent, and color is good, abnormal smells from the patient is fragrant;
3, no the intestines and stomach stimulates: people's Bock greenbrier rhizome soft capsule that shows on probation reduces the stimulation of stomach, intestinal.
4, anti-inflammation is effective: Bock greenbrier rhizome soft capsule and the tablet effect basically identical aspect anti-inflammation.
5, can improve bioavailability: compare with conventional tablet, the bioavailability of this product can improve 10～30%.
Embodiment 1
The preparation of Rhizoma Smilacis Bockii effective component extracts: get the Rhizoma Smilacis Bockii that meets drug standard, break into coarse powder, made it the 10-20 order, with 6,5, the concentration of 5 times of amounts is that 40～80% ethanol extracts respectively 3 times, concentration is preferably 55～70%, merge each time extracting solution,, filter with chitin or the clarification of other clarifier, concentrate being lower than under 60 ℃ of conditions, reclaim ethanol to containing alcohol amount＜20%, filter D101 macroporous resin on the filtrate, receipts connect 45%～70% eluent, concentrate to reclaim ethanol to containing alcohol amount＜20%, with the membrane filtration of 0.4 μ m once, the film of 0.2 μ m refilters once, filtrate is concentrated into solid content below 8%, control feed liquor amount is carried out spray drying, 78 ℃～95 ℃ of control inlet temperatures, 70 ℃～85 ℃ of outlet temperatures get the micronization extract of particle diameter less than 20 μ m.Yield 1.2%～3.5% is equivalent to crude drug 28～83g/g.
Embodiment 2
Prescription (1000):
Rhizoma Smilacis Bockii extract micropowder 75g
Soybean oil 350g
Preparation method: Rhizoma Smilacis Bockii extract is carried out ultra fine with comminution by gas stream or ball mill pulverizing, make particle diameter less than 200 μ m, in the Rhizoma Smilacis Bockii extract adding soybean oil with super-refinement, fully stir, dissolve, filter, outgas, deliver in the jar of filling machine top, stand-by; Simultaneously the gelatin in the soft capsule filling machine top insulation gelatin jar is made the rubber gelatin solution, stand-by; Under 10,000 grades, 22 ℃, the condition of RH%:39%, start rotating mould press pelleting, the soft capsule of making is cleaned, 28 ± 2 ℃ dry 22 hours down, packing, packing promptly get every soft capsule finished product that contains Rhizoma Smilacis Bockii extract 75mg.
Embodiment 3
Prescription (1000):
Rhizoma Smilacis Bockii extract micropowder 105g
PEG-400?????????????????????????????????????????60g
Oleum Arachidis hypogaeae semen 200g
Perilla oil 25g
Method by embodiment 2 makes every soft capsule finished product that contains Rhizoma Smilacis Bockii extract 105mg.
Embodiment 4
Prescription (1000):
Rhizoma Smilacis Bockii extract 175g
Alpha-linolenic acid 100g
Safflower oil 290g
Method by embodiment 2 makes every soft capsule finished product that contains Rhizoma Smilacis Bockii extract 175mg.
Embodiment 5
Prescription (1000):
Rhizoma Smilacis Bockii extract micropowder 200g
Refine Testa oryzae oil 500g
Ethyl hydroxybenzoate 2g
Vanillin 1g
Method by embodiment 2 makes every soft capsule finished product that contains Rhizoma Smilacis Bockii extract 200mg with fragrance.Rubber is modulated into aubergine with amaranth and brilliant black then can get mauve soft capsule.
Embodiment 6
Prescription (1000):
Rhizoma Smilacis Bockii extract micropowder (particle diameter is less than 20 μ m) 200g
Gamma-Linolenic acid 80g
Oleum Hippophae 390g
Vanillin 2g
Make by the method for embodiment 2 and to have fragrance and xanchromatic every soft capsule finished product that contains Rhizoma Smilacis Bockii extract 200mg.
The study of pharmacy of soft capsule product provided by the invention and part pharmacological experiments are as follows:
1, the stability of Rhizoma Smilacis Bockii extract soft capsule
Get the lucifuge keeping at room temperature of 5 samples of embodiment, placed 1,2,3,6,12,24 month, check that on time every grain appearance is constant substantially, effective ingredient does not change through check yet.Therefore, think that tentatively product that the various prescriptions of this Rhizoma Smilacis Bockii (extract) soft capsule make all can reach the shelf-life about 2 years.
The stability test result: assay and discriminating etc. are with reference to the National Standard Rhizoma Smilacis Bockii syrup in the quality standard " and " the relevant general rule of 2000 editions two soft capsules of Chinese pharmacopoeia.The result is as follows:
| Sample | Sample size, discriminating | |||||
| January | February | March | June | December | 24 months | |
| Example 1 | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| Example 2 | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| Example 3 | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| Example 4 | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| Example 5 | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
The result shows the sample of this invention preparation, and through the preliminarily stabilised investigation, product quality is basicly stable, can reach more than 2 years.
2, the analgesic activity of Rhizoma Smilacis Bockii extract soft capsule
Mouse writhing method: 60 of mices, be divided into 4 groups at random, 15 every group, 60min after the ig administration, mouse peritoneal inject 0.7% acetic acid 0.1ml/10g, and record 5～15min mouse writhing reaction times is calculated and comparable group differences significance, the results are shown in following table:
| Group | Body weight | Dosage (mg/Kg) | Turn round the body number of times | Suppression ratio |
| Blank group | ??20±1.1 | Equal-volume | ??30.8±8.00 | |
| The morphine group | ??20±0.9 | ?10 | ??2.4±1.49 | ??92.2％ |
| Soft capsule | ??20±1.2 | ?300 | ??24.6±5.39 | ??41.1％ |
| Soft capsule | ??20±1.0 | ?600 | ??10.0±2.02 | ??72.0％ |
Conclusion: this product has certain analgesic activity, and is dose-effect relationship within the specific limits.
3, Rhizoma Smilacis Bockii extract soft capsule antiinflammatory action
Use the Whttle method, 60 of mices are divided into 4 groups at random, 15 every group, 60min after the ig administration, the blue 0.2ml/ of mouse tail vein injection 0.5% ivens is the timely lumbar injection 0.7% acetic acid 0.2ml/10g in back only, puts to death mice behind the 15min, and intraperitoneal injection of saline 5ml gently rubs the back and extracts peritoneal fluid, centrifugal, supernatant is measured optical density value in the 620nm place, calculate and comparable group differences significance, the results are shown in following table:
| Group | Body weight | Dosage (mg/Kg) | Optical density value | Suppression ratio |
| Blank group | ??20±1.1 | Equal-volume | ??0.29±0.05 | |
| Aspirin | ??20±1.3 | ?200 | ??0.12±0.03 | ??61.2％ |
| The soft capsule group | ??20±1.2 | ?100 | ??0.21±0.04 | ??39.7％ |
| The soft capsule group | ??20±1.0 | ?200 | ??0.10±0.03 | ??69.8％ |
Conclusion: the Rhizoma Smilacis Bockii extract flexible glue has the obvious anti-inflammatory and anti effect, with the blank group difference of highly significant is arranged relatively, and is dose-effect relationship within the specific limits.
4, the stomach irritation of Rhizoma Smilacis Bockii extract soft capsule test
To the stronger volunteer of Rhizoma Smilacis Bockii syrup gastric irritation reaction, participating in the experimenter was 26 patients, was divided into two groups, took Rhizoma Smilacis Bockii extract soft capsule and Rhizoma Smilacis Bockii syrup that embodiment 5 obtains respectively in the past in choosing.The result takes syrupy 13 patient's gastric irritation significant reaction, can not continue medication.The person has only 2 slight gastric irritation reaction to occur and take the soft capsule, all the other 11 medications, 1 all no stomaches, intestinal irritant reaction.Show that soft capsule preparation stimulates greatly and reduces stomach, intestinal.
Listed embodiment only is to the specifying of technical scheme, and is not for the restriction technologies scheme.Therefore technical scheme can not be confined on the embodiment.
Claims (5)
1, a kind of Rhizoma Smilacis Bockii effective component extracts soft capsule is characterized in that every soft capsule contains Rhizoma Smilacis Bockii extract 75-200mg, and surplus is a solvent substrate.
2, soft capsule according to claim 1, it is characterized in that described Rhizoma Smilacis Bockii extract makes by following method: get Rhizoma Smilacis Bockii, it is broken into coarse powder, making it the 10-20 order, is that 40～80% ethanol extracts respectively with the concentration of 6,5,5 times of amounts, and concentration is preferably 55～70%, merge each time extracting solution, through concentrating, filter D on the filtrate
101Macroporous resin is received and is connect 45%～70% eluent, and membrane filtration concentrates, and spray drying gets the micronization extract of particle diameter less than 20 μ m.
3, soft capsule according to claim 1, it is characterized in that making: Rhizoma Smilacis Bockii extract is carried out ultra fine with comminution by gas stream or ball mill pulverizing by following processing method, make particle diameter less than 200 μ m, the Rhizoma Smilacis Bockii extract of super-refinement is added in the solvent substrate, fully stir, dissolve, filter, outgas, deliver in the jar of filling machine top, stand-by; Simultaneously gelatin is made the rubber gelatin solution, stand-by; Under the condition of 10,000 grades, 21-25 ℃, RH%:39-41%, start rotating mould press pelleting, the soft capsule of making is cleaned, 28 ± 2 ℃ dry 19-27 hour down, packing, packing get product.
4, soft capsule according to claim 1 is characterized in that described solvent substrate is one or more plant edible foods or the medicinal oil in refine Testa oryzae oil, safflower oil, linoleic acid, alpha-linolenic acid, gamma-Linolenic acid, polyunsaturated fatty acid, Semen Tritici aestivi germ oil, Radix Oenotherae erythrosepalae oil, perilla oil, Oleum Hippophae, Semen Lini oil, bathypelagic fish oil, Semen Maydis oil, Oleum Vitis viniferae, Folium et Cacumen Artemisiae Halodendri seed oil, walnut oil, soybean oil, the Oleum Arachidis hypogaeae semen.
5, soft capsule according to claim 1 is characterized in that can adding in described solvent substrate or the rubber edible or medicinal pigment, perhaps edible or medicinal deodorant tune.
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| CN 200410022530 CN1695649A (en) | 2004-05-11 | 2004-05-11 | Soft capsule of extractive from active ingredient of jingangteng, and preparation method |
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| CN 200410022530 CN1695649A (en) | 2004-05-11 | 2004-05-11 | Soft capsule of extractive from active ingredient of jingangteng, and preparation method |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101002874B (en) * | 2005-12-16 | 2010-05-19 | 朱志宏 | Compound traditional Chinese medicine with antibiotic and anti-inflammatory function, and its preparing method |
| CN101007130B (en) * | 2005-12-16 | 2010-12-08 | 湖南九典制药有限公司 | An antibiotic and anti-inflammation traditional Chinese medicine composition and its preparation method |
| CN101401896B (en) * | 2008-09-28 | 2011-06-22 | 湖北福人药业股份有限公司 | Extracting method of active principle of sarsaparilla |
| CN103877448A (en) * | 2012-12-19 | 2014-06-25 | 成都立力医药科技有限公司 | Bock greenbrier rhizome extract and preparation method thereof |
| CN104855835A (en) * | 2015-04-27 | 2015-08-26 | 新疆奇台八一面粉有限责任公司 | Ultra-micro microencapsulation wheat germ powder preparation and application |
| CN108095054A (en) * | 2017-12-19 | 2018-06-01 | 张开良 | Vegetalitas capsule of sugar digestion and absorption and preparation method thereof in a kind of reduction meals |
-
2004
- 2004-05-11 CN CN 200410022530 patent/CN1695649A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101002874B (en) * | 2005-12-16 | 2010-05-19 | 朱志宏 | Compound traditional Chinese medicine with antibiotic and anti-inflammatory function, and its preparing method |
| CN101007130B (en) * | 2005-12-16 | 2010-12-08 | 湖南九典制药有限公司 | An antibiotic and anti-inflammation traditional Chinese medicine composition and its preparation method |
| CN101401896B (en) * | 2008-09-28 | 2011-06-22 | 湖北福人药业股份有限公司 | Extracting method of active principle of sarsaparilla |
| CN103877448A (en) * | 2012-12-19 | 2014-06-25 | 成都立力医药科技有限公司 | Bock greenbrier rhizome extract and preparation method thereof |
| CN104855835A (en) * | 2015-04-27 | 2015-08-26 | 新疆奇台八一面粉有限责任公司 | Ultra-micro microencapsulation wheat germ powder preparation and application |
| CN104855835B (en) * | 2015-04-27 | 2018-03-20 | 新疆奇台八一面粉有限责任公司 | A kind of preparation and application of ultra micro microencapsulation wheat germ powder |
| CN108095054A (en) * | 2017-12-19 | 2018-06-01 | 张开良 | Vegetalitas capsule of sugar digestion and absorption and preparation method thereof in a kind of reduction meals |
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