CN103816189A - New micronized Cordyceps sinensis tablet and preparation method thereof - Google Patents
New micronized Cordyceps sinensis tablet and preparation method thereof Download PDFInfo
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- CN103816189A CN103816189A CN201410070497.4A CN201410070497A CN103816189A CN 103816189 A CN103816189 A CN 103816189A CN 201410070497 A CN201410070497 A CN 201410070497A CN 103816189 A CN103816189 A CN 103816189A
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Abstract
The invention provides a new micronized Cordyceps sinensis tablet and its preparation method, and belongs to the technical field of traditional Chinese medicines and health products. The invention comprises the following technical features: Cordyceps sinensis is firstly ultramicro-porphyrized until particle size is uniform and size is less than 1 micron, and moisture content of the micro-powder is controlled to be 3-7%; and any plastic material or other auxiliary materials are not added, and the micro-powder is compressed under low temperature drying condition and under protection of an inert gas by multiple moulding technology so as to obtain the tablet. The technology provided by the invention has broken through the technical barrier that only Cordyceps sinensis powder with moisture being greater than 8% can be compressed to form tablets. By the preparation method, purity of the product is higher, instant dissolution rate is higher, mouthfeel is better, storage life of the product with low moisture can be prolonged, and loss of active substances can be better prevented.
Description
[technical field]
The present invention relates to field of Chinese herbal medicine technology, more specifically, relate to a kind of new aweto micropowder tablet and preparation method thereof.
[background technology]
Cordyceps (formal name used at school: Cordyceps sinensis), has another name called cordyceps sinensis, is called again Cordyceps sinensis, is called for short Cordyceps.It is the traditional expensive Chinese crude drug of name Cordyceps of China, it is to parasitize the Hepialus larva in alpine meadow soil by the Cordyceps fungus of Hypocreales Clavicipitaceae Cordyceps, larva is ossify, under optimum conditions, go out long bar-shaped Stroma and form (being the sporophore of Cordyceps fungus and the complex that Bombyx Batryticatus sclerotium (larva corpse) forms) by Bombyx Batryticatus head end pumping summer.It mainly originates in severe cold areas and the snow-capped mountains and marshlands in Qinghai, Tibet, Sichuan etc.
The traditional Chinese medical science thinks, Cordyceps enters lung kidney two warps, can tonifying the lung the moon, again can kidney-replenishing, and cure mainly and suffer from a deficiency of the kidney, impotence and seminal emission, soreness of waist and knee joint, weak after being ill, chronic cough weakness, phthisical cough expectorant blood, spontaneous sweatings etc., are unique a kind of balance simultaneously, the Chinese medicine that regulates negative and positive.Medical science shows now, and Cordyceps has one, regulates function of immune system; Two, antitumor; Three, improve cellular energy, resisting fatigue; Four, regulate cardiac function, Cordyceps can improve heart hypoxia-bearing capability, reduces the consumption of heart to oxygen, arrhythmia.Five, regulate liver function; Six, regulate respiratory system function; Seven, regulate renal function; Eight, regulate hemopoietic function; Nine, regulate blood fat etc. effect.
In pharmacology's modern study result, Cordyceps of Qinghai Province contains cordycepic acid approximately 7%, saccharide 28.9%, and fat approximately 8.4%, protein approximately 25%, in fat, 82.2% is unsaturated fatty acid, in addition, still contains vitamin B12, Ergota lipidol, hexose alcohol, alkaloid etc.According to medical science analysis, cordycep includes cordycepic acid.Vitamin B12, fat, albumen etc.Cordyceps property is sweet, Wen Ping, nontoxic, be the strengthening by means of tonics medicine of name, conventional meat boiled dinner, the effect that has tonify deficiency to be healthy and strong.Be applicable to treat spitting of blood due to insufficiency of lung-QI and deficiency of both the lung and kidney, pulmonary tuberculosis etc. or sputum mixed with blood, cough.Breathe hard, night sweat etc., to the sun of suffering from a deficiency of the kidney--flaccidity, waist knee joint ache etc. also has good curative effect, the person's that is also oldaged physically weak excellent tonic product.Cordyceps can play calmness, convulsion, cooling effect to central nervous system; Cardiovascular system there is is blood pressure lowering, reduces myocardial oxygen consumption, improve myocardial ischemia, antiarrhythmic effect; To respiratory system energy expansion bronchus, eliminating phlegm and relieving asthma, in addition chronic nephritis, renal failure are had to significant curative effect.Modern medicine research authority also finds: Cordyceps really can be improved body's immunity, strengthens resistance against diseases, is a kind of rare precious Chinese medicine, and its purposes and value will be increasing people's understanding and application.
Because cordyceps yield is lower, effect is remarkable, and price climbs up and up.Deeply developing Cordyceps is present study hotspot.Application number is in 200810303308.8 patent, to have described a kind of method that directly Cordyceps powder is pressed into tablet, conveniently takes and absorbs.But the method using in this patent is that the diameier of Cordyceps is controlled to 1-150um, and moisture Control is at 8-18%.Although the raw clothes that this big or small particle diameter Cordyceps is more conventional or stewed boiling, dissolution rate can improve, situation that neither be optimum.In addition, the moisture of the 8-18% using in this patent is not best for the tablet forming technique of Chinese medicine powder, and the moisture of this content is very unfavorable for the preservation of Cordyceps simultaneously.The water content of for example flour will be lower than 13% just qualified, and its shelf-life is only 3 months.So precious Cordyceps should have the quality standard of requirements at the higher level.The powder moisture of mentioning direct compression employing in the Master's thesis " research of Chinese medicine for lowering high blood pressure wind sheltering sheet direct powder compression preparation technique " of the Zhu Xiaodan of University Of Tianjin is 3-4%.Liu Maojun also mentions grasping pellet moisture is controlled between 4-6% relatively good in " the problems and solutions that should note in Chinese medicinal tablet tabletting process " (" continuation medical education " 33 phases in 2007) literary composition.
[summary of the invention]
The object of the invention is to be to solve the deficiencies in the prior art part and a kind of more excellent Cordyceps powder direct compression technology is provided.Only containing in the medical material of Cordyceps powder, do not add any adjuvant, direct compression molding, its face shaping and hardness meet buccal tablet quality standard.
Technical characterictic of the present invention comprises: first by Cordyceps micronized pulverization to size ratio compared with homogeneous, and size is less than 1um, controls micropowder moisture to 3-7%; Do not add any plastic material or other adjuvants, in cold drying, under inert gas shielding, adopt repeatedly forming technique, be pressed into tablet.
This technological break-through prior art must adopt the Cordyceps powder that is greater than 8% moisture can be pressed into the technology barriers of tablet, make the purity of product higher, mouthfeel is better, and short time dissolution rate is higher, can extend the retention cycle of product compared with low moisture, better prevent the loss of active substance.
When aweto micropowder tablet of the present invention is applied with buccal tablet form, by oral mucosa in conjunction with oral gastrointestinal absorption approach, effective ingredient in aweto micropowder is entered rapidly in human body, can overcome the first pass effect of liver, improve curative effect, and can make the dosage of taking reduce or reduce at double.The meaning that its clinical meaning and data are utilized is very big.
[specific embodiment]
In order to make the present invention easier to understand, will further set forth specific embodiment of the invention below.
In the present invention, inventor is creationary by the highest level of current industry, and water content is 8-18%, the technology of the Cordyceps powder ability tabletting that particle diameter is 1-150um, and further expanding to water content is 3-7%, particle diameter 0.1-1um.In preparation process, do not add any auxiliary element, Cordyceps is unique component of tablet.The present invention has significantly improved the instantaneous dissolution rate of Cordyceps, has improved the preservation time of the active substance of Cordyceps simultaneously.
Selecting particle diameter is the Cordyceps powder of 0.1-1um, first carries out tabletting processing, and tabletting is pulverized after processing, and the particle diameter of pulverizing is 300-500 order, and then carries out again tabletting and pulverize, and powder particle diameter is 80-100 order, preferably carries out tabletting pelletize again.
In concrete enforcement, we find that low temperature has considerable influence for compression molding, and possible low temperature can affect the mobility of micropowder, also likely can have influence on the crystallization of level in micropowder, stable more low easier compression molding.Simultaneously also favourable to the active substance preservation in aweto micropowder in theory, sure mistake improves the quality of buccal tablet.
In addition, whole disintegrating process, compression molding technique are all positioned under the protection of noble gas (carbon dioxide, nitrogen), in aweto micropowder, easily oxidized active substance is able to protectedly, also can improve the drug effect of Cordyceps tablet.
Embodiment 1
Selecting particle diameter is the Cordyceps powder of 0.1-1um, first carries out tabletting processing, and tabletting is pulverized after processing, and the particle diameter of pulverizing is 300-500 order, and then carries out again tabletting and pulverize, and powder particle diameter is 80-100 order, preferably carries out tabletting pelletize again.
Whole process is carried out in minus 20 degrees grimness, pulverizer, tablet machine is covered with hermetic container simultaneously, only leaves the manipulable rubber gloves of staff for operation, filling arbon dioxide in hermetic container.
Adopt above method, compacting is circular, the tablet testing result of 0.25g: moisture 3-7%, and yield rate is greater than 70%, and hardness is greater than 4.2Kg, and average numb sheet rate is less than 5%, and average sliver rate is less than 6%.Reach technological requirement.
Comparative example
Selecting particle diameter is the aweto micropowder of 5-10um, and moisture is 9.5%, and precompression is 28KN, and principal pressure is 28KN, and ambient temperature 25 is spent, and compacting is circular, the tablet of 0.25g.Testing result hardness is greater than 4.2Kg, and average numb sheet rate is less than 5%, and average sliver rate is less than 6%, suitable with yield rate of the present invention.
This comparative example adopts room temperature 25 to spend, prepared by open environment.
The mensuration of total dissolution rate
Selecting particle diameter is each 10 of the Cordyceps tablet (2.5g altogether) that embodiment and comparative example are produced, and Cordyceps herb 2.5g, put into 100ml distilled water, in magnetic force rotation blending instrument, adopt identical speed (100 rpms), sampling in 1,3,5,10,30,60 minute, filter respectively, oven dry dry is weighed, and calculates the amount of stripping material.The results are shown in Table 1.
Dissolution time | 1 minute | 3 minutes | 5 minutes | 10 minutes | 30 minutes | 60 minutes |
The present invention | 0.09041 | 0.1153 | 0.13195 | 0.15714 | 0.16103 | 0.17172 |
Comparative example | 0.06619 | 0.07304 | 0.08516 | 0.09281 | 0.10918 | 0.12973 |
Herb | 0.01037 | 0.02419 | 0.02762 | 0.03390 | 0.04738 | 0.05142 |
Different Cordyceps tablets and Cordyceps herb stripping material are different along with asynchronism(-nization).Although in 1 minute, tablet of the present invention is 9 times of herb dissolution rate, is to remain more than 3 times to 60 minutes, this just distills water-soluble a kind of situation, different with the result of absorption of human body, does not have comparability.But above result can find out, our broken particle diameter is less, and aridity is higher, and overall dissolution rate is apparently higher than industry level.Because water content difference, in the tablet of identical weight, dry matter content of the present invention is just than the many places of comparative example more than 5%, and this may be the reason that dissolution rate is high.
The mensuration of macromole active substance
Adopt embodiment and comparative example respectively to get 1 sample, take 0.25g Cordyceps herb simultaneously, be dissolved to respectively in 100ml sterilized water, get 1ul and use domestic Cordyceps gene identification boxes (production of Bai Yan bio tech ltd, Shanghai) to carry out respectively Cordyceps gene test.This detection kit is to utilize constant temperature gene extension principle, utilizes indicator to carry out color indication to the result of gene amplification, and the needed time of change color is inversely proportional to the Cordyceps mrna concentration in reaction solution.Repeatedly repeated trials, on average arrives the time of positive findings respectively: embodiment 23 minutes, comparative example 24 minutes, herb 45 minutes.
The Cordyceps that embodiment is produced is first respectively according to 5 times of gradient dilutions of geometric ratio, use domestic Cordyceps gene identification boxes (production of Shanghai Bai Yan biotech firm), this detection kit can a certain sample of proportional diluted, two identical reaction tubes of gene template concentration to be detected, the needed time of change color is identical.Utilize this principle, repeatedly repeated trials, detect embodiment and comparative example Cordyceps gene discharge par respectively: embodiment is greater than 5 times of comparative example, is greater than 15625 times of herbs.
Above result is to show efficiency in Cordyceps shattering process and the reservation situation of macromolecular substances by detecting Cordyceps gene (DNA, claims again DNA (deoxyribonucleic acid), is a kind of macromole active substance in organism).Although the integrity of gene and dissolution rate can not substitute the active component of Cordyceps completely, can be from the quality of a side reflection shell-broken effect.
Above result shows, the aweto micropowder tablet agent of manufacture of the present invention, and macromole active substance keeps integrity high, and dissolution rate is high.
The mensuration of preservation loss of activity
Get respectively embodiment and comparative example product, carrying out bubble-cap packs, place 30 degree calorstats, after 30 days, adopt embodiment and comparative example respectively to get 1 sample, be dissolved to respectively in 100ml sterilized water, get 1ul and use domestic Cordyceps gene identification boxes (production of Bai Yan bio tech ltd, Shanghai) to carry out respectively Cordyceps gene test.Repeatedly repeated trials, on average arrives the time of positive findings respectively: embodiment 24 minutes, comparative example 25 minutes.
The Cordyceps that embodiment is produced is first respectively according to 5 times of gradient dilutions of geometric ratio, use domestic Cordyceps gene identification boxes (production of Shanghai Bai Yan biotech firm), repeatedly repeated trials, detect embodiment and comparative example Cordyceps gene discharge par respectively: embodiment is greater than 25 times of comparative example.
Above result demonstration, the aweto micropowder tablet agent water content of manufacture of the present invention is few, causes active substance to lose in storage few, and macromole active substance keeps integrity high, and the shelf-life can extend.
Finally should be noted that; above embodiment is only for illustrating technical scheme of the present invention but not limiting the scope of the invention; although the present invention is described in detail with reference to preferred embodiment; those of ordinary skill in the art is to be understood that; can modify or be equal to replacement technical scheme of the present invention, and not depart from essence and the scope of technical solution of the present invention.
Claims (8)
1. the invention provides a kind of new aweto micropowder tablet and preparation method thereof, feature comprises: first by Cordyceps micronized pulverization to size ratio compared with homogeneous, and size is less than 1um, controls micropowder moisture to 2-8%; Do not add any plastic material or other adjuvants, in cold drying, under inert gas shielding, adopt once or repeatedly forming technique, be pressed into tablet.
2. a kind of new aweto micropowder tablet as claimed in claim 1 and preparation method thereof, is characterized in that, it is that Cordyceps entirety is together pulverized that described Cordyceps is pulverized.
3. a kind of new aweto micropowder tablet as claimed in claim 1 and preparation method thereof, is characterized in that, described carries out micronized pulverization to Cordyceps, and broken particle diameter is between 0.01um-1um.
4. a kind of new aweto micropowder tablet as claimed in claim 1 and preparation method thereof, is characterized in that, controls the moisture of micropowder between 2%-8%.
5. a kind of new aweto micropowder tablet as claimed in claim 1 and preparation method thereof, is characterized in that, described repeatedly molding, refers to and be greater than and comprise more than 2 times forming technique.
6. a kind of new aweto micropowder tablet as claimed in claim 1 and preparation method thereof, is characterized in that, described tablet is the custom call of industry, the dosage form that comprises bulk, column, spherical, oval, ring-type and irregular three-dimensional shape.
7. a kind of new aweto micropowder tablet as claimed in claim 1 and preparation method thereof, is characterized in that, described low temperature refers to the temperature range of-70 degree to 0 degree.
8. a kind of new aweto micropowder tablet as claimed in claim 1 and preparation method thereof, is characterized in that, described noble gas refers to carbon dioxide, nitrogen, argon, neon, helium, krypton, xenon.
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106667774A (en) * | 2015-11-09 | 2017-05-17 | 李治国 | Crushing and tabletting integrated device |
CN107982286A (en) * | 2017-12-11 | 2018-05-04 | 陈超 | A kind of cordyceps sinensis lozenge and preparation method thereof |
CN110496141A (en) * | 2019-09-10 | 2019-11-26 | 杭州华东医药集团新药研究院有限公司 | A kind of pharmaceutical composition containing cordyceps sinensis |
-
2014
- 2014-02-28 CN CN201410070497.4A patent/CN103816189A/en active Pending
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106667774A (en) * | 2015-11-09 | 2017-05-17 | 李治国 | Crushing and tabletting integrated device |
CN107982286A (en) * | 2017-12-11 | 2018-05-04 | 陈超 | A kind of cordyceps sinensis lozenge and preparation method thereof |
CN110496141A (en) * | 2019-09-10 | 2019-11-26 | 杭州华东医药集团新药研究院有限公司 | A kind of pharmaceutical composition containing cordyceps sinensis |
CN110496141B (en) * | 2019-09-10 | 2022-02-25 | 杭州华东医药集团新药研究院有限公司 | A pharmaceutical composition containing Cordyceps |
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Application publication date: 20140528 |