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CN104523774B - A kind of Glabrous Sarcandra Herb chewable tablets and preparation method thereof - Google Patents

A kind of Glabrous Sarcandra Herb chewable tablets and preparation method thereof Download PDF

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Publication number
CN104523774B
CN104523774B CN201410763905.4A CN201410763905A CN104523774B CN 104523774 B CN104523774 B CN 104523774B CN 201410763905 A CN201410763905 A CN 201410763905A CN 104523774 B CN104523774 B CN 104523774B
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glabrous sarcandra
sarcandra herb
parts
chewable tablets
filler
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CN104523774A (en
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张硕
张云
王敏
郭卿
郭瑜
马海波
吴少聪
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SHIJIAZHUANG HUAXIN PHARMACEUTICAL CO Ltd
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Abstract

The present invention relates to a kind of Glabrous Sarcandra Herb chewable tablets and preparation method thereof, it is prepared from by following parts by weight ingredient:3000~3200 parts of Glabrous Sarcandra Herb, 210~230 parts of filler, 5~15 parts of adhesive, 4~8 parts of flavouring, 1~5 part of lubricant, wherein, one or more of the filler in mannitol, lactose or L arabinoses, described adhesive is polyvinylpyrrolidone, and the lubricant is superfine silica gel powder.The present invention also provides the preparation method of the preparation.The problem of present invention can solve current ZHONGJIEFENG PIAN piece great dysphagia, improves medicine mouthfeel, while changing existing extraction and formulation method and technique owes science, it is impossible to the problem of at utmost playing Glabrous Sarcandra Herb drug effect.

Description

A kind of Glabrous Sarcandra Herb chewable tablets and preparation method thereof
Technical field
The present invention relates to a kind of chewable tablets and preparation method thereof, a kind of Glabrous Sarcandra Herb chewable tablets and its preparation side are specifically related to Method, belongs to pharmaceutical technology field,
Background technology
Glabrous Sarcandra Herb, alias Chloranthus glaber, sarcandra, Herba Pileae Scriptae, synthetism lotuses, anti-swollen No. I etc., be Chloranthaceae plant Chloranthus glaber Sarcandra glabra (Thunb.) Nakai drying complete stool.Leaf contains coumarone, lactone, flavones, phenols, cyanogen glucoside, volatile oil And garlic tannic acid;Fruit sandlwood containing pelargonidin glucose.Main component is volatile oil (having bergamio etc. in oil), amber Acid, fumaric acid, coumarone, glycosides displayed, lactone, tannic acid etc..
Glabrous Sarcandra Herb has dispelling wind and removing obstruction in the meridians, function promoting blood circulation and removing blood stasis, and with antibacterial, antiinflammation, with clearing heat and detoxicating, detumescence Effect of dissipating bind, belongs to heat toxin for pneumonia, appendicitis, cellulitis and stops up Sheng patient, and available for assistant treating cancer.
Glabrous Sarcandra Herb has following pharmacological action:
Antibacterial and anti-inflammation functions, Glabrous Sarcandra Herb has broad-spectrum antibacterial action, wherein to staphylococcus aureus, will Hayes dysentery bar Bacterium I is extremely quick, to golden Portugal's persister, Boydii shigella dysenteriae C-2 types, typhoid bacillus H901, paratyphoid A type be Gao Min, to Freund The type of shigella dysenteriae III, Escherichia coli, Pseudomonas aeruginosa also have certain effect.Fumaric acid is to first streptococcus, catarrh ball in Glabrous Sarcandra Herb Bacterium, streptococcus, Bacillus influenzae, Diplococcus pneumopniae quick paramount quick inhibitory action in having.Glabrous Sarcandra Herb is to the not mouse caused by croton oil Rat paw inflammation caused by auricle inflammation, carrageenan and mouse cotton balls internal bud are swollen and have significant inhibitory action.In addition, also can Stomachache substantially caused by mitigation acetic acid and the growth of suppression bacterium.
Antitumaous effect, Glabrous Sarcandra Herb extract and total volatile oil have obvious anti-S180And W256The effect of knurl strain, wherein mouse Crude extract 0.25g/kg is injected intraperitoneally, to S180Inhibiting rate be 42%~49.4% (P < 0.001), to rat W256Suppression Rate is 39.0% (P < 0.01), volatile oil component bergamio 1mg/kg is injected intraperitoneally, to S180Inhibiting rate be 45.3% (P < 0.001).Herba Sarcandrae total flavones are to ribonucleic acid in ehrlich ascites cell (RNA) and DNA (DNA) content There is inhibitory action.
Glabrous Sarcandra Herb clinically with other drug matchings, for antitumor, anti-inflammatory, treatment acute upper respiratory infection, treatment Decrease of platelet, treatment disease of digestive system, treatment oral disease, treatment psoriasis etc., obtain satisfied curative effect, but due to The traditional extraction process level of understanding is limited, and not yet extraction process is carried out to go deep into scientific research, its curative effect is not up to optimization, because This independent patent medicine effect is general, does not have advantage in Clinical practice.
Domestic existing Glabrous Sarcandra Herb chewable tablets has ZHONGJIEFENG ZHUSHEYE, Zhongjiefeng Capsules and ZHONGJIEFENG PIAN.Glabrous Sarcandra Herb is listed Piece piece weighs 500~750mg, and piece type is unfavorable for swallowing greatly, and bigger pain is brought especially for abscess of throat patient medication.
The content of the invention
The present invention is improved on the basis of ZHONGJIEFENG PIAN, it is therefore intended that solve current ZHONGJIEFENG PIAN piece it is great swallow it is tired Difficult the problem of, improve medicine mouthfeel, while changing existing extraction and formulation method and the deficient science of technique, it is impossible at utmost play The problem of Glabrous Sarcandra Herb drug effect, there is provided a kind of convenient to take, in good taste, toxic side effect is small, drug effect improves, it is rapid to work, be conducive to The Glabrous Sarcandra Herb chewable tablets that curative effect of medication is played, and its preparation method is provided.
To solve the above problems, the technical scheme is that:
A kind of Glabrous Sarcandra Herb chewable tablets, it is prepared from by the composition of following parts by weight:3000~3200 parts of Glabrous Sarcandra Herb, filling 210~230 parts of agent, 5~15 parts of adhesive, 4~8 parts of flavouring, 1~5 part of lubricant, wherein, the filler is selected from sweet dew One or more in alcohol, lactose or L-arabinose, described adhesive is polyvinylpyrrolidone, and the lubricant is micro mist Silica gel.
Preferably, Glabrous Sarcandra Herb chewable tablets of the present invention, it is prepared from by the composition of following parts by weight:Glabrous Sarcandra Herb 3125 parts, 220 parts of filler, 10 parts of adhesive, 6 parts of flavouring, 3 parts of lubricant.
It is further preferred that Glabrous Sarcandra Herb chewable tablets of the present invention, wherein, the filler is mannitol:Lactose:L- Arabinose weight ratio is 9:7:6 mixture.
Preferably, Glabrous Sarcandra Herb chewable tablets of the present invention, wherein, the flavouring is flavoring orange essence.
Preferably, Glabrous Sarcandra Herb chewable tablets of the present invention, it is prepared from according to following preparation method:
Step one:Glabrous Sarcandra Herb complete stool is taken, is shredded, is extracted, concentration dry, pulverize into glabrous sarcandra herb extract standby;
Step 2:Glabrous sarcandra herb extract obtained by step one is sufficiently mixed with filler, flavouring, is gathered with 5~10% The vinylpyrrolidone aqueous solution crosses the pelleting of 20 mesh sieves, 50~60 DEG C of dryings 1~2 hour, 16 as binder solution softwood Mesh whole grain is standby;
Step 3:Dry particle obtained by step 2 adds mix lubricant uniformly, and tabletting is produced.
Preferably, Glabrous Sarcandra Herb chewable tablets of the present invention, wherein, in the preparation method, the concrete operations of step one Method is:Glabrous Sarcandra Herb coarse crushing, plus 10,8,8 times of amount decoctings are boiled three times, 4~5 hours for the first time, second, third time respectively 1 ~2 hours, decocting liquid filtration, filtrate merged, and is condensed into 1.1~1.15g/cm of relative density3Thick paste, be dried under reduced pressure into dry leaching Cream, is crushed, wherein, volatile oil, the dry extract that gained volatilization oil atomization is uniformly sprayed into after crushing are collected in first time decoction process In, produce glabrous sarcandra herb extract.
The present invention also provides the preparation method of the Glabrous Sarcandra Herb chewable tablets, and it comprises the following steps:
Step one:Glabrous Sarcandra Herb complete stool is taken, is shredded, is extracted, concentration dry, pulverize into glabrous sarcandra herb extract standby;
Step 2:Glabrous sarcandra herb extract obtained by step one is sufficiently mixed with filler and flavouring, with 5% polyethylene Pyrrolidone solution crosses the pelleting of 20 mesh sieves as binder solution softwood, 50~60 DEG C of dryings 1~2 hour, 16 mesh sieves Whole grain is standby;
Step 3:Dry particle obtained by step 2 adds mix lubricant uniformly, tabletting.
Further, the preparation method of Glabrous Sarcandra Herb chewable tablets of the present invention, wherein, the concrete operations of the step one For:Glabrous Sarcandra Herb coarse crushing, plus 10,8,8 times of amount decoctings are boiled three times, and 4~5 hours for the first time, be respectively 1~2 small for the second time, for the third time When, decocting liquid filtration, filtrate merges, and is condensed into 1.1~1.15g/cm of relative density3Thick paste, be dried under reduced pressure into dry extract, powder It is broken, wherein, volatile oil is collected in first time decoction process, gained volatilization oil atomization is uniformly sprayed into the dry extract after crushing, i.e., Obtain glabrous sarcandra herb extract.
The excellent results of the present invention are:
1st, Glabrous Sarcandra Herb chewable tablets of the invention, is transformed and is obtained on the basis of existing ZHONGJIEFENG PIAN, it is in Glabrous Sarcandra Herb Improved on traditional extraction technique, first, by the species and addition of investigating Extraction solvent, it is determined that optimal extraction Scheme, second, volatile oil is collected during water extraction, it is ensured that being sufficiently reserved for volatility water insoluble ingredients, breach biography The limitation for technique of uniting, it has unexpectedly been found that obtained chewable tablets drug effect is significantly improved compared with conventional tablet.
2nd, the present invention is by investigating the investigations of filler type and quantity, preferably the species and additional proportion of filler, Final preferably mannitol, lactose and L-arabinose, wherein, mannitol can bring refrigerant mouthfeel, lactose compressibility for chewable tablets It is good, L-arabinose tool sweet taste, in addition, being investigated for disintegrant, for chewable tablets, the selection of disintegrant is extremely closed Important, if selection is unreasonable may to cause medicine not collapsing in mouth, influence mouthfeel and drug effect performance, inventor is in Glabrous Sarcandra Herb It was unexpectedly observed that L-arabinose can produce the effect of disintegrant sample in Glabrous Sarcandra Herb chewable tablets in the research of chewable tablets, it is substituted His disintegrant generates excellent effect, compared with other disintegrants, can produce more preferable calving disaggregation, through repetition test, hair A person of good sense is by mannitol, lactose and L-arabinose three according to 9:7:After 6 mixing, gained tablet smooth in appearance is in good taste, disintegration Effect is good, tabletting high income.In addition, the present invention has investigated the effect of different adhesives, 5~10% polyethylene pyrrole is finally determined Pyrrolidone makes pellet for adhesive, and the disintegration of gained tablet, dissolution rate are preferable.The present invention adds flavouring to improve mouthfeel, excellent Flavoring orange essence, increase convenience and patient's compliance are selected, abscess of throat patient is especially suitable for and takes.
3rd, Glabrous Sarcandra Herb chewable tablets of the present invention, is shown by the pharmacodynamic evaluation experiment of rat ear inflammatory model:The present invention Glabrous Sarcandra Herb chewable tablets antiphlogistic effects are better than listing tablet, as a result with significant difference.
4th, Glabrous Sarcandra Herb chewable tablets of the present invention, is shown by acute toxicity and mutagenicity research:Glabrous Sarcandra Herb its mouse oral LD50 The nontoxic scope of category is determined, mouse inbred strain, mouse marrow cell micro nuclear test, Salmonella reversion test are feminine gender, are not found Mutagenicity.Glabrous Sarcandra Herb chewable tablets of the present invention is to large and small mouse acute oral median lethal dose (LD50), bisexuality is all higher than 10g/kgB.W., true border is nontoxic.
Embodiment
The present invention is embodied by following examples, and following examples can be used for explaining the present invention but not as this hair The restriction of bright protection domain.
Embodiment 1
Got the raw materials ready according to following prescription:
Glabrous Sarcandra Herb 3125g, mannitol 90g, lactose 70g, L-arabinose 60g, polyvinylpyrrolidone 10g, orange are fragrant Smart 6g, superfine silica gel powder 3g.
Preparation method:
Step one:Glabrous Sarcandra Herb complete stool is taken, is shredded, is extracted, concentration dry, pulverize into glabrous sarcandra herb extract standby;Wherein, The extraction process of Glabrous Sarcandra Herb is:Glabrous Sarcandra Herb coarse crushing, plus 10,8,8 times of amount decoctings are boiled three times, for the first time 4 hours, second and third time point Other 1.5 hours, decocting liquid filtration, filtrate merged, and is condensed into 1.1~1.15g/cm of relative density3Thick paste, be dried under reduced pressure into dry leaching Cream, is crushed, wherein, volatile oil, the dry extract that gained volatilization oil atomization is uniformly sprayed into after crushing are collected in first time decoction process In, produce glabrous sarcandra herb extract;
Step 2:Glabrous sarcandra herb extract and mannitol, lactose, L-arabinose and flavoring orange essence obtained by step one is abundant Mixing, with 5% aqueous povidone solution as binder solution softwood, crosses the pelleting of 20 mesh sieves, 55 DEG C of dryings 2 Hour, 16 mesh sieve whole grains are standby;
Step 3:Dry particle obtained by step 2 adds superfine silica gel powder and is well mixed, tabletting.
Embodiment 2
Got the raw materials ready according to following prescription:
Glabrous Sarcandra Herb 3100g, mannitol 170g, lactose 150g, polyvinylpyrrolidone 10g, flavoring orange essence 6g, superfine silica gel powder 3g。
Preparation method:
Step one:Glabrous Sarcandra Herb complete stool is taken, is shredded, is extracted, concentration dry, pulverize into glabrous sarcandra herb extract standby;Wherein, The extraction process of Glabrous Sarcandra Herb is:Glabrous Sarcandra Herb coarse crushing, plus 10,8,8 times of amount decoctings are boiled three times, 5 hours for the first time, second and the 3rd Secondary each 1 hour, decocting liquid filtration, filtrate merged, and is condensed into 1.1~1.15g/cm of relative density3Thick paste, be dried under reduced pressure into dry leaching Cream, is crushed, wherein, volatile oil, the dry extract that gained volatilization oil atomization is uniformly sprayed into after crushing are collected in first time decoction process In, produce glabrous sarcandra herb extract;
Step 2:Glabrous sarcandra herb extract obtained by step one is sufficiently mixed with mannitol, lactose and flavoring orange essence, with 5% Aqueous povidone solution as binder solution softwood, cross the pelleting of 20 mesh sieves, 60 DEG C of dryings 1 hour, 16 mesh Sieve whole grain standby;
Step 3:Dry particle obtained by step 2 adds superfine silica gel powder and is well mixed, tabletting.
Embodiment 3
Got the raw materials ready according to following prescription:
Glabrous Sarcandra Herb 3200g, lactose 150g, L-arabinose 170g, polyvinylpyrrolidone 10g, flavoring orange essence 6g, micro mist Silica gel 3g.
Preparation method:
Step one:Glabrous Sarcandra Herb complete stool is taken, is shredded, is extracted, concentration dry, pulverize into glabrous sarcandra herb extract standby;Wherein, The extraction process of Glabrous Sarcandra Herb is:Glabrous Sarcandra Herb coarse crushing, plus 10,8,8 times of amount decoctings are boiled three times, for the first time 4 hours, second and third time point Other 2 hours, decocting liquid filtration, filtrate merged, and is condensed into 1.1~1.15g/cm of relative density3Thick paste, be dried under reduced pressure into dry leaching Cream, is crushed, wherein, volatile oil, the dry extract that gained volatilization oil atomization is uniformly sprayed into after crushing are collected in first time decoction process In, produce glabrous sarcandra herb extract;
Step 2:Glabrous sarcandra herb extract obtained by step one is sufficiently mixed with lactose, L-arabinose and flavoring orange essence, is used 5% aqueous povidone solution crosses the pelleting of 20 mesh sieves, 50 DEG C of dryings 1 hour, 16 as binder solution softwood Mesh sieve whole grain is standby;
Step 3:Dry particle obtained by step 2 adds superfine silica gel powder and is well mixed, tabletting.
The Glabrous Sarcandra Herb chewable tablets of embodiment 4 is to the rat auricle inflammation pharmacodynamic evaluation caused by LPS
1st, trial drug:The Glabrous Sarcandra Herb chewable tablets of the embodiment of the present invention 1, positive control drug is commercially available ZHONGJIEFENG PIAN.
2nd, experimental animal and packet:
Experimental animal:6 week old Wistar rats 60, inject LPS using auricle and form a local inflammation focus in.
Experiment packet:It is divided into basic, normal, high test group, positive controls, negative control group and blank group, every group 10.It is real Apply the basic, normal, high dosage group of Glabrous Sarcandra Herb chewable tablets of example 1 (dosage is respectively 3,10,30mg glabrous sarcandra herb extracts/kg/d, 1g extracts Equivalent to crude drug 13.5g), (10mg glabrous sarcandra herb extracts/kg/d, 1g extracts are equivalent to crude drug for positive controls 13.3g), negative control group gives blank, and blank group is not injected LPS and is not administered.
3rd, test method:Modeling starts to be administered daily after one week, and Glabrous Sarcandra Herb chewable tablets and ZHONGJIEFENG PIAN pulverize gavage, afterwards One month continuous observation animal situation is simultaneously recorded.
4th, observation index:
1. body outward appearance, local redness are festered area;2. TNF secretes concentration level;3. rat serum routine monitoring;4. rat Exercise attitudes, the state of mind, feed inflow, changes of weight etc..
5th, evaluation criterion is shown in Table 1:
The inflammation level evaluation standard of table 1
6th, result of the test:
Naive animals body condition, feed, activity etc. are normal, and TNF values are low without fluctuation.
Negative control group is upgraded to 4 grades after being chosen as 3 grades, 5 days when being administered.
Positive controls be administered when be chosen as being reduced to after 3 grades, 11 days be reduced to 1 grade, 23 days after 2 grades, 18 days after be reduced to 0 grade, always Effective percentage 87%.
Low dosage test group be administered when be chosen as being reduced to after 3 grades, 8 days be reduced to 1 grade, 20 days after 2 grades, 12 days after be reduced to 0 grade, always Effective percentage 82%.
Middle dosage test group be administered when be chosen as being reduced to after 3 grades, 6 days be reduced to 1 grade, 11 days after 2 grades, 9 days after be reduced to 0 grade, always Effective percentage 92%.
High dose test group be administered when be chosen as being reduced to after 3 grades, 2 days be reduced to 1 grade, 8 days after 2 grades, 4 days after be reduced to 0 grade, always have Efficiency 99%.
High, middle dose group antiphlogistic effects are better than positive controls, there is significant difference;Low dose group resists for two weeks before administration Scorching effect is substantially better than positive controls, there is significant difference.
The test-meal of embodiment 5 is tested
100 inflammatory patients of random selection take the Glabrous Sarcandra Herb chewable tablets of embodiment 1~3 and commercially available ZHONGJIEFENG PIAN, to mouthfeel Evaluated, 98%, which thinks that the Glabrous Sarcandra Herb chewable tablets of embodiment 1~3 is easily chewed, easily swallows, in good taste, there is refrigerant sense and fruit Sweet taste etc., receiving is more easily than with commercially available ZHONGJIEFENG PIAN dysphagia, and the mouthfeel of wherein embodiment 1~3 compares, embodiment 1 Mouthfeel is optimal.
The slaking test of embodiment 6
According to Chinese Pharmacopoeia one disintegration time limited of version in 2010 lower inspection technique, 6 are respectively taken to the chewable tablets of embodiment 1~3 Piece is measured, as a result each in 15min by screen cloth, wherein the 6 of embodiment 1 piece are averagely by the screen cloth time 8.5min, embodiment 2 is 12.2min, and embodiment 3 is 7.3min.
The technical concept and advantage of above-described embodiment only to illustrate the invention, the present invention can also have other forms to become Change, as well known to the skilled person, above-described embodiment is functioned only as to the exemplary role in foregoing invention protection domain, right For those of ordinary skill in the art, there are many conventional deformations and other implementations in the protection domain that the present invention is limited Example, these deformations and embodiment are all by within the pending protection domain of the present invention.

Claims (3)

1. a kind of Glabrous Sarcandra Herb chewable tablets, it is characterised in that be prepared from by the composition of following parts by weight:Glabrous Sarcandra Herb 3000~3200 Part, 210~230 parts of filler, 5~15 parts of adhesive, 4~8 parts of flavouring, 1~5 part of lubricant;Wherein, the filler is Mannitol:Lactose:L-arabinose weight ratio is 9:7:6 mixture, described adhesive is polyvinylpyrrolidone, described to rectify Taste agent is flavoring orange essence, and the lubricant is superfine silica gel powder.
2. Glabrous Sarcandra Herb chewable tablets as claimed in claim 1, it is characterised in that:It is prepared from by the composition of following parts by weight:It is swollen Save 3125 parts of wind, 220 parts of filler, 10 parts of adhesive, 6 parts of flavouring, 3 parts of lubricant.
3. the preparation method of Glabrous Sarcandra Herb chewable tablets as claimed in claim 1 or 2, it is characterised in that:Comprise the following steps:
Step one:Glabrous Sarcandra Herb complete stool is taken, Glabrous Sarcandra Herb coarse crushing plus 10,8,8 times of amount decoctings are boiled three times, for the first time 4~5 hours, second Secondary, third time is respectively 1~2 hour, and decocting liquid filtration, filtrate merges, and is condensed into relative density 1.1-1.15g/cm3Thick paste, Dry extract is dried under reduced pressure into, is crushed, wherein, volatile oil is collected in first time decoction process, gained volatilization oil atomization is uniformly sprayed into In dry extract after crushing, glabrous sarcandra herb extract is produced, it is standby;
Step 2:Glabrous sarcandra herb extract obtained by step one is sufficiently mixed with filler and flavouring, with 5% polyvinyl pyrrole The alkanone aqueous solution crosses the pelleting of 20 mesh sieves as binder solution softwood, 50~60 DEG C of dryings 1~2 hour, 16 mesh sieve whole grains It is standby;
Step 3:Dry particle obtained by step 2 adds mix lubricant uniformly, tabletting.
CN201410763905.4A 2014-12-11 2014-12-11 A kind of Glabrous Sarcandra Herb chewable tablets and preparation method thereof Active CN104523774B (en)

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Citations (3)

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Publication number Priority date Publication date Assignee Title
CN1939358A (en) * 2005-09-30 2007-04-04 江西本草天工科技有限责任公司 Sarcandra glaber dispersant tablets
JP2008247854A (en) * 2007-03-30 2008-10-16 Shiseido Co Ltd Antioxidant, dna damage suppressant, and external skin preparation
CN103705832A (en) * 2013-12-27 2014-04-09 王恩芹 Astragalus chewable tablets and preparation method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1939358A (en) * 2005-09-30 2007-04-04 江西本草天工科技有限责任公司 Sarcandra glaber dispersant tablets
JP2008247854A (en) * 2007-03-30 2008-10-16 Shiseido Co Ltd Antioxidant, dna damage suppressant, and external skin preparation
CN103705832A (en) * 2013-12-27 2014-04-09 王恩芹 Astragalus chewable tablets and preparation method thereof

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Title
肿节风含片制备工艺的研究;李迪等;《医药世界》;20070228(第2期);64-66 *

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