CN105535147A - Taste-improved Gegen Qinlian pills and preparation method - Google Patents
Taste-improved Gegen Qinlian pills and preparation method Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/488—Pueraria (kudzu)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/718—Coptis (goldthread)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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Abstract
The invention relates to taste-improved Gegen Qinlian pills and a preparation method. With the extracts of radix puerariae, scutellaria baicalensis, coptis chinensis and liquorice as active ingredients, the pills are prepared by the following steps: performing first taste masking with sodium alginate; performing second taste masking with No.IV acrylic resin; and implementing a pill screening process or two pill screening processes. The product prepared in the invention can cover the bitter taste and unpleasant taste of medicines relatively well and is easily acceptable to the patients. Meanwhile, by adopting relatively strict pill screening and material backflow control processes, the particle sizes of the products are distributed in a relatively narrow range, and the material loss is effectively reduced.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of Gegen Qinlian ball and preparation method of taste modified form.
Background technology
GEGEN QINLIAN TANG is China's traditional Chinese medical science recipe, is formed by Radix Puerariae 24g, Huang Fen 9g, Rhizoma Coptidis 9g, Radix Glycyrrhizae 6g decocting.Record according to " Treatise on Febrile Diseases sun abnormal pulse is demonstrate,proved and controls ": " TAI YANG syndrome, syndrome of decoction GUI ZHI (Ramulus cinnamomi) cure anti-purgation, and profit is then only lower.Irregularly rapid pulse person, shows non-solution also; Dyspnea and sweating, GEGEN QINLIAN TANG master it.”
In order to adapt to development and people's taking convenience of modern Chinese medicine, medical research worker develops the dosage forms such as oral liquid, granule, capsule, pill, tablet, powder according to " GEGEN QINLIAN TANG " this traditional Chinese medical science recipe.
About Gegen Qinlian ball, " Chinese Pharmacopoeia 2015 editions " 1581 pages describes its prescription and method for making, is specially: Radix Puerariae 1000g, Radix Scutellariae 375g, Rhizoma Coptidis 375g, Radix Glycyrrhizae Preparata 250g; Above four tastes, get Radix Scutellariae, Rhizoma Coptidis, use 50% ethanol as solvent respectively, flood and carry out percolation after 24 hours, collect liquid of filtering, and reclaim ethanol, and suitably concentrate; Radix Puerariae adds water and is decocted first 30 minutes, then adds Radix Scutellariae, Rhizoma Coptidis medicinal residues and Radix Glycyrrhizae Preparata, continues to decoct secondary, each 1.5 hours, collecting decoction, filtered, filtrate is concentrated in right amount, adds above-mentioned concentrated solution, continues to be condensed into thick paste, decompression cold drying, being ground into most fine powder, is wetting agent with ethanol, general ball, makes 300g, sieves, dry in less than 60 DEG C, to obtain final product.
CN101156906A discloses the extraction process of Gegen Qinlian medicine combination, and the preparation method of various dosage form.Wherein, the preparation technology about Gegen Qinlian pill is: by the Radix Puerariae extract 62g of preparation, Radix Scutellariae extract 60g, Rhizoma Coptidis extract 26g, Radix Glycyrrhizae extract 20g mix homogeneously, then with Pulvis Talci 100g, microcrystalline Cellulose 682g, aspartame 50g, with 50% ethanol for binding agent crosses 24 mesh sieve granules, put into pellet processing machine pill, drying, subpackage, packaging, obtain 1000 bags, to obtain final product.
Shenyang Pharmaceutical University Li Qing slope, the people such as You Jian propose a kind of extrusion spheronization legal system for GEGEN QINLIAN DIWAN (extrusion spheronization legal system is for GEGEN QINLIAN DIWAN. " Chinese herbal medicine " the 36th volume the 10th phase: 1473-1476).The method is by controlling moisture content, extruded velocity, round as a ball rotating speed and 4 key parameters of round as a ball time to produce narrow diameter distribution, GEGEN QINLIAN DIWAN that roundness is good.
For a long time, due to the problem of the property of medicine own, there is taste more bitter in Gegen Qinlian ball, and part user is difficult to the problem accepted.Preparation about Gegen Qinlian ball is more is pay close attention to the extraction process of effective ingredient, its pelletizing process or adopt traditional general ball technique, or adopts and extrude-round as a ball one-tenth ball method.In actual production, the pill making craft of Gegen Qinlian ball adopts the general ball machine of general pharmacy that market is purchased, and its pelletizing process is more extensive, working strength is high, and medicine losing quantity is large, and particle size distribution is wider, and the operation relative complex of extrusion spheronization method, production cost is higher.
Summary of the invention
The object of this invention is to provide Gegen Qinlian ball of a kind of taste modified form and preparation method thereof.
The Gegen Qinlian ball of taste modified form of the present invention comprises active constituents of medicine, the first taste masking ingredients and the second taste masking ingredients.
Wherein, active component is Radix Puerariae, Radix Scutellariae, Rhizoma Coptidis, Radix Glycyrrhizae four Chinese medicine material carry out extracting the extract obtained, generally in paste with the method for the effective ingredient of Gegen Qinlian ball recorded according to " Chinese Pharmacopoeia 2015 editions " of weight ratio of 8: 3: 3: 2 respectively;
Inventor studies and finds that the fine powder to Gegen Qinlian active component adds the general ball of 0.05%-0.45% sodium alginate comparatively easy-formation, sodium alginate has certain film property simultaneously, bitterness and the disagreeable taste of some drugs can be covered, and realize the technique effect of the present invention's first time taste masking;
The Adding Way of 0.05%-0.45% sodium alginate can adopt directly to add in fine powder and carry out wet granulation, or carries out spray when general ball and add;
Adopt IV acrylic resin and 95% the solution prepared by 1: 16 ~ 20 weight portions of ethanol carry out second time taste masking;
The Adding Way of second time odor mask adopts during general ball and sprays the mode added.
Can select afterwards to add flavoring ingredients again, as steviol glycosides, aspartame, xylitol, sorbitol, mannitol etc., also can select not add flavoring ingredients.
The preparation method of the Gegen Qinlian ball of taste modified form of the present invention, is characterized in that, comprise following steps:
(1) by the fluid extract decompression cold drying containing active constituents of medicine, and pulverize, cross 60 order-100 mesh sieves, the fine powder obtained that sieves is used as general ball;
(2) fine powder obtained to step 1 adds the first taste masking ingredients, add alcoholic solution as wetting agent, general ball 20-40min, add the second taste masking ingredients again, strengthen general ball 20-40min, pill crosses 10 orders, 16 order twice sieves, is greater than 10 object pills and is back to pulverizing program and again pulverizes, be less than 16 object pill backflows to continue as female ball, all the other enter subsequent processing for qualified pill;
(3) the qualified pill of step 2 gained is carried out drying at 70 DEG C-85 DEG C, obtain product.
Present invention also offers another set of pill making craft, it is characterized in that, comprise following steps:
(1) by the fluid extract containing active constituents of medicine, decompression cold drying, and pulverize, cross 60 order-100 mesh sieves, the fine powder obtained that sieves divides two parts to be used as general ball;
(2) a part of fine powder step 1 obtained adds the first taste masking ingredients, add alcoholic solution as wetting agent, general ball 20-40min, pill crosses 12 orders, 20 order twice sieves, be greater than 12 object pills to be back to pulverizing program and again to pulverize, be less than 20 object pills to be back in first time general ball operation, all the other pills enter the second general ball operation as female ball after 60 DEG C of-70 DEG C of dryings;
(3) another part fine powder obtained to step 1 adds the second taste masking ingredients, the female ball obtained step 2 after mix homogeneously strengthens general ball 20-40min, pill crosses 10 orders, 16 order twice sieves, be greater than 10 object pills to be back to pulverizing program and again to pulverize, be less than 16 object pill backflows to continue as female ball, all the other enter subsequent processing for qualified pill;
(4) the qualified pill of step 3 gained is carried out drying at 70 DEG C-85 DEG C, obtain product.
In the preparation method of the Gegen Qinlian ball of the taste modified form more than the present invention provided, the drying process that female ball or qualified pill adopt can be selected to adopt any one drying mode in microwave drying, drying under reduced pressure or spraying dry.
In addition, the Gegen Qinlian ball of taste modified form that prepared by the present invention can also select to add any one in steviol glycosides, aspartame, xylitol, sorbitol or mannitol as flavoring ingredients.
The present invention is the obtained good Gegen Qinlian ball of taste improved effect, have employed sodium alginate respectively and IV acrylic resin carries out twice taste masking, obtains good taste improved effect.Two sections that design in addition general ball sieving technologies, the Gegen Qinlian ball prepared also has certain controlled-release effect.Relative to prior art, the Gegen Qinlian ball taste adopting the present invention to prepare is good, is easy to bedding and clothing user and accepts.
Meanwhile, present invention employs the screening of comparatively strict pill and feed back control sequence, make Granularity Distribution in a narrower scope, and the material loss effectively reduced, there is positive effect to raising certified products productive rate and reduction production cost.
Accompanying drawing explanation
Accompanying drawing 1 is the flow chart of general ball technique of the present invention.
Accompanying drawing 2 is the flow chart of the general ball technique of another kind of the present invention.
Detailed description of the invention
Embodiment 1
By the fluid extract decompression cold drying containing active constituents of medicine, and pulverize, cross 60 mesh sieves, the fine powder obtained that sieves is used as general ball; Get 2kg fine powder and add the first taste masking ingredients; add the ethanol of 80% as wetting agent; general ball 40min; add the second taste masking ingredients again, strengthen general ball 20min, pill crosses 10 orders, 16 order twice sieves; be greater than 10 object pills to be back to pulverizing program and again to pulverize; be less than 16 object pill backflows to continue as female ball, all the other qualified pills carry out drying at 85 DEG C, obtain product.
Embodiment 2
By the fluid extract decompression cold drying containing active constituents of medicine, and pulverize, cross 80 mesh sieves, the fine powder obtained that sieves is used as general ball; Get 2kg fine powder and add the first taste masking ingredients; add the ethanol of 80% as wetting agent; general ball 35min; add the second taste masking ingredients again, strengthen general ball 25min, pill crosses 10 orders, 16 order twice sieves; be greater than 10 object pills to be back to pulverizing program and again to pulverize; be less than 16 object pill backflows to continue as female ball, all the other qualified pills carry out drying at 80 DEG C, obtain product.
Embodiment 3
By the fluid extract decompression cold drying containing active constituents of medicine, and pulverize, cross 100 mesh sieves, the fine powder obtained that sieves is used as general ball; Get 2kg fine powder and add the first taste masking ingredients; add the ethanol of 80% as wetting agent; general ball 30min; add the second taste masking ingredients again, strengthen general ball 30min, pill crosses 10 orders, 16 order twice sieves; be greater than 10 object pills to be back to pulverizing program and again to pulverize; be less than 16 object pill backflows to continue as female ball, all the other qualified pills carry out drying at 75 DEG C, obtain product.
Embodiment 4
By the fluid extract decompression cold drying containing active constituents of medicine, and pulverize, cross 100 mesh sieves, the fine powder obtained that sieves is used as general ball; Get 2kg fine powder and add the first taste masking ingredients; add the ethanol of 80% as wetting agent; general ball 20min; add the second taste masking ingredients again, strengthen general ball 40min, pill crosses 10 orders, 16 order twice sieves; be greater than 10 object pills to be back to pulverizing program and again to pulverize; be less than 16 object pill backflows to continue as female ball, all the other qualified pills carry out drying at 70 DEG C, obtain product.
Embodiment 5
By the fluid extract decompression cold drying containing active constituents of medicine, and pulverize, cross 60 mesh sieves, the fine powder obtained that sieves divides two parts to be used as general ball;
Get the general ball fine powder of 1.0kg and add the first taste masking ingredients, add alcoholic solution as wetting agent, general ball 30min, pill crosses 12 orders, 20 order twice sieves, be greater than 12 object pills to be back to pulverizing program and again to pulverize, be less than 20 object pills to be back in first time general ball operation, all the other pills enter the second general ball operation as female ball after 70 DEG C of dryings;
Get the general ball fine powder of 1.0kg and add the second taste masking ingredients; after mix homogeneously, general ball 30min is strengthened to female ball that the first general ball operation obtains; pill crosses 10 orders, 16 order twice sieves; be greater than 10 object pills to be back to pulverizing program and again to pulverize; be less than 16 object pill backflows to continue as female ball; all the other qualified pills carry out drying at 85 DEG C, obtain product.
Embodiment 6
By the fluid extract decompression cold drying containing active constituents of medicine, and pulverize, cross 80 mesh sieves, the fine powder obtained that sieves divides two parts to be used as general ball;
Get the general ball fine powder of 1.5kg and add the first taste masking ingredients, add alcoholic solution as wetting agent, general ball 40min, pill crosses 12 orders, 20 order twice sieves, be greater than 12 object pills to be back to pulverizing program and again to pulverize, be less than 20 object pills to be back in first time general ball operation, all the other pills enter the second general ball operation as female ball after 65 DEG C of dryings;
Get the general ball fine powder of 0.5kg and add the second taste masking ingredients; after mix homogeneously, general ball 20min is strengthened to female ball that the first general ball operation obtains; pill crosses 10 orders, 16 order twice sieves; be greater than 10 object pills to be back to pulverizing program and again to pulverize; be less than 16 object pill backflows to continue as female ball; all the other qualified pills carry out drying at 80 DEG C, obtain product.
Embodiment 7
By the fluid extract decompression cold drying containing active constituents of medicine, and pulverize, cross 100 mesh sieves, the fine powder obtained that sieves divides two parts to be used as general ball;
Get the general ball fine powder of 0.5kg and add the first taste masking ingredients, add alcoholic solution as wetting agent, general ball 20min, pill crosses 12 orders, 20 order twice sieves, be greater than 12 object pills to be back to pulverizing program and again to pulverize, be less than 20 object pills to be back in first time general ball operation, all the other pills enter the second general ball operation as female ball;
Get the general ball fine powder of 1.5kg and add the second taste masking ingredients; after mix homogeneously, general ball 40min is strengthened to female ball that the first general ball operation obtains; pill crosses 10 orders, 16 order twice sieves; be greater than 10 object pills to be back to comminution by gas stream program and again to pulverize; be less than 16 object pill backflows to continue as female ball; all the other qualified pills carry out drying at 70 DEG C, obtain product.
Experimental example 8
Gegen Qinlian ball is when leaching, and dissolving the berberine hydrochloride is the main component producing bitterness.How many taste masking effects is evaluated with the content soaking berberine hydrochloride in the soak of 10S and 20S under every 500g product room temperature in distilled water respectively.Under the same conditions, in soak, the content of berberine hydrochloride is less, represents that taste masking effectiveness comparison is good.The detection method of the content of berberine hydrochloride is carried out with reference to the content assaying method of the Gegen Qinlian ball that " Chinese Pharmacopoeia 2015 editions " is recorded.
Using the Gegen Qinlian ball of commercial type as experiment reference sample.
Contrast sample A only adds the Gegen Qinlian ball that the first taste masking ingredients makes.Its preparation method is: by the fluid extract decompression cold drying containing active constituents of medicine, and carry out comminution by gas stream, cross 100 mesh sieves, obtain the fine powder of general ball; Get 2kg fine powder and add the first taste masking ingredients; add the ethanol of 80% as wetting agent; general ball 40min; pill crosses 10 orders, 16 order twice sieves; be greater than 10 object pills to be back to comminution by gas stream program and again to pulverize; be less than 16 object pill backflows to continue as female ball, all the other qualified pills carry out drying at 85 DEG C, obtain product.
Contrast sample B only adds the Gegen Qinlian ball that the second taste masking ingredients makes.Its preparation method is: by the fluid extract decompression cold drying containing active constituents of medicine, and carry out comminution by gas stream, cross 100 mesh sieves, obtain the fine powder of general ball; Get 2kg fine powder and add the ethanol of 80% as wetting agent; general ball 40min; add the second taste masking ingredients and carry out coating; pill crosses 10 orders, 16 order twice sieves; be greater than 10 object pills to be back to comminution by gas stream program and again to pulverize; be less than 16 object pill backflows to continue as female ball, all the other qualified pills carry out drying at 85 DEG C, obtain product.
The product of above-mentioned reference sample, contrast sample A, contrast sample B and embodiment 1-7 gained is detected, in distilled water, soaks the stripping quantity of 10S or 20S berberine hydrochloride under being converted into every 500g product room temperature respectively, obtain data as follows:
Conclusion:
(1) taste modified form Gegen Qinlian ball of the present invention has obvious taste masking effect relative to commercially available Gegen Qinlian ball.
(2) taste modified form Gegen Qinlian ball of the present invention adopts twice taste masking technique, has obvious taste masking effect relative to the Gegen Qinlian ball only with a kind of odor mask.
(3) the Gegen Qinlian ball adopting the embodiment 1-4 of one section of general ball technique to prepare is slightly good relative to the embodiment 5-7 taste masking effect of the general ball technique of employing two sections, but the Gegen Qinlian ball ratio adopting the embodiment 5-7 of two sections of general ball techniques to prepare is conducive to the release of drug effect.
Claims (4)
1. a Gegen Qinlian ball for taste modified form, is characterized in that comprising active constituents of medicine, the first taste masking ingredients and the second taste masking ingredients;
Described active constituents of medicine is Radix Puerariae, Radix Scutellariae, Rhizoma Coptidis, Radix Glycyrrhizae four Chinese medicine material carry out extracting the extract obtained by the weight ratio of 8: 3: 3: 2 respectively;
The first described taste masking ingredients is 0.05%-0.45% sodium alginate;
The second described taste masking ingredients is the solution prepared by 1: 16 ~ 20 weight portions of ethanol of IV acrylic resin and 95%.
2. the Gegen Qinlian ball of taste modified form according to claim 1, is characterized in that adopting following method to make:
(1) by the fluid extract decompression cold drying containing active constituents of medicine, and pulverize, cross 60 order-100 mesh sieves, the fine powder obtained that sieves is used as general ball;
(2) fine powder obtained to step 1 adds the first taste masking ingredients, add alcoholic solution as wetting agent, general ball 20-40min, add the second taste masking ingredients again, strengthen general ball 20-40min, pill crosses 10 orders, 16 order twice sieves, is greater than 10 object pills and is back to comminution by gas stream program and again pulverizes, be less than 16 object pill backflows to continue as female ball, all the other enter subsequent processing for qualified pill;
(3) the qualified pill of step 2 gained is carried out drying at 70 DEG C-85 DEG C, obtain product.
3. the Gegen Qinlian ball of taste modified form according to claim 1, is characterized in that adopting following method to make:
(1) by the fluid extract decompression cold drying containing active constituents of medicine, and pulverize, cross 60 order-100 mesh sieves, the fine powder obtained that sieves divides two parts to be used as general ball;
(2) a part of fine powder step 1 obtained adds the first taste masking ingredients, add alcoholic solution as wetting agent, general ball 20-40min, pill crosses 12 orders, 20 order twice sieves, be greater than 12 object pills to be back to comminution by gas stream program and again to pulverize, be less than 20 object pills to be back in first time general ball operation, all the other pills enter the second general ball operation as female ball after 60 DEG C of-70 DEG C of dryings;
(3) another part fine powder obtained to step 1 adds the second taste masking ingredients, the female ball obtained step 2 after mix homogeneously strengthens general ball 20-40min, pill crosses 10 orders, 16 order twice sieves, be greater than 10 object pills to be back to comminution by gas stream program and again to pulverize, be less than 16 object pill backflows to continue as female ball, all the other enter subsequent processing for qualified pill;
(4) the qualified pill of step 3 gained is carried out drying at 70 DEG C-85 DEG C, obtain product.
4. the Gegen Qinlian ball of the taste modified form according to claim 1-3, is characterized in that adding any one in steviol glycosides, aspartame, xylitol, sorbitol or mannitol as flavoring ingredients.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1994468A (en) * | 2006-01-06 | 2007-07-11 | 牛祝琴 | Unfavorable taste-masking drug granule, chewable formulation and preparation process thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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Application publication date: 20160504 |