CN1579494A - Micropill of traditional Chinese medicine and its preparation method - Google Patents
Micropill of traditional Chinese medicine and its preparation method Download PDFInfo
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Abstract
The invention is a Chinese traditional medicine micro pill and its manufacturing method, the particle size of the micro pill is less than 2mm. the medicine is the compound of medicine and accessories, the external layer of the pill is packaged with a layer of packaging layer, the medicine is the extract of the Chinese traditional medicine, the accessories are the microcrystal cellulose, micro-powder cellulose. Compared with current technology, the product has following merits: 1. upgrades the stability of the substance, makes the substance avoid from the affection of external environment, improves the reaction activation and durability of the substance; 2. masks the taste, prolongs the storing time of volatile substance; 3. the fluidity is excellent, and is not apt to be crashed, and it is easy to be filled when produced into capsule; 4. it is convenient for children and old sufferer; 5. the micro pill is convenient to be transmitted, the occupied area is small.
Description
The present invention is a kind of Chinese medicine pellet and preparation method thereof, belongs to technical field of Chinese medicine.
Technical background: the quality of drug quality is to be determined by the character of Chinese medicine and ingredient thereof, because property of Chinese materia medica instability, in storage, be subject to temperature, humidity, sunlight, air, mycete, the influence of extraneous factors such as insect, in order to guarantee the curative effect of medicine, the at present domestic method that generally adopts has: one, owing to contain phlegmatic temperament mostly in the Chinese medicine preparation, lipopolysaccharide etc. draw moist material, the easy moisture absorption in storage process, thereby influence the quality of Chinese medicine, therefore a lot of producers take method such as precipitate with ethanol to remove the moist material that draws wherein, but it is destroyed also to have some effective ingredient simultaneously, thereby influences the whole curative effect of Chinese medicine.Two, after Chinese crude drug is extracted into extractum,, need in freezer, store owing to the extractum unstable properties, and if in storage process, deal with improperly, mycete also easily grown.So extract dry powder is made with extract dry by the producer that has, to increase its stability.But extract dry powder easily produces dust, also easily environment is produced when gradation is used and pollutes, and is extremely inconvenient.In addition the effective ingredient that extracts made the storage, the keeping that become after the final drug it, transported or the like and all to have certain problem: floor space is big, and medicine makes moist easily, and cost of transportation is higher or the like.
The objective of the invention is to: a kind of Chinese medicine pellet and preparation method thereof is provided, and it has the following advantages: 1, improve Stability of Substance, make material avoid the influence of external environment, improve reactivity, the durability of material.2, the storage time of odor barrier, prolongation volatile material.3, good fluidity, non-friable, easily fill when making capsule.4, micropill is convenient to store transportation, and floor space is little, can be transported to the dosage form that the selling spot is distributed into to be needed after enterprise produces; Make product can be relatively easy to be sold to all parts of the world, can solve the problem that medicine becomes damp and rotten easily with less input in addition.5, being convenient to swallow difficult child and gerontal patient takes.
The present invention constitutes like this: Chinese medicine pellet: the micropill particle diameter less than 2mm, be the mixture of medicine and adjuvant, in coated outside one deck coatings of micropill, medicine is that extract, the adjuvant of Chinese crude drug is microcrystalline Cellulose, micropowder cellulose, starch, kieselguhr, dextrin, magnesium stearate, Pulvis Talci one or more mixture wherein.The preparation method of Chinese medicine pellet: behind medicine and adjuvant mix homogeneously, with coating pan roll into the ball method, centrifugal ball method, squeezing roll circule method or the fluid bed pill method made made the particle diameter of micropill, micropill less than 2mm.Specifically: behind medicine and adjuvant mix homogeneously, make micropill, with thin film coating material micropill is carried out coating then.If contain insoluble composition or volatile oil component in the medicine, then: earlier Chinese crude drug is extracted, with insoluble composition in the medical material or volatile oil component cyclodextrin inclusion compound, behind all the other medicines and the adjuvant mix homogeneously, make micropill, and then micropill is carried out coating with thin film coating material.Used adjuvant can be microcrystalline Cellulose, micropowder cellulose, starch, kieselguhr, dextrin, magnesium stearate, Pulvis Talci one or more a mixture wherein among the present invention; Used coating material can be one or more the mixture in methylcellulose, ethyl cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, carboxylic propyl methocel sodium, polyoxyethylene water-soluble resin, para-amino benzoic acid acetylcellulose, acrylic resin, titanium dioxide, zein, gelatin, Polyethylene Glycol, glycerol, isopropyl alcohol, Pulvis Talci, Oleum Ricini, polyoxyethylene sorbitan monoleate, propylene glycol, the ethanol, and cyclodextrin is a beta-schardinger dextrin-.With the LIUWEIDIHUANG JIAONANG is example, and LIUWEIDIHUANG JIAONANG is on the books on national drug standards WS3-B-1518-93-2002, and its prescription is Radix Rehmanniae Preparata 1408g, Cortex Moutan 528g, Rhizoma Dioscoreae 704g, Fructus Corni 704g, Rhizoma Alismatis 528g, Poria 528g.Preparation method is: gets Poria 110g and is ground into fine powder, tail over part and decoct with water three times with the residue Poria, and each 30 minutes, filter, merging filtrate is concentrated into the thick paste shape; Fructus Corni adds the alcohol reflux secondary, and each 1 hour, filter, medicinal residues are standby, and filtrate recycling ethanol is concentrated into the thick paste shape; The Cortex Moutan vapor distillation, and adding 1mol/L hydrochloric acid solution makes crystallization in the distillate of collecting, and filters, crystallization washes with water, and cold drying is ground into fine powder, with beta-schardinger dextrin-Cortex Moutan extract is carried out enclose; Three flavors such as aqueous solution after the distillation and Cortex Moutan medicinal residues, Fructus Corni medicinal residues and all the other Radix Rehmanniae Preparata decoct with water three times, each 1 hour, filter, merging filtrate by macroporous adsorptive resins, is used 70% ethanol elution, collect eluent, reclaim ethanol, be concentrated into the thick paste shape, add above-mentioned Poria thick paste, Fructus Corni thick paste and Poria fine powder, mix drying under reduced pressure, be ground into fine powder, add above-mentioned Benexate Hydrochloride, mixing gets drug powder.With drug powder: microcrystalline Cellulose: starch=mix at 45: 16: 8; the 2/5-4/5 that gets total medicated powder puts in the coating granulator; with the 3%HPMC aqueous solution is binding agent; make 40-60 purpose master batch; put into the rotating disk of coating granulator after the oven dry again; with the 3%HPMC aqueous solution is binding agent, adds mixed medicated powder rolling and makes 18-24 purpose micropill, drying.Put again in the coating pelletizing machine.With 6% film coating liquid micropill is carried out coating.The prescription of film coating liquid is: acrylic resin II number: hydroxypropyl emthylcellulose: titanium dioxide: zein: Polyethylene Glycol: glycerol: water=20: 2: 5: 8: 4: 1.5: 40.Technological parameter is: spouting velocity: 15-60r/min, engine speed: 80-150r/min is for powder speed: 15-50r/min.
Compared with prior art, this product has the following advantages: 1, improve Stability of Substance, make material avoid the influence of external environment, improve reactivity, the durability of material.2, the storage time of odor barrier, prolongation volatile material.3, good fluidity, non-friable, easily fill when making capsule.4, being convenient to swallow difficult child and gerontal patient takes.5, micropill is convenient to store transportation, and floor space is little, can be transported to the dosage form that the selling spot is distributed into to be needed after enterprise produces; Make product can be relatively easy to be sold to all parts of the world, can solve the problem that medicine becomes damp and rotten easily with less input in addition, reached goal of the invention.
Embodiments of the invention 1: with Radix Isatidis decoct, concentrate, dry, powder 1000g after pulverizing, with microcrystalline Cellulose 600g mix homogeneously, with 5%PVP alcohol liquid is binding agent, at first prepare 60 purpose granules and make parent nucleus, be binding agent with 5%PVP alcohol liquid again, add the mixed powder amplification and make 40 purpose micropills, incapsulate, promptly.
Embodiments of the invention 2: a kind of reed mentioned in ancient books is made up of Radix Scutellariae 250g, Fructus Forsythiae 250g, Rhizoma Coptidis 100g, Cortex Phellodendri 400g, Radix Paeoniae Rubra 250g, Radix Glycyrrhizae 100g in flakes, and is on the books in Chinese Pharmacopoeia one one of version in 2000.Its preparation method is:
Above Six-element, Radix Paeoniae Rubra, Rhizoma Coptidis powder are broken into fine powder; All the other Radix Scutellariaes, Fructus Forsythiae, Cortex Phellodendri, Radix Glycyrrhizae decoct with water three times, and collecting decoction filters, and the relative density when filtrate is concentrated into 50 ℃ is the clear paste of 1.35-1.40, adds Radix Paeoniae Rubra, Rhizoma Coptidis fine powder, mixing, and drying is ground into 120 order fine powders.Thing fine powder 1000g gets it filled, with microcrystalline Cellulose 440g, starch 125g mix homogeneously, with 10% ethylmethylcellulose aqueous solution is binding agent, make parent nucleus with at first preparing 80 purpose granules, be binding agent with 10% ethylmethylcellulose aqueous solution again, add the mixed powder amplification and make 60 purpose micropills, be pressed into the tablet that weighs 0.55g with tablet machine, promptly.
Embodiments of the invention 3: get the powder 500g after Rhizoma Gastrodiae is sterilized, pulverized, with dextrin 300g mix homogeneously, 5%PVP alcohol liquid is binding agent, at first prepare 60 purpose granules and make parent nucleus, be binding agent with 5%PVP alcohol liquid again, add the mixed powder amplification and make 40 purpose micropills, promptly.
Embodiments of the invention 4: extracting honeysuckle decocts, concentrates, dry, the powder 1000g after pulverizing, with microcrystalline Cellulose 360g, kieselguhr 100g, starch 80g mix homogeneously, with the 8%HPMC aqueous solution is binding agent, at first prepare 80 purpose granules and make parent nucleus, be binding agent with the 8%HPMC aqueous solution again, add the mixed powder amplification and make 60 purpose micropills, with film coating liquid micropill is carried out coating, promptly.Film coating liquid prescription is: methylcellulose 14g, hydroxypropyl cellulose 33g, PEG400 48ml.
Embodiments of the invention 5: get that Herba Ephedrae decocts, concentrates, dry, the powder 800g after pulverizing, with magnesium stearate 350g mix homogeneously, with 6% aqueous solution is binding agent, at first prepare 60 purpose granules and make parent nucleus, be binding agent with 6% aqueous solution again, add the mixed powder amplification and make 40 purpose micropills, with film coating liquid micropill is carried out coating, promptly.Film coating liquid prescription is: carboxylic propyl methocel sodium 16g, ethyl cellulose 10g, Oleum Ricini 8ml, propylene glycol 38ml, Pulvis Talci 10g, 95% ethanol 48ml.
Embodiments of the invention 6: get the powder 1000g after Herba Houttuyniae is dried, pulverized, with micropowder cellulose 360g, Pulvis Talci 200g mix homogeneously, with the aqueous solution is binding agent, at first prepare 80 purpose granules and make parent nucleus, be binding agent again with the aqueous solution, add the mixed powder amplification and make 60 purpose micropills, with film coating liquid micropill is carried out coating, film coating liquid prescription is: polyoxyethylene sorbitan monoleate 23.5g, sodium carboxymethyl cellulose 33g, glycerol 38ml.Be pressed into the tablet that specification is 0.5g with the micropill of tablet machine after, promptly with coating.
Embodiments of the invention 7: the Cornu Saigae Tataricae capsule, on the books on one one of Chinese Pharmacopoeia version in 2000.Its preparation method is rasped to fine powder for getting Cornu Saigae Tataricae.Get Cornu Saigae Tataricae powder 1000g, with micropowder cellulose 400g, dextrin 100g mix homogeneously, with 6%PVP alcohol liquid is binding agent, make parent nucleus with at first preparing 80 purpose granules, be binding agent with 6%PVP alcohol liquid again, add the mixed powder amplification and make 60 purpose micropills, incapsulate behind the film coating liquid coating of usefulness, promptly.Film coating liquid prescription is: hydroxyethyl-cellulose 22.5g: para-amino benzoic acid acetylcellulose 18g: gelatin 10g, polyoxyethylene water-soluble resin 0.3g, 91% isopropyl alcohol 75ml.
Embodiments of the invention real 8: its prescription of Liuwei Dihuang preparation is Radix Rehmanniae Preparata 1408g, Cortex Moutan 528g, Rhizoma Dioscoreae 704g, Fructus Corni 704g, Rhizoma Alismatis 528g, Poria 528g.
Preparation method is: gets Poria 110g and is ground into fine powder, tail over part and decoct with water three times with the residue Poria, and each 30 minutes, filter, merging filtrate is concentrated into the thick paste shape; Fructus Corni adds the alcohol reflux secondary, and each 1 hour, filter, medicinal residues are standby, and filtrate recycling ethanol is concentrated into the thick paste shape; The Cortex Moutan vapor distillation, and adding 1mol/L hydrochloric acid solution makes crystallization in the distillate of collecting, and filters, crystallization washes with water, and cold drying is ground into fine powder, with beta-schardinger dextrin-Cortex Moutan extract is carried out enclose; Three flavors such as aqueous solution after the distillation and Cortex Moutan medicinal residues, Fructus Corni medicinal residues and all the other Radix Rehmanniae Preparata decoct with water three times, each 1 hour, filter, merging filtrate by macroporous adsorptive resins, is used 70% ethanol elution, collect eluent, reclaim ethanol, be concentrated into the thick paste shape, add above-mentioned Poria thick paste, Fructus Corni thick paste and Poria fine powder, mix drying under reduced pressure, be ground into fine powder, add above-mentioned Benexate Hydrochloride, mixing gets drug powder.Thing powder 1000g gets it filled; with microcrystalline Cellulose 350, starch 180 mix homogeneously; getting mixed powder 900g puts in the coating granulator; with the 3%HPMC aqueous solution is binding agent; making 40-60 purpose master batch, put into the rotating disk of coating granulator after the oven dry again, is binding agent with the 3%HPMC aqueous solution; add mixed medicated powder rolling and make 18-24 purpose micropill, drying.Put again in the coating pelletizing machine.With film coating liquid micropill is carried out coating.The prescription of film coating liquid is: acrylic resin II 90g: hydroxypropyl emthylcellulose 9g: titanium dioxide 22.5g: zein 36g: PEG200 5ml: glycerol 7ml: water 180ml.Technological parameter is: spouting velocity: 15-60r/min, engine speed: 80-150r/min is for powder speed: 15-50r/min.Promptly get the micropill granule of the medical material of respectively distinguishing the flavor of, can utilize the dosage form that micropill is made into to be needed as required.
The stability experiment result of present embodiment:
1, heat stability experiment: take by weighing each some parts of micropill and extract dry powder respectively, be sealed in the vial, respectively at 60 ℃, place 10d in 80 ℃ of thermostatic drying chambers, in the 0th, 1, paeonol and content of ursolic acid are measured in sampling in 3,5,10 days, the results are shown in Table 1
Table 1 heat is to the influence of micropill and extract dry powder content
Temperature/℃ heated time/sky paeonol content % ursolic acid content %
Micropill extract dry powder micropill extract dry powder
60 0 1.752 1.758 0.345 0.352
1 1.717 0.326 0.338 0.083
3 1.621 0.112 0.317 0.035
5 1.588 0.049 0.310 0.018
10 1.592 0.051 0.308 0.015
80 1 1.697 0.129 0.335 0.042
3 1.635 0.116 0.322 0.028
5 1.595 0.099 0.314 0.023
10 1.543 0.078 0.305 0.021
2, take by weighing each some parts of micropill and extract dry powder respectively, insert in two airtight vessel, relative humidity is respectively 75% (NaCl) and 92.5% (KNO
3), room temperature is placed 10d, and in the 0th, 1, sampling and measuring paeonol and content of ursolic acid the results are shown in Table 2 in the time of 3,5,10 days.
Table 2 humidity is to the influence of micropill and extract dry powder content
Humidity % sample time/d paeonol content % ursolic acid content %
Micropill extract dry powder micropill extract dry powder
75 0 1.752 1.758 0.345 0.352
1 1.716 1.603 0.325 0.316
3 1.689 1.482 0.319 0.296
5 1.682 1.385 0.308 0.278
10 1.650 1.272 0.310 0.254
92.5 1 1.709 1.631 0.321 0.310
3 1.673 1.362 0.316 0.273
5 1.681 1.295 0.309 0.252
10 1.638 0.915 0.301 0.183
3, take by weighing each some parts of micropill and extract dry powder respectively, irradiation 10d (illumination 4500lx), in the 0th, 1, sampling and measuring paeonol and content of ursolic acid the results are shown in Table 3 in the time of 3,5,10 days.
Table 3 light is to the influence of micropill and extract dry powder content
Illumination/lx sample time/d paeonol content % ursolic acid content %
Micropill extract dry powder micropill extract dry powder
4500 0 1.752 1.758 0.345 0.352
1 1.699 1.705 0.334 0.325
3 1.685 1.511 0.331 0.302
5 1.692 1.223 0.325 0.242
10 1.643 0.966 0.320 0.193
3, discuss: experiment shows that the heat stability of micropill, wet stability and light stability are apparently higher than extract dry powder.
Claims (6)
1, a kind of Chinese medicine pellet, it is characterized in that: the particle diameter of micropill is less than 2mm, it is the mixture of medicine and adjuvant, in coated outside one deck coatings of micropill, medicine is that extract, the adjuvant of Chinese crude drug is microcrystalline Cellulose, micropowder cellulose, starch, kieselguhr, dextrin, magnesium stearate, Pulvis Talci one or more mixture wherein.
2, according to the preparation method of the described Chinese medicine pellet of claim 1, it is characterized in that: behind medicine and adjuvant mix homogeneously, roll into the ball method, centrifugally make particle diameter that ball method, squeezing roll circule method or fluid bed pill method make micropill, micropill for less than 2mm with coating pan.
3, according to the preparation method of the described Chinese medicine pellet of claim 2, it is characterized in that: behind medicine and adjuvant mix homogeneously, make micropill, with thin film coating material micropill is carried out coating then.
4, according to the preparation method of claim 2,3 described Chinese medicine pellets, it is characterized in that: earlier Chinese crude drug is extracted, with insoluble composition in the medical material or volatile oil component cyclodextrin inclusion compound, behind all the other medicines and the adjuvant mix homogeneously, make micropill, and then micropill is carried out coating with thin film coating material.
5, according to the preparation method of claim 2,3 described Chinese medicine pellets, it is characterized in that: used adjuvant can be microcrystalline Cellulose, micropowder cellulose, starch, kieselguhr, dextrin, magnesium stearate, Pulvis Talci one or more a mixture wherein.
6, preparation method according to the described Chinese medicine pellet of claim 3, it is characterized in that: used coating material can be a methylcellulose, ethyl cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, carboxylic propyl methocel sodium, the polyoxyethylene water-soluble resin, the para-amino benzoic acid acetylcellulose, acrylic resin, titanium dioxide, zein, gelatin, Polyethylene Glycol, glycerol, isopropyl alcohol, Pulvis Talci, Oleum Ricini, polyoxyethylene sorbitan monoleate, propylene glycol, the mixture of one or more in the ethanol, cyclodextrin are beta-schardinger dextrin-.
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Cited By (8)
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| CN101095718B (en) * | 2006-06-30 | 2011-07-27 | 范敏华 | Method for preparation of coffee pellets for slimming |
| CN101095440B (en) * | 2006-06-30 | 2011-08-03 | 范敏华 | Slimming function of kutin tea and method for manufacturing kutin tea micro-pill |
| CN102552035A (en) * | 2012-02-04 | 2012-07-11 | 安徽山河药用辅料股份有限公司 | Method for preparing pharmaceutic adjuvant and pellet cores via microcrystalline cellulose and starch by aid of physical mixing method |
| CN104026582A (en) * | 2014-06-26 | 2014-09-10 | 河南科技大学 | Soft peony peptide capsule for maintaining beauty and keeping young of female and preparation method thereof |
| CN107744510A (en) * | 2017-10-25 | 2018-03-02 | 广东罗浮山国药股份有限公司 | A kind of preparation method of micro-pill type granule |
| CN107802615A (en) * | 2017-10-20 | 2018-03-16 | 芜湖天成普阳中药科技有限公司 | A kind of preparation technology of three yellow extract enteric-coated micropills |
| CN108078953A (en) * | 2016-11-21 | 2018-05-29 | 广州中大南沙科技创新产业园有限公司 | A kind of taste masking coated composition |
| CN113546049A (en) * | 2021-04-30 | 2021-10-26 | 贵州汉方药业有限公司 | Flexible pill medicine adhesive and flexible pill prepared by using same |
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2004
- 2004-01-13 CN CNB2004100216820A patent/CN100475194C/en not_active Expired - Fee Related
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101095718B (en) * | 2006-06-30 | 2011-07-27 | 范敏华 | Method for preparation of coffee pellets for slimming |
| CN101095440B (en) * | 2006-06-30 | 2011-08-03 | 范敏华 | Slimming function of kutin tea and method for manufacturing kutin tea micro-pill |
| CN102552035A (en) * | 2012-02-04 | 2012-07-11 | 安徽山河药用辅料股份有限公司 | Method for preparing pharmaceutic adjuvant and pellet cores via microcrystalline cellulose and starch by aid of physical mixing method |
| CN104026582A (en) * | 2014-06-26 | 2014-09-10 | 河南科技大学 | Soft peony peptide capsule for maintaining beauty and keeping young of female and preparation method thereof |
| CN104026582B (en) * | 2014-06-26 | 2015-06-03 | 河南科技大学 | Soft peony peptide capsule for maintaining beauty and keeping young of female and preparation method thereof |
| CN108078953A (en) * | 2016-11-21 | 2018-05-29 | 广州中大南沙科技创新产业园有限公司 | A kind of taste masking coated composition |
| CN107802615A (en) * | 2017-10-20 | 2018-03-16 | 芜湖天成普阳中药科技有限公司 | A kind of preparation technology of three yellow extract enteric-coated micropills |
| CN107744510A (en) * | 2017-10-25 | 2018-03-02 | 广东罗浮山国药股份有限公司 | A kind of preparation method of micro-pill type granule |
| CN113546049A (en) * | 2021-04-30 | 2021-10-26 | 贵州汉方药业有限公司 | Flexible pill medicine adhesive and flexible pill prepared by using same |
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| CN100475194C (en) | 2009-04-08 |
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