CN100358508C - Delay, control release drug of prepared aconite root which can regulate the function of middle-warmer, and its preparation method - Google Patents
Delay, control release drug of prepared aconite root which can regulate the function of middle-warmer, and its preparation method Download PDFInfo
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- CN100358508C CN100358508C CNB031116442A CN03111644A CN100358508C CN 100358508 C CN100358508 C CN 100358508C CN B031116442 A CNB031116442 A CN B031116442A CN 03111644 A CN03111644 A CN 03111644A CN 100358508 C CN100358508 C CN 100358508C
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Abstract
The present invention relates to a traditional Chinese medicine, particularly to an aconite root slow and controlled release preparation used for regulating the middle energy and a preparing method thereof. The present invention slowly releases the medicine or releases the medicine at a constant speed or a speed close to the constant rate, and has the characteristics of long medical-effect maintenance, high effect, low dosage and portability. The preparation is prepared from aconite root, pilose asiabell root, dried ginger, white atractylodes rhizome and licorice root, and adjuvant materials or adjuvant materials of permeation active substances used for preparing the slow and control release preparation or adjuvant materials used for preparing a coating solution. The preparation can be made into a coating type or a non-coating type. The preparing method comprises pharmacy technology and preparation technology, wherein the pharmacy technology uses all the steps or at least one step of pulverization, extraction, concentration, separation, refining, etc., for obtaining medical ingredients, and the preparation technology mixes the aconite root medicine for regulating the middle energy with the adjuvant materials to be respectively made into various slow and controlled release preparations.
Description
Technical field:
The invention belongs to medical technical field, it relates to the novel formulation content of Chinese medicine compound Fuzi Lizhong Wan, promptly refers on the basis of Fuzi Lizhong Wan, and a kind of Chinese medicine novel form is provided---sustained-release preparation and preparation method thereof in the Chinese medicine compound Radix Aconiti Lateralis Preparata reason.
Background technology:
Along with the development of pharmaceutics, the research of preparations of new generation such as slow release, controlled release has become to be paid attention to and the quickish field of development speed very much, and the exploitation of sustained-release preparation has also improved the level of clinical application.Over nearly 30 years, be that the sustained-release preparation of crude drug has carried out a large amount of research and obtained considerable progress at aspects such as its design principle, adjuvant and moulding process, biopharmaceutics characteristics with chemical medicine.So far, existing a large amount of chemical medicine sustained-release preparation product ripe and determined curative effect is applied to clinical.
Compare with chemical medicine sustained-release preparation research, the research of Chinese medicine sustained-release preparation is considerably less, and does not see that sophisticated Chinese medicine compound sustained-release preparation kind listing is arranged, and big large time delay is compared in this development with whole medicine sustained and controlled release drug-supplying system.And Chinese medicine is the rarity of the Chinese nation, and form of Chinese drug is that Chinese medicine plays one's part to the full and the important embodiment and the carrier of curative effect, and the two close of Chinese medicine and form of Chinese drug combines and develop the core content that becomes the modernization of Chinese medicine.
Therefore, inquire into research Chinese medicine sustained-release preparation and become very urgent problem, its listing will realize the Chinese medicine sustained-release preparation breakthrough of zero, also the modernization to Chinese medicine preparation steps a substantial step, and contributes for final solution Chinese medicine conventional dosage forms is difficult to satisfy the problem that dosage is little, toxic and side effects is low, slow controlled release is put.
Fuzi Lizhong Wan is the cold relieving name side of warming middle-JIAO and strengthening the spleen, derives from Song's " formulary of peaceful benevolent dispensary ", cures mainly Deficiency and coldness of spleen and stomach, coldness and pain in the epigastrium, vomiting is had loose bowels and hands and feet being not warm, and Pharmacopoeia of the People's Republic of China version in 2000 is recorded, and determined curative effect is respond well.But the pill dose is big, brings the inconvenience of swallowing to the patient, makes not at that time, and its dissolve scattered time limit also is difficult to control, and how pill is made with the crude drug grinding and processing, is subject to microbial contamination, and the long bacterium of pill is mildewed; The means of the method for inspection that relates in the pharmacopeia and quality control are still insufficient in addition, await additional or perfect.
Summary of the invention:
The present invention refers on the basis of Fuzi Lizhong Wan, and a kind of Chinese medicine novel form is provided---sustained-release preparation and preparation method thereof in the Radix Aconiti Lateralis Preparata reason.
It comprises Radix Aconiti Lateralis Preparata, Radix Codonopsis, Rhizoma Zingiberis, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae, it is characterized in that: comprise required adjuvant or the osmo active substance adjuvant of preparation sustained-release preparation in its preparation, or the required adjuvant of configuration coating solution.The described adjuvant of sustained-release preparation is that blocker, binding agent, porogen, lubricant, wetting agent, membrane material, emulsifying agent, solvent or other play the slow controlled-release material of slow-releasing and controlled-releasing action.The required adjuvant of sustained-release preparation that also comprises preparations such as adopting inclusion technique, solid dispersions technique, microencapsulation technology in the adjuvant.The dosage form of said preparation can be matrix type slow-release tablet, osmotic pump type controlled release tablet, in-stomach floating type slow-release tablet, multi-layered type slow-release tablet, lose and separate controlled release agent types such as sheet class, capsule class, gel-like or granular pattern class such as type slow-release tablet, intestinal location type slow-release tablet, impulse type slow-release tablet, also comprises and makes the various sustained-release preparations that microcapsule, microsphere, micropill etc. are made the controlled release agent type more earlier.Described preparation can be coating type or coating type not.The preparation method that the present invention works out comprises pharmacy technology and preparation process, and the former step or one of them or several steps acquisition medicinal ingredient such as refers to adopt pulverizings, extractions, concentrate, separate, make with extra care and the process and the method for quality testing are provided; The latter refers to adopt certain technology, medicinal ingredient and relevant adjuvant is made sustained-release preparation in the Radix Aconiti Lateralis Preparata reason and the process and the method for quality testing are provided.Required controlled slowly releasing adjuncts of sustained-release preparation and solvent etc. in the preparation Radix Aconiti Lateralis Preparata reason, the ratio of used amount does not limit.
The preparation method that the present invention works out comprises pharmacy technology and preparation process, and the former step or one of them or several steps acquisition medicinal ingredient such as refers to adopt pulverizings, extractions, concentrate, separate, make with extra care and the process and the method for quality testing are provided; The latter refers to adopt certain technology, medicinal ingredient and relevant adjuvant is made sustained-release preparation in the Radix Aconiti Lateralis Preparata reason and the process and the method for quality testing are provided.
The relevant auxiliary materials that the present invention selects refers to preparation sustained-release preparation required comprise blocker, binding agent, porogen, lubricant, wetting agent, membrane material, emulsifying agent, solvent or other and plays the slow controlled-release material of slow-releasing and controlled-releasing action; If the osmotic pump type sustained-release preparation comprises that also osmo active substance is as adjuvant; If the coating type sustained-release preparation also comprises the required adjuvant of configuration coating solution; If the sustained-release preparation that adopts certain technology (as inclusion technique, solid dispersions technique, microencapsulation technology etc.) preparation is arranged, then comprise the required adjuvant of this type of technology of employing.Blocker can adopt hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, cellulose families such as ethyl cellulose, gelatin, Cera Flava etc., binding agent and wetting agent can adopt polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, dextrin, starch, rubber cement, ethanol, water etc., porogen can adopt microcrystalline Cellulose, Pulvis Talci, silicon dioxide, sucrose etc., lubricant can adopt stearic acid, magnesium stearate, Pulvis Talci, starch, liquid Paraffin etc., membrane material can adopt polyvinyl alcohol, Pioloform, polyvinyl acetal, ethylene-vinyl acetate copolymer, cellulose family etc., emulsifying agent can adopt spans, Tweens, soap class etc., solvent can adopt dehydrated alcohol, ethanol, water etc.; The active permeate substance of osmotic pump type sustained-release preparation (can be electrolyte such as sodium chloride, potassium chloride, potassium sulfate, sodium bicarbonate, saccharides such as lactose, fructose, glucose, sucrose, other solid matter or above-mentioned several mixture such as Pulvis Talci, dextrin, starch, mannitol); The coating fluid prescription of coating type sustained-release preparation can be cellulose acetate, hydroxypropyl emthylcellulose, ethyl cellulose, the hydroxypropylmethylcellulose acetate methylcellulose, hydroxypropylmethylcellulose acetate methylcellulose succinate, cellulose acetate-phthalate, the O-phthalic acid methyl cellulose, the phthalic acid hydroxyethyl-cellulose, the phthalic acid hydroxyethylmethyl-cellulose, hexahydrophthalic acid hydroxyethylmethyl-cellulose carboxymethylethylcellulose, cellulose and derivant and their ethers such as tetrahydroxy cellulose acetate-phthalate, esters and above-mentioned salt, polyethylene, polypropylene, polystyrene, polrvinyl chloride, polyamide, polyimides, polylactic acid, polyglycolic acid, the polylactic acid-polyglycolic acid copolymer, poly-(diglycolic acid-ethylene glycol), poly-phthalic acid, poly-phthalic acid vinyl acetate, epoxy resin, polyester, acetal polymer, Merlon, polymer and derivant or their acids such as polyurethanes, amide-type and esters and above-mentioned several copolymers, acrylic resin, methacrylic resin, acrylic acid-methacrylic resin copolymer, polyacrylate, poly-(methacrylic acid-methyl methacrylate), methacrylic acid-methyl acrylate copolymer, methacrylic acid trimethylammonium ester-acrylate copolymer, acrylic resin or derivant and their copolymers thereof such as methacrylic acid trimethylammonium ester-methacrylate copolymer, chitin, polysaccharides such as chitosan, ethylene-vinyl acetate copolymer, maleic acid-phthalic acid derivatives copolymer, octadecanol, glycerol-stearate, nylon, glucosan, stomach slightly solubility materials such as polysiloxanes, sodium alginate, natural products such as Lac, and top described material adds that plasticizer (comprises sorbitol, mannitol, ethylene glycol, pure and mild polyalcohols such as glycerol, glycerol acetate, sebacate, stearate, esters such as phthalic acid ester, polyethylene glycols, polyalcohols such as polypropylene glycol, alkoxide, polyesters and dextrin, polyvinylpyrrolidone etc.) formulated; Adopt the required adjuvant of sustained-release preparation of certain technology preparation to can be cyclodextrins such as beta-schardinger dextrin-, hydroxypropyl cyclodextrin, gelatin, arabic gum etc.Above listed adjuvant can be changed mutually under certain conditions or substitute and use, and can be used as blocker as hydroxypropyl emthylcellulose, also can join coating solution and use; Sodium alginate is classified the required adjuvant of coating solution as, if be fit to use in blocker, then can be used as blocker and uses.Employed controlled slowly releasing adjuncts and solvent etc., the ratio of used amount is unrestricted.
Advantage of the present invention is: this preparation process through repeatedly the experiment, favorable reproducibility, steady quality has good feasibility, and the outward appearance of preparation is level and smooth, bright clean, after putting goods on the market as sustained-release preparation, will obtain huge economic benefit.When the present invention makes sustained-release preparation, because of the medical material process concentrates, makes with extra care, consumption is little, being convenient to patient takes, outward appearance is bright clean, attractive in appearance and be difficult for going mouldy, dissolution and bioavailability are better than pill, the strict quality standard of pressing is operated, the more important thing is this durative action preparation, can make the release of drug slow or constant speed or approximate constant speed, overcome the peak valley phenomenon of dose (blood drug level) in the body, blood drug level is steady, drug effect is kept lastingly, have efficient, long-acting, dosage is little, easy to carry, medicining times is few and toxic and side effects is low characteristics.Safety, effectiveness and the controllability of medicine have been improved.
This preparation recipe is reasonable, technology is advanced, quality controllable, comprise that matrix tablet, osmotic pump tablet, floating in stomach sheet, multilayer tablet, erosion separate controlled release agent types such as sheet class, capsule class, gel-like or granular pattern class such as formula slow-release tablet, intestinal locate mode slow-release tablet, pulsed slow-release tablet, also comprise and make the various sustained-release preparations that microcapsule, microsphere, micropill etc. are made the controlled release agent type more earlier.And this preparation can be coating type or coating type not.
Description of drawings:
Fig. 1 is the external stripping release profiles of the present invention according to sustained-release matrix tablets in the Radix Aconiti Lateralis Preparata reason of embodiment 3 preparations
Among the figure-◆-tablet1; ■ tablet2; ▲ tablet3
The specific embodiment:
Embodiment 1:
Radix Aconiti Lateralis Preparata reason Chinese medicine 10g, NaCl15%, cellulose acetate 25.5g, Macrogol 4000 4.5g
Take by weighing Radix Aconiti Lateralis Preparata reason Chinese medicine 10g, add the sodium chloride that accounts for drug weight 15%, uniform mixing after the drying, adds an amount of magnesium stearate, tabletting.Take by weighing cellulose acetate 25.5g, after acetone 970ml dissolving, add the water 30ml that contains Macrogol 4000 4.5g again, stir, as coating solution label is carried out coating, punching promptly gets controlled release preparation in the osmotic pump type Radix Aconiti Lateralis Preparata reason.
Radix Aconiti Lateralis Preparata reason Chinese medicine solid dispersion 5g, hydroxypropyl emthylcellulose 15g, microcrystalline Cellulose 10g, magnesium stearate 0.5%
It is an amount of in conjunction with the solid dispersion that forms to take by weighing Radix Aconiti Lateralis Preparata reason Chinese medicine and ethyl cellulose, adds hydroxypropyl emthylcellulose 15g and microcrystalline Cellulose 10g, mix homogeneously, drying, the magnesium stearate of adding gross weight 0.5%, tabletting, wrap one deck coloured film clothing again, promptly get slow releasing preparation in the Radix Aconiti Lateralis Preparata reason.
Embodiment 3
Part medicine 5g in the Radix Aconiti Lateralis Preparata reason, volatile oil clathrate compound 0.25g in the Radix Aconiti Lateralis Preparata reason, ethyl cellulose 15g, polyvinylpyrrolidone 8g, magnesium stearate 0.5%
Take by weighing in the Radix Aconiti Lateralis Preparata reason among the part medicine 5g and Radix Aconiti Lateralis Preparata reason volatile oil through the clathrate 0.25g of beta-cyclodextrin inclusion compound gained, mix, add ethyl cellulose 15g and polyvinylpyrrolidone 8g, mix homogeneously, behind mistake 30 mesh sieves, drying, the magnesium stearate that adds gross weight 0.5%, tabletting wraps one deck coloured film clothing again, promptly gets sustained-release matrix tablets in the Radix Aconiti Lateralis Preparata reason.
Embodiment 4
Radix Aconiti Lateralis Preparata reason Chinese medicine 5g, sodium carboxymethyl cellulose 10g, magnesium stearate 0.5%, Pulvis Talci 7g, hydroxypropyl emthylcellulose 20g, polyethylene glycol 6000 3g, tween 80 2mL
Take by weighing Radix Aconiti Lateralis Preparata reason Chinese medicine 5g, sodium carboxymethyl cellulose 10g and magnesium stearate 0.5%, after being pressed into sheet, pulverize, sieve, making homogeneous granules is filler, and with Pulvis Talci 7g, hydroxypropyl emthylcellulose 20g, the solution of polyethylene glycol 6000 3g and tween 80 2mL preparation carries out coating for whitewashing liquid by the bed spray drying, granule behind the coating reinstalls capsule, promptly gets slow releasing capsule in the Radix Aconiti Lateralis Preparata reason.
Embodiment 5
Water soluble drug 2.5g in the Radix Aconiti Lateralis Preparata reason, fat-soluble medicine 2.5g in the Radix Aconiti Lateralis Preparata reason, red iron oxide 0.2g, yellow iron oxide 0.2g, ethyl cellulose 10g, polyethylene glycol oxide 10g, magnesium stearate is an amount of
Take by weighing water soluble drug 2.5g, red iron oxide 0.2g, ethyl cellulose 5g and polyethylene glycol oxide 5g mix homogeneously in the Radix Aconiti Lateralis Preparata reason, add small amount of ethanol liquid system soft material, granulate, after the drying, add magnesium stearate, mixing makes red granules; Fat-soluble medicine 2.5g, yellow iron oxide 0.2g in the Radix Aconiti Lateralis Preparata reason, ethyl cellulose 5g and polyethylene glycol oxide 5g operate with method, add magnesium stearate, make yellow particle; Above two kinds of granules are made double-deck label, wrap the thin film clothing again, promptly get long-acting slow-release sheet in the Radix Aconiti Lateralis Preparata reason.
Claims (7)
1, sustained-release preparation in the Chinese medicine compound Radix Aconiti Lateralis Preparata reason is characterized in that: comprises Radix Aconiti Lateralis Preparata, Radix Codonopsis, Rhizoma Zingiberis, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae in the preparation, and comprises required adjuvant or the osmo active substance adjuvant of preparation sustained-release preparation, or the required adjuvant of configuration coating solution.
2, sustained-release preparation in the Chinese medicine compound Radix Aconiti Lateralis Preparata according to claim 1 reason is characterized in that: the described adjuvant of sustained-release preparation is that blocker, binding agent, porogen, lubricant, wetting agent, membrane material, emulsifying agent, solvent or other play the slow controlled-release material of slow-releasing and controlled-releasing action.
3, sustained-release preparation in the Chinese medicine compound Radix Aconiti Lateralis Preparata reason according to claim 1 is characterized in that: the required adjuvant of sustained-release preparation that also comprises preparations such as adopting inclusion technique, solid dispersions technique, microencapsulation technology in the adjuvant.
4, sustained-release preparation in the Chinese medicine compound Radix Aconiti Lateralis Preparata according to claim 1 reason is characterized in that: required controlled slowly releasing adjuncts of sustained-release preparation and solvent etc. in the preparation Radix Aconiti Lateralis Preparata reason, the ratio of used amount does not limit.
5, sustained-release preparation in the Chinese medicine compound Radix Aconiti Lateralis Preparata reason according to claim 1, it is characterized in that: the dosage form of said preparation can be matrix type slow-release tablet, osmotic pump type controlled release tablet, in-stomach floating type slow-release tablet, multi-layered type slow-release tablet, lose and separate controlled release agent types such as sheet class, capsule class, gel-like or granular pattern class such as type slow-release tablet, intestinal location type slow-release tablet, impulse type slow-release tablet, also comprises and makes the various sustained-release preparations that microcapsule, microsphere, micropill etc. are made the controlled release agent type more earlier.
6, sustained-release preparation in the Chinese medicine compound Radix Aconiti Lateralis Preparata according to claim 4 reason is characterized in that: described preparation can be coating type or coating type not.
7, the preparation method of sustained-release preparation in a kind of Chinese medicine compound Radix Aconiti Lateralis Preparata reason as claimed in claim 1, it is characterized in that: preparation method of the present invention comprises pharmacy technology and preparation process, steps such as the former refers to adopt to pulverize, extract, concentrate, separate, refining or one of them or several steps obtain medicinal ingredient, and the latter refers to that Radix Aconiti Lateralis Preparata is managed Chinese medicine to be mixed with above-mentioned adjuvant and make all kinds of sustained-release preparations respectively:
A, Radix Aconiti Lateralis Preparata is managed Chinese medicine mix with active permeate substance or blocker, after adding lubricant again, tabletting, coating solution and the coloured film clothing that makes with plasticizer respectively carries out coating again, makes in the osmotic pump type Radix Aconiti Lateralis Preparata reason slow releasing preparation in controlled release preparation or the Radix Aconiti Lateralis Preparata reason respectively;
B or Radix Aconiti Lateralis Preparata is managed Chinese medicine mix with the cyclodextrin adjuvant adds blocker and binding agent mix homogeneously again, sieves, and dry back adds lubricant and wraps one deck coloured film clothing again, promptly get Radix Aconiti Lateralis Preparata manage in sustained-release matrix tablets;
C, Radix Aconiti Lateralis Preparata managed Chinese medicine and blocker and mix lubricant after, press large stretch of, the single-size that makes through crushing screening is a filler, the solution of reuse porogen, blocker, plasticizer, emulsifying agent preparation carries out coating for whitewashing liquid by the bed spray drying, granule behind the coating reinstalls capsule, promptly gets slow releasing capsule in the Radix Aconiti Lateralis Preparata reason;
D, with Radix Aconiti Lateralis Preparata manage that Chinese medicine is rare with polyoxyethylene, blocker, red iron oxide or yellow iron oxide mix and add small amount of ethanol liquid system soft material; granulate; after the drying; add magnesium stearate; mixing can make red granules or yellow particle, and above two kinds of granules are made double-deck label; wrap the thin film clothing again, can get long-acting slow-release sheet in the Radix Aconiti Lateralis Preparata reason.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031116442A CN100358508C (en) | 2003-05-13 | 2003-05-13 | Delay, control release drug of prepared aconite root which can regulate the function of middle-warmer, and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB031116442A CN100358508C (en) | 2003-05-13 | 2003-05-13 | Delay, control release drug of prepared aconite root which can regulate the function of middle-warmer, and its preparation method |
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| CN1481854A CN1481854A (en) | 2004-03-17 |
| CN100358508C true CN100358508C (en) | 2008-01-02 |
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| CN102188714B (en) * | 2010-03-11 | 2013-03-13 | 伦西全 | Method for preparing premix for medicament sugar-coating |
| CN103385924A (en) * | 2012-05-08 | 2013-11-13 | 王捷 | Traditional Chinese medicine sustained-release tablet with pain relieving effect, and preparation method thereof |
| CN103566319A (en) * | 2012-07-25 | 2014-02-12 | 中国科学院上海药物研究所 | Radix aconiti lateralis praeparata middle-jiao qi regulation reconstructed tablet and preparation method thereof |
| CN104274547A (en) * | 2014-10-28 | 2015-01-14 | 贵州黄平美娘冲民族服饰有限公司 | Foot bath powder for treating cold-damp diarrhea |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1365675A (en) * | 2001-01-18 | 2002-08-28 | 杨孟君 | Nano medicine 'Fuzilizhong' and its preparing process |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1365675A (en) * | 2001-01-18 | 2002-08-28 | 杨孟君 | Nano medicine 'Fuzilizhong' and its preparing process |
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