CN1785259A - Jinsuo emission-arresting fast dispersing solid preparation and its preparation method - Google Patents
Jinsuo emission-arresting fast dispersing solid preparation and its preparation method Download PDFInfo
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Abstract
A fast dispersing solid Chinese medicine for arresting emission is prepared from 6 Chinese-medicinal materials including milkvetch seed, gordon euryale seed, oyster sheel, lotus seed, etc through crushing or extracting, superfine pulverizing, and mixing with disintegrant, adhesive, suspending aid, flowing aid, flavouring and coloring agent.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation, particularly relate to fast dispersion solid medicine of a kind of and Chinese medicine patent medicine Jinsuo emission-arresting and preparation method thereof.
Technical background
Jinsuo emission-arresting pill capsule prescription comes from " the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation ", form by Chinese medicines such as Semen Astragali Complanati (stir-fry), Semen Euryales (steaming), Stamen Nelumbinis, Os Draconis (forging), Concha Ostreae (forging), Semen Nelumbinis, has the reinforcing the kindey to control nocturnal emission effect, it is not solid to be used to suffer from a deficiency of the kidney, the seminal emission lingering diarrhea, spiritlessness and weakness, extremity are aching and limp, lumbago tinnitus.The jinsuo gujing pills standard of recording in " the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation " has (related content) at present:
Jinsuo gujing pills (the watered pill; " the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation " first, standard numbering: WS3-B-0097-89)
[prescription method for making] Semen Astragali Complanati (stir-fry) 60g, Semen Euryales (steaming) 60g, Stamen Nelumbinis 60g, Os Draconis (forging) 30g, Concha Ostreae (forging) 30g, Semen Nelumbinis 120g, above Six-element is ground into fine powder, sieves, and mixing is used water pill, drying, promptly.
Jinsuo gujing pills (big honeyed pills; " the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation " the 11, standard numbering: WS3-B-2173-96)
[prescription] (ditto)
[method for making] above Six-element is ground into fine powder, sieves mixing.Every 100g powder adds refined honey 120～125g and makes big honeyed pills, promptly.(the heavy 9g of every ball.)
Jinsuo gujing pills (concentrated pill; " the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation " the 11, standard numbering: WS3-B-2174-96)
[prescription] (ditto)
[method for making] above Six-element is broken into fine powder with Semen Euryales, Os Draconis, Concha Ostreae, Semen Nelumbinis powder; Semen Astragali Complanati, Stamen Nelumbinis are ground into coarse powder, decoct with water secondary, 3 hours for the first time, 2 hours for the second time, decocting liquid filtered, it is the clear paste of 1.30～1.35 (20 ℃) that merging filtrate, concentrating under reduced pressure become relative density, adds above-mentioned fine powder, mixing, pill, oven dry below 80 ℃ is with the active carbon coating, promptly.(per 15 balls are equivalent to total medical material 3g.)
Superfine communication technique is meant the material particles more than 3 millimeters is crushed to process below 100 microns.Researcher thinks, because granular size develops to miniaturization, thus can cause surface area and porosity to increase very significantly, so the micronizing body has unique physics and chemical property.For example, have fine solubility, dispersibility, adsorptivity, chemism etc., so application is very extensive.Studies show that all available micronizing apparatus processing of raw material such as many edible animals and plants, microorganism, medicine become superfine powder, the medicine of miniaturization has very strong surface adsorption power and affinity, therefore, has good dispersibility and dissolubility, assimilates easily.
Dispersible preparation is that a kind of water that do not need in the oral cavity can disintegrate or dissolved preparation fast.Requirement has: 1. in the oral cavity rapidly disintegrate, no grittiness, good mouthfeel, swallow easily, to the oral mucosa nonirritant.Should stipulate under the character item in the quality standard: disintegrate rapidly, no grittiness, good mouthfeel in the oral cavity; 2. set up suitable disintegration time mensuration method and limit, and be incorporated into standard; 3. to insoluble medicine, should set up suitable dissolution determination method and limit; 4. other should meet general rule requirement under the tablet item.The characteristics of dispersible preparation are fast: 1. absorption is fast, bioavailability is high; 2. instructions of taking does not need water 3. intestinal is residual few, few side effects; 4. avoid the first pass effect of liver sausage.
Jinsuo gujing pills has had launch to sell at home, but in the practice, the weak point of jinsuo gujing pills is that preparation technology is outmoded, and dosage form is a water-honeyed pill, uses inconvenience, brings many troubles for the patient of dysphagia.The present invention adopts superfine communication technique and quick dispersion technology that the Jinsuo emission-arresting pill is transformed, transformation process has overcome the difficulty that Chinese medicine preparation faces in the modified form process, particularly superfine communication technique and quick dispersion technology are applied to the difficulty that Chinese patent medicine faces, as moisture absorption, unstable, defectives such as technology is loaded down with trivial details, grope through screening and technology, under the constant situation of Chinese medicine preparation, prepared a kind of solid preparation similar to the jinsuo gujing pills effect with quick disintegration properties.
Summary of the invention
The invention provides a kind of superfine communication technique and quick dispersion technology in conjunction with the new technique that is used for Chinese patent medicine, the quick dispersible preparation of particularly making in conjunction with the technology of preparing of Chinese patent medicine jinsuo gujing pills similar to the jinsuo gujing pills effect obtained beyond thought effect.
Quick dispersible preparation of the present invention be with the Chinese medicine principal agent through after pulverizing and/or extracting processing, with at least a disintegrating agent with meet water to form full-bodied swelling adjuvant formulated, said preparation is met water disintegrate and form uniform viscosity suspension rapidly.
The quick dispersible preparation of the present invention, the prescription of its Chinese medicine part is composed as follows:
60 parts of Semen Astragali Complanatis (stir-fry), 60 parts of Semen Euryaless (steaming), 60 parts of Stamen Nelumbiniss, 30 parts of Os Draconis (forging), 30 parts of Concha Ostreaes (forging), 120 parts in Semen Nelumbinis
More than form, part is a weight portion, calculates with crude drug, if with the gram is unit, can be made into 1000 agent medicine preparations, described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, granule 1000g, oral liquid 1000ml etc. also can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be a unit with milli part also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, and for especial patient, the proportioning of can corresponding adjustment forming increases or reduce being no more than 100%.
Single medicinal material, especially ministerial drug and adjuvant drug in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.
Its adjuvant of quick dispersible preparation of the present invention is significant to the present invention, and adjuvant of the present invention is selected from disintegrating agent, adhesive, suspending (thickening) agent, fluidizer, correctives, rectifys toner.Wherein suspending (thickening) agent, strong toner add according to the needs of preparation, if preparation does not need, just do not add.
The used adjuvant of the present invention obtains through screening, wherein disintegrating agent is selected from, super carboxymethyl starch sodium (upright collapsing), carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (LS-HPC), crospolyvinylpyrrolidone (polyvinylpolypyrrolidone, PVPP), cross-linking sodium carboxymethyl cellulose (CCMC-Na, CCNa), low-substituted hydroxypropyl cellulose (LHPC) etc.For the less starch of swellbility, microcrystalline Cellulose etc. can guarantee the quick disintegrate of preparation (also can use under＜3min) the situation, but preferably swellbility greater than the disintegrating agent of 5ml/g.Adhesive is selected from polyvidone (PVP), for hyprolose sodium (HPMC); Suspending agent is selected from xanthan gum, Ka Baimu (CARBOMER), HPMC, melon glue.Fluidizer is selected from differential silica gel, Pulvis Talci, magnesium stearate.Correctives is selected from various essence, as Apis essence, green tea essence, Fructus Citri tangerinae essence, apple essence, flavoring pineapple essence, grape essence etc.Strong toner is any pharmaceutically useful pigment or makes the final user mode of preparation present the coloring matter that meets medicinal standard of certain color state.
The present invention also provides the preparation method of quick dispersible preparation of the present invention, this preparation method comprises, Chinese medicine pulverizing medicinal materials and/or extraction with above proportioning, ground product or extract obtain product after drying, through micronizing, obtain medicinal powder or the extract powder of particle diameter less than 75 μ m, this powder is as active constituents of medicine, mixed in the proper ratio with adjuvant through micronizing, make quick dispersible preparation of the present invention with the preparation technique of galenic pharmacy routine.Chinese medicine pulverizing medicinal materials described in this method can be as " the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation " first according to traditional method, standard numbering: WS3-B-0097-89) Semen Astragali Complanati (stir-fry) 60g, Semen Euryales (steaming) 60g, Stamen Nelumbinis 60g, Os Draconis (forging) 30g, Concha Ostreae (forging) 30g, Semen Nelumbinis 120g, above Six-element, be ground into fine powder, sieve, mixing, promptly.Described extraction can use decocting in water to extract, alcohol reflux, and ethanol percolation extracts, and the decocting in water precipitate with ethanol extracts, and any one in the multiple extracting method such as alcohol heavy extraction to boil water selected to use as required, and preferably decocting in water extracts.Decocting in water adopts and adds water 10-15 doubly, and decocting boils 2-3 time, and 1-3 hour for the first time, 1-3 hour for the second time, 1-3 hour for the third time, collecting decoction filtered, and concentrate drying obtains extract extractum.
In order to provide preparation good quick dispersive ability, need the granularity of strict control active constituents of medicine and adjuvant, just grain diameter is little.Therefore, the process characteristic of preparation of the present invention is, before the preparations shaping active constituents of medicine and adjuvant is all carried out micronization; Its objective is the wettability that increases the powder particle surface, promote the medicine stripping.The present invention adopts the method for micronizing, obtains Chinese medicine medicinal powder or the Chinese medicine extract of particle diameter less than 75 μ m, then with particle diameter quite or littler adjuvant is mixed evenly makes pharmaceutical preparation.For tablet, can adopt powder straight forming, wet granulation molding or dry granulation molding to prepare.
Superfine communication technique of the present invention, principal agent of the present invention and adjuvant are processed into particle diameter less than 75 μ m by existing superfine grinding method, are preferably less than 30 μ m, most preferably be micro powder granule less than 10 μ m, at present, micronization technology has two kinds of chemical method and Mechanical Method.Chemical synthesis can make micron order, submicron order even nano level powder body.The mechanical crushing method cost is low, output is big, be the preparation ultrafine powder main means, now large-scale application in commercial production.Micronizing can be divided into dry pulverization process and waterproof pulverization: different according to the principle that produces crush force in the crushing process, dry pulverization process has several forms such as air-flowing type, dither formula, screw (rod) mill formula, paddle type mill and Self-milling; Waterproof pulverization mainly is colloid mill and homogenizer.The present invention can obtain the product of particle diameter less than 75 μ m by above arbitrary method, preferably uses air-flow dry powder comminuting method.
Therefore, the disintegrating agent of the present invention in material principal agent of guaranteeing to use and adjuvant, adhesive, suspending (thickening) agent, fluidizer, correctives, to rectify toner etc. evenly mixed under all having less than the situation of 75 μ m particle diameters, the preparation solid preparation; Said preparation also has the high dispersive characteristic when being beneficial to absorption, can better absorb, and can take with solid form, also can add to take after making preparation be distributed in the liquid behind the liquid when taking, as use mixing in water for oral taking.
Quick dispersible preparation of the present invention, the part by weight of its principal agent and adjuvant is 100: 1～600, preferably 100: 50-400, more preferably 100: 100-200, wherein the part by weight of principal agent and disintegrating agent is 100: 10～500, preferably 100: 100-400, more preferably 100: 200-300.
Quick dispersible preparation of the present invention includes but not limited to fast disintegrating tablet as oral cavity disintegration tablet, and it can directly place the oral cavity, disperses by saliva, and disintegrate rapidly, no grittiness, good mouthfeel are beneficial to and swallow in the oral cavity.Also can be made into dispersible tablet, disperse fast in water, its dispersion liquid does not have grittiness, good mouthfeel, absorbs rapidly.
The weight proportion of principal agent of the present invention and adjuvant is preferably following proportioning:
100 parts of principal agents
Disintegrating agent, 10-500 part
Adhesive, 1-10 part
Suspending (thickening) agent, 0-10 part
Fluidizer, 0.5-5 part
Correctives, 0-2 part
Rectify toner.0-2 part
Wherein, preferred disintegrating agent is super carboxymethyl starch sodium (upright collapsing), carboxymethyl starch sodium (CMS-Na), microcrystalline Cellulose.Preferred adhesive is selected from polyvidone (PVP), for hyprolose sodium (HPMC).Preferred fluidizer is a differential silica gel.Preferred correctives is Apis essence, green tea essence.
Most preferred prescription composition of the present invention is listed in the embodiment of the invention.
Quick dispersible preparation of the present invention, its Chinese medicine preparation is identical with jinsuo gujing pills, and patent medicine has the reinforcing the kindey to control nocturnal emission effect, and it is not solid to be used to suffer from a deficiency of the kidney, the seminal emission lingering diarrhea, spiritlessness and weakness, extremity are aching and limp, lumbago tinnitus.
Medicine in the embodiment of the invention has been carried out experimentation, proved that quick dispersible preparation of the present invention is better than the conventional formulation jinsuo gujing pills on curative effect, can reach the effect of conventional medicament, more obtained patient's welcome in the use with littler dosage.
The invention has the advantages that: the present invention is on the basis of the jinsuo gujing pills prescription of determined curative effect and preparation process, adopt vanguard technology technology such as superfine communication technique, increased the dispersion of medical material effectively, and use quickly disintegrated adjuvant, make preparation have the feature of quick dispersion and very big degree of scatter simultaneously, thereby it is convenient that the more former dosage form of medicine is taken, by quick disintegrate (＜3min) reach the purpose that improves bioavailability.Can put into when dispersible tablet uses and take after water disperses, or directly place mouth, become liquid apace, and for this series products of Jinsuo emission-arresting preparation, be particularly suitable for making preparation of the present invention, can solve as dysphagia person, or the patient's medication problem under the special environment that can not obtain water, provide a great convenience.Wherein particle diameter less than the medicinal powder of 75 μ m or the extract powder adjuvant identical or littler with particle diameter mixed be key factor of the present invention.
Outside the requirement to corresponding drug standard of the quality evaluation of quickly disintegrated solid preparation and official preparation general rule, preparation disintegration time high spot reviews content, disintegration time＜3min.
It has taking convenience, absorption is fast, bioavailability is high and untoward reaction is few, and steady quality is non-hygroscopic, technology is simple etc., the patient who is particularly suitable for dysphagia takes, and can characteristics such as produce with conventional tablet production technology and equipment, is a kind of good novel form.
The specific embodiment
With specific embodiment the present invention is elaborated below.Jinsuo emission-arresting fast dispersing solid preparation of the present invention, and the solid preparation with quick disintegrate feature (as dispersible tablet) of the side of deriving is to make by the represented method of following embodiment, and involved method is the technological means that those skilled in the art can grasp and use.Following examples are implementation example of the present invention, and the part embodiment for claim of the present invention should not be construed as the restriction to claim of the present invention of going up in all senses.
Embodiment 1
60 parts of Semen Astragali Complanatis (stir-fry), 60 parts of Semen Euryaless (steaming), 60 parts of Stamen Nelumbiniss, 30 parts of Os Draconis (forging), 30 parts of Concha Ostreaes (forging), 120 parts in Semen Nelumbinis, above Six-element is ground into fine powder, sieves, mixing, micronizing is crossed 400 orders, per 100 parts of powder and adjuvant are evenly mixed, powder is pressed full length film, with Xin Feier coating material package clothing, promptly.This product is a dispersible tablet, one time 1～2, drop into and take after scattering in about 150～200ml water; 2 times on the one.Preparation prescription sees Table 1:
Table 1 preparation prescription and main evaluation result thereof
| The principal agent amount 1 | Disintegrating agent/consumption | Adhesive/consumption | Fluidizer/consumption | Other 2 | Disintegration time (min) |
| 100 | CMS-Na/20 CMS-Na/50 CMS-Na/100 CMS-Na/200 | PVP/3 PVP/3 PVP/3 PVP/4 | Differential silica gel/1 | Green tea essence/0.5% xylitol/0.5% | 2.3 0.6 0.5 0.5 |
Annotate: (1) is 100 parts with the principal agent amount, and other supplementary product consumption is a relative quantity, umber.(down together)
(2) other is the tender agent etc. of distinguishing the flavor of.(down together)
Embodiment 2
Prescription is the same, and Semen Euryales, Os Draconis, Concha Ostreae, Semen Nelumbinis powder are broken into fine powder; Semen Astragali Complanati, Stamen Nelumbinis are ground into coarse powder, decoct with water secondary, 3 hours for the first time, 2 hours for the second time, decocting liquid filters, and it is the clear paste of 1.30～1.35 (20 ℃) that merging filtrate, concentrating under reduced pressure become relative density, adds above-mentioned fine powder, mixing, oven dry is crushed to below the 75 μ m below 80 ℃; Per 100 parts of powder and adjuvant are evenly mixed, and full length film is pressed in the back of granulating, promptly.This product is an oral cavity disintegration tablet, oral (containing), one time 1, or drop into and take after scattering in about 150～200ml water; 2～3 times on the one.Preparation prescription sees Table 2:
Table 2 preparation prescription and main evaluation result thereof
| The principal agent amount | Disintegrating agent/consumption | Adhesive/consumption | Other | Disintegration time/min |
| 100 | CMS-Na/20 CMS-Na/50 CMS-Na/100 | PVP/2 | Green tea essence/0.5% xylitol/0.5% | 1.9 0.8 0.7 |
Claims (10)
1. Jinsuo emission-arresting fast dispersing solid preparation, make by following Chinese medicine raw materials by weight proportion, 60 parts of Semen Astragali Complanatis (stir-fry), 60 parts of Semen Euryaless (steaming), 60 parts of Stamen Nelumbiniss, 30 parts of Os Draconis (forging), 30 parts of Concha Ostreaes (forging), 120 parts in Semen Nelumbinis is characterized in that, described fast dispersion solid medicine is after above-mentioned Chinese medicine is pulverized or extracted, carry out micronizing, obtain principal agent, this principal agent be selected from disintegrating agent, adhesive, suspending agent, fluidizer, correctives, the adjuvant of rectifying toner mixes, make preparation with the galenic pharmacy routine techniques, wherein the granularity of principal agent that all uses and adjuvant is all less than 75 μ m particle diameters.
2. the fast dispersion solid medicine of claim 1 is characterized in that, wherein the granularity of principal agent that all uses and adjuvant is all less than 30 μ m particle diameters.
3. the fast dispersion solid medicine of claim 1 is characterized in that, wherein the granularity of principal agent that all uses and adjuvant is all less than 10 μ m particle diameters.
4. the fast dispersion solid medicine of claim 1, it is characterized in that, wherein disintegrating agent is selected from, super carboxymethyl starch sodium, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, starch, microcrystalline Cellulose; Adhesive is selected from polyvidone, for hyprolose sodium; Suspending agent is selected from xanthan gum, Ka Baimu, HPMC, melon glue; Fluidizer is selected from differential silica gel, Pulvis Talci, magnesium stearate; Correctives is selected from various essence, and strong toner is any pharmaceutically useful pigment or makes the final user mode of preparation present the coloring matter that meets medicinal standard of certain color state.
5. the fast dispersion solid medicine of claim 1 is characterized in that, is tablet, and it is composed as follows:
100 parts of principal agents
Disintegrating agent, 10-500 part
Adhesive, 1-10 part
Suspending agent, 0-10 part
Fluidizer, 0.5-5 part
Correctives, 0-2 part
Rectify toner.0-2 part.
6. the preparation method of the described fast dispersion solid medicine of claim 1 is characterized in that, the process following steps:
(1) get respectively distinguish the flavor of medical material or decoction pieces according to the Chinese medicine preparation in the claim 1, after pulverizing or extracting, carry out the micronizing of granularity less than 75 μ m particle diameters, standby;
(2) resulting micropowders identical or littler with particle diameter is selected from following adjuvant: disintegrating agent, adhesive, suspending agent, fluidizer, correctives or strong toner mix homogeneously are prepared into preparation.
7. preparation method according to claim 6, it is characterized in that, wherein disintegrating agent is selected from, super carboxymethyl starch sodium, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, starch, microcrystalline Cellulose; Adhesive is selected from polyvidone, for hyprolose sodium; Suspending agent is selected from xanthan gum, Ka Baimu, HPMC, melon glue; Fluidizer is selected from differential silica gel, Pulvis Talci, magnesium stearate; Correctives is selected from various essence, and strong toner is any pharmaceutically useful pigment or makes the final user mode of preparation present the coloring matter that meets medicinal standard of certain color state.
8. according to the described preparation method of claim 6, it is characterized in that the ratio of principal agent and adjuvant is 100: 1～600 in the preparation.
9. according to the described preparation method of claim 6, it is characterized in that the ratio of principal agent and disintegrating agent is 100: 10～500 in the preparation.
10. according to the described preparation method of claim 6, it is characterized in that described preparation is a tablet, adopt powder straight forming, wet granulation molding or dry granulation molding.
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| CNB2005100872858A CN100384404C (en) | 2005-07-28 | 2005-07-28 | Jinsuo emission-arresting fast dispersing solid preparation and its preparation method |
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| CNB2005100872858A CN100384404C (en) | 2005-07-28 | 2005-07-28 | Jinsuo emission-arresting fast dispersing solid preparation and its preparation method |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103977118A (en) * | 2014-05-29 | 2014-08-13 | 张玉芳 | Traditional Chinese medicine for treating spermatorrhea |
| CN105106146A (en) * | 2015-09-02 | 2015-12-02 | 重庆百农网投资有限公司 | Directly-compressed tablet comprising traditional Chinese medicine including lotus seeds and oyster shells |
| CN115282122A (en) * | 2022-08-10 | 2022-11-04 | 宁夏启元国药有限公司 | Process for preparing concentrated Chinese medicinal pill |
-
2005
- 2005-07-28 CN CNB2005100872858A patent/CN100384404C/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103977118A (en) * | 2014-05-29 | 2014-08-13 | 张玉芳 | Traditional Chinese medicine for treating spermatorrhea |
| CN103977118B (en) * | 2014-05-29 | 2015-12-02 | 张玉芳 | A kind of Chinese medicine for the treatment of seminal emission |
| CN105106146A (en) * | 2015-09-02 | 2015-12-02 | 重庆百农网投资有限公司 | Directly-compressed tablet comprising traditional Chinese medicine including lotus seeds and oyster shells |
| CN105106146B (en) * | 2015-09-02 | 2018-03-30 | 重庆百农网投资有限公司 | Vertical compression tablet containing Chinese medicine lotus seeds and oyster shell |
| CN115282122A (en) * | 2022-08-10 | 2022-11-04 | 宁夏启元国药有限公司 | Process for preparing concentrated Chinese medicinal pill |
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| CN100384404C (en) | 2008-04-30 |
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