CN100486564C - Jinkui kidney qi fast dispersion solid preparation and its preparation method - Google Patents
Jinkui kidney qi fast dispersion solid preparation and its preparation method Download PDFInfo
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- CN100486564C CN100486564C CNB2005100872561A CN200510087256A CN100486564C CN 100486564 C CN100486564 C CN 100486564C CN B2005100872561 A CNB2005100872561 A CN B2005100872561A CN 200510087256 A CN200510087256 A CN 200510087256A CN 100486564 C CN100486564 C CN 100486564C
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Abstract
A fast dispersing solid Chinese medicine for replenishing kidney Qi is prepared from 20 Chinese-medicinal materials including rehmannia root, yam, tuckahoe, cinnarnon twig, 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 pieces of Jin ' gui shenqi and preparation method thereof.
Technical background
" Ministry of Public Health standard for traditional Chinese medicines " contained JINGUI SHENQI WAN (standard No. WS3-B-3892-98) has warming and recuperating the kidney-YANG, and the effect of promote the circulation of qi and water is used for edema due to deficiency of the kidney, soreness of the waist and knees, dysuria, aversion to cold and cold limbs card.Its prescription and preparation method are: Radix Rehmanniae 108g, Rhizoma Dioscoreae 27g, Fructus Corni (wine is processed) 27g, Poria 78g, Cortex Moutan 27g, Rhizoma Alismatis 27g, Ramulus Cinnamomi 27g, Radix Aconiti Lateralis Preparata (processing) 4.5g, Radix Achyranthis Bidentatae (decaptitating) 27g, Semen Plantaginis (salt is processed) 27g, more than ten the flavor, be ground into fine powder, sieve mixing.Every 100g powder adds refined honey 35～50g and an amount of water pill, and drying is made water-honeyed pill; Or add refined honey 110～130g and make big honeyed pills, promptly.
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.Fast the characteristics of dispersible preparation are: 1. absorb 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.
JINGUI SHENQI WAN has had launch to sell at home, but in the practice, the weak point of JINGUI SHENQI WAN is that preparation technology is outmoded, and dosage form is a water-honeyed pill, uses inconvenience, brings many troubles for the patient of old, children and dysphagia.The present invention adopts superfine communication technique and quick dispersion technology that the pieces of Jin ' gui shenqi 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN similar to the JINGUI SHENQI WAN 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:
108 parts of Radix Rehmanniae, 27 parts of Rhizoma Dioscoreaes, 27 parts of Fructus Corni (wine is processed), 78 parts in Poria, 27 parts of Cortex Moutans, 27 parts of Rhizoma Alismatis, 27 parts of Ramulus Cinnamomi, 4.5 parts of Radix Aconiti Lateralis Preparatas (processing), 27 parts of Radix Achyranthis Bidentataes (decaptitating), 27 parts of Semen Plantaginiss (salt is processed),
(or Radix Rehmanniae Preparata 160 parts, 80 parts of Fructus Corni (processed)s, 60 parts of Cortex Moutans, 80 parts of Rhizoma Dioscoreaes, 120 parts in Poria, 60 parts of Rhizoma Alismatis, 20 parts of Cortex Cinnamomis, 20 parts of Radix Aconiti Lateralis Preparata, 40 parts of Radix Achyranthis Bidentataes, 40 parts of Semen Plantaginiss)
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 according to traditional method as the method in " Ministry of Public Health standard for traditional Chinese medicines ": earlier that medical material is mixed, be ground into fine powder, sieve, mixing obtains.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 100:1～600,100:50-400 preferably, 100:100-200 more preferably, 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 JINGUI SHENQI WAN, and patent medicine has warming and recuperating the kidney-YANG, and the effect of promote the circulation of qi and water is used for edema due to deficiency of the kidney, soreness of the waist and knees, dysuria, aversion to cold and cold limbs card.
The preparation method of above JINGUI SHENQI WAN fast dispersion solid medicine also is used in the side of deriving of JINGUI SHENQI WAN, and these add flavor side and comprise: JISHENG SHENQI WAN (Jiawei Shenqi Wan), ten is mended ball, Yougui Wan, the kidney-Yang-Reinforcing Bolus.
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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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 pieces of Jin ' gui shenqi preparation, be particularly suitable for making preparation of the present invention, can solve as dysphagia person (especially old man, child), 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 old, children and 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.Pieces of Jin ' gui shenqi dispersible tablet of the present invention, and the solid preparation with quick disintegrate feature of the side of deriving is to make by the represented method of following embodiment, 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
108 parts of Radix Rehmanniae, 27 parts of Rhizoma Dioscoreaes, 27 parts of Fructus Corni (wine is processed), 78 parts in Poria, 27 parts of Cortex Moutans, 27 parts of Rhizoma Alismatis, 27 parts of Ramulus Cinnamomi, 4.5 parts of Radix Aconiti Lateralis Preparatas (processing), 27 parts of Radix Achyranthis Bidentataes (decaptitating), 27 parts of Semen Plantaginiss (salt is processed), mixed, micronizing, cross 400 orders, per 100 parts of powder and adjuvant are evenly mixed, the back tabletting of granulating, promptly.See Table 1:
Table 1 preparation prescription and main evaluation result thereof
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
108 parts of Radix Rehmanniae, 27 parts of Rhizoma Dioscoreaes, 27 parts of Fructus Corni (wine is processed), 78 parts in Poria, 27 parts of Cortex Moutans, 27 parts of Rhizoma Alismatis, 27 parts of Ramulus Cinnamomi, 4.5 parts of Radix Aconiti Lateralis Preparatas (processing), 27 parts of Radix Achyranthis Bidentataes (decaptitating), 27 parts of Semen Plantaginiss (salt is processed), mixed, micronizing, cross 400 orders, per 100 parts of powder with disintegrating agent (seeing Table 2) mixing after, it is an amount of to add refined honey 35～50g and water, general ball, drying is made water-honeyed pill; Or add refined honey 90～110g and make small honey pill or big honeyed pills, promptly.
Table 2 preparation prescription and main evaluation result thereof
Embodiment 3
160 parts of Radix Rehmanniae Preparata, 80 parts of Fructus Corni (system), 60 parts of Cortex Moutans, 80 parts of Rhizoma Dioscoreaes, 120 parts in Poria, 60 parts of Rhizoma Alismatis, 20 parts of Cortex Cinnamomis, 20 parts of Radix Aconiti Lateralis Preparatas (system), 40 parts of Radix Achyranthis Bidentataes, 40 parts of Semen Plantaginiss, mixed, micronizing, cross 400 orders, per 100 parts of powder and adjuvant are evenly mixed, the back tabletting of granulating, with Xin Feier coating material package clothing, promptly.See Table 3:
Table 3 preparation prescription and main evaluation result thereof
Embodiment 4
160 parts of Radix Rehmanniae Preparata, 80 parts of Fructus Corni (system), 60 parts of Cortex Moutans, 80 parts of Rhizoma Dioscoreaes, 120 parts in Poria, 60 parts of Rhizoma Alismatis, 20 parts of Cortex Cinnamomis, 20 parts of Radix Aconiti Lateralis Preparatas (system), 40 parts of Radix Achyranthis Bidentataes, 40 parts of Semen Plantaginiss, mixed, micronizing, cross 400 orders, per 100 parts of powder with disintegrating agent (seeing Table 4) mixing after, it is an amount of to add refined honey 35～50g and water, general ball, drying is made water-honeyed pill; Or add refined honey 90～110g and make small honey pill or big honeyed pills, promptly.
Table 4 preparation prescription and main evaluation result thereof
Claims (1)
1. a Jinkui kidney qi fnst dispersion solid preparation is a tablet, is made by following Chinese medicine raw materials by weight proportion, 108 parts of Radix Rehmanniae, 27 parts of Rhizoma Dioscoreaes, 27 parts of wine Fructus Corni Preparata, 78 parts in Poria, 27 parts of Cortex Moutans, 27 parts of Rhizoma Alismatis, 27 parts of Ramulus Cinnamomi, 4.5 parts of Radix Aconiti Lateralis Preparata, decaptitate 27 parts of Radix Achyranthis Bidentataes, 27 parts of Semen Plantaginis (processed with salt) 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 and disintegrating agent, adhesive, the adjuvant of fluidizer and correctives mixes, and makes preparation with the galenic pharmacy routine techniques, wherein the granularity of principal agent that all uses and adjuvant is all less than 10 μ m particle diameters, and it is composed as follows:
100 parts of principal agents,
150 parts of disintegrating agent microcrystalline Cellulose,
Adhesive is for 3 parts in hyprolose sodium,
1 part in fluidizer differential silica gel,
1 part in correctives green tea essence.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2005100872561A CN100486564C (en) | 2005-07-28 | 2005-07-28 | Jinkui kidney qi fast dispersion solid preparation and its preparation method |
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| CNB2005100872561A CN100486564C (en) | 2005-07-28 | 2005-07-28 | Jinkui kidney qi fast dispersion solid preparation and its preparation method |
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| CN1785344A CN1785344A (en) | 2006-06-14 |
| CN100486564C true CN100486564C (en) | 2009-05-13 |
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Non-Patent Citations (4)
| Title |
|---|
| 《中华人民共和国卫生部药品标准中药成方制剂》（第二十册）. 中华人民共和国卫生部药典委员会，191页，中华人民共和国卫生部. 1998 |
| 《中华人民共和国卫生部药品标准中药成方制剂》（第二十册）. 中华人民共和国卫生部药典委员会，191页，中华人民共和国卫生部. 1998 * |
| 中药超微粉碎研究进展与思考. 胡学军，蔡光先，杨永华，郑爱华.世界科学技术，第4卷第5期. 2002 |
| 中药超微粉碎研究进展与思考. 胡学军，蔡光先，杨永华，郑爱华.世界科学技术，第4卷第5期. 2002 * |
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Address after: 1266 No. 330052 Nanchang Huiren Jiangxi economic and Technological Development Zone Avenue. Patentee after: JIANGXI HUIREN PHARMACEUTICAL CO.,LTD. Address before: 330043 1189 Yingbin Avenue, Nanchang, Jiangxi Patentee before: Jiangxi Huiren Pharmaceutical Co.,Ltd. |
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Granted publication date: 20090513 |