CN100398131C - Infant spleen-tonifying fast dispersion solid preparation and its preparation method - Google Patents
Infant spleen-tonifying fast dispersion solid preparation and its preparation method Download PDFInfo
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- CN100398131C CN100398131C CNB2005100872720A CN200510087272A CN100398131C CN 100398131 C CN100398131 C CN 100398131C CN B2005100872720 A CNB2005100872720 A CN B2005100872720A CN 200510087272 A CN200510087272 A CN 200510087272A CN 100398131 C CN100398131 C CN 100398131C
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Abstract
The present invention relates to a fast diffusion solid preparation for strengthening the spleen of a baby. The solid preparation is prepared from Chinese medicinal raw materials: 400 portions by weight of stir-baked white lablab, 120 portions of yam, 120 portions by weight of stir-baked Endothelium Corneum Gigeriae Galli, 120 portions by weight of stir-baked white atractylodes rhizome, 8 portions by weight of tendrilleaf fritillary bulb, 120 portions by weight of stir-baked common aucklandia root, 120 portions by weight of sodium bicarbonate and 0.25 portion by weight of bezoar. The present invention is characterized in that the fast diffusion solid preparation is prepared by that after being crushed or extracted, the Chinese medicines are crushed into ultrafine powder to obtain a sovereign medicine; the sovereign medicine is mixed with an auxiliary material selected from a disintegrating agent, an adhesive, a suspending agent, a flow aid agent, a taste rectifying agent and a color rectifying agent and made into the preparation by a convention technique of pharmaceutics, wherein the granularity of all used sovereign medicine and auxiliary materials is smaller than the granule diameter of 75 mum.
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 infant spleen-tonifying and preparation method thereof.
Technical background
The conventional Chinese medicine patent medicine of infant spleen tonifyning granules for recording in " health standard for traditional Chinese medicines promulgated by the ministries or commissions of the Central Government "; prescription is made up of eight flavors such as Semen Lablab Album (stir-fry), Rhizoma Dioscoreae, Endothelium Corneum Gigeriae Galli (stir-fry), the Rhizoma Atractylodis Macrocephalae (stir-fry), Bulbus Fritillariae Cirrhosae, the Radix Aucklandiae, sodium bicarbonate, Calculus Bovis; spleen invigorating is arranged; help digestion; the effect of antidiarrheal; be used for infantile dyspepsia, the breast food does not advance abdominal pain diarrhea.At present " health standard for traditional Chinese medicines promulgated by the ministries or commissions of the Central Government " (06, prescription and the method for making WS3-B-1230-92) recorded are as follows:
[prescription and method for making] Semen Lablab Album (stir-fry) 400g, Rhizoma Dioscoreae 120g, Endothelium Corneum Gigeriae Galli (stir-fry) 120g; the Rhizoma Atractylodis Macrocephalae (stir-fry) 120g, Bulbus Fritillariae Cirrhosae 8g, the Radix Aucklandiae (stir-fry) 120g; sodium bicarbonate 120g, Calculus Bovis 0.25g, more than eight the flavor; except that Calculus Bovis, sodium bicarbonate, Six-elements such as Semen Lablab Album are ground into fine powder, with the Calculus Bovis porphyrize; with sodium bicarbonate and above-mentioned powder facing-up; sieve, mixing, promptly.(every bottle/bag dress 0.5g.)
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.
Infant spleen tonifyning granules has had launch to sell at home, but in the practice, the weak point of infant spleen tonifyning granules is that preparation technology is outmoded, uses inconvenience, brings many troubles for the patient of dysphagia.The present invention adopts superfine communication technique and quick dispersion technology that the infant spleen-tonifying powder preparation 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 infant spleen tonifyning granules 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 infant spleen tonifyning granules similar to the infant spleen tonifyning granules 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:
400 parts of Semen Lablab Albums (stir-fry), 120 parts of Rhizoma Dioscoreaes, 120 parts of Endothelium Corneum Gigeriae Galli (stir-fry), 120 parts of the Rhizoma Atractylodis Macrocephalaes (stir-fry), 8 parts of Bulbus Fritillariae Cirrhosaes, 120 parts of the Radix Aucklandiae (stir-fry), 120 parts of sodium bicarbonate, 0.25 part of Calculus Bovis,
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 unit with the milligram 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 " health standard for traditional Chinese medicines promulgated by the ministries or commissions of the Central Government " (06 according to traditional method; WS3-B-1230-92) prescription and the method for making recorded are as follows: Semen Lablab Album (stir-fry) 400g; Rhizoma Dioscoreae 120g; Endothelium Corneum Gigeriae Galli (stir-fry) 120g; the Rhizoma Atractylodis Macrocephalae (stir-fry) 120g, Bulbus Fritillariae Cirrhosae 8g, the Radix Aucklandiae (stir-fry) 120g; sodium bicarbonate 120g; Calculus Bovis 0.25g, more than eight the flavor, except that Calculus Bovis, sodium bicarbonate; Six-elements such as Semen Lablab Album are ground into fine powder; with the Calculus Bovis porphyrize,, sieve with sodium bicarbonate and above-mentioned powder facing-up; 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 infant spleen tonifyning granules, and patent medicine has spleen invigorating, helps digestion, and the effect of antidiarrheal is used for infantile dyspepsia, and the breast food does not advance abdominal pain diarrhea.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 infant spleen tonifyning granules 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 infant spleen tonifyning granules 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 infant spleen-tonifying 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.Infant spleen-tonifying fast dispersion solid preparation of the present invention, and the roughly the same square solid preparation with quick disintegrate feature (as dispersible tablet) 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
Semen Lablab Album (stir-fry) 400g, Rhizoma Dioscoreae 120g, Endothelium Corneum Gigeriae Galli (stir-fry) 120g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 120g, Bulbus Fritillariae Cirrhosae 8g, the Radix Aucklandiae (stir-fry) 120g, sodium bicarbonate 120g, Calculus Bovis 0.25g, more than eight the flavor, with Calculus Bovis, sodium bicarbonate porphyrize, Six-elements such as surplus Semen Lablab Album are ground into fine powder, above each several part fine powder is mixed, through micronizing, crosses 400 orders; Per 100 parts of powder and adjuvant are evenly mixed, pressed powder (0.25g), promptly.This product is dispersible tablet, and is oral, one time 1～2, drop into and take after disintegrate becomes homogeneous solution in about 30-50ml water; 2 times on the one, or follow the doctor's advice.Preparation prescription sees 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.(2) other is the tender agent etc. of distinguishing the flavor of.(down together)
Embodiment 2
Semen Lablab Album (stir-fry) 400g, Rhizoma Dioscoreae 120g, Endothelium Corneum Gigeriae Galli (stir-fry) 120g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 120g, Bulbus Fritillariae Cirrhosae 8g, the Radix Aucklandiae (stir-fry) 120g, sodium bicarbonate 120g, Calculus Bovis 0.25g, more than eight the flavor, with Calculus Bovis, sodium bicarbonate porphyrize, Six-elements such as surplus Semen Lablab Album decoct with 8 times of amounts of water and extracted 2 hours, filter, and add 6 times in water again, decoct and extracted 2 hours, filter; Merge filtrate twice, filtrate is condensed into the thick paste that relative density is 1.30～1.35 (60 ℃), and drying is ground into fine powder, sieves; Above each several part fine powder is mixed, through micronizing, crosses 300 orders; Per 100 parts of powder and adjuvant are evenly mixed, the back tabletting (0.2g) of granulating, promptly.This product dispersible tablet, oral, one time 1～2, drop into and take after disintegrate becomes homogeneous solution in about 30-50ml water; 2 times on the one, or follow the doctor's advice.Preparation prescription sees Table 2:
Table 2 preparation prescription and main evaluation result thereof
Claims (10)
1. infant spleen-tonifying fast dispersion solid preparation; make by following Chinese medicine raw materials by weight proportion; stir-fry is from 400 parts in Seem Lablab Album; 120 parts of Rhizoma Dioscoreaes; 120 parts of Endothelium Corneum Gigeriae Galli (parched)s, 120 parts of Rhizoma Atractylodis Macrocephalae (parched)s, 8 parts of Bulbus Fritillariae Cirrhosaes; fry 120 parts of the Radix Aucklandiae; 120 parts of sodium bicarbonate, 0.25 part of Calculus Bovis 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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| CN101804072B (en) * | 2010-04-16 | 2011-11-30 | 马应龙药业集团股份有限公司 | Calculus bovis factitius superfine powder and preparation method |
| CN102579784A (en) * | 2011-12-21 | 2012-07-18 | 江西济民可信药业有限公司 | Preparation method of tonifying spleen granule for infants |
| CN103783509B (en) * | 2013-12-31 | 2016-02-17 | 陈慧婷 | A kind of Endothelium Corneum Gigeriae Galli Chinese yam dispersible tablet and preparation method |
| CN108354906A (en) * | 2018-05-25 | 2018-08-03 | 四川厚德医药科技有限公司 | A kind of medicinal oral instant dissipates and preparation method thereof |
| CN112316103B (en) * | 2020-10-28 | 2023-05-05 | 健民药业集团股份有限公司 | Preparation method of infant spleen-strengthening powder |
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| 卫生部颁药品标准中药成方制剂. 卫生部，38. 2001 |
| 卫生部颁药品标准中药成方制剂. 卫生部，38. 2001 * |
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