CN102178749A - Chinese medicinal composition and preparation method thereof - Google Patents
Chinese medicinal composition and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a preparation method for a Chinese medicinal composition, which comprises the following steps of: mixing 456 to 2,280 weight parts of ovateleaf holly bark in 580 to 2,900 weight parts of ovateleaf holly bark, 2,280 to 11,400 weight parts of garden euphorbia herb and 1,140 to 5,700 weight parts of Chinese knotweed herb, adding deionized water in an amount which is 8 times the weight of the mixture, decocting for the first time for 2 hours and collecting decoction; adding the deionized water in an amount which is 6 times the weight of the mixture, decocting for the second time for 1 hour, collecting decoction, mixing the two-time decoction, filtering, collecting filter liquor, and concentrating to form thick paste with the density of between 1.25 and 1.30; and adding the residual weight parts of ovateleaf holly bark into the thick paste, and sieving with a 100-mesh sieve to prepare ovateleaf holly bark fine powder, namely the Chinese medicinal composition. In the preparation method, the transfer rate of medicinal active ingredients is improved to over 96 percent, and the leaching of invalid ingredients is reduced. The prepared Chinese medicinal composition has an obvious treatment effect on bacillary dysentery and acute and chronic gastroenteritis (P is less than 0.05).
Description
Technical field
The present invention relates to tcm field, particularly a kind of Chinese medicine composition and preparation method thereof.
Background technology
Bacillary dysentery is the infectious intestinal disease that is caused by dysentery bacterium, is major lesions with the colon suppurative inflammation, and is main clinical manifestation with whole body poisoning symptom, stomachache, diarrhoea (often discharging blood pus Mucous Stool continually) and tenesmus etc.
Acute gastroenteritis is divided into external and endogenous two big classes.External acute gastritis comprises two kinds of simple property and corrosivity; In give birth to acute gastroenteritis and comprise infectiousness and suppurative two kinds.Simple property gastroenteritis can be caused by chemicals, physical property stimulation or oral antibacterial and bacteriotoxin etc.Corrosivity gastroenteritis is to be caused by caustic such as oral strong acid.Infectiousness gastroenteritis is when systemic infection, and antibacterial or bacteriotoxin are followed that blood enters the intestines and stomach tissue and produced gastroenteritis, therefore are called acute hematogenous gastroenteritis again.Suppurative gastroenteritis is then often caused by streptococcus, staphylococcus or escherichia coli etc.Chronic gastritis can be divided into three kinds of shallow, atrophic and plumpnesses because the evolution process of superficial gastritis is its final result with atrophic gastritis often, often the two and deposit, so also can be described as shallow table atrophic gastritis.The malfunction of higher nervous activity, the conversion of acute gastritis, frequent oral excitants, some resistive hyperemia, achlorhydria, protein and vitamin B complex shortage etc. all might form chronic gastritis.
Ramulus et Folium Bauhiniae Faberi is the dry herb of euphorbia plant Ramulus et Folium Bauhiniae Faberi (Euphorbia hirta L.), contains flavonoid glycoside such as ground squirrel prunasin (xanthorhamnin), Quercitroside, contains two kinds of triterpenoid compound, taraxacerin and taraxols simultaneously.The stem of garden euphorbia herb contains river alkanol (Myricyl alcohol), taraxerol (Taraxerol), freidelin (Friedelin), B-Amyrin (β-Amyrin), cupreol (β-Sitosterol) and thirty-alkane (Hentriacontane).The flower of garden euphorbia herb contains gallic acid (Ellagic acid).The modern pharmacology result of study shows that Ramulus et Folium Bauhiniae Faberi lyophilizing decoct (dosage is 350-700mg/kg) in the diarrhea of mouse experimental model that is brought out by Oleum Ricini, arachidonic acid and PGE2, has anti-diarrhea effect.The antidiarrheal composition is the chromocor compound quercimentin that is present in the Ramulus et Folium Bauhiniae Faberi lyophilizing decoct, and the dosage of anti-diarrhea effect is 25mg/kg.In addition, Ramulus et Folium Bauhiniae Faberi decocting liquid also has obvious suppression or kills the dysentery bacterium effect, and staphylococcus aureus, bacillus pyocyaneus are all had obvious inhibitory action.
The Herb Polygoni Chinensis is the dry herb of Polygonaceae arsesmart Herb Polygoni Chinensis (Polygonum chinense L.), contains flavonoid glycoside, and staphylococcus aureus, Bacillus typhi, dysentery bacterium and escherichia coli are all had obvious inhibitory action.
Cortex Ilicis Rotundae is the dry bark of holly plant Ilex rotunda Thunb. (Ilex rotunda Thunb.), contains flavonoid glycoside, phenols, tannin, triterpene glycosides, and isolates β-Amyrin (cupreol of β-Amyrin) (β-Sitosterol) and stearic acid.The modern pharmacology result of study shows that Cortex Ilicis Rotundae flavonoid glycoside part has relaxation effect to isolated ileum segments in guinea pigs, and can antagonism the enterospasm that causes of acetylcholine.Decoct can suppress staphylococcus aureus, Hemolytic streptococcus and dysentery (Fu Shi), typhoid fever, bacillus pyocyaneus in vitro.
Though at present the Chinese medicinal tablet of the treatment bacillary dysentery of being made by these three kinds of Chinese crude drugs, acute chronic gastroenteritis can cover that adverse drug is smelt flavor, improves medicine stability, improves bioavailability of medicament, swallowed easily, taking convenience, dosage are accurate, be easy to carry and store, but in its preparation process, the rate of transform of effective ingredient is lower, only be 60-70%, and the too high drug effect that influences of invalid components leaching rate.Therefore, provide a kind of Chinese medicine composition for the treatment of bacillary dysentery, acute chronic gastroenteritis and preparation method thereof, have realistic meaning.
Summary of the invention
The present invention is directed in the medicine of present bacillary dysentery, acute and chronic gastroenteritis, lower, the too high present situation that influences drug effect of invalid components leaching rate of the effective ingredient rate of transform in Ramulus et Folium Bauhiniae Faberi, Herb Polygoni Chinensis, the Cortex Ilicis Rotundae three flavor Chinese crude drugs, a kind of preparation method of Chinese medicine composition is provided, this preparation method has all been brought up to more than 96% active constituents of medicine gallic acid, luteolin, syringoside and the pedunculoside rate of transform, has reduced the leaching of invalid element.
In order to realize the foregoing invention purpose, the invention provides following technical scheme:
The invention provides a kind of preparation method of Chinese medicine composition, raw material comprises: Ramulus et Folium Bauhiniae Faberi 2280-11400 weight portion, Herb Polygoni Chinensis 1140-5700 weight portion, Cortex Ilicis Rotundae 580-2900 weight portion;
Step 1: get the Cortex Ilicis Rotundae of 456-2280 weight portion and mix with the Ramulus et Folium Bauhiniae Faberi of 2280-11400 weight portion, the Herb Polygoni Chinensis of 1140-5700 weight portion, the deionized water that adds 8 times of weight portions carries out decocting the first time 2h, collects decocting liquid; The deionized water that adds 6 times of weight portions again carries out decocting the second time 1h, collects decocting liquid, merges with for the first time described decocting liquid, filters and collects filtrate, is condensed into the thick paste that relative density is 1.25-1.30;
Step 2: the Cortex Ilicis Rotundae of residuals weight part is pulverized, crossed 100 mesh sieves, make the Cortex Ilicis Rotundae fine powder;
Step 3: in described thick paste, add described Cortex Ilicis Rotundae fine powder, make described Chinese medicine composition.
Ramulus et Folium Bauhiniae Faberi decocting liquid has tangible pharmacologically active, so the present invention adopts the extraction process by water route, active ingredient gallic acid in the extraction garden euphorbia herb.Gallic acid, chemical name are 3,4, the 5-trihydroxybenzoic acid, and molecular formula is C
7H
6O
5, molecular weight is 170.12, structural formula is as follows:
It is acicular crystal (absolute methanol or a chloroform), fusing point 235-240 ℃ (decomposition).The 1g gallic acid can be fused to 87mL water, 3mL boiling water, 6mL ethanol, 100mL ether, 10mL glycerol and 5mL acetone, is dissolved in benzene, chloroform and petroleum ether hardly.UV λ dioxane max nm (ε): 221 (20900), 269 (9340); UV λ dioxane min nm (ε): 238 (2100); UVEtOHmax nm (ε): 216 (25700), 271 (8320); UV λ EtOHmin nm (ε): 239 (2190).Its pharmacological action is: (1) anti-bacteria and anti-virus: external staphylococcus aureus, sarcina, α-type streptococcus, Neisseria gonorrhoeae, bacillus pyocyaneus, bacterium flexneri, Bacillus typhi Hd, Salmonella paratyphi A etc. are had inhibitory action, its Mlc is 5mg/mL.Under 3% concentration, 17 kinds of funguses there is bacteriostasis, influenza virus is also had certain inhibitory action.(2) antitumor: the mouse lung adenoma that morpholine is added due to the sodium nitrite has strong inhibitory action.
The present invention adopts the extraction process by water route, and the effective ingredient that extracts among the Herb Polygoni Chinensis is a luteolin.Luteolin (luteolin), molecular formula be 3 ', 4 ', 5,7-luteolin, chemical formula are C
15H
10O
6, molecular weight is 286.23, structural formula is as follows:
Luteolin is yellow acicular crystal, fusing point 328-330 ℃.Be slightly soluble in water, the tool faintly acid dissolves in the alkaline solution, and is stable under the normal condition.It is the natural flavone compounds, is present in the various plants.Have multiple pharmacologically active, as antiinflammatory, antiallergic, antitumor, antibiotic, antiviral etc., clinical anti-inflammatory effect, anti-allergic effects and the immunological enhancement of being mainly used in also has bacteriostasis to staphylococcus aureus, Diplococcus pneumoniae, bacillus pyocyaneus.
The effect of the enterospasm that the Cortex Ilicis Rotundae water extract has is significantly antibacterial, lax ileum, antagonism acetylcholine cause so the present invention adopts the water extraction process route, is extracted the effective ingredient syringoside and the pedunculoside of Cortex Ilicis Rotundae.Syringoside, molecular formula and molecular weight: C
17H
24O
9372.36; Clear crystal, fusing point: 192 ℃, be dissolved in hot water and ethanol, be slightly soluble in cold water, be insoluble to ether substantially.Pharmacological action: hemostasis, anti-liver poison, it recovers the enzymatic activity of microsomal enzyme system and suppresses lipid peroxidation.Pedunculoside, molecular formula are C
36H
58O
10, molecular weight is 650, is white, needle-shaped crystals, has the effect of anti-inflammatory analgetic, structure is as follows:
The Chinese medicine composition that the present invention also provides above-mentioned preparation method to make.
In addition, the present invention also provides above-mentioned Chinese medicine composition in preparation treatment bacillary dysentery, the application in the acute and chronic gastroenteritis.
On this basis, the present invention also provides a kind of Chinese medicine preparation, comprises above-mentioned Chinese medicine composition and acceptable accessories.
As preferably, this acceptable accessories comprises a kind of or both the above mixture in starch, Pulvis Talci, magnesium stearate, dextrin, sucrose, cyclodextrin, the sodium benzoate.
As preferably, this acceptable accessories is a starch.
As preferably, the starch consumption is 5.3% of a described Chinese medicine composition weight.
Preferably, described Chinese medicine preparation is capsule or tablet, the present invention granulates after with described Chinese medicine composition mixing, compacting in flakes, bag film-coat or sugar-coat make Chinese medicinal tablet, perhaps will granulate behind the described Chinese medicine composition mixing, filled hard capsules makes the Chinese medicinal capsule agent.
In the Chinese medicine composition that makes according to preparation method of the present invention, the effective ingredient gallic acid rate of transform is 96.15%, and the luteolin rate of transform is 98.96%, and the syringoside rate of transform is 97.63%, the rate of transform of pedunculoside is 98.65%, is significantly higher than existing method (P＜0.5).Chinese medicine composition provided by the invention and capsule thereof or tablet to bacillary dysentery, acute and chronic enteritis, acute and chronic gastritis sufferer's obvious effective rate at 78.81-90.62%, total effective rate has remarkable therapeutical effect (P＜0.05) at 93.22-98.44% to bacillary dysentery, acute and chronic enteritis, acute and chronic gastritis.
Description of drawings
Accompanying drawing 1 shows the sucting wet curve of Chinese medicine composition provided by the present invention, and vertical coordinate is a water content, and abscissa is a relative humidity.
The specific embodiment
The invention discloses a kind of Chinese medicine composition and preparation method thereof, those skilled in the art can use for reference this paper content, suitably improve technological parameter and realize.Special needs to be pointed out is that all similarly replace and change apparent to those skilled in the art, they all are regarded as being included in the present invention.Method of the present invention and application are described by preferred embodiment, the related personnel obviously can change or suitably change and combination methods and applications as herein described in not breaking away from content of the present invention, spirit and scope, realizes and use the technology of the present invention.
The invention provides a kind of preparation method of Chinese medicine composition, raw material comprises: Ramulus et Folium Bauhiniae Faberi 2280-11400 weight portion, Herb Polygoni Chinensis 1140-5700 weight portion, Cortex Ilicis Rotundae 580-2900 weight portion;
Step 1: get the Cortex Ilicis Rotundae of 456-2280 weight portion and mix with the Ramulus et Folium Bauhiniae Faberi of 2280-11400 weight portion, the Herb Polygoni Chinensis of 1140-5700 weight portion, the deionized water that adds 8 times of weight portions carries out decocting the first time 2h, collects decocting liquid; The deionized water that adds 6 times of weight portions again carries out decocting the second time 1h, collects decocting liquid, merges with for the first time described decocting liquid, filters and collects filtrate, is condensed into the thick paste that relative density is 1.25-1.30;
Step 2: the Cortex Ilicis Rotundae of residuals weight part is pulverized, crossed 100 mesh sieves, make the Cortex Ilicis Rotundae fine powder;
Step 3: in described thick paste, add described Cortex Ilicis Rotundae fine powder, make described Chinese medicine composition.
The Chinese medicine composition that the present invention also provides above-mentioned preparation method to make.
In addition, the present invention also provides above-mentioned Chinese medicine composition in preparation treatment bacillary dysentery, the application in the acute and chronic gastroenteritis.
On this basis, the present invention also provides a kind of Chinese medicine preparation, comprises above-mentioned Chinese medicine composition and acceptable accessories.
As preferably, this acceptable accessories comprises a kind of or both the above mixture in starch, Pulvis Talci, magnesium stearate, dextrin, sucrose, cyclodextrin, the sodium benzoate.
As preferably, this acceptable accessories is a starch.
As preferably, the starch consumption is 5.3% of a described Chinese medicine composition weight.
Preferably, described Chinese medicine preparation is capsule or tablet, the present invention granulates after with described Chinese medicine composition mixing, compacting in flakes, bag film-coat or sugar-coat make Chinese medicinal tablet, perhaps will granulate behind the described Chinese medicine composition mixing, filled hard capsules makes the Chinese medicinal capsule agent.
Preparation method provided by the invention adopts orthogonal experiment, is evaluation index with four kinds of effective ingredient for the treatment of bacillary dysenterys, acute and chronic gastroenteritis, designs the reasonable weight value coefficient, and by variance analysis, preferred best decocting process.
According to preliminary experiment and bibliographical information, tentatively determine to decoct with water secondary, add for the first time 8 times of water gagings, with the second time amount of water and twice decocting time be the investigation factor, carry out three factors, three horizontal L
9(3
4) orthogonal test.Because the effective ingredient of Ramulus et Folium Bauhiniae Faberi treatment primary disease is gallic acid (C
7H
6O
4); The active ingredient that the Herb Polygoni Chinensis treats primary disease is luteolin (C
15H
10O
6); The active ingredient of Cortex Ilicis Rotundae treatment primary disease is syringoside (C
17H
24O
9) and pedunculoside (C
36H
58O
10), so, be respectively gallic acid 0.5, luteolin 0.3, syringoside and pedunculoside and all be respectively 0.1 with these four kinds foundations for the treatment of the effective ingredient of primary disease as the design weight coefficient; With above-mentioned four kinds of effective ingredient of decocting out respectively in each medical material shared percentage be evaluation index, and, filter out best decocting extraction process condition with the measurement index of comprehensive grading as extraction effect.Finishing screen is selected best decocting extraction conditions for decocting with water twice, adds 8 times of water gagings for the first time, decocts 2 hours, adds 6 times of water gagings for the second time, decocts 1 hour.Adopt best decocting extraction conditions, kept effective medicinal component in the medical material to greatest extent, the rate of transform that makes active ingredient is all more than 96%.
Below in conjunction with embodiment, further set forth the present invention:
Each parameter is to the influence of extraction effect in the preparation method of embodiment 1 Chinese medicine composition
Fixedly decoct amount of water the first time, investigate the influence of amount of water for the second time and twice decocting time the effective medicinal components rate of transform:
Take by weighing Ramulus et Folium Bauhiniae Faberi 2280g, Herb Polygoni Chinensis 1140g, Cortex Ilicis Rotundae 456g, decoct with water secondary, add for the first time 8 times of amounts that water is three kinds of raw material total amounts, carry out decocting by the orthogonal test condition and extract collecting decoction, filter, filtrate is condensed into the thick paste of relative density 1.25-1.30 (70 ℃), and is dry, pulverized 100 mesh sieves, and fine powder gets dry extract, the accurate title, decided dried cream fine powder total amount, and adopt the percentage composition of the above-mentioned four kinds of effective ingredient of high effective liquid chromatography for measuring in crude drug respectively.The orthogonal test factor level sees Table 1, and result of the test sees Table 2.
Table 1 decocting extracts orthogonal test factor level table
Table 2 decocting extracts orthogonal test table
Decocting extracts orthogonal test, adopts the comprehensive grading method to carry out data analysis, and four each component content weight coefficients of evaluation index are respectively: gallic acid 0.5, luteolin 0.3, syringoside and pedunculoside are all 0.1.The scoring of each medicinal active ingredient=these this composition percentage composition of composition percentage composition/maximum * these composition weight coefficient * 100; The summation of 4 medicinal active ingredient scorings in the comprehensive grading of every test=this test.
Extreme difference R shows that each factor is to extraction effect influence size, factor A＞B＞C in the table 2; The K value shows each level to extraction effect influence size, and factor A is K
2＞K
3＞K
1, factor B is K
3＞K
2＞K
1, factor C is K
3＞K
1＞K
2From table 2 intuitive analysis, best decocting extraction conditions is A
2B
3C
1
Each factor is carried out variance analysis to the influence of the medicinal ingredient rate of transform, the results are shown in Table 3.
The variance analysis of table 3 decocting extraction effect
Variance analysis is calculated:
Look into the F-distribution tables of critical values, get F
0.05(2,2)=19.00
F
0.01(2，2)＝99.00
Table 3 The results of analysis of variance shows: the influence of A factor and B factor all has extremely significantly meaning (the P value all＜0.01); The C factor affecting does not have significance meaning (P＞0.05), and associative list 2 intuitive analysiss determine that best decocting extraction conditions is A
2B
3C
1, promptly decoct with water secondary, decoct 2h for the first time, add 6 times of water gagings for the second time and decoct 1h.
Fixing amount of water and twice decocting time for the second time, investigate for the first time amount of water to the influence of the effective medicinal components rate of transform:
Under above-mentioned optimum condition, with the amount of water that the first time, decocting boiled is the investigation factor, with above-mentioned four kinds of effective medicinal components respectively the percentage composition in each medical material be evaluation index, the best amount of water that screening decocts with water for the first time, its weight coefficient of effective ingredient of above-mentioned four kinds of treatment primary disease is respectively: gallic acid 0.5, luteolin 0.3, syringoside 0.1, pedunculoside 0.1, and with the measurement index of comprehensive grading as extraction effect.
Take by weighing Ramulus et Folium Bauhiniae Faberi 2280g, Herb Polygoni Chinensis 1140g, Cortex Ilicis Rotundae 456g respectively, decoct with water twice, add the water of 6 times, 8 times, 10 times amounts for the first time respectively, decocted 2 hours, and added 6 times of water gagings for the second time, decocted 1 hour, collecting decoction, filter, filtrate is condensed into the thick paste of relative density 1.25-1.30 (70 ℃), drying, be ground into fine powder, the accurate title, decided dried cream fine powder total amount, and adopt the percentage composition of the above-mentioned four kinds of effective ingredient of high effective liquid chromatography for measuring in crude drug respectively, and result of the test sees Table 4.
The amount of water that table 4 decocts for the first time is to the influence of extraction effect
Decocting extracts test, adopts the comprehensive grading method to carry out data analysis, and each component content weight coefficient is respectively gallic acid 0.5, luteolin 0.3, syringoside 0.1, pedunculoside 0.1.The scoring of each medicinal active ingredient=these this composition percentage composition of composition percentage composition/maximum * these composition weight coefficient * 100; Comprehensive grading=4 an effective medicinal components scoring summation.Table 4 result shows, when decocting for the first time, adds 8 times of water gaging extraction effect the bests.
Comprehensive above-mentioned result of the test, best decocting extraction conditions adds 8 times of water gagings for the first time for decocting with water twice, decocts 2h; Add for the second time 6 times of water gagings, decoct 1h.
Concentrate the investigation of thick paste relative density:
Present production technology only will be extracted filtrate and be condensed into thick paste, not the index of amount.In preparation method provided by the invention, adopt the assay method of thick paste relative density to be: the relative density of liquid drug, generally measure with pycnometric method; The relative density of volatile liquid, available Webster proportion claim to measure.Measure the relative density of preparation with pycnometric method: get cleaning, the fixed density bottle of dry and accurate title, after filling test sample, put in 20 ℃ of water-baths and place 10-20min, there is the bottle stopper of pore at the insertion center, too much liquid is overflowed from consent, and dry with the liquid that filter paper will overflow, take out density bottle then, dry, accurately claim surely, deduct density bottle weight, try to achieve test sample weight after, test sample is inclined, clean density bottle, fill the cold water that newly boiled, the weight of water when method records same temperature on the photograph, be calculated as follows, promptly.Test sample relative density=test sample weight/water weight.
According to document and knowhow, determine that relative density is the index of thick paste amount, to receive the cream amount, to make suitable soft material and add ormal weight Cortex Ilicis Rotundae fine powder external demand to add amount of starch serve as to investigate index, relative density is investigated.Get Ramulus et Folium Bauhiniae Faberi 2280g, Herb Polygoni Chinensis 1140g, Cortex Ilicis Rotundae 580g, totally 3 parts, extract according to fixed process conditions, concentrate, investigate according to table 5 design, the results are shown in Table 5.Relative density is received the on-the-spot title of cream amount and is decided with the on-site measurement of mother-in-law Mei Shi gravimeter.
Table 5 relative density is investigated the result
Experimental result shows: relative density does not have obvious influence to receiving the cream amount.But relative density is more little, and making suitable soft material, need to add amount of starch big more.When relative density surpasses 1.30 (70 ℃ of heat are surveyed), then thick paste can not absorb fully to the Cortex Ilicis Rotundae fine powder of process stipulation amount.In conjunction with practical situation, select relative density 1.25-1.30 (70 ℃ of heat are surveyed) to be advisable.
Adjuvant and supplementary product consumption are investigated:
According to fixed process conditions, after the extraction thick paste is finished, need make suitable soft material granulation, add technology ormal weight Cortex Ilicis Rotundae fine powder and still need add appropriate amount of auxiliary materials outward.Adjuvant commonly used has starch, smart, according to knowhow, considers production cost, selects starch as adsorbent.The starch consumption serves as to investigate index with the soft material screen cloth of can cannot not granulating stickingly.Get Ramulus et Folium Bauhiniae Faberi 2280g, Herb Polygoni Chinensis 1140g, Cortex Ilicis Rotundae 580g, totally 3 parts, concentrate by determining that process conditions are extracted, investigate the starch consumption according to table 6 design, the results are shown in Table 6.
Table 6 starch consumption is investigated the result
From experimental result as can be seen, adding amount of starch adds 0.024kg with each recipe quantity thick paste and is advisable.
The research of moulding process:
(1) each recipe quantity medical material is 4000g, needing to extract medical material is 3876g, press extraction ratio 7.8%, can the amount of getting dry extract 252g, add Cortex Ilicis Rotundae medical material fine powder 124g, according to experimental result, each recipe quantity should add starch 24g, can do the about 450g of granule, 1000 of each recipe quantity systems (sheet), then every dress granule and plain sheet heavily are 0.45g, so specification is defined as every dress 0.45g (or every heavy 0.45g).
(2) determining of critical relative humidity:
Get the about 2g of granule, put in the weighing botle, the accurate title, decided totally 12 parts, be divided into two groups, every group 6 parts, open wide weighing botle, put into relative humidity respectively and be 30.0%, 42.76%, 57.70%, 75.28%, 84.26%, 92.48% environment, in 25 ℃ of incubators, placed 96 hours, take out weighing botle, add a cover the accurate title in back and decide, calculate water absorption rate.The results are shown in Table 7.
The moisture absorption situation of mixture under each relative humidity condition of table 7
| Relative humidity (RH) | 30.00 | 42.76 | 57.70 | 75.28 | 84.26 | 92.48 |
| Average water absorption rate (%) | 2.2 | 2.9 | 4.5 | 12.3 | 18.8 | 28.2 |
With the water content is vertical coordinate, and relative humidity is an abscissa, draws sucting wet curve, sees Figure of description 1.From sucting wet curve as can be seen, along with envionmental humidity increases, particulate hydroscopicity is also increasing, and the flex point of its sucting wet curve is about 60%, and therefore, capsule should control environment relative humidity below 60% when filling.
Embodiment 2 preparation methoies provided by the invention are to the influence of the effective ingredient rate of transform
Take by weighing Ramulus et Folium Bauhiniae Faberi 4560g, Herb Polygoni Chinensis 2280g, Cortex Ilicis Rotundae 912g, the best decocting condition that filters out according to embodiment 1, decoct with water twice, add for the first time 8 times of water gagings, decoct 2h, add for the second time 6 times of water gagings, decoct 1h, collecting decoction, filter, filtrate is condensed into the thick paste of relative density 1.25～1.30 (70 ℃), drying, pulverized 100 mesh sieves, fine powder gets dry extract, the fixed dried cream fine powder total amount of accurate title, and adopt the percentage composition of the above-mentioned four kinds of effective ingredient of high effective liquid chromatography for measuring in crude drug respectively, and crude drug is carried out percentage composition measure, the effective ingredient rate of transform tried to achieve.
Chinese medicine composition to preparation detects, and investigates extraction effect, the results are shown in Table 8.
Table 8 decocting extracts the checking result
Table 8 result shows, it is consistent that decocting extracts the best decocting extraction conditions result of the test that filters out among checking result and the embodiment 1, and the rate of transform of effective ingredient proves that all more than 96% the decocting extraction process is best preparation method among the embodiment 1.
The capsule that embodiment 3 makes according to preparation method provided by the invention
Take by weighing Ramulus et Folium Bauhiniae Faberi 6840g, Herb Polygoni Chinensis 3420g, Cortex Ilicis Rotundae 1368g, remove impurity is cleaned, oven dry, and Ramulus et Folium Bauhiniae Faberi and Herb Polygoni Chinensis are cut into the 10mm section, and it is standby that Cortex Ilicis Rotundae is ground into coarse powder; Above-mentioned three flavor medical materials are decocted with water twice, add 8 times of water gagings for the first time, decoct 2h, add 6 times of water gagings for the second time, decoct 1h, collecting decoction filters, and filtrate is condensed into the thick paste of relative density 1.25-1.30 (70 ℃).Other gets Cortex Ilicis Rotundae and pulverizes, and crosses 100 mesh sieves, gets fine powder 372g and starch 72g and adds in the above-mentioned thick paste, and mixing is granulated, and fills 3000 capsules, every dress 0.45g.Be capsule, remove and show pitchy, bitter in the mouth, puckery after the capsule shells.Oral, a 3-4 grain, 3 times on the one.
The tablet that embodiment 4 makes according to preparation method provided by the invention
Take by weighing Ramulus et Folium Bauhiniae Faberi 9120g, Herb Polygoni Chinensis 4560g, Cortex Ilicis Rotundae 1824g, remove impurity, clean, oven dry, Ramulus et Folium Bauhiniae Faberi and Herb Polygoni Chinensis are cut into the 10mm section, it is standby that Cortex Ilicis Rotundae is ground into coarse powder, above-mentioned three flavor medical materials are decocted with water twice, add for the first time 8 times of water gagings, decoct 2h, add 6 times of water gagings for the second time, decoct 1h, collecting decoction filters, and filtrate is condensed into the thick paste of relative density 1.25-1.30 (70 ℃).Other gets Cortex Ilicis Rotundae and pulverizes, and crosses 100 mesh sieves, gets fine powder 496g and starch 96g and adds in the above-mentioned thick paste, and mixing is granulated, and is pressed into 4000, bag film-coat, every heavy 0.45g.Oral, a 3-4 sheet, 3 times on the one.
The Chinese medicinal capsule agent that embodiment 5 makes according to preparation method provided by the invention
Cortex Ilicis Rotundae 620g is pulverized, cross 100 mesh sieves, standby.Again Ramulus et Folium Bauhiniae Faberi 11400g, Herb Polygoni Chinensis 5700g, Cortex Ilicis Rotundae 2280g are mixed, add for the first time deionized water and decoct 2h, the mass ratio of raw material and deionized water is 1: 8, collect decocting liquid, to the capable 1h that decocts for the second time of raw material, the mass ratio of raw material and deionized water is 1: 6, collects decocting liquid, merge with for the first time described decocting liquid, filter, collect filtrate, be condensed into the thick paste of relative density 1.25-1.30 (70 ℃), add and state Cortex Ilicis Rotundae fine powder and starch 120g, mixing is granulated, and is encapsulated, make 5000, every dress 0.45g.Oral, a 3-4 grain, 3 times on the one.This Chinese medicine composition is a capsule, remove softgel shell after, its content shows pitchy; Bitter in the mouth, puckery.
The maximum resistance test of embodiment 6 acute toxicities
Chinese medicinal capsule agent or the tablet made according to preparation method provided by the invention carry out the maximum resistance test of acute toxicity in animal body, day maximum tolerated dose to the mouse stomach administration is adult 516 times of clinical consumption per day, does not observe the Chinese medicinal capsule agent that preparation method provided by the invention makes or the toxic reaction of tablet under this dosage.
Embodiment 7 long term toxicity tests
Chinese medicinal capsule agent or the tablet of making according to preparation method provided by the invention carried out 6 months long term toxicity tests in animal body, give the rat oral gavage administration every day, dosage be equivalent to respectively to be grown up 100 times, 50 times, 25 times of clinical day dose.Observation item comprises General observation and comprises the complete detection of 29 of hematological examinations.The result shows that obvious adverse reaction does not all appear in three dosages, shows that it is safe that the Chinese medicinal capsule agent of making according to preparation method provided by the invention or tablet are used for clinical use.
Embodiment 8 long-term clinical trials
Oral Chinese medicinal capsule agent provided by the invention or tablet, a 3-4 grain (sheet), 3 times on the one, serve on for two weeks, obvious adverse reaction is not found in clinical observation, curative effect sees Table 9.Curative effect determinate standard is carried out with reference to " Clinical Researches of New Drugs guideline " version in 2002.
Table 9 clinical therapeutic efficacy
Clinical therapeutic efficacy shows, Chinese medicinal capsule agent provided by the invention or tablet to bacillary dysentery, acute and chronic enteritis, acute and chronic gastritis sufferer's obvious effective rate at 78.81-90.62%, total effective rate has remarkable therapeutical effect (P＜0.05) at 93.22-98.44% to bacillary dysentery, acute and chronic enteritis, acute and chronic gastritis.
Embodiment 9 Detection of Stability
Placed 24 months under room temperature stock condition according to Chinese medicinal capsule agent and tablet that the preparation method of Chinese medicine composition provided by the invention is made, every detection index all meets statutory standards, and this product steady quality is described.
The above only is a preferred implementation of the present invention; should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.
Claims (8)
1. the preparation method of a Chinese medicine composition is characterized in that, raw material comprises: Ramulus et Folium Bauhiniae Faberi 2280-11400 weight portion, Herb Polygoni Chinensis 1140-5700 weight portion, Cortex Ilicis Rotundae 580-2900 weight portion;
Step 1: get the Cortex Ilicis Rotundae of 456-2280 weight portion and mix with the Ramulus et Folium Bauhiniae Faberi of 2280-11400 weight portion, the Herb Polygoni Chinensis of 1140-5700 weight portion, the deionized water that adds 8 times of weight portions carries out decocting the first time 2h, collects decocting liquid; The deionized water that adds 6 times of weight portions again carries out decocting the second time 1h, collects decocting liquid, merges with for the first time described decocting liquid, filters and collects filtrate, is condensed into the thick paste that relative density is 1.25-1.30;
Step 2: the Cortex Ilicis Rotundae of residuals weight part is pulverized, crossed 100 mesh sieves, make the Cortex Ilicis Rotundae fine powder;
Step 3: in described thick paste, add described Cortex Ilicis Rotundae fine powder, make described Chinese medicine composition.
2. the Chinese medicine composition that makes of the described preparation method of claim 1.
3. the described Chinese medicine composition of claim 2 is in preparation treatment bacillary dysentery, the application in the acute and chronic gastroenteritis.
4. a Chinese medicine preparation is characterized in that, comprises described Chinese medicine composition of claim 2 and acceptable accessories.
5. Chinese medicine preparation as claimed in claim 4 is characterized in that, described acceptable accessories comprises a kind of or both the above mixture in starch, Pulvis Talci, magnesium stearate, dextrin, sucrose, cyclodextrin, the sodium benzoate.
6. Chinese medicine preparation as claimed in claim 5 is characterized in that, described acceptable accessories is a starch.
7. Chinese medicine preparation as claimed in claim 6 is characterized in that, the starch consumption is 5.3% of a described Chinese medicine composition weight.
8. as each described Chinese medicine preparation of claim 4 to 7, it is characterized in that described Chinese medicine preparation is capsule or tablet.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103536881A (en) * | 2013-10-09 | 2014-01-29 | 董成祥 | Drug for treating chronic gastritis |
| CN107308221A (en) * | 2017-07-07 | 2017-11-03 | 陕西君碧莎制药有限公司 | Fly upward new application of the enterogastritis capsule in treatment pelvic inflammatory sequelae |
| CN107961239A (en) * | 2017-12-18 | 2018-04-27 | 陕西君碧莎制药有限公司 | A kind of three pharmaceutical composition and its application in terms of enterogastritis is treated |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101007071A (en) * | 2006-01-27 | 2007-08-01 | 刘晓 | Traditional Chinese medicine for treating acute and chronic gastroenteritis and bacterial dysentery and its processing technology |
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2010
- 2010-12-31 CN CN2010106205469A patent/CN102178749A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101007071A (en) * | 2006-01-27 | 2007-08-01 | 刘晓 | Traditional Chinese medicine for treating acute and chronic gastroenteritis and bacterial dysentery and its processing technology |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103536881A (en) * | 2013-10-09 | 2014-01-29 | 董成祥 | Drug for treating chronic gastritis |
| CN103536881B (en) * | 2013-10-09 | 2016-04-20 | 张树立 | A kind of medicine for the treatment of chronic gastritis |
| CN107308221A (en) * | 2017-07-07 | 2017-11-03 | 陕西君碧莎制药有限公司 | Fly upward new application of the enterogastritis capsule in treatment pelvic inflammatory sequelae |
| CN107308221B (en) * | 2017-07-07 | 2020-10-20 | 陕西君碧莎制药有限公司 | New application of Feiyang gastroenteritis capsule in treating pelvic inflammatory sequelae |
| CN107961239A (en) * | 2017-12-18 | 2018-04-27 | 陕西君碧莎制药有限公司 | A kind of three pharmaceutical composition and its application in terms of enterogastritis is treated |
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Application publication date: 20110914 |