CN102000319B - Preparation method of stomach warming and soothing tablets - Google Patents

Preparation method of stomach warming and soothing tablets Download PDF

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CN102000319B
CN102000319B CN2010105643945A CN201010564394A CN102000319B CN 102000319 B CN102000319 B CN 102000319B CN 2010105643945 A CN2010105643945 A CN 2010105643945A CN 201010564394 A CN201010564394 A CN 201010564394A CN 102000319 B CN102000319 B CN 102000319B
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radix
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rhizoma
warming
decocting
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CN102000319A (en
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尹子郡
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GUANGDONG SINOTAU PHARMACEUTICAL CO., LTD.
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YANGLING WUWEI PHARMACEUTICAL GROUP CO Ltd
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Abstract

The invention discloses a preparation method of stomach warming and soothing tablets, comprising the following steps of: pulverizing and sieving four medicinal materials including cinnamon, amomum fruit, fevervine and baked ginger, decocting eight medicinal materials including membranous milkvetch root, clovershrub, corydalis tuber, white paeony roots, common bletilla pseudobulb, gallnut, the root of red-rooted salvia and liquorice for three times, mixing the decocted filtrates and concentrating the decocted filtrates to a thick paste with the relative density of 1.30 (60 DEG C) by pressure reduction, mixing the sieved medicinal materials with the concentrated thick paste, drying, pulverizing, pelletizing, tabletting and packaging with sugar coatings to obtain the stomach warming and soothing tablets. The preparation method has simple process, the prepared stomach warming and soothing tablets have a miraculous effect on treating spleen-stomach deficiency cold type and liver-spleen incoordination type gastric ulcers, duodenal ulcers and chronic gastritis.

Description

A kind of method for preparing of warming the stomach Shu Le sheet
Technical field
The invention belongs to medical technical field, be specifically related to a kind of method for preparing of warming the stomach Shu Le sheet.
Background technology
The peptic ulcer major part occurs in stomach or duodenum, is called for short Peptic Ulcers, and clinical manifestation is main with stomachache, and pain is limited to top, has chronic, periodically and 3 characteristics of rhythmicity.Primary disease is equivalent to diseases such as Chinese medicine gastric abscess, noisy, acid regurgitation.Chronic gastritis is uncomfortable with the conscious gastral cavilty of patient portion painful abdominal mass plug, distension or distending pain, outbreak repeatedly, and, belch indigestion and loss of appetite with lack of appetite, loose stool or defecation are not well etc. is the common gastrointestinal disorder of main clinical manifestation.The very strong medicine of specific aim lacks very much at present, and warming the stomach Shu Le sheet is developing just in such cases.
In solid preparation, powder, granule are difficult for covering the bad smell of medicine, and the easy moisture absorption, are difficult for preserving, and affect the treatment; When capsule dissolved under one's belt, owing to the too high gastric mucosa that stimulates of medicine local concentration, some hygroscopicity composition became fragile because of making the capsule wall overdrying; The pill dissolve scattered time limit is difficult to control, and production procedure is long, is subject to microbial contamination, the long bacterium of pill is mildewed, and the bad smell of medicine is difficult for covering.
Summary of the invention
Technical problem to be solved by this invention is to above-mentioned deficiency of the prior art a kind of method for preparing of warming the stomach Shu Le sheet to be provided.The warming the stomach Shu Le sheet dissolution and the bioavailability of preparation are good than pill, and dosage is accurate, and steady quality is taken, carried, transportation etc. is more convenient.
For solving the problems of the technologies described above, the technical scheme that the present invention adopts is: a kind of method for preparing of warming the stomach Shu Le sheet is characterized in that this method may further comprise the steps:
(1) gets by weight Radix Astragali 88-138 part, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 20-70 part, Rhizoma Corydalis 20-70 part; Radix Paeoniae Alba 88-138 part, fevervine 88-138 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 88-138 part; Fructus Amomi 3.5-8.5 part, Galla Chinensis 3.5-8.5 part, Cortex Cinnamomi 8.5-13.5 part; Radix Salviae Miltiorrhizae 20-70 part, Radix Glycyrrhizae 20-70 part, Rhizoma Zingiberis Preparatum 20-70 part;
(2) Cortex Cinnamomi described in the step (1), Fructus Amomi, fevervine and Rhizoma Zingiberis Preparatum are pulverized, excessively mixing behind 100 mesh sieves;
(3) with the Radix Astragali described in the step (1), Radix Campylotropis Hirtella (Herba Myrsines Africanae), Rhizoma Corydalis, the Radix Paeoniae Alba, Pseudobulbus Bletillae (Rhizoma Bletillae), Galla Chinensis, Radix Salviae Miltiorrhizae and Radix Glycyrrhizae eight flavor medical material decocte with water three times; The amount of water that decocts for the first time is 8～12 times of need decocting herbs gross weight; Decocting time is 1.5 hours, and the amount of water that decocts for the second time is 8～12 times of need decocting herbs gross weight, and decocting time is 1.5 hours; The amount of water that decocts for the third time is 8～12 times of need decocting herbs gross weight; Decocting time is 1 hour, filters the back merging filtrate, and being evaporated to 60 ℃, to record relative density be 1.30 thick paste;
(4) medical material after sieving in the step (2) is added described in the step (3) in the thick paste, mix homogeneously is granulated, and is dry below 60 ℃, adds 0.5% the magnesium stearate of quality for dry back product quality, tabletting, and sugar coating obtains warming the stomach Shu Le sheet.
The medical material of respectively distinguishing the flavor of described in the above-mentioned steps (1) is counted by weight: Radix Astragali 100-126 part, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 32-58 part, Rhizoma Corydalis 32-58 part; Radix Paeoniae Alba 100-126 part, fevervine 100-126 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 100-126 part; Fructus Amomi 5-7 part, Galla Chinensis 5-7 part, Cortex Cinnamomi 10-12 part; Radix Salviae Miltiorrhizae 32-58 part, Radix Glycyrrhizae 32-58 part, Rhizoma Zingiberis Preparatum 32-58 part.
Described in the above-mentioned steps (3) in the decoction process, the amount of water that decocts for the first time is for needing 10 times of decocting herbs gross weight, and the amount of water that decocts for the second time is for needing 10 times of decocting herbs gross weight, and the amount of water that decocts for the third time is for needing 12 times of decocting herbs gross weight.
The said medical material of respectively distinguishing the flavor of is counted by weight: 113 parts of the Radixs Astragali, 45 parts of Radix Campylotropis Hirtella (Herba Myrsines Africanae)s, 45 parts of Rhizoma Corydalis, 113 parts of the Radix Paeoniae Albas, 113 parts of fevervines, 113 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), 6 parts of Fructus Amomis, 6 parts of Galla Chinensiss, 11 parts of Cortex Cinnamomis, 45 parts of Radix Salviae Miltiorrhizaes, 45 parts in Radix Glycyrrhizae, 45 parts of Rhizoma Zingiberis Preparatums.
Said weight portion can be weight metering units such as gram, two, jin, kilogram, ton.
12 used flavor medical materials are commercially available process check character and close imperial Chinese crude drug.
The warming the stomach Shu Le sheet of the present invention preparation is a coated tablet, shows sepia, mildly bitter flavor, the heavy 0.25g of every plain sheet after removing sugar-coat.The warming the stomach Shu Le sheet of preparation has warming middle-Jiao and tonifying deficiency, regulating the liver and spleen, promoting flow of QI and blood, the effect of pain relieving granulation promoting.Be used for Deficiency and coldness of spleen and stomach and incoordination between the liver and spleen type gastric ulcer, duodenal ulcer, chronic gastritis, disease is seen epigastric pain, abdominal distention happiness temperature, acid regurgitation belch.
The raw medicinal material that the present invention selects for use has following effect: the Radix Astragali is a monarch drug, has tonifying Qi and lifting yang, promote the production of body fluid and nourish blood, and the stagnant blood stasis dispelling of row, the effect of expelling pus and promoting granulation, it is weak to be used for the deficiency of vital energy, sinking of QI of middle-JIAO, arthralgia pain is numb, bursts for a long time and does not hold back; Radix Campylotropis Hirtella (Herba Myrsines Africanae), Rhizoma Corydalis are ministerial drug, have and invigorate blood circulation, circulation of qi promoting, pain relieving, the effect of convergence; The Radix Paeoniae Alba, fevervine, Pseudobulbus Bletillae (Rhizoma Bletillae), Fructus Amomi, Galla Chinensis, Cortex Cinnamomi, all ginsengs, Rhizoma Zingiberis Preparatum are adjuvant drug, have easing the affected liver to relieve pain, suppressing liver-YANG, and expelling wind and removing dampness, promoting digestion and removing stagnation, detumescence and promoting granulation, the removing dampness appetizing, warming spleen and stopping diarrha, removing dampness is held back skin ulcer, blood circulation promoting and blood stasis dispelling, the effect of inducing menstruation to relieve menalgia; Radix Glycyrrhizae is a messenger drug, has invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, the effect of relieving spasm to stop pain, and can coordinating the actions of various ingredients in a prescription play altogether warming middle-Jiao and tonifying deficiency, regulating the liver and spleen disharmony type gastric ulcer, duodenal ulcer, chronic gastritis, disease is seen epigastric pain, abdominal distention happiness temperature, acid regurgitation belch.
The medicine multiple that each amount of water is institute's decocting herb material total amount in carrying out the process that decocts for three times that the present invention adopts orthogonal test the Radix Astragali, Radix Campylotropis Hirtella (Herba Myrsines Africanae), Rhizoma Corydalis, the Radix Paeoniae Alba, Pseudobulbus Bletillae (Rhizoma Bletillae), Galla Chinensis, Radix Salviae Miltiorrhizae, Radix Glycyrrhizae eight flavors to be needed decoct carries out preferably.Through the great mass of data inquiry, the effective ingredient of Radix Astragali treatment primary disease is astragaloside (C 41H 68O 14); The effective ingredient of corydalis tuber for treating primary disease is tetrahydropalmatine (C 21H 25O 4); The effective ingredient of Radix Paeoniae Alba treatment primary disease is peoniflorin (C 23H 28O 11); The effective ingredient of Galla Chinensis treatment primary disease is salvianolic acid B (C 36H 30O 16); The effective ingredient of Radix Glycyrrhizae treatment primary disease is liquirtin (C 21H 22O 9).
The amount of water that extracts with three decoctings is that the multiple of institute's decocting herb material gross weight is the investigation factor, carries out three factors, three horizontal L 9(3 4) orthogonal test, because above-mentioned six kinds of compositions are the effective ingredient of treatment primary disease, so with its foundation as the design weight coefficient; With above-mentioned six kinds of effective ingredient that decoct out respectively each the flavor medical material in shared percentage composition be evaluation index; Because the Radix Astragali is a monarch drug, so the weight coefficient of astragaloside is 0.25, the weight coefficient of all the other five kinds of compositions is all 0.15; And, filter out the best amount of water of each decoction with the measurement index of comprehensive grading as extraction effect.
Experimental technique: with the Radix Astragali, Radix Campylotropis Hirtella (Herba Myrsines Africanae), Rhizoma Corydalis, the Radix Paeoniae Alba, Pseudobulbus Bletillae (Rhizoma Bletillae), Galla Chinensis, Radix Salviae Miltiorrhizae, Radix Glycyrrhizae eight flavor medical materials, decocte with water three times, first and second time are all and decocted 1.5 hours; Decocted for the third time 1 hour, each medical material of distinguishing the flavor of is got 1/10 of recipe quantity respectively, adds the water of eight flavor medical material gross weight different multiples at every turn; Filter, it is the thick paste of 1.30 (60 ℃) that merging filtrate, concentrating under reduced pressure become relative density; Dry below 60 ℃, be ground into fine powder, the accurate title, decide; Adopt each component content of high effective liquid chromatography for measuring respectively, be converted into and respectively extract the percentage composition of composition in corresponding medical material, result of the test sees the following form respectively.
Table 1 warming the stomach Shu Le sheet decocting extracts orthogonal test factor level table
Table 2 warming the stomach Shu Le sheet decocting extracts orthogonal test table
Figure BDA0000034990500000042
Annotate: decocting extracts six evaluation indexes of orthogonal test; Adopt the comprehensive grading method to carry out data analysis; Monarch drug Astragaloside content weight coefficient is 0.25; The weight coefficient of all the other five kinds of effective ingredient is all 0.15, every kind of effective ingredient percentage composition scoring=these this effective ingredient percentage composition of effective ingredient percentage composition/maximum * these composition weight coefficient * 100; Comprehensive grading=six kind of effective ingredient scoring sum.
Table 3 warming the stomach Shu Le sheet decocting extracts orthogonal experiments
Figure BDA0000034990500000051
Extreme difference R value size shows that it is A＞C＞B that each factor influences size order to extraction effect from table 3; From each factor level (analysis of K value), factor A is K again 2＞K 3＞K 1, factor B is K 2＞K 3＞K 1, factor C is K 2＞K 3＞K 1From table 3 intuitive analysis, best decocting extraction conditions is A 2B 2C 3Consider big production practical situation, be necessary the lower horizontal significance of each factor is carried out variance analysis that the result sees the following form.
The variance analysis of table 4 decocting extraction effect
Figure BDA0000034990500000052
Annotate: the variance analysis computing formula
s 2 = 1 n Σ i = 1 n ( x i - x ‾ ) 2 (quadratic sum)
M = S 2 n - 1 (mean square)
M Mistake=M D(F value)
Look into the F-distribution tables of critical values, get F 0.05(2,2)=19.00, F 0.01(2,2)=99.00
Show that from table 4 The results of analysis of variance factor A, B, C all have significance meaning (P＜0.05) to extraction effect, that is to say that the amount of water during three extractions is all very big to the extraction effect influence.The analysis of associative list 2, table 3 and table 4, best decocting extraction conditions is decided to be A 2B 2C 3, promptly first and second time amount of water is 10 times of institute's decocting herbs gross weight, and decocting time was all 1.5 hours, and amount of water is 12 times of institute's decocting herbs gross weight for the third time, and decocting time is 1 hour; Medical material to decocting after three times filters; Merging filtrate, it is the thick paste of 1.30 (60 ℃) that 60 ℃ of concentrating under reduced pressure become relative density, dry below 60 ℃; Pulverize; The accurate title, decide, and adopts each component content of high effective liquid chromatography for measuring respectively, is converted into the percentage composition of effective ingredient in this medical material of respectively frying in shallow oil proposition.Condition is got three batches of recipe quantity medical material checkings in view of the above, and the result sees the following form.
Table 5 decocting extraction conditions demonstration test result
Figure BDA0000034990500000061
As shown in table 5, demonstration test result is consistent with the best decocting extraction of quadrature result.Prove that the preferred best decocting extraction conditions of above-mentioned orthogonal experiment is practicable, the rate of transform of effective ingredient is all more than 95%.
The present invention compared with prior art has the following advantages:
1, technology of the present invention is simple, and the warming the stomach Shu Le sheet of preparation is to Deficiency and coldness of spleen and stomach and incoordination between the liver and spleen type gastric ulcer, duodenal ulcer, and chronic gastritis has special effect.Its prescription is formed and is met theory of Chinese medical science, determined curative effect, and no obvious adverse reaction, this prescription does not contain the toxicity medical material, does not also contain eighteen incompatible medicaments, nineteen medicaments of mutual restraint medical material.
2, the warming the stomach Shu Le sheet of the present invention's preparation, its dissolution and bioavailability are good than pill; Dosage is accurate, and tablet content content difference is less, steady quality.Tablet is a drying solid, and some easy oxidation deterioration and deliquescent effective ingredient can borrow sugar coating protect, and light, air, moisture are less to its influence; Take, carry, transportation etc. is more convenient; Can realize mechanization production, output is big, and cost is low, and sanitary standard reaches easily.
3, the present invention has kept in the medical material effective each effective ingredient of indication to greatest extent, and the rate of transform of each effective ingredient has reduced the leaching of invalid components simultaneously all more than 95%, has strengthened medication effect, has reduced production cost.
The specific embodiment
Embodiment 1
(1) gets by weight Radix Astragali 113g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 45g, Rhizoma Corydalis 45g, Radix Paeoniae Alba 113g, fevervine 113g, Pseudobulbus Bletillae (Rhizoma Bletillae) 113g, Fructus Amomi 6g, Galla Chinensis 6g, Cortex Cinnamomi 11g, Radix Salviae Miltiorrhizae 45g, Radix Glycyrrhizae 45g, Rhizoma Zingiberis Preparatum 45g;
(2) Cortex Cinnamomi described in the step (1), Fructus Amomi, fevervine and Rhizoma Zingiberis Preparatum are pulverized, excessively mixing behind 100 mesh sieves;
(3) with the Radix Astragali described in the step (1), Radix Campylotropis Hirtella (Herba Myrsines Africanae), Rhizoma Corydalis, the Radix Paeoniae Alba, Pseudobulbus Bletillae (Rhizoma Bletillae), Galla Chinensis, Radix Salviae Miltiorrhizae, Radix Glycyrrhizae eight flavor medical material decocte with water three times; The amount of water that decocts for the first time is 10 times of need decocting herbs gross weight; Decocting time is 1.5 hours, and the amount of water that decocts for the second time is 10 times of need decocting herbs gross weight, and decocting time is 1.5 hours; The amount of water that boils for the third time is 12 times of need decocting herbs gross weight; Decocting time is 1 hour, filters the back merging filtrate, and filtrate decompression is concentrated into the thick paste that relative density is 1.30 (60 ℃);
(4) medical material after sieving in the step (2) is added described in the step (3) in the thick paste, mix homogeneously is granulated, and is dry below 60 ℃, adds 0.5% the magnesium stearate of quality for dry back product quality, tabletting, and sugar coating obtains warming the stomach Shu Le sheet, the heavy 0.25g of every plain sheet.
Embodiment 2
Present embodiment is identical with the method for preparing of embodiment 1, and wherein difference is: used raw medicinal material is Radix Astragali 138g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 70g, Rhizoma Corydalis 70g, Radix Paeoniae Alba 138g, fevervine 138g, Pseudobulbus Bletillae (Rhizoma Bletillae) 138g, Fructus Amomi 8.5g, Galla Chinensis 8.5g, Cortex Cinnamomi 13.5g, Radix Salviae Miltiorrhizae 70g, Radix Glycyrrhizae 70g, Rhizoma Zingiberis Preparatum 70g.
Embodiment 3
Present embodiment is identical with the method for preparing of embodiment 1, and wherein difference is: used raw medicinal material is Radix Astragali 88g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 20g, Rhizoma Corydalis 20g, Radix Paeoniae Alba 88g, fevervine 88g, Pseudobulbus Bletillae (Rhizoma Bletillae) 88g, Fructus Amomi 3.5g, Galla Chinensis 3.5g, Cortex Cinnamomi 8.5g, Radix Salviae Miltiorrhizae 20g, Radix Glycyrrhizae 20g, Rhizoma Zingiberis Preparatum 20g.
Embodiment 4
Present embodiment is identical with the method for preparing of embodiment 1; Wherein difference is: used raw medicinal material is Radix Astragali 100g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 32g, Rhizoma Corydalis 32g, Radix Paeoniae Alba 100g; Fevervine 100g, Pseudobulbus Bletillae (Rhizoma Bletillae) 100g, Fructus Amomi 5g, Galla Chinensis 5g, Cortex Cinnamomi 10g, Radix Salviae Miltiorrhizae 32g, Radix Glycyrrhizae 32g, Rhizoma Zingiberis Preparatum 32g.
Embodiment 5
Present embodiment is identical with the method for preparing of embodiment 1; Wherein difference is: used raw medicinal material is Radix Astragali 126g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 58g, Rhizoma Corydalis 58g, Radix Paeoniae Alba 126g; Fevervine 126g, Pseudobulbus Bletillae (Rhizoma Bletillae) 126g, Fructus Amomi 7g, Galla Chinensis 7g, Cortex Cinnamomi 12g, Radix Salviae Miltiorrhizae 58g, Radix Glycyrrhizae 58g, Rhizoma Zingiberis Preparatum 58g.
Embodiment 6
(1) gets by weight Radix Astragali 88g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 20g, Rhizoma Corydalis 20g, Radix Paeoniae Alba 88g, fevervine 88g, Pseudobulbus Bletillae (Rhizoma Bletillae) 88g, Fructus Amomi 3.5g, Galla Chinensis 3.5g, Cortex Cinnamomi 8.5g, Radix Salviae Miltiorrhizae 20g, Radix Glycyrrhizae 20g, Rhizoma Zingiberis Preparatum 20g;
(2) Cortex Cinnamomi described in the step (1), Fructus Amomi, fevervine and Rhizoma Zingiberis Preparatum are pulverized, excessively mixing behind 100 mesh sieves;
(3) with the Radix Astragali described in the step (1), Radix Campylotropis Hirtella (Herba Myrsines Africanae), Rhizoma Corydalis, the Radix Paeoniae Alba, Pseudobulbus Bletillae (Rhizoma Bletillae), Galla Chinensis, Radix Salviae Miltiorrhizae, Radix Glycyrrhizae eight flavor medical material decocte with water three times; The amount of water that decocts for the first time is 12 times of need decocting herbs gross weight; Decocting time is 1.5 hours, and the amount of water that decocts for the second time is 8 times of need decocting herbs gross weight, and decocting time is 1.5 hours; The amount of water that boils for the third time is 8 times of need decocting herbs gross weight; Decocting time is 1 hour, filters the back merging filtrate, and filtrate decompression is concentrated into the thick paste that relative density is 1.30 (60 ℃);
(4) medical material after sieving in the step (2) is added described in the step (3) in the thick paste, mix homogeneously is granulated, and is dry below 60 ℃, adds 0.5% the magnesium stearate of quality for dry back product quality, tabletting, and sugar coating obtains warming the stomach Shu Le sheet, the heavy 0.25g of every plain sheet.
Embodiment 7
Present embodiment is identical with the method for preparing of embodiment 6, and wherein difference is: used raw medicinal material is Radix Astragali 138g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 70g, Rhizoma Corydalis 70g, Radix Paeoniae Alba 138g, fevervine 138g, Pseudobulbus Bletillae (Rhizoma Bletillae) 138g, Fructus Amomi 8.5g, Galla Chinensis 8.5g, Cortex Cinnamomi 13.5g, Radix Salviae Miltiorrhizae 70g, Radix Glycyrrhizae 70g, Rhizoma Zingiberis Preparatum 70g.
Embodiment 8
Present embodiment is identical with the method for preparing of embodiment 6, and wherein difference is: used raw medicinal material is Radix Astragali 113g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 45g, Rhizoma Corydalis 45g, Radix Paeoniae Alba 113g, fevervine 113g, Pseudobulbus Bletillae (Rhizoma Bletillae) 113g, Fructus Amomi 6g, Galla Chinensis 6g, Cortex Cinnamomi 11g, Radix Salviae Miltiorrhizae 45g, Radix Glycyrrhizae 45g, Rhizoma Zingiberis Preparatum 45g.
Embodiment 9
Present embodiment is identical with the method for preparing of embodiment 6; Wherein difference is: used raw medicinal material is Radix Astragali 100g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 32g, Rhizoma Corydalis 32g, Radix Paeoniae Alba 100g; Fevervine 100g, Pseudobulbus Bletillae (Rhizoma Bletillae) 100g, Fructus Amomi 5g, Galla Chinensis 5g, Cortex Cinnamomi 10g, Radix Salviae Miltiorrhizae 32g, Radix Glycyrrhizae 32g, Rhizoma Zingiberis Preparatum 32g.
Embodiment 10
Present embodiment is identical with the method for preparing of embodiment 6; Wherein difference is: used raw medicinal material is Radix Astragali 126g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 58g, Rhizoma Corydalis 58g, Radix Paeoniae Alba 126g; Fevervine 126g, Pseudobulbus Bletillae (Rhizoma Bletillae) 126g, Fructus Amomi 7g, Galla Chinensis 7g, Cortex Cinnamomi 12g, Radix Salviae Miltiorrhizae 58g, Radix Glycyrrhizae 58g, Rhizoma Zingiberis Preparatum 58g.
Embodiment 11
(1) gets by weight Radix Astragali 138g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 70g, Rhizoma Corydalis 70g, Radix Paeoniae Alba 138g, fevervine 138g, Pseudobulbus Bletillae (Rhizoma Bletillae) 138g, Fructus Amomi 8.5g, Galla Chinensis 8.5g, Cortex Cinnamomi 13.5g, Radix Salviae Miltiorrhizae 70g, Radix Glycyrrhizae 70g, Rhizoma Zingiberis Preparatum 70g;
(2) Cortex Cinnamomi described in the step (1), Fructus Amomi, fevervine and Rhizoma Zingiberis Preparatum are pulverized, excessively mixing behind 100 mesh sieves;
(3) with the Radix Astragali described in the step (1), Radix Campylotropis Hirtella (Herba Myrsines Africanae), Rhizoma Corydalis, the Radix Paeoniae Alba, Pseudobulbus Bletillae (Rhizoma Bletillae), Galla Chinensis, Radix Salviae Miltiorrhizae, Radix Glycyrrhizae eight flavor medical material decocte with water three times; The amount of water that decocts for the first time is 8 times of need decocting herbs gross weight; Decocting time is 1.5 hours, and the amount of water that decocts for the second time is 12 times of need decocting herbs gross weight, and decocting time is 1.5 hours; The amount of water that boils for the third time is 10 times of need decocting herbs gross weight; Decocting time is 1 hour, filters the back merging filtrate, and filtrate decompression is concentrated into the thick paste that relative density is 1.30 (60 ℃);
(4) medical material after sieving in the step (2) is added described in the step (3) in the thick paste, mix homogeneously is granulated, and is dry below 60 ℃, adds 0.5% the magnesium stearate of quality for dry back product quality, tabletting, and sugar coating obtains warming the stomach Shu Le sheet, the heavy 0.25g of every plain sheet.
Embodiment 12
Present embodiment is identical with the method for preparing of embodiment 11, and wherein difference is: used raw medicinal material is Radix Astragali 88g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 20g, Rhizoma Corydalis 20g, Radix Paeoniae Alba 88g, fevervine 88g, Pseudobulbus Bletillae (Rhizoma Bletillae) 88g, Fructus Amomi 3.5g, Galla Chinensis 3.5g, Cortex Cinnamomi 8.5g, Radix Salviae Miltiorrhizae 20g, Radix Glycyrrhizae 20g, Rhizoma Zingiberis Preparatum 20g.
Embodiment 13
Present embodiment is identical with the method for preparing of embodiment 11, and wherein difference is: used raw medicinal material is Radix Astragali 113g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 45g, Rhizoma Corydalis 45g, Radix Paeoniae Alba 113g, fevervine 113g, Pseudobulbus Bletillae (Rhizoma Bletillae) 113g, Fructus Amomi 6g, Galla Chinensis 6g, Cortex Cinnamomi 11g, Radix Salviae Miltiorrhizae 45g, Radix Glycyrrhizae 45g, Rhizoma Zingiberis Preparatum 45g.
Embodiment 14
Present embodiment is identical with the method for preparing of embodiment 11; Wherein difference is: used raw medicinal material is Radix Astragali 100g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 32g, Rhizoma Corydalis 32g, Radix Paeoniae Alba 100g; Fevervine 100g, Pseudobulbus Bletillae (Rhizoma Bletillae) 100g, Fructus Amomi 5g, Galla Chinensis 5g, Cortex Cinnamomi 10g, Radix Salviae Miltiorrhizae 32g, Radix Glycyrrhizae 32g, Rhizoma Zingiberis Preparatum 32g.
Embodiment 15
Present embodiment is identical with the method for preparing of embodiment 11; Wherein difference is: used raw medicinal material is Radix Astragali 126g, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 58g, Rhizoma Corydalis 58g, Radix Paeoniae Alba 126g; Fevervine 126g, Pseudobulbus Bletillae (Rhizoma Bletillae) 126g, Fructus Amomi 7g, Galla Chinensis 7g, Cortex Cinnamomi 12g, Radix Salviae Miltiorrhizae 58g, Radix Glycyrrhizae 58g, Rhizoma Zingiberis Preparatum 58g.
The usage and dosage of warming the stomach Shu Le sheet: oral, one time 5,3 times on the one.
The warming the stomach Shu Le sheet of the present invention's preparation through long-term clinical, has carried out clinical observation to 182 routine Deficiency and coldness of spleen and stomach and incoordination between the liver and spleen type gastric ulcer, 180 routine duodenal ulcers and 178 routine chronic gastritis patients; Oral, one time 5,3 times on the one; Around taking altogether, clinical obvious effective rate is respectively 78.57%, 77.22% and 78.65%, and total effective rate is respectively 96.70%, 97.25% and 95.51%; The patient takes none example of back has obvious adverse reaction; Having clear improvement with back patient's body constitution, is comparatively ideal at present treatment gastric ulcer, the pure Chinese medicinal preparation of duodenal ulcer and chronic gastritis.Efficacy assessment standard is with reference to " new Chinese medicine clinical research indication principle ", Chinese Medicine science and technology publishing house, version execution in 2002.
The present invention has carried out acute toxicity test: get mice, also do not cause death with the heavy dose of clothes of irritating of these article.Through the maximum resistance test of acute toxicity, day maximum tolerated dose of this medicine mouse stomach administration be equivalent to be grown up 492 times of clinical day dose.After observing end, put to death animal and perform an autopsy on sb, main organs no abnormality seen situation shows that warming the stomach Shu Le sheet toxicity is extremely low as a result.
The present invention has also carried out chronic toxicity test: get three groups of rats; It is the blank group; The large and small dose groups of warming the stomach Shu Le sheet, blank group are irritated the stomach ordinary water, and the large and small dose groups of warming the stomach Shu Le sheet is irritated stomach dosage every day and is respectively 150 times, 100 times of clinical Coming-of-Age Day consumption; Once a day, successive administration is six months.The result shows: the body weight of each administration treated animal, activity, hair, feces, hematological examination, hepatic and renal function inspection are compared there was no significant difference with the blank group; Parenchymal visceras such as the administration treated animal heart, liver, kidney, lung, gross necropsy is not seen abnormal phenomenas such as hyperemia, edema, dirty body ratio, pathology sheet and blank group be there was no significant difference relatively.Show warming the stomach Shu Le sheet to the above-mentioned dosage of rat, gastric infusion six months was safe continuously.
Long-term stable experiment shows that the warming the stomach Shu Le sheet of the present invention's preparation is pressed commercially available back; Under normal temperature condition, stored 24 months; Each item test rating and the preceding more equal no significant difference of test, each item index all meets national statutory standards, explains that these article have good stability.
In sum, the present invention combines the etiology and pathogenesis and the Therapeutic Principle of the traditional Chinese medical science, proves through long-term clinical practice, and its prescription is superior to other prescription, and its production technology is best production technology.The warming the stomach Shu Le sheet of the present invention's preparation has warming middle-Jiao and tonifying deficiency, regulating the liver and spleen, promoting flow of QI and blood, the effect of pain relieving granulation promoting.To Deficiency and coldness of spleen and stomach and incoordination between the liver and spleen type gastric ulcer, duodenal ulcer, chronic gastritis has special effect, is worth in clinical, applying.

Claims (3)

1. the method for preparing of a warming the stomach Shu Le sheet is characterized in that, this method may further comprise the steps:
(1) gets by weight Radix Astragali 88-138 part, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 20-70 part, Rhizoma Corydalis 20-70 part; Radix Paeoniae Alba 88-138 part, fevervine 88-138 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 88-138 part; Fructus Amomi 3.5-8.5 part, Galla Chinensis 3.5-8.5 part, Cortex Cinnamomi 8.5-13.5 part; Radix Salviae Miltiorrhizae 20-70 part, Radix Glycyrrhizae 20-70 part, Rhizoma Zingiberis Preparatum 20-70 part;
(2) Cortex Cinnamomi described in the step (1), Fructus Amomi, fevervine and Rhizoma Zingiberis Preparatum are pulverized, excessively mixing behind 100 mesh sieves;
(3) with the Radix Astragali described in the step (1), Radix Campylotropis Hirtella (Herba Myrsines Africanae), Rhizoma Corydalis, the Radix Paeoniae Alba, Pseudobulbus Bletillae (Rhizoma Bletillae), Galla Chinensis, Radix Salviae Miltiorrhizae and Radix Glycyrrhizae eight flavor medical material decocte with water three times; The amount of water that decocts for the first time is 10 times of need decocting herbs gross weight; Decocting time is 1.5 hours, and the amount of water that decocts for the second time is 10 times of need decocting herbs gross weight, and decocting time is 1.5 hours; The amount of water that decocts for the third time is 12 times of need decocting herbs gross weight; Decocting time is 1 hour, filters the back merging filtrate, and being evaporated to 60 ℃, to record relative density be 1.30 thick paste;
(4) medical material after sieving in the step (2) is added described in the step (3) in the thick paste, mix homogeneously is granulated, and is dry below 60 ℃, adds 0.5% the magnesium stearate of quality for dry back product quality, tabletting, and sugar coating obtains warming the stomach Shu Le sheet.
2. the method for preparing of a kind of warming the stomach Shu Le sheet according to claim 1 is characterized in that, the medical material of respectively distinguishing the flavor of described in the step (1) is counted by weight: Radix Astragali 100-126 part, Radix Campylotropis Hirtella (Herba Myrsines Africanae) 32-58 part; Rhizoma Corydalis 32-58 part, Radix Paeoniae Alba 100-126 part, fevervine 100-126 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 100-126 part; Fructus Amomi 5-7 part, Galla Chinensis 5-7 part, Cortex Cinnamomi 10-12 part; Radix Salviae Miltiorrhizae 32-58 part, Radix Glycyrrhizae 32-58 part, Rhizoma Zingiberis Preparatum 32-58 part.
3. the method for preparing of a kind of warming the stomach Shu Le sheet according to claim 2 is characterized in that, the said medical material of respectively distinguishing the flavor of is counted by weight: 113 parts of the Radixs Astragali, 45 parts of Radix Campylotropis Hirtella (Herba Myrsines Africanae)s; 45 parts of Rhizoma Corydalis, 113 parts of the Radix Paeoniae Albas, 113 parts of fevervines, 113 parts of Pseudobulbus Bletillae (Rhizoma Bletillae); 6 parts of Fructus Amomis, 6 parts of Galla Chinensiss, 11 parts of Cortex Cinnamomis; 45 parts of Radix Salviae Miltiorrhizaes, 45 parts in Radix Glycyrrhizae, 45 parts of Rhizoma Zingiberis Preparatums.
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