CN102293995A - Spleen-invigorating the qi-replenishing particle and preparation method thereof - Google Patents
Spleen-invigorating the qi-replenishing particle and preparation method thereof Download PDFInfo
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Abstract
A spleen-invigorating the qi-replenishing particle and a preparation method thereof of the invention relate to a composition which is mainly from plants and a preparation method thereof. The purpose is to provide a spleen-invigorating the qi-replenishing particle with good solubility, good solution appearance, and good taste and smell, and a preparation method thereof. The spleen-invigorating the qi-replenishing particle of the invention comprises raw material drugs and auxiliary materials with a mass ratio of (4:1)-(6:1), wherein the raw material drugs comprise the following components by mass: 18-22 parts of mix-fried astragalus; 5-6.5 parts of radix codonopsis; 9-11 parts of mix-fried licorice; 5-6.5 parts of angelica; 5-6.5 parts of fried atractylodes; 5-6.5 parts of cimicifuga foetida; 5-6.5 parts of radix bupleuri; 5-6.5 parts of tangerine peel; 1.5-2.5 parts of ginger; 3.5-4.5 parts of jujube; the auxiliary materials comprise lactose and dextrin, wherein lactose accounts for 50%-90% of the total mass of the auxiliary materials, and the balance of dextrin; or in the auxiliary materials, lactose is used instead of lactose and dextrin.
Description
Technical field
The present invention relates to a kind of composition and method of making the same that mainly comes from plant.
Background technology
Invigorating the spleen and replenishing QI granule prescription is taken from the permanent BUZHONG YIQI TANG of creating (this side head is stated from " Treatise on the spleen and stomach ") in gold dollar Lee in period east.This product is made up of the Radix Astragali, Radix Codonopsis, Radix Glycyrrhizae, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Pericarpium Citri Reticulatae, Rhizoma Cimicifugae, Radix Bupleuri, Rhizoma Zingiberis, Fructus Jujubae.Wherein Radix Astragali QI invigorating is monarch, and the Radix Glycyrrhizae invigorating middle warmer is a minister, Rhizoma Atractylodis Macrocephalae spleen invigorating, and the Radix Angelicae Sinensis invigorating middle warmer, the Pericarpium Citri Reticulatae QI invigorating is adjuvant drug, and Rhizoma Cimicifugae, Radix Bupleuri are lifted living clear sun and are made for drawing.This product is widely used in clinical inside and outside, woman, each section of youngster, has invigorating the spleen and replenishing QI, the effect of ascending up spleen-Qi and Yang.Be used for the treatment of weakness of the spleen and stomach, sinking of QI of middle-JIAO, fatigue and asthenia, lack of appetite abdominal distention, chronic diarrhea, proctoptosis and uterine prolapse, evident in efficacy, several having no side effect.
Yet, find that in production practices for many years the invigorating the spleen and replenishing QI granule is only granulated with a kind of adjuvant of dextrin, the granule melting, solution appearance, mouthfeel and the abnormal smells from the patient that make are all bad, have influenced patient's compliance to a certain extent.
Summary of the invention
Invigorating the spleen and replenishing QI granule that the technical problem to be solved in the present invention provides that a kind of melting is good, solution appearance is good, mouthfeel and abnormal smells from the patient are good and preparation method thereof.
A kind of invigorating the spleen and replenishing QI granule comprises that mass ratio is the crude drug and the adjuvant of (4: 1)-(6: 1), and wherein: crude drug is made up of the following component by mass parts:
Adjuvant is made up of lactose and dextrin, and lactose accounts for the 50%-90% of adjuvant gross mass, and all the other are dextrin.
The preferred percent that invigorating the spleen and replenishing QI granule of the present invention, wherein said lactose account for the adjuvant gross mass is 50%.
Invigorating the spleen and replenishing QI granule of the present invention, wherein said adjuvant substitutes lactose and dextrin with lactose.
Invigorating the spleen and replenishing QI granule of the present invention, the preferred mass ratio of wherein said crude drug and adjuvant is 5: 1.
Invigorating the spleen and replenishing QI granule of the present invention, the optimum ratio of wherein said crude drug is made up of the following component by mass parts:
The particulate method of the above-mentioned invigorating the spleen and replenishing QI of a kind of preparation may further comprise the steps:
1) crude drug Radix Astragali Preparata, Radix Codonopsis, Radix Glycyrrhizae Preparata, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae (parched), Rhizoma Cimicifugae, Radix Bupleuri, Pericarpium Citri Reticulatae, Rhizoma Zingiberis Recens, Fructus Jujubae are mixed, add its quality 8-10 decocting doubly at every turn and boil, decoct altogether twice: decocted 90-150 minute for the first time, leach decocting liquid; Decocted 40-80 minute for the second time, leach decocting liquid; Collecting decoction leaves standstill, and filters, and it is 1.0-1.3 that filtrate decompression is concentrated into relative density, and temperature is 80 ℃ when measuring relative density, puts and is chilled to 20-30 ℃, obtains concentrated filtrate I;
2) in concentrated filtrate I, add equate with its quality, percentage by volume is 95% ethanol water, stirs, left standstill 24 hours, filter, it is 1.0-1.3 that the gained filtrate decompression is concentrated into relative density, and temperature is 70 ℃ when measuring relative density, obtains concentrated filtrate II;
3) concentrated filtrate II is carried out spray drying according to following condition, obtain dry powder: 180 ℃ of inlet temperature, leaving air temp 85-90 ℃, advance amount of liquid medicine 30-40kg/ hour, evaporated water 20-30kg/ hour, nebulizer 8000-10000 rev/min.
4) in above-mentioned dry powder, add adjuvant, dry granulation; Carry out the medicine grain aluminum-plastic packaged again.
The present invention prepares the particulate method of above-mentioned invigorating the spleen and replenishing QI, and it is the 3g/ bag that wherein said medicine grain carries out when aluminum-plastic packaged.
Relative density of the present invention is to use gravimeter to measure.
Invigorating the spleen and replenishing QI granule that invigorating the spleen and replenishing QI granule of the present invention and preparation method thereof provides that a kind of melting is good, solution appearance is good, mouthfeel and abnormal smells from the patient are good and preparation method thereof.
The specific embodiment
Embodiment 1
1) crude drug Radix Astragali Preparata 180g, Radix Codonopsis 50g, Radix Glycyrrhizae Preparata 90g, Radix Angelicae Sinensis 50g, Rhizoma Atractylodis Macrocephalae (parched) 50g, Rhizoma Cimicifugae 50g, Radix Bupleuri 50g, Pericarpium Citri Reticulatae 50g, Rhizoma Zingiberis Recens 15g, Fructus Jujubae 35g are mixed, each decocting that adds quality 5kg boils, decoct altogether twice: decocted 90 minutes for the first time, leach decocting liquid; Decocted 40 minutes for the second time, leach decocting liquid; Collecting decoction leaves standstill, and filters, and it is 1.0 that filtrate decompression is concentrated into relative density, and temperature is 80 ℃ when measuring relative density, puts and is chilled to 20 ℃, obtains concentrated filtrate I;
2) in concentrated filtrate I, add equate with its quality, percentage by volume is 95% ethanol water, stirs, left standstill 24 hours, filter, it is 1.0 that the gained filtrate decompression is concentrated into relative density, and temperature is 70 ℃ when measuring relative density, obtains concentrated filtrate II;
3) concentrated filtrate II is carried out spray drying according to following condition: 180 ℃ of inlet temperature, leaving air temp 85-90 ℃, advance 8000 rev/mins in amount of liquid medicine 30kg/ hour, evaporated water 20kg/ hour, nebulizer; Obtain dry powder 155g.
4) in above-mentioned dry powder, add dextrin 53g, lactose 53g, dry granulation; The medicine grain is carried out aluminum-plastic packagedly, the 3g/ bag obtains 87 bags again.
Embodiment 2
1) crude drug Radix Astragali Preparata 220g, Radix Codonopsis 64g, Radix Glycyrrhizae Preparata 110g, Radix Angelicae Sinensis 65g, Rhizoma Atractylodis Macrocephalae (parched) 65g, Rhizoma Cimicifugae 65g, Radix Bupleuri 65g, Pericarpium Citri Reticulatae 65g, Rhizoma Zingiberis Recens 25g, Fructus Jujubae 45g are mixed, each decocting that adds quality 7.9kg boils, decoct altogether twice: decocted 150 minutes for the first time, leach decocting liquid; Decocted 80 minutes for the second time, leach decocting liquid; Collecting decoction leaves standstill, and filters, and it is 1.3 that filtrate decompression is concentrated into relative density, and temperature is 80 ℃ when measuring relative density, puts and is chilled to 30 ℃, obtains concentrated filtrate I;
2) in concentrated filtrate I, add equate with its quality, percentage by volume is 95% ethanol water, stirs, left standstill 24 hours, filter, it is 1.0 that the gained filtrate decompression is concentrated into relative density, and temperature is 70 ℃ when measuring relative density, obtains concentrated filtrate II;
3) concentrated filtrate II is carried out spray drying according to following condition: 180 ℃ of inlet temperature, leaving air temp 85-90 ℃, advance 10000 rev/mins in amount of liquid medicine 40kg/ hour, evaporated water 30kg/ hour, nebulizer; Obtain dry powder 198g.
4) in above-mentioned dry powder, add dextrin 20g and lactose 177.5g, dry granulation; The medicine grain is carried out aluminum-plastic packagedly, the 3g/ bag obtains 132 bags again.
Embodiment 3
1) crude drug Radix Astragali Preparata 200g, Radix Codonopsis 60g, Radix Glycyrrhizae Preparata 100g, Radix Angelicae Sinensis 60g, Rhizoma Atractylodis Macrocephalae (parched) 60g, Rhizoma Cimicifugae 60g, Radix Bupleuri 60g, Pericarpium Citri Reticulatae 60g, Rhizoma Zingiberis Recens 20g, Fructus Jujubae 40g are mixed, each decocting that adds quality 6.5kg boils, decoct altogether twice: decocted 120 minutes for the first time, leach decocting liquid; Decocted 60 minutes for the second time, leach decocting liquid; Collecting decoction leaves standstill, and filters, and it is 11 that filtrate decompression is concentrated into relative density, and temperature is 80 ℃ when measuring relative density, puts and is chilled to 25 ℃, obtains concentrated filtrate I;
2) in concentrated filtrate I, add equate with its quality, percentage by volume is 95% ethanol water, stirs, left standstill 24 hours, filter, it is 1.0 that the gained filtrate decompression is concentrated into relative density, and temperature is 70 ℃ when measuring relative density, obtains concentrated filtrate II;
3) concentrated filtrate II is carried out spray drying according to following condition: 180 ℃ of inlet temperature, leaving air temp 85-90 ℃, advance 10000 rev/mins in amount of liquid medicine 40kg/ hour, evaporated water 30kg/ hour, nebulizer; Obtain dry powder 180g;
4) in above-mentioned dry powder, add dextrin 44g and lactose 100g, dry granulation; The medicine grain is carried out aluminum-plastic packagedly, the 3g/ bag obtains 108 bags again.
Experimental example 4
The production scale of step 1-3 among the embodiment 3 is made corresponding change in proportion, and all working conditions remain unchanged.
1) crude drug Radix Astragali Preparata 1008.3g, Radix Codonopsis 302.5g, Radix Glycyrrhizae Preparata 504.2g, Radix Angelicae Sinensis 302.5g, Rhizoma Atractylodis Macrocephalae (parched) 302.5g, Rhizoma Cimicifugae 302.5g, Radix Bupleuri 302.5g, Pericarpium Citri Reticulatae 302.5g, Rhizoma Zingiberis Recens 100.8g, Fructus Jujubae 201.6g are mixed, each decocting that adds quality 32.8kg boils, decoct altogether twice: decocted 120 minutes for the first time, leach decocting liquid; Decocted 60 minutes for the second time, leach decocting liquid; Collecting decoction leaves standstill, and filters, and it is 11 that filtrate decompression is concentrated into relative density, and temperature is 80 ℃ when measuring relative density, puts and is chilled to 25 ℃, obtains concentrated filtrate I;
2) in concentrated filtrate I, add equate with its quality, percentage by volume is 95% ethanol water, stirs, left standstill 24 hours, filter, it is 1.0 that the gained filtrate decompression is concentrated into relative density, and temperature is 70 ℃ when measuring relative density, obtains concentrated filtrate II;
3) concentrated filtrate II is carried out spray drying according to following condition: 180 ℃ of inlet temperature, leaving air temp 85-90 ℃, advance 10000 rev/mins in amount of liquid medicine 40kg/ hour, evaporated water 30kg/ hour, nebulizer; Obtain dry powder 907.5g;
4) dry powder is divided into 11 parts, every part of 82.5g, every part adds dextrin and lactose amounts to 67.5g, the ratio that adds dextrin and lactose mass parts in 11 parts of dry powder respectively is 1: 9,2: 8,3: 7,4: 6,5: 5,6: 4:, 7: 3,8: 2,9: 1,10: 0 (using dextrin entirely), 0: 10 (being lactose entirely), dry granulation, every bag 3 the gram, aluminum-plastic packaged, promptly get the 1-11 that writes out a prescription sample each 50 bags.
Evaluation methodology: with scoring assess sample melting and solution appearance, mouthfeel and abnormal smells from the patient (evaluation criterion sees Table 1).Form 5 people and appraise group through discussion, everyone marks according to standard, and the mark addition that 5 people are provided is as the reciprocal fraction of melting and solution appearance, mouthfeel and abnormal smells from the patient, with two mark additions, as the total points of prescription or sample correspondence.The results are shown in Table 2.
Table 1 melting and solution appearance, mouthfeel and abnormal smells from the patient evaluation criterion
| Melting and solution appearance | Mouthfeel and abnormal smells from the patient |
| 5 minutes: granule all dissolved rapidly, did not have muddiness, was the entire body uniform liquid. | 5 minutes: little sweet, there are not other bad smells. |
| 4 minutes: the granule off-bottom, do not have muddy. | 4 minutes: little sweet, little puckery. |
| 3 minutes: granule slowly dissolved, and the surface is white foam slightly. | 3 minutes: little sweet, puckery, abnormal smells from the patient was light. |
| 2 minutes: granule dissolved within 5min substantially, and slight haze is arranged, surperficial adularescent foam. | 2 minutes: little hardship, puckery, abnormal smells from the patient was light. |
| 1 minute: particulate fraction dissolved, and was suspendible shape solution, surperficial adularescent foam. | 1 minute: bitter, puckery, abnormal smells from the patient was light. |
Table 2 prescription screening result
Above prescription screening result shows, when dextrin and lactose by 0: 10-5: when 5 mixed are used, particulate abnormal smells from the patient and mouthfeel, melting and solution appearance are all relatively good.But consider cost factor (usually: the price of lactose is more than 2 times of dextrin), 2 the prescription chambers of experimentizing checkings selecting dextrin and lactose ratio to be respectively 4: 6 and 5: 5 are studied.
Experimental example 5
The production scale of step 1-3 among the embodiment 4 is made corresponding change, and all working conditions remain unchanged.
1) crude drug Radix Astragali Preparata 1833.3g, Radix Codonopsis 550g, Radix Glycyrrhizae Preparata 916.7g, Radix Angelicae Sinensis 550g, Rhizoma Atractylodis Macrocephalae (parched) 550g, Rhizoma Cimicifugae 550g, Radix Bupleuri 550g, Pericarpium Citri Reticulatae 550g, Rhizoma Zingiberis Recens 183.3g, Fructus Jujubae 366.5g are mixed, each decocting that adds quality 59.4kg boils, decoct altogether twice: decocted 120 minutes for the first time, leach decocting liquid; Decocted 60 minutes for the second time, leach decocting liquid; Collecting decoction leaves standstill, and filters, and it is 11 that filtrate decompression is concentrated into relative density, and temperature is 80 ℃ when measuring relative density, puts and is chilled to 25 ℃, obtains concentrated filtrate I;
2) in concentrated filtrate I, add equate with its quality, percentage by volume is 95% ethanol water, stirs, left standstill 24 hours, filter, it is 1.0 that the gained filtrate decompression is concentrated into relative density, and temperature is 70 ℃ when measuring relative density, obtains concentrated filtrate II;
3) concentrated filtrate II is carried out spray drying according to following condition: 180 ℃ of inlet temperature, leaving air temp 85-90 ℃, advance 10000 rev/mins in amount of liquid medicine 40kg/ hour, evaporated water 30kg/ hour, nebulizer; Obtain dry powder 1650g;
4) dry powder is divided into 2 parts, every part of 825g, every part adds dextrin and lactose amounts to 675g, and the mass ratio that adds dextrin and lactose in 2 parts of dry powder respectively is 4: 6,5: 5, dry granulation, every bag 3 gram, aluminum-plastic packaged, promptly get respectively 500 bags in sample 1 and sample 2.According to the evaluation methodology among the embodiment 4 is the sample scoring, the results are shown in Table 3.
Table 3 laboratory proofing result
Above laboratory proofing result shows, when production scale being extended to 10 times of embodiment 4, dextrin and lactose be when mixed was used by 5: 5, and particulate mouthfeel and abnormal smells from the patient are basic identical when melting and solution appearance and 4: 6 mixed.Consider from the angle of saving cost, select the prescription of 5: 5 ratios to produce checking research in batches.
Experimental example 6
Choose and state the dextrin that laboratory proofing obtains: the mass ratio of lactose is 5: 5 a prescription, and according to embodiment 5 described methods, scale is made corresponding adjustment, and all working conditions remain unchanged, and prepare 3 batch samples, 30,000 bags every batch (every packed 3 grams).Estimate the melting and the solution appearance of gained sample with the evaluation methodology among the embodiment 4, mouthfeel and abnormal smells from the patient, and compare with the batch process product that does not add lactose, the results are shown in Table 4.
Table 4 is produced the checking result in batches
More than the result of Pi Liangshengchaning further shows, the melting of product behind the increase lactose in the former prescription, solution appearance, aspects such as mouthfeel and abnormal smells from the patient all have clear improvement than the original product that does not add lactose, and prompting adding lactose can significantly improve the patient and use the particulate compliance of invigorating the spleen and replenishing QI.
Experimental example 7
3 batch samples that experimental example 6 is made are carried out aluminum-plastic packaged, put shady and cool dry place and deposit 36 months, carry out study on the stability according to invigorating the spleen and replenishing QI granular mass standard WS3-224 (Z-224)-2003 (Z), and compare with the original product that does not add lactose.Table 5 is the experimental result of three batches of products, and the result is the arithmetic mean of instantaneous value of three batches of products.
Table 5 study on the stability result
+: up to specification or identical with the quality standard regulation.
Wherein, discriminating 1 and discriminating 2 are meant the discriminating 1 among the invigorating the spleen and replenishing QI granular mass standard WS3-224 (Z-224)-2003 (Z) and differentiate 2.
From above long-time stability investigation result, adding 3 batch samples of producing behind an amount of lactose and the original product that does not add lactose production in former prescription is not having significant change qualitatively, and deposits maintenance in 36 months and stablize under the condition of storage of regulation.
Above-described embodiment is described preferred implementation of the present invention; be not that scope of the present invention is limited; design under the prerequisite of spirit not breaking away from the present invention; various distortion and improvement that those of ordinary skills make technical scheme of the present invention all should fall in the definite protection domain of claims of the present invention.
Claims (7)
1. an invigorating the spleen and replenishing QI granule is characterized in that: comprise that mass ratio is the crude drug and the adjuvant of (4: 1)-(6: 1);
Wherein: crude drug is made up of the following component by mass parts:
Adjuvant is made up of lactose and dextrin, and lactose accounts for the 50%-90% of adjuvant gross mass, and all the other are dextrin.
2. invigorating the spleen and replenishing QI granule according to claim 1 is characterized in that: the preferred percent that described lactose accounts for the adjuvant gross mass is 50%.
3. invigorating the spleen and replenishing QI granule according to claim 1 is characterized in that: described adjuvant substitutes lactose and dextrin with lactose.
4. according to claim 2 or 3 described invigorating the spleen and replenishing QI granules, it is characterized in that: the preferred mass ratio of described crude drug and adjuvant is 5: 1.
5. invigorating the spleen and replenishing QI granule according to claim 4, the optimum ratio of wherein said crude drug by by mass parts following component is formed:
6. one kind prepares the particulate method of above-mentioned invigorating the spleen and replenishing QI, it is characterized in that may further comprise the steps:
1) crude drug Radix Astragali Preparata, Radix Codonopsis, Radix Glycyrrhizae Preparata, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae (parched), Rhizoma Cimicifugae, Radix Bupleuri, Pericarpium Citri Reticulatae, Rhizoma Zingiberis Recens, Fructus Jujubae are mixed, add its quality 8-10 decocting doubly at every turn and boil, decoct altogether twice: decocted 90-150 minute for the first time, leach decocting liquid; Decocted 40-80 minute for the second time, leach decocting liquid; Collecting decoction leaves standstill, and filters, and it is 1.0-1.3 that filtrate decompression is concentrated into relative density, and temperature is 80 ℃ when measuring relative density, puts and is chilled to 20-30 ℃, obtains concentrated filtrate I;
2) in concentrated filtrate I, add equate with its quality, percentage by volume is 95% ethanol water, stirs, left standstill 24 hours, filter, it is 1.0-1.3 that the gained filtrate decompression is concentrated into relative density, and temperature is 70 ℃ when measuring relative density, obtains concentrated filtrate II;
3) concentrated filtrate II is carried out spray drying according to following condition, obtain dry powder: 180 ℃ of inlet temperature, leaving air temp 85-90 ℃, advance amount of liquid medicine 30-40kg/ hour, evaporated water 20-30kg/ hour, nebulizer 8000-10000 rev/min;
4) in above-mentioned dry powder, add adjuvant, dry granulation; Carry out the medicine grain aluminum-plastic packaged again.
7. the particulate method of the above-mentioned invigorating the spleen and replenishing QI of preparation according to claim 6 is characterized in that: it is the 3g/ bag that described medicine grain carries out when aluminum-plastic packaged.
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| CN103535825A (en) * | 2013-10-10 | 2014-01-29 | 荣成宏业实业有限公司 | Tumor postoperation healthy drink prepared by utilizing enzymolysis for extracting scallop glycoprotein |
| CN104257975A (en) * | 2014-10-13 | 2015-01-07 | 张洪涛 | Chinese herbal medicine for treating vagina or uterine prolapse of breeding cows |
| CN104381543A (en) * | 2014-12-02 | 2015-03-04 | 鲍显诵 | Tea with functions of raising yang and consolidating foundation |
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| CN102935219A (en) * | 2012-12-05 | 2013-02-20 | 中国科学院昆明植物研究所 | Traditional Chinese medicine or food for four-season regulating and nourishing as well as preparation method and application thereof |
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| CN103535825B (en) * | 2013-10-10 | 2015-05-20 | 荣成宏业实业有限公司 | Tumor postoperation healthy drink prepared by utilizing enzymolysis for extracting scallop glycoprotein |
| CN104257975A (en) * | 2014-10-13 | 2015-01-07 | 张洪涛 | Chinese herbal medicine for treating vagina or uterine prolapse of breeding cows |
| CN104381543A (en) * | 2014-12-02 | 2015-03-04 | 鲍显诵 | Tea with functions of raising yang and consolidating foundation |
| CN104958509A (en) * | 2015-07-31 | 2015-10-07 | 苏州法莫生物技术有限公司 | Traditional Chinese medicine composition |
| CN104984013A (en) * | 2015-07-31 | 2015-10-21 | 苏州法莫生物技术有限公司 | Traditional Chinese medicinal composition for treating spleen deficiency diarrhea |
| CN104984012A (en) * | 2015-07-31 | 2015-10-21 | 苏州法莫生物技术有限公司 | Traditional Chinese medicinal prescription for treating spleen deficiency diarrhea |
| CN105056092A (en) * | 2015-08-21 | 2015-11-18 | 北京汉典制药有限公司 | Preparation method of ginseng, poria cocos and white atractylodes rhizome granules and prepared ginseng, poria cocos and white atractylodes rhizome granules |
| CN105056092B (en) * | 2015-08-21 | 2019-05-03 | 北京汉典制药有限公司 | A kind of preparation method of granule containing ginseng, Siberian cocklebur, lagehead atractylodes and its granule containing ginseng, Siberian cocklebur, lagehead atractylodes of preparation |
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