CN103055128A - Preparation process of stomach invigorating and digestion helping tablet - Google Patents
Preparation process of stomach invigorating and digestion helping tablet Download PDFInfo
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- CN103055128A CN103055128A CN2013100393129A CN201310039312A CN103055128A CN 103055128 A CN103055128 A CN 103055128A CN 2013100393129 A CN2013100393129 A CN 2013100393129A CN 201310039312 A CN201310039312 A CN 201310039312A CN 103055128 A CN103055128 A CN 103055128A
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Abstract
The invention relates to a preparation process of a stomach invigorating and digestion helping tablet. The preparation process comprises the following steps of: extracting tangerine peel by using 75% ethanol, replacing half-quantity extraction of radix pseudostellariae and Chinese yam by combined extraction of full-quantity medicinal materials and other medicinal materials, further pelletizing by taking extractum as an adhesive through a one-step pelletizing technology, mixing and tabletting. According to the preparation process of the stomach invigorating and digestion helping tablet, the stomach invigorating and digestion helping tablet is prepared by carrying out full-quantity medicinal material extraction on the Chinese yam and the radix pseudostellariae and alcohol extraction on the tangerine peel, and the disadvantages of products produced by using the original processes are effectively avoided; effective constituents of the stomach invigorating and digestion helping tablet are easily absorbed and utilized by human bodies; the microbial limit standard exceeding problem of a finished product is effectively avoided, and the mouth feel of the stomach invigorating and digestion helping tablet is improved; by adopting the extraction by using the 75% ethanol, the content of aurantiamarin is nearly doubled or more, so that the content of the aurantiamarin which is a functional constituent in the preparation and the treatment effect of the tablet are substantially improved; all the medicinal materials are prepared into the extractum and pelletized by spraying, the fluidity of prepared particles is good, the appearance of the tablet is neat, the uniformly pressed tablet surface is uniform in color and luster and free of pocking marks and colored patches, and the appearance quality of the tablet is improved; and the quality is stable.
Description
Technical field
The present invention relates to a kind of preparation technology of JIANWEI XIAOSHI PIAN, belong to the medicine preparation field.
Background technology
At present, people more and more are concerned about for the health of oneself, some little slight illness also enter people's visual line of sight gradually, " dyspepsia " this noun has progressed into people's life, the advertisement of relevant " dyspepsia " emerges in an endless stream TV, man who brings news of appointment, especially appears at people at the moment for what child's dyspeptic advertisement was covered the sky and the earth especially, and the child is because taste zoon not yet, dyspeptic sickness rate is higher than other crowds, and cardinal symptom is particular about food, anorexia.On the one hand, the child is in the stage of growing up, and the head of a family worries that dyspepsia can affect its growth promoter, solves dyspeptic demand more urgent.And on the other hand, the head of a family worries that again the medicine toxic and side effects can hurt the healthy of child, and very careful on medication is selected, it is not excessive to be would rather be scarce.Therefore, a lot of heads of a family are because can not find suitable medicine, and adopt the solutions such as some earthwork among the people, dietetic therapy more, finally cause child market sickness rate high, and demand is the most urgent, but the low vicious circle of medication rate." JIANWEI XIAOSHI PIAN " compared with motilium, digestive enzyme, and JIANWEI XIAOSHI PIAN is " Chinese patent medicine ", and composition is by " integration of edible and medicinal herbs " drug matching of Ministry of Public Health approval, safe without toxic side effect.In the composition of this medicine, Fructus Crataegi, Fructus Hordei Germinatus are the dyspepsia and intestinal stasis relieving medicine, and Radix Pseudostellariae, Rhizoma Dioscoreae are the stomach invigorating resistance and supplementing qi medicine, and Pericarpium Citri Reticulatae is the intestinal stasis relieving medicine of regulating the flow of vital energy.And compare with motilium, JIANWEI XIAOSHI PIAN and digestive enzyme are " chewable tablet ", instant edible.
" the invigorating the stomach and promoting digestion tablet recipe that text of Chinese pharmacopoeia version in 2010 is included: Pericarpium Citri Reticulatae 6.87kg, Fructus Hordei Germinatus (stir-fry) 51.42kg, Fructus Crataegi 34.29kg, Radix Pseudostellariae 34.29kg.Method for making: the above five tastes, get crown prince's half-and-half amount and Rhizoma Dioscoreae powder and be broken into fine powder, three flavors such as all the other Pericarpium Citri Reticulataes and residue Radix Pseudostellariae decoct with water secondary, each 2 hours, collecting decoction filters, and the filtrate cryoconcentration is to the thick paste shape, or be condensed into the clear paste that relative density is 1.08～1.12 (65 ℃), spray drying.Add above-mentioned fine powder, cane sugar powder and dextrin an amount of, mixing, granulation, drying is pressed into 1600, and get final product.
Along with the progress of technology and the development of society, JIANWEI XIAOSHI PIAN exposes some defectives that exist on the production technology gradually.Show as the difficult control of clinical medicine microbial limit, the functional component content of hesperidin is unstable, curative effect is not obvious, the poor problem that waits process aspect of mouthfeel, have a strong impact on application and the sale of this product, restrict the demand of people's medications, be difficult to adapt to the requirement of modernization, international solid preparation of Chinese medicine.
JIANWEI XIAOSHI PIAN Radix Pseudostellariae, the former powder of Rhizoma Dioscoreae medical material directly are used as medicine at present, effective ingredient can not get effective release at gastric and just is excreted, bioavailability is low, do not have therapeutical effect, the former powder of Rhizoma Dioscoreae is eaten something rare the sensation that has fiber crops, JIANWEI XIAOSHI PIAN is chewable tablet, contains the former powder mouthfeel of Rhizoma Dioscoreae relatively poor, also can cause the throat discomfort to cause the reflex cough.The adding of a large amount of former powder of medical material causes the preparation microbial limit to exceed standard.
Summary of the invention
In order to remedy the deficiency of existing production technology, the invention provides a kind of active constituent content high, unilateral appearance color is evenly bright and clean, and the preparation technology of the JIANWEI XIAOSHI PIAN that mouthfeel is good has effectively avoided the shortcoming of original explained hereafter product.
Technical solution of the present invention is:
A kind of preparation technology of JIANWEI XIAOSHI PIAN is characterized in that may further comprise the steps:
(1) the 22.9g Pericarpium Citri Reticulatae is added 6-12 and doubly measure 70-80% ethanol extraction twice, each 1.5 hours, filter, filtrate recycling ethanol also was concentrated into relative density 1.08-1.12(65 ℃) extractum;
(2) 228.6g Radix Pseudostellariae, 171.4g Rhizoma Dioscoreae, 114.3g Fructus Crataegi, 171.4g Fructus Hordei Germinatus (parched) are added the decocting that 9-15 doubly measures and boil secondary, each 1.5 hours, collecting decoction, filter, filtrate decompression is concentrated into the thick paste shape, or is condensed into the clear paste that relative density is 1.08～1.12 (65 ℃), merges with above-mentioned Pericarpium Citri Reticulatae extractum, stir evenly, for subsequent use;
(3) cross 100 mesh sieves after will sucrose pulverizing, will Icing Sugar 420-480g and dextrin 20-80g add in the one-step-granulating method dry as the binding agent spray granulation with extract extractum, granulate; Add mix lubricant even, be pressed into 1000 or 1600 with particular manufacturing craft, or film coating, and get final product;
(4) carry out the aluminium-plastic panel inner packing with Aluminium-coating Packer, mounted box, vanning warehouse-in.
Described step (1) adds 8 times of amount 75% ethanol extractions twice with the 22.9g Pericarpium Citri Reticulatae, and each 1.5 hours, filter, filtrate recycling ethanol also was concentrated into relative density 1.08-1.12(65 ℃) extractum; Described step (2) is boiled secondary with the decocting that 228.6g Radix Pseudostellariae, 171.4g Rhizoma Dioscoreae, 114.3g Fructus Crataegi, 171.4g Fructus Hordei Germinatus (parched) add 12 times of amounts, each 1.5 hours, collecting decoction, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.08～1.12 (65 ℃), merge with above-mentioned Pericarpium Citri Reticulatae extractum, stir evenly, for subsequent use.
The described Icing Sugar of step (3) is 450g, and dextrin is 50g, and described lubricant is magnesium stearate.
JIANWEI XIAOSHI PIAN of the present invention, it further improves and is on the basis of former technique: with Pericarpium Citri Reticulatae 75% ethanol extraction, Radix Pseudostellariae, Rhizoma Dioscoreae two flavors are extracted by half amount and change to full dose medical material and other medical material united extraction, with extractum as binding agent adopt that the one-step palletizing technology is granulated, mixing, tabletting.The water boiling and extraction Hesperidin is adopted in extraction to Pericarpium Citri Reticulatae under Chinese Pharmacopoeia version JIANWEI XIAOSHI PIAN in 2010 the method for making item, because Hesperidin is a kind of glucosides of flavanone in the Pericarpium Citri Reticulatae, be insoluble in water, therefore adopt the content of its functional component Hesperidin in the water decoction that the decocting cooking method extracts very low, for improving the content of Pericarpium Citri Reticulatae glycosides in the Pericarpium Citri Reticulatae, the Pericarpium Citri Reticulatae medical material is adopted 75% ethanol extraction, can increase substantially the content of Hesperidin in the extract.Existing technique has effectively been avoided the shortcoming of original explained hereafter product with Rhizoma Dioscoreae and the full medicinal material extract of Radix Pseudostellariae, Pericarpium Citri Reticulatae alcohol extraction production JIANWEI XIAOSHI PIAN.
JIANWEI XIAOSHI PIAN of the present invention has the following advantages:
1) on the constant basis of original prescription amount, with adding after Radix Pseudostellariae and the Rhizoma Dioscoreae extracts active ingredients, improved the bioavailability of Radix Pseudostellariae and Rhizoma Dioscoreae effective ingredient.Traditional Chinese medicine historical preparation is the differentiation of Chinese medicine decoction, is in order to make things convenient for the patient to take, to be convenient to transportation and storage.In order conveniently to take and to transport but can not reduce its curative effect, original technique Radix Pseudostellariae and the former powder of Rhizoma Dioscoreae medical material directly add, and effective ingredient can not get effective stripping at gastric, so just do not have good therapeutical effect.New production technology, Chinese crude drug all with extracts active ingredients, concentrated, are made tablet again, and the utilization that can be absorbed by the body soon of its effective ingredient just can be played therapeutical effect in the very short time.Its preparation technology has kept the drug effect that decoction can play fully.
2) with the Radix Pseudostellariae in the original production process and Rhizoma Dioscoreae medicinal material extract, avoid in preparation, adding the former powder of medical material, effectively avoid the finished product microbial limit problem that exceeds standard.The former powder of Rhizoma Dioscoreae is eaten something rare the sensation that has fiber crops, and JIANWEI XIAOSHI PIAN is chewable tablet, contains the former powder mouthfeel of Rhizoma Dioscoreae relatively poor, also can cause the throat discomfort to cause the reflex cough.The Rhizoma Dioscoreae effective ingredient no longer adds former powder through extracting, and has improved the JIANWEI XIAOSHI PIAN mouthfeel.
3) Hesperidin is a kind of glucosides of flavanone in the Pericarpium Citri Reticulatae, be insoluble in water or ethanol, therefore adopt 75% ethanol to carry, the content of functional component Hesperidin is improved nearly more than 1 times, thereby increase substantially content and the product therapeutic effect of functional component Hesperidin in the preparation.
4) because Radix Pseudostellariae fine powder and sucrose, starch color distinction are larger, during former explained hereafter, unilateral mottle to occur serious.Present extract spray granulation, the unilateral color and luster that is pressed into is even, without pit, mottle, has improved the product appearance quality.Medical material all prepares extractum, and the preparation mobility of particle is good, and plain sheet outward appearance is clean and tidy, homogeneous.
5) steady quality: through 6 months accelerated tests and 24 months long-term stable experiments, every quality index was compared without significant difference with 0 month, showed that the product quality of producing with this production technology is highly stable.
Active constituent content relatively sees Table 1 in JIANWEI XIAOSHI PIAN of the present invention and commercially available (the pharmacopeia technique in 2010).
The stability experiment data result of JIANWEI XIAOSHI PIAN of the present invention sees Table 2.
The quality standard of JIANWEI XIAOSHI PIAN of the present invention:
[character] this product is fallow or Film coated tablets, also can be Special-shaped sheet.Film coated tablets shows sundown after removing coating; Gas is slightly fragrant, distinguishes the flavor of little sweet, sour.
This product (1000 tablet recipes are got 48, and 1600 tablet recipes are got 30), porphyrize are got in [discriminating] (1), add methanol 50ml, reflux 30 minutes filters, filtrate evaporate to dryness, residue add water 20ml makes dissolving, by D101 type macroporous adsorptive resins (internal diameter 1.2cm, the high 15cm of post), water 200ml eluting discards water lotion, use again ethanol 100ml eluting, collect ethanol elution, evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution.Other gets Radix Pseudostellariae control medicinal material 5g, decocts with water 2 hours, and is centrifugal, gets supernatant, by D101 type macroporous adsorptive resins, is made in the same way of control medicinal material solution.According to the thin layer chromatography test, absorb each 20 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take toluene-ethyl acetate (4:1) as developing solvent, launch, take out, dry, spray is heated to the speckle colour developing at 105 ℃ clear with 1% vanillin sulfuric acid solution.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the speckle of aobvious same color.
(2) get this product (1000 tablet recipes are got 48, and 1600 tablet recipes are got 30), porphyrize, add methanol 50ml, reflux 30 minutes filters, the filtrate evaporate to dryness, residue adds water 20ml makes dissolving, extracts 2 times with the ethyl acetate jolting, each 20ml, combined ethyl acetate liquid, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets Fructus Crataegi control medicinal material 2g, adds water 100ml, decocts 1 hour, filters, and filtrate is concentrated into 20ml, regulates pH value to 1～2 with dilute hydrochloric acid, extracts 2 times with the ethyl acetate jolting, is made in the same way of control medicinal material solution.According to the thin layer chromatography test, draw each 20 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take cyclohexane extraction-ethyl acetate-formic acid (20:20:1) as developing solvent, launch, take out, dry, spray is heated to the speckle colour developing at 105 ℃ clear with 2% ferric chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the principal spot of aobvious same color.
Get this product [inspection] disintegration by inspection technique inspection disintegration, the result should be up to specification.
20 of weight differential tablet takings, the respectively weight of accurately weighed each sheet.Every weight and designation card heavy phase relatively, the tablet that exceeds limit test of weight variation must not be more than 2, and 1 times of 1 overrun must not be arranged.（±5%）
Limit test of microbe
Get this product, according to the microbial limit test inspection, in every 1g test sample, bacterial population must not be crossed 10000cfu, and the yeast and mold number must not be crossed 100cfu, and escherichia coli must not detect, and coliform should be less than 100cfu; Must not detect demodicid mite alive.
[assay]High performance liquid chromatography.
Chromatographic condition and system suitability are take octadecylsilane chemically bonded silica as filler; Take methanol-0.5% glacial acetic acid solution (40:60) as mobile phase; The detection wavelength is 283nm.Number of theoretical plate calculates by the Hesperidin peak should be not less than 2000.
Hesperidin reference substance 12.5mg is got in the preparation of reference substance solution, and is accurately weighed, puts in the 100ml measuring bottle, adds methanol and makes dissolving and be diluted to scale, shake up, precision measures 3ml, puts in the 25ml measuring bottle, add 50% methanol and be diluted to scale, shake up, namely get (containing Hesperidin 15 μ g among every 1ml).
This product on the weight differential item is got in the preparation of need testing solution, and porphyrize is got approximately 2g, and is accurately weighed, the accurate methanol 20ml that adds, weighed weight was put in the water-bath reflux 1 hour, let cool, weighed weight is again supplied the weight of less loss with methanol, shake up, filter, precision measures subsequent filtrate 5ml, put in the 10ml measuring bottle, thin up shakes up to scale, filter, get subsequent filtrate, and get final product.
Algoscopy
Precision is drawn reference substance solution and each 20 μ l of need testing solution respectively, and the injection liquid chromatography is measured.And get final product.
Every of this product contains Pericarpium Citri Reticulatae with Hesperidin (C
28H
34O
15) meter, must not be less than 0.12mg.
The specific embodiment
The present invention will be further described below in conjunction with embodiment, but be not limited to this.
Embodiment 1:
This embodiment is made by the stock and adjunct of following weight proportion: per 1000 stock and adjuncts by following weight proportion are made: Radix Pseudostellariae 228.6g, Pericarpium Citri Reticulatae 22.9g, Rhizoma Dioscoreae 171.4g, Fructus Hordei Germinatus (stir-fry) 171.4g, Fructus Crataegi 114.3g,
Sucrose 450g, dextrin 50g, magnesium stearate 3g.
The technical process of its making is as follows:
1) Pericarpium Citri Reticulatae is placed in the multi-function extractor, add 8 times of amount 75% ethanol extractions twice, each 1.5 hours, filter, filtrate recycling ethanol also was concentrated into relative density 1.08-1.12(65 ℃) thick paste.
2) decocting that full dose Radix Pseudostellariae, full dose Rhizoma Dioscoreae, Fructus Crataegi, Fructus Hordei Germinatus (parched) is added 12 times of amounts boils secondary, and each 1.5 hours, collecting decoction filtered, and filtrate decompression is concentrated into the thick paste shape, or is condensed into the clear paste that relative density is 1.08～1.12 (65 ℃).
3) sucrose is pulverized rear 100 mesh sieves of crossing.
4) with dry as the binding agent spray granulation with extract extractum in Icing Sugar and the dextrin adding one-step-granulating method, granulate.
5) to add mix lubricant even for whole good granule.
6) with JIANWEI XIAOSHI PIAN particular manufacturing craft tabletting.
7) carry out the aluminium-plastic panel inner packing with Aluminium-coating Packer.
8) mounted box, vanning warehouse-in.The every heavy 0.8g of sheet:
Embodiment 2:
This embodiment is made by the stock and adjunct of following weight proportion: per 1600 stock and adjuncts by following weight proportion are made: Radix Pseudostellariae 228.6g, Pericarpium Citri Reticulatae 22.9g, Rhizoma Dioscoreae 171.4g, Fructus Hordei Germinatus (stir-fry) 171.4g, Fructus Crataegi 114.3g, sucrose 450g, dextrin 50g, magnesium stearate 3g.
The technical process of its making is as follows:
1) Pericarpium Citri Reticulatae is placed in the multi-function extractor, add 8 times of amount 75% ethanol extractions twice, each 1.5 hours, filter, filtrate recycling ethanol also was concentrated into relative density 1.08-1.12(65 ℃) thick paste.
2) decocting that full dose Radix Pseudostellariae, full dose Rhizoma Dioscoreae, Fructus Crataegi, Fructus Hordei Germinatus (parched) is added 12 times of amounts boils secondary, and each 1.5 hours, collecting decoction filtered, and filtrate decompression is concentrated into the thick paste shape, or is condensed into the clear paste that relative density is 1.08～1.12 (65 ℃).
3) sucrose is pulverized rear 100 mesh sieves of crossing.
4) with dry as the binding agent spray granulation with extract extractum in Icing Sugar and the dextrin adding one-step-granulating method, granulate.
5) to add mix lubricant even for whole good granule.
6) with JIANWEI XIAOSHI PIAN particular manufacturing craft tabletting.
7) carry out the aluminium-plastic panel inner packing with Aluminium-coating Packer.
8) mounted box, vanning warehouse-in.The every heavy 0.5g of sheet.
Claims (3)
1. the preparation technology of a JIANWEI XIAOSHI PIAN is characterized in that may further comprise the steps:
(1) the 22.9g Pericarpium Citri Reticulatae is added 6-12 and doubly measure 70-80% ethanol extraction twice, each 1.5 hours, filter, filtrate recycling ethanol also was concentrated into relative density 1.08-1.12(65 ℃) extractum;
(2) 228.6g Radix Pseudostellariae, 171.4g Rhizoma Dioscoreae, 114.3g Fructus Crataegi, 171.4g Fructus Hordei Germinatus (parched) are added the decocting that 9-15 doubly measures and boil secondary, each 1.5 hours, collecting decoction, filter, filtrate decompression is concentrated into the thick paste shape, or is condensed into the clear paste that relative density is 1.08～1.12 (65 ℃), merges with above-mentioned Pericarpium Citri Reticulatae extractum, stir evenly, for subsequent use;
(3) cross 100 mesh sieves after will sucrose pulverizing, will Icing Sugar 420-480g and dextrin 20-80g add in the one-step-granulating method dry as the binding agent spray granulation with extract extractum, granulate; Add mix lubricant even, be pressed into 1000 or 1600 with particular manufacturing craft, or film coating, and get final product;
(4) carry out the aluminium-plastic panel inner packing with Aluminium-coating Packer, mounted box, vanning warehouse-in.
2. the preparation technology of JIANWEI XIAOSHI PIAN according to claim 1, it is characterized in that: described step (1) adds twice of 8 times of amount 75% ethanol extraction with the 22.9g Pericarpium Citri Reticulatae, each 1.5 hours, filter, filtrate recycling ethanol also was concentrated into relative density 1.08-1.12(65 ℃) extractum; Described step (2) is boiled secondary with the decocting that 228.6g Radix Pseudostellariae, 171.4g Rhizoma Dioscoreae, 114.3g Fructus Crataegi, 171.4g Fructus Hordei Germinatus (parched) add 12 times of amounts, each 1.5 hours, collecting decoction, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.08～1.12 (65 ℃), merge with above-mentioned Pericarpium Citri Reticulatae extractum, stir evenly, for subsequent use.
3. the preparation technology of JIANWEI XIAOSHI PIAN according to claim 1, it is characterized in that: the described Icing Sugar of step (3) is 450g, and dextrin is 50g, and described lubricant is magnesium stearate.
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Cited By (5)
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| CN105341582A (en) * | 2015-11-19 | 2016-02-24 | 黄海娟 | Hawthorn fruit-containing food digesting beverage and preparation technology thereof |
| CN105477032A (en) * | 2015-12-28 | 2016-04-13 | 山西金科海生物科技有限公司 | Fructus hippophae tablet for strengthening stomach and promoting digestion |
| CN105521362A (en) * | 2015-12-26 | 2016-04-27 | 悦康药业集团安徽天然制药有限公司 | Preparation method of stomach strengthening and food digesting tablet |
| CN108143881A (en) * | 2017-12-30 | 2018-06-12 | 高俊 | A kind of preparation method of XIAOSHI PIAN |
| CN112220916A (en) * | 2020-10-26 | 2021-01-15 | 西南药业股份有限公司 | Preparation process of biological enzyme tablet and product thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105341582A (en) * | 2015-11-19 | 2016-02-24 | 黄海娟 | Hawthorn fruit-containing food digesting beverage and preparation technology thereof |
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| CN105521362B (en) * | 2015-12-26 | 2019-05-28 | 悦康药业集团安徽天然制药有限公司 | A kind of preparation method of digestion-promoting stomachic |
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| CN105477032B (en) * | 2015-12-28 | 2019-01-29 | 山西金科海生物科技有限公司 | A kind of fructus hippophae digestion-promoting stomachic |
| CN108143881A (en) * | 2017-12-30 | 2018-06-12 | 高俊 | A kind of preparation method of XIAOSHI PIAN |
| CN112220916A (en) * | 2020-10-26 | 2021-01-15 | 西南药业股份有限公司 | Preparation process of biological enzyme tablet and product thereof |
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Application publication date: 20130424 |