CN101474318A - Rhizoma alismatis dispensing granule as well as preparation method and quality control method thereof - Google Patents

Rhizoma alismatis dispensing granule as well as preparation method and quality control method thereof Download PDF

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CN101474318A
CN101474318A CN 200810184579 CN200810184579A CN101474318A CN 101474318 A CN101474318 A CN 101474318A CN 200810184579 CN200810184579 CN 200810184579 CN 200810184579 A CN200810184579 A CN 200810184579A CN 101474318 A CN101474318 A CN 101474318A
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rhizoma alismatis
spray drying
granule
decoction pieces
shallow oil
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吴玢
付静
张翠
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Beijing Tcmages Pharmaceutical Co Ltd
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Beijing Tcmages Pharmaceutical Co Ltd
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Abstract

The invention discloses an alisma orientale prescription granule, a preparation method and a quality control method thereof. The alisma orientale prescription granule takes alisma orientale herbal pieces prepared for decoction as the raw material and is prepared by the processes of twice extraction by water, reduced pressure concentration, spray drying, and the like; each gram of the alisma orientale prescription granule corresponds to 5-10g of crude drug dosage; the quality of both alisma orientale herbal pieces prepared for decoction and alisma orientale prescription granule is identified by infrared fingerprint spectra. The alisma orientale prescription granule of the invention has integral and advanced preparation process and specific and controllable quality control standard, wherein, the advanced process can be realized and the detection method related to the quality standard is scientific, advanced and fast and convenient with strong feasibility. Experiments show that the decoction composed by the alisma orientale prescription granule of the invention contains the same ingredients as the herbal pieces mixedly decocted liquor containing alisma orientale of the classical prescription, the prescription granule process of bulk composition is realized and the process of the invention is reasonable; furthermore, the invention applies the technology of infrared fingerprint spectra to the quality control of the traditional Chinese medicine, thus the primary problem in the macro quality control of the traditional Chinese medicine, namely the authenticity identification of the traditional Chinese medicine is instantly solved.

Description

A kind of Rhizoma Alismatis granule and preparation method thereof and method of quality control
Technical field
The present invention relates to a kind of Chinese medicinal granule and preparation method thereof and method of quality control, particularly a kind of Rhizoma Alismatis granule and preparation method thereof and method of quality control.
Background technology
Chinese medicinal granule is under Chinese medical theory instructs, and the prepared slices of Chinese crude drugs are formed through various processes, is used for the granule that clinical tcm prescription allotment is used; Compare with traditional Chinese herbs decoction, its taking convenience, dose is little, and is quality controllable, preserves easily, is easy to carry; Chinese medicinal granule is in the pilot production status at home at present, product technology and quality standard disunity.At present Chinese medicinal granule mostly is traditional water and extracts, and perhaps extracts water extraction behind the volatile oil, and different production unit causes the product quality of different manufacturers inconsistent because production equipment is different with production technology, and there is difference in drug effect.The specificity of its quality standard is limit by certain test conditions and scope, lacks other due quality informations of product, and present standard can't be judged the quality good or not and the overall picture of Chinese medicinal granule product comprehensively.
Infrared spectrometry is one of conventional means of differentiating chemical compound and definite structure of matter.In pharmaceutical analysis, " fingerprint " characteristic that has with infrared spectrum is the common method that adopts of various countries' pharmacopeia as the foundation of drug identification.But since Chinese crude drug, the prepared slices of Chinese crude drugs and Chinese patent medicine itself all be more than the Western medicine complexity many mixture systems, the spectrum analysis difficulty makes conventional infrared spectrometry fail its due effect of performance in Chinese medicine quality control and management in the long term.
Summary of the invention
The objective of the invention is to disclose a kind of Rhizoma Alismatis granule; The present invention also aims to disclose the preparation method of this granule; The present invention also aims to disclose the method for quality control of this granule.
The present invention seeks to be achieved through the following technical solutions:
The suitable crude drug amount of the every gram of Rhizoma Alismatis granule of the present invention 5-10 gram, the Infrared fingerprint spectra of this granule such as Fig. 1.The preparation method of Rhizoma Alismatis granule of the present invention comprises: get the Rhizoma Alismatis decoction pieces, use twice of water extraction; Wherein the Rhizoma Alismatis decoction pieces adopts Infrared fingerprint spectra to carry out quality discrimination, Rhizoma Alismatis decoction pieces standard Infrared fingerprint spectra such as Fig. 2.
The preparation method of Rhizoma Alismatis granule of the present invention comprises the steps: to get the Rhizoma Alismatis decoction pieces, adds the water of 5-15 times of weight portion, extracts 0.5-3 hour, promptly one fries in shallow oil; One fries in shallow oil the water that the back medicinal residues add 5-15 times of weight portion of Rhizoma Alismatis decoction pieces, extracts 0.5-3 hour, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to the concentrated solution of relative density 1.00-1.15; The concentrated solution spray drying gets the Rhizoma Alismatis spray drying powder; The Rhizoma Alismatis spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Rhizoma Alismatis spray drying powder, 20-60 purpose Rhizoma Alismatis granule.
The preparation method of Rhizoma Alismatis granule of the present invention is preferably as follows step: get the Rhizoma Alismatis decoction pieces, add the water of 8 times of weight portions, extracted 2 hours, promptly one fry in shallow oil; One fries in shallow oil the water that the back medicinal residues add 7 times of weight portions of Rhizoma Alismatis decoction pieces, extracts 1.5 hours, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to the concentrated solution of relative density 1.05-1.10; The concentrated solution spray drying gets the Rhizoma Alismatis spray drying powder; The Rhizoma Alismatis spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Rhizoma Alismatis spray drying powder, 20-60 purpose Rhizoma Alismatis granule.
The preparation method of Rhizoma Alismatis granule of the present invention is preferably as follows step: get the Rhizoma Alismatis decoction pieces, add the water of 10 times of weight portions, extracted 2 hours, promptly one fry in shallow oil; One fries in shallow oil the water that the back medicinal residues add 6 times of weight portions of Rhizoma Alismatis decoction pieces, extracts 1 hour, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to the concentrated solution of relative density 1.00-1.05; The concentrated solution spray drying gets the Rhizoma Alismatis spray drying powder; The Rhizoma Alismatis spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Rhizoma Alismatis spray drying powder, 20-60 purpose Rhizoma Alismatis granule.
The preparation method of Rhizoma Alismatis granule of the present invention is preferably as follows step: get the Rhizoma Alismatis decoction pieces, add the water of 14 times of weight portions, extracted 2.5 hours, promptly one fry in shallow oil; One fries in shallow oil the water that the back medicinal residues add 11 times of weight portions of Rhizoma Alismatis decoction pieces, extracts 2.5 hours, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to the concentrated solution of relative density 1.10-1.15; The concentrated solution spray drying gets the Rhizoma Alismatis spray drying powder; The Rhizoma Alismatis spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Rhizoma Alismatis spray drying powder, 20-60 purpose Rhizoma Alismatis granule.
The drying process with atomizing parameter is in the above-mentioned preparation method: 40 ℃-50 ℃ of medicinal liquid preheat temperatures; 170 ℃-185 ℃ of inlet temperature; 450-700 rev/min of material revolution speed; 70 ℃-85 ℃ of leaving air temps; Wind send 40 ℃-50 ℃ of temperature.
The granulation parameter is in the above-mentioned preparation method: main pinch roller pressure: 4-6MPa; Side pressure wheel pressure: 0.4-0.6MPa; The speed of mainshaft: 300-500 rev/mins; Feed voltage: 100-150V; Granular size: 20-60 order.
The method of quality control of Rhizoma Alismatis granule of the present invention comprises the steps: that the Rhizoma Alismatis granule adopts Infrared fingerprint spectra to carry out quality discrimination, and the Infrared fingerprint spectra discrimination method is: use Fourier transform infrared spectrometer, measurement range is 4000cm -1-400cm -1, DTGS detector, resolution 4cm -1, scanning times 16 times is deducted water and carbon dioxide constantly and is disturbed in the scanning process, and envionmental humidity is lower than 60%, and the potassium bromide direct compression process detects; Rhizoma Alismatis granule Infrared fingerprint spectra has following feature: as shown in Figure 1 at 1053cm -1Absorption maximum is arranged, and there is an absworption peak that intensity is big, peak shape is wide at this place, is stairstepping; At 2938cm -1, 1633cm -1, 1408cm -1, 925cm -1, 618cm -1There is characteristic absorption at the place.
The method of quality control of the Rhizoma Alismatis decoction pieces described in the Rhizoma Alismatis granule preparation method of the present invention comprises the steps: that the Rhizoma Alismatis decoction pieces is the certified products that meet a regulation of Pharmacopoeia of the People's Republic of China version in 2005; The Rhizoma Alismatis decoction pieces adopts Infrared fingerprint spectra to carry out quality discrimination, and the Infrared fingerprint spectra discrimination method is: use Fourier transform infrared spectrometer, measurement range is 4000cm -1-400cm -1, DTGS detector, resolution 4cm -1, scanning times 16 times is deducted water and carbon dioxide constantly and is disturbed in the scanning process, and envionmental humidity is lower than 60%, and the potassium bromide direct compression process detects; The Infrared fingerprint spectra of Rhizoma Alismatis decoction pieces has following feature: as shown in Figure 2 at 1000cm -1-1200cm -1Scope in an absworption peak that intensity is big, peak shape is wide is arranged, be stairstepping, its absorption is 1018cm from high to low -1, 1079cm -1, 1156cm -1At 2930cm -1, 1645cm -1, 1548cm -1, 1417cm -1, 1243cm -1, 862cm -1There is characteristic absorption at the place.
Infrared fingerprint spectra wherein of the present invention can be to reach Infrared fingerprint spectra more than 90% with its dependency.
Description of drawings:
Fig. 1: the Infrared fingerprint spectra of Rhizoma Alismatis granule;
Fig. 2: the Infrared fingerprint spectra of Rhizoma Alismatis decoction pieces Rhizoma Alismatis;
Fig. 3: Rhizoma Alismatis granule and Rhizoma Alismatis decoction pieces thin layer chromatography are relatively;
Fig. 4: Rhizoma Alismatis granule and Rhizoma Alismatis decoction pieces thin-layer sample Infrared fingerprint spectra are relatively;
Fig. 5: contain Rhizoma Alismatis classics side decoction pieces decocting liquid and Rhizoma Alismatis soup that granule is joined " whole part " infrared spectrogram relatively.
Complete, advanced production technology that rhizoma alismatis granule of the present invention has and specificity strong, Controlled quality control standard, technology advanced person can realize, the detection method that quality standard relates to Science, advanced person, quick, workable. By great many of experiments, contrasted the warp that contains the rhizoma alismatis medicine materical crude slice Allusion quotation side's medicine materical crude slice closes decocting liquid and rhizoma alismatis soup that granule is joined of the present invention " full composition " infrared spectrogram, and is right Compare rhizoma alismatis granule of the present invention and rhizoma alismatis medicine materical crude slice thin-layer chromatogram, contrasted rhizoma alismatis granule and pool Rush down medicine materical crude slice thin-layer sample infrared finger print atlas, the result show the classical side's medicine materical crude slice that contains the rhizoma alismatis medicine materical crude slice close decocting liquid with Rhizoma alismatis granule of the present invention is joined soup infrared finger print atlas peak shape, peak position, Relative Peak intensity basic one Cause, namely to close the decocting liquid composition suitable for rhizoma alismatis soup that granule is joined of the present invention and medicine materical crude slice, and pool of the present invention Rush down infrared finger print atlas peak shape, peak position, the Relative Peak intensity basic one of granule and medicine materical crude slice thin-layer sample Cause, so rhizoma alismatis granule of the present invention realizes the technology of full component prescription particle, proved worker of the present invention The reasonability of skill; And the present invention is applied to the quality control of Chinese medicine with infrared spectrum technology, and this is a kind of Innovation on the thinking, this not only meets traditional chinese medicine about the theory of " monarch, minister, help, make ", Also given prominence to the group effect of Chinese medicine, simultaneously the problem of complexity oversimplified, certain Chinese medicine as one Integral body is observed its " fingerprint ", thereby has solved rapidly a head in the control of Chinese medicine macroscopic quality Want problem---the evaluation of the Chinese medicine true and false.
Following experimental example and embodiment are used for further specifying but are not limited to the present invention.
Experimental example 1
(1) rhizoma alismatis granule and rhizoma alismatis medicine materical crude slice thin-layer chromatography are relatively
Get rhizoma alismatis granule 1.0g, add water 30ml and make dissolving, 90ml and saturated food add diethyl ether Salt solution 2ml, shake well leaves standstill and makes its layering, keeps ether liquid, and water layer repeats according to upper method with ether Extraction once, combined ether liquid is concentrated into driedly, residue adds ethyl acetate 1ml makes dissolving, as for examination Product solution. Get rhizoma alismatis control medicinal material 0.2g, add water 30ml, decocted 40 minutes, filter, filtrate is dense Be reduced to 20ml, add diethyl ether 50ml and saturated aqueous common salt 2ml, the same method is made control medicinal material Solution. According to thin-layered chromatography (" appendix VIB of Chinese Pharmacopoeia 2005 version) test, draw above-mentioned Need testing solution, control medicinal material solution each 10 μ, 25 μ l put respectively in same silica GF254 thin layer On the plate, take benzene-ethyl acetate-formic acid (5:4:1.5) as solvent, launch, exhibition is apart from 9cm. Get Go out, dry, put under the uviol lamp (254nm) and inspect. As shown in Figure 3, in the test sample chromatogram, On the position of corresponding with the control medicinal material chromatogram (Rf is about 0.31 place), the fluorescence spot of aobvious same color.
(2) rhizoma alismatis granule and rhizoma alismatis medicine materical crude slice thin-layer sample infrared finger print atlas are relatively
Measure the rhizoma alismatis medicine materical crude slice of preparation in (1) and rhizoma alismatis prescription with FTIS The grain thin-layer sample, its result as shown in Figure 4, the thin layer of rhizoma alismatis granule and rhizoma alismatis medicine materical crude slice Sample infrared finger print atlas peak shape, peak position, Relative Peak intensity are basically identical.
The result proves that rhizoma alismatis granule of the present invention is consistent with rhizoma alismatis medicine materical crude slice composition, and technology of the present invention is to close Reason.
Experimental example 2 contains rhizoma alismatis classics side medicine materical crude slice decocting liquid and rhizoma alismatis soup that granule is joined " full composition " infrared spectrogram comparative experiments
Liuwei Dihuang Wan comes from key to Therapeutics of Children's Diseases, and prescription forms and comprises prepared rhizome of rehmannia, Fructus Corni, does Chinese yam, rhizoma alismatis, Poria cocos, 6 flavour of a drug of the root bark of tree peony; The effect tonifying yin.
1, experiment purpose: the similarities and differences of research Liuwei Dihuang Wan medicine materical crude slice decocting liquid and granular recipe, determine rhizoma alismatis The reasonability of granule technology and equivalent.
2, experimental technique: get 6 flavour of a drug prescriptions such as rhizoma alismatis by Liuwei Dihuang Wan prescription proportioning, press medicine materical crude slice The decocting method of decoction decocts preparation medicine materical crude slice decocting liquid sample; Get respectively by Liuwei Dihuang Wan prescription proportioning in addition and remove Other medicine materical crude slice that rhizoma alismatis is outer, the decocting method of pressing the medicine materical crude slice decoction decocts, and soup suitably concentrates, and presses Six-element ground Yellow ball prescription proportioning and equivalent relation are got the rhizoma alismatis granule and are added in the concentrated medicament, are stirred to fully molten Separate preparation granular recipe sample; Drink respectively sheet decocting liquid sample, the granular recipe sample carries out infrared spectrum Detect.
3, testing conditions: instrument is FTIS, and measurement range is 4000 cm-1-400cm -1, DTGS detector, resolution ratio 4cm-1, scanning times 16 times, in the scanning process constantly Deduction water and carbon dioxide disturb, and envionmental humidity is lower than 60%, and the KBr direct compression process is examined Survey.
4, testing result: decoction pieces decocting liquid sample and granular recipe sample Infrared fingerprint spectra peak shape, peak position, relative peak intensity basically identical as shown in Figure 5, dependency reaches 95.44%.It is consistent to prove that Rhizoma Alismatis soup that granule is joined of the present invention and decoction pieces close the decocting liquid composition, it is consistent with a Rhizoma Alismatis decoction pieces fried composition promptly to add Rhizoma Alismatis granule of the present invention, and equivalent and production technology that Rhizoma Alismatis granule 1g of the present invention is equivalent to Rhizoma Alismatis decoction pieces 5-10g are rational.
Following embodiment all can realize the effect of above-mentioned experimental example, and required Rhizoma Alismatis decoction pieces adopts Infrared fingerprint spectra to carry out quality discrimination among the following embodiment, meets the standard Infrared fingerprint spectra of the Rhizoma Alismatis decoction pieces in the technique scheme; The Rhizoma Alismatis granule that following embodiment makes adopts Infrared fingerprint spectra to carry out quality discrimination, meets the Infrared fingerprint spectra of the Rhizoma Alismatis granule in the technique scheme; The every gram of Rhizoma Alismatis granule described in the following embodiment contains suitable crude drug amount 5-10 gram.
The specific embodiment
Embodiment 1: the Rhizoma Alismatis granule
Get Rhizoma Alismatis decoction pieces 100kg, add the water of 800kg, extracted 2 hours, promptly one fry in shallow oil; One fries in shallow oil the back medicinal residues adds 800kg water, extracts 1.5 hours, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to relative density 1.05-1.10; Concentrated solution is 45 ℃ of preheatings, 180 ℃ of inlet temperature, 550 rev/mins of material revolution speeds, 80 ℃ of leaving air temps, wind send spray drying under the condition of 45 ℃ of temperature, the Rhizoma Alismatis spray drying powder; The adjuvant dextrin that in the Rhizoma Alismatis spray drying powder, adds himself weight portion 0-5%; The Rhizoma Alismatis spray drying powder is 5MPa at main pinch roller pressure, and side pressure wheel pressure is 0.5MPa, and the speed of mainshaft is 400 rev/mins, and feed voltage is a dry granulation under the condition of 120V, 20-60 purpose Rhizoma Alismatis granule, suitable crude drug amount 10 grams of the every gram of Rhizoma Alismatis granule.
Embodiment 2: the Rhizoma Alismatis granule
Get Rhizoma Alismatis decoction pieces 100kg, add the water of 1000kg, extracted 2 hours, promptly one fry in shallow oil; One fries in shallow oil the back medicinal residues adds 600kg water, extracts 1 hour, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to relative density 1.00-1.05; Concentrated solution is 50 ℃ of preheatings, 170 ℃ of inlet temperature, 600 rev/mins of material revolution speeds, 75 ℃ of leaving air temps, wind send spray drying under the condition of 50 ℃ of temperature, the Rhizoma Alismatis spray drying powder; The adjuvant dextrin that in the Rhizoma Alismatis spray drying powder, adds himself weight portion 5-15%; At main pinch roller pressure is 6MPa, and side pressure wheel pressure is 0.4MPa, and the speed of mainshaft is 450 rev/mins, and feed voltage is a dry granulation under the condition of 110V, 20-60 purpose Rhizoma Alismatis granule, suitable crude drug amount 7 grams of the every gram of Rhizoma Alismatis granule;
The method of quality control of wherein said Rhizoma Alismatis decoction pieces comprises the steps: that the Rhizoma Alismatis decoction pieces adopts Infrared fingerprint spectra to carry out quality discrimination, and the Infrared fingerprint spectra discrimination method is: use Fourier transform infrared spectrometer, measurement range is 4000cm -1-400cm -1, DTGS detector, resolution 4cm -1, scanning times 16 times is deducted water and carbon dioxide constantly and is disturbed in the scanning process, and envionmental humidity is lower than 60%, and the potassium bromide direct compression process detects; The Infrared fingerprint spectra of Rhizoma Alismatis decoction pieces has following feature: as shown in Figure 2 at 1000cm -1-1200cm -1Scope in an absworption peak that intensity is big, peak shape is wide is arranged, be stairstepping, its absorption is 1018cm from high to low -1, 1079cm -1, 1156cm -1At 2930cm -1, 1645cm- 1, 1548cm -1, 1417cm -1, 1243cm -1, 862cm -1There is characteristic absorption at the place.
Embodiment 3: the Rhizoma Alismatis granule
Get Rhizoma Alismatis decoction pieces 100kg, add the water of 1400kg, extracted 2.5 hours, promptly one fry in shallow oil; One fries in shallow oil the back medicinal residues adds 1100kg water, extracts 2.5 hours, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to relative density 1.10-1.15; Concentrated solution is 45 ℃ of preheatings, 170 ℃ of inlet temperature, 600 rev/mins of material revolution speeds, 75 ℃ of leaving air temps, wind send spray drying under the condition of 50 ℃ of temperature, the Rhizoma Alismatis spray drying powder; The lactose that in the Rhizoma Alismatis spray drying powder, adds himself weight portion 15-25%; At main pinch roller pressure is 4MPa, and side pressure wheel pressure is 0.4MPa, and the speed of mainshaft is 500 rev/mins, and feed voltage is a dry granulation under the condition of 130V, 20-60 purpose Rhizoma Alismatis granule, suitable crude drug amount 5 grams of the every gram of Rhizoma Alismatis granule;
The method of quality control of gained Rhizoma Alismatis granule comprises the steps: to adopt Infrared fingerprint spectra to carry out quality discrimination, and the Infrared fingerprint spectra discrimination method is: use Fourier transform infrared spectrometer, measurement range is 4000cm -1-400cm -1, DTGS detector, resolution 4cm -1, scanning times 16 times is deducted water and carbon dioxide constantly and is disturbed in the scanning process, and envionmental humidity is lower than 60%, and the potassium bromide direct compression process detects; Rhizoma Alismatis granule Infrared fingerprint spectra has following feature: as shown in Figure 1 at 1053cm -1Absorption maximum is arranged, and there is an absworption peak that intensity is big, peak shape is wide at this place, is stairstepping; At 2938cm -1, 1633cm -1, 1408cm -1, 925cm -1, 618cm -1There is characteristic absorption at the place.

Claims (9)

1, a kind of Rhizoma Alismatis granule is characterized in that the suitable crude drug amount of the every gram of described Rhizoma Alismatis granule 5-10 gram.
2, a kind of Rhizoma Alismatis granule is characterized in that this Rhizoma Alismatis granule Infrared fingerprint spectra has following feature: adopt Fourier transform infrared spectrometer to measure, at 1053cm -1Absorption maximum is arranged, and there is an absworption peak that intensity is big, peak shape is wide at this place, is stairstepping; At 2938cm -1, 1633cm -1, 1408cm -1, 925cm -1, 618cm -1There is characteristic absorption at the place.
3, Rhizoma Alismatis granule as claimed in claim 1 is characterized in that the Infrared fingerprint spectra of this granule has following feature: at 1053cm -1Absorption maximum is arranged, and there is an absworption peak that intensity is big, peak shape is wide at this place, is stairstepping; At 2938cm -1, 1633cm -1, 1408cm -1, 925cm -1, 618cm -1There is characteristic absorption at the place.
4, a kind of preparation method of Rhizoma Alismatis granule is characterized in that this method comprises a kind of in the following method:
Get the Rhizoma Alismatis decoction pieces, add the water of 5-15 times of weight portion, extracted 0.5-3 hour, promptly one fry in shallow oil; One fries in shallow oil the water that the back medicinal residues add 5-15 times of weight portion of Rhizoma Alismatis decoction pieces, extracts 0.5-3 hour, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to the concentrated solution of relative density 1.00-1.15; The concentrated solution spray drying gets the Rhizoma Alismatis spray drying powder; The Rhizoma Alismatis spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Rhizoma Alismatis spray drying powder, the Rhizoma Alismatis granule;
Or get the Rhizoma Alismatis decoction pieces, and add the water of 8 times of weight portions, extracted 2 hours, promptly one fry in shallow oil; One fries in shallow oil the water that the back medicinal residues add 7 times of weight portions of Rhizoma Alismatis decoction pieces, extracts 1.5 hours, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to the concentrated solution of relative density 1.05-1.10; The concentrated solution spray drying gets the Rhizoma Alismatis spray drying powder; The Rhizoma Alismatis spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Rhizoma Alismatis spray drying powder, the Rhizoma Alismatis granule;
Or get the Rhizoma Alismatis decoction pieces, and add the water of 10 times of weight portions, extracted 2 hours, promptly one fry in shallow oil; One fries in shallow oil the water that the back medicinal residues add 6 times of weight portions of Rhizoma Alismatis decoction pieces, extracts 1 hour, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to the concentrated solution of relative density 1.00-1.05; The concentrated solution spray drying gets the Rhizoma Alismatis spray drying powder; The Rhizoma Alismatis spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Rhizoma Alismatis spray drying powder, the Rhizoma Alismatis granule;
Or get the Rhizoma Alismatis decoction pieces, and add the water of 14 times of weight portions, extracted 2.5 hours, promptly one fry in shallow oil; One fries in shallow oil the water that the back medicinal residues add 11 times of weight portions of Rhizoma Alismatis decoction pieces, extracts 2.5 hours, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to the concentrated solution of relative density 1.10-1.15; The concentrated solution spray drying gets the Rhizoma Alismatis spray drying powder; The Rhizoma Alismatis spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Rhizoma Alismatis spray drying powder, the Rhizoma Alismatis granule.
5, the preparation method of Rhizoma Alismatis granule as claimed in claim 4 is characterized in that wherein said drying process with atomizing parameter is: 40 ℃-50 ℃ of medicinal liquid preheat temperatures; 170 ℃-185 ℃ of inlet temperature; 450-700 rev/min of material revolution speed; 70 ℃-85 ℃ of leaving air temps; Wind send 40 ℃-50 ℃ of temperature; Wherein said granulation parameter is: main pinch roller pressure: 4-6MPa; Side pressure wheel pressure: 0.4-0.6MPa; The speed of mainshaft: 300-500 rev/mins; Feed voltage: 100-150V; Granular size: 20-60 order.
6, the preparation method of Rhizoma Alismatis granule as claimed in claim 4 is characterized in that wherein the quality discrimination of Rhizoma Alismatis decoction pieces Infrared fingerprint spectra is: use Fourier transform infrared spectrometer, measurement range is 4000cm -1-400cm -1, DTGS detector, resolution 4cm -1, scanning times 16 times is deducted water and carbon dioxide constantly and is disturbed in the scanning process, and envionmental humidity is lower than 60%, and the potassium bromide direct compression process detects; The Infrared fingerprint spectra of Rhizoma Alismatis decoction pieces has following feature: at 1000cm -1-1200cm -1Scope in an absworption peak that intensity is big, peak shape is wide is arranged, be stairstepping, its absorption is 1018cm from high to low -1, 1079cm -1, 1156cm -1At 2930cm -1, 1645cm -1, 1548cm -1, 1417cm -1, 1243cm -1, 862cm -1There is characteristic absorption at the place.
7, a kind of preparation method of Rhizoma Alismatis granule is characterized in that this method comprises a kind of in the following method:
Get the Rhizoma Alismatis decoction pieces, add the water of 5-15 times of weight portion, extracted 0.5-3 hour, promptly one fry in shallow oil; One fries in shallow oil the water that the back medicinal residues add 5-15 times of weight portion of Rhizoma Alismatis decoction pieces, extracts 0.5-3 hour, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to the concentrated solution of relative density 1.00-1.15; The concentrated solution spray drying gets the Rhizoma Alismatis spray drying powder; The Rhizoma Alismatis spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Rhizoma Alismatis spray drying powder, 20-60 purpose Rhizoma Alismatis granule; Wherein the Rhizoma Alismatis decoction pieces adopts Infrared fingerprint spectra to carry out quality discrimination, and the Infrared fingerprint spectra discrimination method is: use Fourier transform infrared spectrometer, measurement range is 4000cm -1-400cm -1, DTGS detector, resolution 4cm -1, scanning times 16 times is deducted water and carbon dioxide constantly and is disturbed in the scanning process, and envionmental humidity is lower than 60%, and the potassium bromide direct compression process detects; The Infrared fingerprint spectra of Rhizoma Alismatis decoction pieces has following feature: at 1000cm -1-1200cm -1Scope in an absworption peak that intensity is big, peak shape is wide is arranged, be stairstepping, its absorption is 1018cm from high to low -1, 1079cm -1, 1156cm -1At 2930cm -1, 1645cm -1, 1548cm -1, 1417cm -1, 1243cm -1, 862cm -1There is characteristic absorption at the place;
Or get the Rhizoma Alismatis decoction pieces, and add the water of 8 times of weight portions, extracted 2 hours, promptly one fry in shallow oil; One fries in shallow oil the water that the back medicinal residues add 7 times of weight portions of Rhizoma Alismatis decoction pieces, extracts 1.5 hours, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to the concentrated solution of relative density 1.05-1.10; The concentrated solution spray drying gets the Rhizoma Alismatis spray drying powder; The Rhizoma Alismatis spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Rhizoma Alismatis spray drying powder, 20-60 purpose Rhizoma Alismatis granule; Wherein the Rhizoma Alismatis decoction pieces adopts Infrared fingerprint spectra to carry out quality discrimination, and the Infrared fingerprint spectra discrimination method is: use Fourier transform infrared spectrometer, measurement range is 4000cm -1-400cm -1, DTGS detector, resolution 4cm -1, scanning times 16 times is deducted water and carbon dioxide constantly and is disturbed in the scanning process, and envionmental humidity is lower than 60%, and the potassium bromide direct compression process detects; The Infrared fingerprint spectra of Rhizoma Alismatis decoction pieces has following feature: at 1000cm -1-1200cm -1Scope in an absworption peak that intensity is big, peak shape is wide is arranged, be stairstepping, its absorption is 1018cm from high to low -1, 1079cm -1, 1156cm -1At 2930cm -1, 1645cm -1, 1548cm -1, 1417cm -1, 1243cm -1, 862cm -1There is characteristic absorption at the place;
Or get the Rhizoma Alismatis decoction pieces, and add the water of 10 times of weight portions, extracted 2 hours, promptly one fry in shallow oil; One fries in shallow oil the water that the back medicinal residues add 6 times of weight portions of Rhizoma Alismatis decoction pieces, extracts 1 hour, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to the concentrated solution of relative density 1.00-1.05; The concentrated solution spray drying gets the Rhizoma Alismatis spray drying powder; The Rhizoma Alismatis spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Rhizoma Alismatis spray drying powder, 20-60 purpose Rhizoma Alismatis granule; Wherein the Rhizoma Alismatis decoction pieces adopts Infrared fingerprint spectra to carry out quality discrimination, and the Infrared fingerprint spectra discrimination method is: use Fourier transform infrared spectrometer, measurement range is 4000cm -1-400cm -1, DTGS detector, resolution 4cm -1, scanning times 16 times is deducted water and carbon dioxide constantly and is disturbed in the scanning process, and envionmental humidity is lower than 60%, and the potassium bromide direct compression process detects; The Infrared fingerprint spectra of Rhizoma Alismatis decoction pieces has following feature: at 1000cm -1-1200cm -1Scope in an absworption peak that intensity is big, peak shape is wide is arranged, be stairstepping, its absorption is 1018cm from high to low -1, 1079cm -1, 1156cm -1At 2930cm -1, 1645cm -1, 1548cm -1, 1417cm -1, 1243cm -1, 862cm -1There is characteristic absorption at the place;
Or get the Rhizoma Alismatis decoction pieces, and add the water of 14 times of weight portions, extracted 2.5 hours, promptly one fry in shallow oil; One fries in shallow oil the water that the back medicinal residues add 11 times of weight portions of Rhizoma Alismatis decoction pieces, extracts 2.5 hours, promptly two fries in shallow oil; Merge two liquid of boiling medicine, be evaporated to the concentrated solution of relative density 1.10-1.15; The concentrated solution spray drying gets the Rhizoma Alismatis spray drying powder; The Rhizoma Alismatis spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Rhizoma Alismatis spray drying powder, 20-60 purpose Rhizoma Alismatis granule; Wherein the Rhizoma Alismatis decoction pieces adopts Infrared fingerprint spectra to carry out quality discrimination, and the Infrared fingerprint spectra discrimination method is: use Fourier transform infrared spectrometer, measurement range is 4000cm -1-400cm -1, DTGS detector, resolution 4cm -1, scanning times 16 times is deducted water and carbon dioxide constantly and is disturbed in the scanning process, and envionmental humidity is lower than 60%, and the potassium bromide direct compression process detects; The Infrared fingerprint spectra of Rhizoma Alismatis decoction pieces has following feature: at 1000cm -1-1200cm -1Scope in an absworption peak that intensity is big, peak shape is wide is arranged, be stairstepping, its absorption is 1018cm from high to low -1, 1079cm -1, 1156cm -1At 2930cm -1, 1645cm -1, 1548cm -1, 1417cm -1, 1243cm -1, 862cm -1There is characteristic absorption at the place.
8, the preparation method of Rhizoma Alismatis granule as claimed in claim 7 is characterized in that wherein said drying process with atomizing parameter is: 40 ℃-50 ℃ of medicinal liquid preheat temperatures; 170 ℃-185 ℃ of inlet temperature; 450-700 rev/min of material revolution speed; 70 ℃-85 ℃ of leaving air temps; Wind send 40 ℃-50 ℃ of temperature; Wherein said granulation parameter is: main pinch roller pressure: 4-6MPa; Side pressure wheel pressure: 0.4-0.6MPa; The speed of mainshaft: 300-500 rev/mins; Feed voltage: 100-150V; Granular size: 20-60 order.
9, as claim 2,3 arbitrary described Rhizoma Alismatis granules, it is characterized in that wherein said Infrared fingerprint spectra testing conditions is: use Fourier transform infrared spectrometer, measurement range is 4000cm -1-400cm -1, DTGS detector, resolution 4cm -1, scanning times 16 times is deducted water and carbon dioxide constantly and is disturbed in the scanning process, and envionmental humidity is lower than 60%, and the potassium bromide direct compression process detects.
CN 200810184579 2007-12-18 2008-12-17 Rhizoma alismatis dispensing granule as well as preparation method and quality control method thereof Pending CN101474318A (en)

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