CN101474290A - Figwort root dispensing granule as well as preparation method and quality control method thereof - Google Patents
Figwort root dispensing granule as well as preparation method and quality control method thereof Download PDFInfo
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- CN101474290A CN101474290A CN 200810184570 CN200810184570A CN101474290A CN 101474290 A CN101474290 A CN 101474290A CN 200810184570 CN200810184570 CN 200810184570 CN 200810184570 A CN200810184570 A CN 200810184570A CN 101474290 A CN101474290 A CN 101474290A
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Abstract
The invention discloses a figwort prescription granule, a preparation method and a quality control method thereof. The prescription granule takes figwort decoction pieces as the raw materials and the figwort prescription granule is prepared through the process flows of twice water extraction, vaccum concentration, sponging drying, etc; 1g of the figwort prescription granule is equal to 3-5g of crude drug; the quality of both figwort decoction pieces and figwort prescription granule are identified by infrared fingerprint spectra. The figwort prescription granule of the invention has complete and advanced production process, specific and controllable quality control standard, scientific, advanced and fast detecting method related to the quality standard and strong operability. A great number of experiments, the prepared soup of the figwort prescription granule of the invention and the mixed simmered liquid of the classical prescription decoction pieces containing figwort have equal components, thus realizing the technique of full ingredient prescription granule and proving the rationality of the technique of the invention; furthermore, the invention applies the technology of infrared spectroscopy technology to the quality control of the traditional Chinese medicines, rapidly solving the primary problem in the macro quality control of the traditional Chinese medicines---the identification of the truth of the traditional Chinese medicines.
Description
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 Radix Scrophulariae 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 Radix Scrophulariae 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 Radix Scrophulariae granule of the present invention 3-5 gram, the Infrared fingerprint spectra of this granule such as Fig. 1.The preparation method of Radix Scrophulariae granule of the present invention comprises: get the Radix Scrophulariae decoction pieces, use twice of water extraction; Wherein the Radix Scrophulariae decoction pieces adopts Infrared fingerprint spectra to carry out quality discrimination, Radix Scrophulariae decoction pieces standard Infrared fingerprint spectra such as Fig. 2.
The preparation method of Radix Scrophulariae granule of the present invention comprises the steps: to get the Radix Scrophulariae 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 Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The Radix Scrophulariae spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Radix Scrophulariae spray drying powder, 20-60 purpose Radix Scrophulariae granule.
The preparation method of Radix Scrophulariae granule of the present invention is preferably as follows step: get the Radix Scrophulariae 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 Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The Radix Scrophulariae spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Radix Scrophulariae spray drying powder, 20-60 purpose Radix Scrophulariae granule.
The preparation method of Radix Scrophulariae granule of the present invention is preferably as follows step: get the Radix Scrophulariae 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 Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The Radix Scrophulariae spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Radix Scrophulariae spray drying powder, 20-60 purpose Radix Scrophulariae granule.
The preparation method of Radix Scrophulariae granule of the present invention is preferably as follows step: get the Radix Scrophulariae 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 Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The Radix Scrophulariae spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Radix Scrophulariae spray drying powder, 20-60 purpose Radix Scrophulariae 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: the 0.4-0.6MPa speed of mainshaft: 300-500 rev/mins; Feed voltage: 100-150V; Granular size: 20-60 order.
The method of quality control of Radix Scrophulariae granule of the present invention comprises the steps: that the Radix Scrophulariae 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; Radix Scrophulariae granule Infrared fingerprint spectra has following feature: as shown in Figure 1 at 1026cm
-1Absorption maximum is arranged, and this absworption peak is stairstepping, and its absorption is 1026cm from high to low
-1, 1076cm
-1, 1149cm
-1At 2929cm
-1, 1631cm
-1, 1415cm
-1There is characteristic absorption at the place.
The method of quality control of the Radix Scrophulariae decoction pieces described in the Radix Scrophulariae granule preparation method of the present invention comprises the steps: that the Radix Scrophulariae decoction pieces is the certified products that meet a regulation of Pharmacopoeia of the People's Republic of China version in 2005; The Radix Scrophulariae 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 Radix Scrophulariae decoction pieces has following feature: as shown in Figure 2 at 1052cm
-1Absorption maximum is arranged, and there are two more weak absworption peaks these absworption peak both sides; At 2928cm
-1, 1643cm
-1, 1421cm
-1, 1255cm
-1, 799cm
-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 Radix Scrophulariae granule;
Fig. 2: the Infrared fingerprint spectra of Radix Scrophulariae decoction pieces Radix Scrophulariae;
Fig. 3: Radix Scrophulariae granule and Radix Scrophulariae decoction pieces thin layer chromatography are relatively;
Fig. 4: Radix Scrophulariae granule and Radix Scrophulariae decoction pieces thin-layer sample Infrared fingerprint spectra are relatively;
Fig. 5: contain Radix Scrophulariae classics side decoction pieces decocting liquid and Radix Scrophulariae soup that granule is joined " whole part " infrared spectrogram relatively.
Complete, advanced production technology that radix scrophulariae 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 radix scrophulariae medicine materical crude slice Allusion quotation side's medicine materical crude slice closes decocting liquid and radix scrophulariae soup that granule is joined of the present invention " full composition " infrared spectrogram, and is right Compare radix scrophulariae granule of the present invention and radix scrophulariae medicine materical crude slice thin-layer chromatogram, contrasted radix scrophulariae granule and profound Ginseng 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 radix scrophulariae medicine materical crude slice close decocting liquid with Radix scrophulariae 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 radix scrophulariae soup that granule is joined of the present invention and medicine materical crude slice, and the present invention is profound Infrared finger print atlas peak shape, peak position, the Relative Peak intensity basic one of ginseng granule and medicine materical crude slice thin-layer sample Cause, so radix scrophulariae 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) radix scrophulariae granule and radix scrophulariae medicine materical crude slice thin-layer chromatography are relatively
Differentiate a lower thin-layered chromatography according to middle radix scrophulariae of Pharmacopoeia of the People's Republic of China version in 2005 Test prepares sample with radix scrophulariae medicine materical crude slice and radix scrophulariae granule, measures acquired results such as Fig. 3 Shown in, in the radix scrophulariae granule chromatogram, with the corresponding position of radix scrophulariae medicine materical crude slice chromatogram on, aobvious identical The spot of color.
(2) radix scrophulariae granule and radix scrophulariae medicine materical crude slice thin-layer sample infrared finger print atlas are relatively
Measure the radix scrophulariae medicine materical crude slice of preparation in (1) and radix scrophulariae prescription with FTIS The thin-layer sample of grain is measured with FTIS. Its result as shown in Figure 4, and is profound Thin-layer sample infrared finger print atlas peak shape, peak position, the Relative Peak of ginseng granule and radix scrophulariae medicine materical crude slice are strong Spend basically identical.
The result proves that radix scrophulariae granule of the present invention is consistent with radix scrophulariae medicine materical crude slice composition, and technology of the present invention is to close Reason.
Experimental example 2 contains radix scrophulariae classics side medicine materical crude slice decocting liquid and radix scrophulariae soup that granule is joined " full composition " infrared spectrogram comparative experiments
Zengye Tang comes from " the warm disease bar is distinguished ", and prescription forms and comprises radix scrophulariae, the tuber of dwarf lilyturf, 3 flavour of a drug of glutinous rehmannia; Effect increases liquid and moisturizes.
1, experiment purpose: the similarities and differences of research Zengye Tang medicine materical crude slice decocting liquid and granular recipe, determine the radix scrophulariae prescription The reasonability of particle technology and equivalent.
2, experimental technique: get 3 flavour of a drug prescriptions such as radix scrophulariae by Zengye Tang prescription proportioning, press the medicine materical crude slice decoction Decocting method decoct preparation medicine materical crude slice decocting liquid sample; Get except radix scrophulariae respectively by Zengye Tang prescription proportioning in addition Other medicine materical crude slice, the decocting method of pressing the medicine materical crude slice decoction decocts, and soup suitably concentrates, and presses Zengye Tang prescription proportioning Get the radix scrophulariae granule with equivalent relation and add in the concentrated medicament, be stirred to fully dissolving, the preparation particle is joined The quadrat sampling product; Drinking respectively sheet decocting liquid sample, granular recipe sample carries out infrared spectrum and detects.
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 94.05%.It is consistent to prove that Radix Scrophulariae soup that granule is joined of the present invention and decoction pieces close the decocting liquid composition, it is consistent with a Radix Scrophulariae decoction pieces fried composition promptly to add Radix Scrophulariae granule of the present invention, and equivalent and production technology that Radix Scrophulariae granule 1g of the present invention is equivalent to Radix Scrophulariae decoction pieces 3-5g are rational.
Following embodiment all can realize the effect of above-mentioned experimental example, and required Radix Scrophulariae decoction pieces adopts Infrared fingerprint spectra to carry out quality discrimination among the following embodiment, meets the standard Infrared fingerprint spectra of the Radix Scrophulariae decoction pieces in the technique scheme; The Radix Scrophulariae granule that following embodiment makes adopts Infrared fingerprint spectra to carry out quality discrimination, meets the Infrared fingerprint spectra of the Radix Scrophulariae granule in the technique scheme; The every gram of Radix Scrophulariae granule described in the following embodiment contains suitable crude drug amount 3-5g.
The specific embodiment
Embodiment 1: the Radix Scrophulariae granule
Get Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The adjuvant dextrin that in the Radix Scrophulariae spray drying powder, adds himself weight portion 0-5%; The Radix Scrophulariae 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 Radix Scrophulariae granule, suitable crude drug amount 5 grams of the every gram of Radix Scrophulariae granule.
Embodiment 2: the Radix Scrophulariae granule
Get Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The adjuvant dextrin that in the Radix Scrophulariae 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 Radix Scrophulariae granule, suitable crude drug amount 4 grams of the every gram of Radix Scrophulariae granule;
The method of quality control of wherein said Radix Scrophulariae decoction pieces comprises the steps: that the Radix Scrophulariae 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 Radix Scrophulariae decoction pieces has following feature: as shown in Figure 2 at 1052cm
-1Absorption maximum is arranged, and there are two more weak absworption peaks these absworption peak both sides; At 2928cm
-1, 1643cm
-1, 1421cm
-1, 1255cm
-1, 799cm
-1There is characteristic absorption at the place.
Embodiment 3: the Radix Scrophulariae granule
Get Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The lactose that in the Radix Scrophulariae 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 Radix Scrophulariae granule, suitable crude drug amount 3 grams of the every gram of Radix Scrophulariae granule;
The method of quality control of gained Radix Scrophulariae 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; Radix Scrophulariae granule Infrared fingerprint spectra has following feature: as shown in Figure 1 at 1026cm
-1Absorption maximum is arranged, and this absworption peak is stairstepping, and its absorption is 1026cm from high to low
-1, 1076cm
-1, 1149cm
-1At 2929cm
-1, 1631cm
-1, 1415cm
-1There is characteristic absorption at the place.
Claims (9)
1, a kind of Radix Scrophulariae granule is characterized in that the suitable crude drug amount of the every gram of described Radix Scrophulariae granule 3-5 gram.
2, a kind of Radix Scrophulariae granule is characterized in that this Radix Scrophulariae granule Infrared fingerprint spectra has following feature: adopt Fourier transform infrared spectrometer to measure, at 1026cm
-1Absorption maximum is arranged, and this absworption peak is stairstepping, and its absorption is 1026cm from high to low
-1, 1076cm
-1, 1149cm
-1At 2929cm
-1, 1631cm
-1, 1415cm
-1There is characteristic absorption at the place.
3, Radix Scrophulariae granule as claimed in claim 1 is characterized in that the Infrared fingerprint spectra of this granule has following feature: at 1026cm
-1Absorption maximum is arranged, and this absworption peak is stairstepping, and its absorption is 1026cm from high to low
-1, 1076cm
-1, 1149cm
-1At 2929cm
-1, 1631cm
-1, 1415cm
-1There is characteristic absorption at the place.
4, a kind of preparation method of Radix Scrophulariae granule is characterized in that this method comprises a kind of in the following method:
Get the Radix Scrophulariae 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 Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The Radix Scrophulariae spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Radix Scrophulariae spray drying powder, the Radix Scrophulariae granule;
Or get the Radix Scrophulariae 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 Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The Radix Scrophulariae spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Radix Scrophulariae spray drying powder, the Radix Scrophulariae granule;
Or get the Radix Scrophulariae 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 Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The Radix Scrophulariae spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Radix Scrophulariae spray drying powder, the Radix Scrophulariae granule;
Or get the Radix Scrophulariae 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 Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The Radix Scrophulariae spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Radix Scrophulariae spray drying powder, the Radix Scrophulariae granule.
5, the preparation method of Radix Scrophulariae 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 Radix Scrophulariae granule as claimed in claim 4 is characterized in that wherein the quality discrimination of Radix Scrophulariae 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 Radix Scrophulariae decoction pieces has following feature: at 1052cm
-1Absorption maximum is arranged, and there are two more weak absworption peaks these absworption peak both sides; At 2928cm
-1, 1643cm
-1, 1421cm
-1, 1255cm
-1, 799cm
-1There is characteristic absorption at the place.
7, a kind of preparation method of Radix Scrophulariae granule is characterized in that this method comprises a kind of in the following method:
Get the Radix Scrophulariae 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 Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The Radix Scrophulariae spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Radix Scrophulariae spray drying powder, 20-60 purpose Radix Scrophulariae granule; Wherein the Radix Scrophulariae 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 Radix Scrophulariae decoction pieces has following feature: at 1052cm
-1Absorption maximum is arranged, and there are two more weak absworption peaks these absworption peak both sides; At 2928cm
-1, 1643cm
-1, 1421cm
-1, 1255cm
-1, 799cm
-1There is characteristic absorption at the place;
Or get the Radix Scrophulariae 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 Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The Radix Scrophulariae spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Radix Scrophulariae spray drying powder, 20-60 purpose Radix Scrophulariae granule; Wherein the Radix Scrophulariae 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 Radix Scrophulariae decoction pieces has following feature: at 1052cm
-1Absorption maximum is arranged, and there are two more weak absworption peaks these absworption peak both sides; At 2928cm
-1, 1643cm
-1, 1421cm
-1, 1255cm
-1, 799cm
-1There is characteristic absorption at the place;
Or get the Radix Scrophulariae 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 Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The Radix Scrophulariae spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Radix Scrophulariae spray drying powder, 20-60 purpose Radix Scrophulariae granule; Wherein the Radix Scrophulariae 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 Radix Scrophulariae decoction pieces has following feature: at 1052cm
-1Absorption maximum is arranged, and there are two more weak absworption peaks these absworption peak both sides; At 2928cm
-1, 1643cm
-1, 1421cm
-1, 1255cm
-1, 799cm
-1There is characteristic absorption at the place;
Or get the Radix Scrophulariae 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 Radix Scrophulariae 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 Radix Scrophulariae spray drying powder; The Radix Scrophulariae spray drying powder is directly granulated or add adjuvant dextrin or the lactose dry granulation of himself weight portion 0-25% in the Radix Scrophulariae spray drying powder, 20-60 purpose Radix Scrophulariae granule; Wherein the Radix Scrophulariae 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 Radix Scrophulariae decoction pieces has following feature: at 1052cm
-1Absorption maximum is arranged, and there are two more weak absworption peaks these absworption peak both sides; At 2928cm
-1, 1643cm
-1, 1421cm
-1, 1255cm
-1, 799cm
-1There is characteristic absorption at the place.
8, the preparation method of Radix Scrophulariae 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 Radix Scrophulariae 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.
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