CN105232717A - Preparation method and application of Soft fiber traditional Chinese medicine decocting-free preparation - Google Patents
Preparation method and application of Soft fiber traditional Chinese medicine decocting-free preparation Download PDFInfo
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Abstract
The invention provides a preparation method and application of a soft fiber traditional Chinese medicine decocting-free preparation and belongs to the technical field of traditional Chinese medicine preparation. The preparation method includes the sequential steps: subjecting traditional Chinese medicinal materials to dicing or slicing, boiling and pulping, carrying out ethanol extraction and ultrasonic-assisted extraction, performing inorganic ceramic membrane filtering, concentrating and spray-drying to obtain powder, sterilizing the powder, and performing vacuum packaging to obtain finished products. The problems that in extraction by a conventional single method, utilization of raw materials is low, effective ingredients are badly destructed and extraction efficiency is low are solved, and the prepared preparation is more convenient to use and is more suitable for modern people's quick life. The whole technical process is simple to control and green, various process steps are synergistic, the preparation method is higher in applicability and extraction efficiency, the active ingredients are protected effectively, and product utilization is better increased.
Description
Technical field
The invention belongs to Chinese drug preparation technique field, be specifically related to preparation method and application thereof that fiber soft quality Chinese crude drug exempts from fried dose.
Background technology
Chinese medicine is Chinese nation's crystallization of wisdom, for ensureing that people ' s health has made tremendous contribution.The traditional dosage form of Chinese medicine has pill, powder, unguentum, medicated wine etc., but the deficiencies such as conventional dosage forms majority exists, and taking dose is large, dosage form thick, appearance poor, along with the raising of social development and people's economic level, these deficiencies have seriously constrained the paces of Chinese medicine development, introduce high-tech, utilizing new technique to improve the quality of Chinese medicine, is one of important channel of innovation of Chinese medicinal dosage form.
Fiber soft quality Chinese crude drug general reference fibre-bearing and the stronger Chinese crude drug of toughness, as common Cortex Phellodendri, Radix Glycyrrhizae, Radix Puerariae, Radix Ginseng, Folium Ilicis etc., these medical materials toughness under general state is stronger, add pretreated difficulty, and deal with the extracted amount that can reduce effective ingredient improperly, cause unnecessary waste, especially for all the more so valuable ingredient of Chinese medicine.Current advanced technology, as superfine communication technique neither be very high to the crush efficiency of this type of Chinese medicine, and be different from conventional general crushing technology due to superfine communication technique, therefore different Chinese crude drugs is all needed to develop suitable disintegrating process, disintegrating apparatus, otherwise the extraction of active component can be made to have a greatly reduced quality, and this is also the major reason that restriction superfine communication technique is popularized.Therefore, find more flexibly, the preparation method being convenient to commercial production and extensive use is vital for the utilization of fiber soft quality Chinese crude drug.
Summary of the invention
Technical problem to be solved by this invention is, for the deficiencies in the prior art, provides a kind of efficacy stability, effectively extracts and protects the fiber soft quality Chinese crude drug of effective ingredient to exempt from the preparation method of fried dose.
For solving the problems of the technologies described above, the technical solution adopted in the present invention is: fiber soft quality Chinese crude drug exempts from the preparation method of fried dose, comprises the following steps:
1) by Chinese crude drug roguing, clean, drain, then cutting or section;
2) added in steaming pot and carry out steaming and decocting by the Chinese crude drug after cutting or section, steaming and decocting is to well-done;
3) proceed in beater by well-done Chinese crude drug, add water making beating, obtains slurry;
4) in step 3) gained slurry, the ethanol that volume ratio is 40 ~ 50% is added, the volume ratio controlling slurry and ethanol is 1:5 ~ 1:8, soak 30 ~ 45 minutes at 20 ~ 25 DEG C, then ultrasonic Treatment 20 ~ 30 minutes, filter, obtain alcohol extract and filtering residue, filtering residue is squeezed fluid, be incorporated in alcohol extract, the filtering residue after squeezing is proceeded in step 3);
5) by step 4) gained alcohol extract reclaim under reduced pressure ethanol to the greatest extent, utilize inorganic ceramic membrane filtration at 25 DEG C, obtain filtrate; When described filtrate being concentrated into 60 DEG C, relative density is the extractum of 1.05 ~ 1.12, and proceeded in spray drying device by described extractum and carry out spraying dry, obtain powder body, by powder body sterilizing, vacuum packaging, obtains fiber soft quality Chinese crude drug and exempt from fried dose.
Preferably, Chinese crude drug be cut into section or the sheet that greatest length is no more than 2 centimetres in described cutting or section.
Preferably, adding water described in step 3) is the water adding well-done Chinese crude drug quality 1 ~ 2 times.
Preferably, soaking described in step 4) is carry out dynamic soaking in steeping tank; Described dynamic soaking preferably arranges eccentric rabbling mechanism respectively in the upper and lower of described steeping tank.
Preferably, the process conditions of ultrasonic Treatment described in step 4) are: supersonic frequency 35 ~ 50kHz, ultrasonic power 500 ~ 600W.
Preferably, inorganic ceramic film described in step 5) is Al
2o
3ceramic membrane, aperture is 0.2 μm, and operation pressure reduction is 0.06 ~ 0.08MPa.
Present invention also offers above-mentioned preparation method gained fiber soft quality Chinese crude drug to exempt from fried dose and preparing the application in compound preparation, fiber soft quality Chinese crude drug is exempted from fried dose directly to add in described compound preparation, make pharmaceutically acceptable dosage form, comprise decoction, granule, tablet, capsule, injection, powder, unguentum, pill.
The feature of binding fiber soft quality Chinese crude drug of the present invention, in order to be come out by the active substance in Chinese crude drug cell wall as much as possible, is convenient to extract, take a series ofly to be closely connected, fruitful process means.Cutting or section are carried out to Chinese crude drug, medical material can be beneficial to and deposit and the processing of subsequent handling, then carry out steaming and decocting, medical material is ripe by changing, tenacity of fibre weakens, and process of then pulling an oar, adds water and can impel fibre swelling, cell rupture is accelerated in making beating, expose active substance, finally carry out ultrasonic assistant alcohol steep, increase the dissolution of active substance further, extract carries out spraying dry the most at last, obtains powder body.Whole process links closely step by step, mutually works in coordination with, and effectively increases the dissolution of active substance, improves the extraction efficiency of active component, prepares to be easy to carry, to use and exempt from flexibly to decoct powder.
Compared with prior art, its beneficial effect is in the present invention:
The Chinese crude drug that the present invention is directed to fiber soft quality processes, by the combination of cutting or section, steaming and decocting, making beating, alcohol steep and ultrasonic assistant, solve the problem that raw material availability when utilizing conventional single method to extract is low, effective ingredient destroys seriously and extraction efficiency is not high, being prepared into preparation uses more convenient, more adapts to the allegro life of modern people.Whole process control of the present invention is simple, environmental protection, each processing step Synergistic, and make preparation method universality of the present invention stronger, extraction efficiency is higher, and active component obtains available protecting, improves the availability of finished product preferably.
Detailed description of the invention
In order to understand the present invention better, set forth content of the present invention below in conjunction with embodiment is clear further, but protection content of the present invention is not only confined to the following examples.In the following description, a large amount of concrete details is given to provide more thorough understanding of the invention.But, it will be apparent to one skilled in the art that the present invention can be implemented without the need to these details one or more.In other example, in order to avoid obscuring with the present invention, technical characteristics more well known in the art are not described.
Fiber soft quality Chinese crude drug general reference fibre-bearing and the stronger Chinese crude drug of toughness, as Cortex Phellodendri, Radix Glycyrrhizae, Radix Puerariae, Radix Ginseng, Folium Ilicis etc.
1) by Chinese crude drug roguing, clean, drain, then cutting or section;
In this step, Chinese crude drug be cut into section or the sheet that greatest length is no more than 2 centimetres in described cutting or section; Drain, be by the Chinese crude drug nature drip-dry after cleaning or control dry;
2) added in steaming pot and carry out steaming and decocting by the Chinese crude drug after cutting or section, steaming and decocting is to well-done;
In this step, well-done decision method can be measure medical material central temperature method or by empirical methods such as color, abnormal smells from the patient changes: said steaming pot is Chinese medicine steaming pot;
3) proceed in beater by well-done Chinese crude drug, add water making beating, obtains slurry;
In this step, adding water described in is the water adding well-done Chinese crude drug quality 1 ~ 2 times; Said beater is Chinese medicine beater;
4) in step 3) gained slurry, the ethanol that volume ratio is 40 ~ 50% is added, the volume ratio controlling slurry and ethanol is 1:5 ~ 1:8, soak 30 ~ 45 minutes at 20 ~ 25 DEG C, then ultrasonic Treatment 20 ~ 30 minutes, filter, obtain alcohol extract and filtering residue, filtering residue is squeezed fluid, be incorporated in alcohol extract, the filtering residue after squeezing is proceeded in step 3);
In this step, described immersion carries out dynamic soaking in steeping tank, to make coarse powder fully mix with water, is in suspended dispersion, is beneficial to infiltration and subsequent treatment.This dynamic soaking arranges eccentric rabbling mechanism respectively in the upper and lower of described steeping tank.The process conditions of described ultrasonic Treatment are: supersonic frequency 35 ~ 50kHz, and ultrasonic power 500 ~ 600W can accelerate breaking of cell wall like this, strengthen the release of intracellular organic matter, diffusion and dissolving.
5) by step 4) gained alcohol extract reclaim under reduced pressure ethanol to the greatest extent, utilize inorganic ceramic membrane filtration at 25 DEG C, obtain filtrate; When described filtrate being concentrated into 60 DEG C, relative density is the extractum of 1.05 ~ 1.12, and proceeded to by extractum in spray drying device and carry out spraying dry, obtain powder body, by powder body sterilizing, vacuum packaging, must exempt from fried dose.
In this step, the most ethanol of reclaim under reduced pressure is this area routine operation technology; Described inorganic ceramic film is Al
2o
3ceramic membrane, aperture is 0.2 μm, and operation pressure reduction is 0.06 ~ 0.08MPa, through the process of inorganic ceramic membrane microfiltration, can remove the impurity such as tiny float, is further purified by extracting solution.Described concentrating is that filtrate is carried out vacuum-concentrcted, when being concentrated into 60 DEG C, relative density is the extractum of 1.05 ~ 1.12, can carry out in vacuum-concentrcted equipment, vacuum-concentrcted can reduce the boiling point of material, increase the temperature difference of steam and storeroom, improve concentrated speed, thermal loss is few, concentrate at low ambient temperatures, the loss of heat-sensitive materials can be prevented.Spraying dry generally divides three phases to complete: atomization-dry-be separated, completes in spray drying device; Wherein, be atomized and realized by nebulizer, the present invention adopts pneumatic atomizer, and drying completes in drying tower, dried material and air separation, collects and obtains fines.Gained fines is through sterilizing, and vacuum packaging, gets product.
Present invention also offers above-mentioned preparation method gained fiber soft quality Chinese crude drug and exempt from the fried dose of application comprised in the compound preparation of fiber soft quality Chinese crude drug in preparation, fiber soft quality Chinese crude drug is exempted from fried dose directly to add in described compound preparation, make any pharmaceutically acceptable dosage form, as decoction, granule, tablet, capsule, injection, powder, unguentum or pill.
Below by specific embodiment, those skilled in the art can be implemented.
Embodiment 1
The present embodiment illustrates for Cortex Phellodendri the preparation method that fiber soft quality Chinese crude drug of the present invention exempts from fried dose, carries out according to the following steps:
1) by Cortex Phellodendri roguing, clean, drain, be then cut into the segment that greatest length is no more than 2 centimetres;
2) added in steaming pot by the Cortex Phellodendri after cutting and carry out steaming and decocting, slowly heat when steaming and decocting starts, to boil and pressure remains between 38kPa to keeping micro-after boiling, steaming and decocting is advisable to well-done;
3) proceeded in Chinese medicine beater by well-done Cortex Phellodendri, the water adding well-done Cortex Phellodendri quality 1.5 times is pulled an oar, and obtains slurry;
4) in step 3) gained slurry, the ethanol that volume ratio is 40% is added, the volume ratio controlling slurry and ethanol is 1:6, soak 35 minutes at 20 ~ 25 DEG C, then ultrasonic Treatment 20 minutes, supersonic frequency 40kHz, ultrasonic power 500W, filter, obtain alcohol extract and filtering residue, filtering residue is squeezed fluid, be incorporated in alcohol extract, the filtering residue after squeezing is proceeded in step 3);
Said immersion carries out dynamic soaking in steeping tank, arranges eccentric rabbling mechanism respectively, to make coarse powder fully mix with water, be in suspended dispersion in the upper and lower of this steeping tank, is beneficial to infiltration and subsequent treatment.
5) by step 4) gained alcohol extract reclaim under reduced pressure ethanol to the greatest extent, at 25 DEG C, Al is utilized
2o
3ceramic membrane filter, the aperture of ceramic membrane used is 0.2 μm, and operation pressure reduction controls, at 0.07MPa, to obtain filtrate; When described filtrate being concentrated into 60 DEG C, relative density is the extractum of 1.08, and proceeded to by extractum in spray drying device and carry out spraying dry, obtain powder body, by powder body sterilizing, vacuum packaging, must exempt from fried dose.
The present embodiment Cortex Phellodendri is the bark of rutaceae Cortex Phellodendri or wampee, the medical material of gathering between 3 ~ June.
Embodiment 2
The present embodiment illustrates for Radix Glycyrrhizae the preparation method that fiber soft quality Chinese crude drug of the present invention exempts from fried dose, carries out according to the following steps:
1) by Radix Glycyrrhizae roguing, clean, drain, be then cut into the segment that greatest length is no more than 2 centimetres;
2) added in steaming pot by the Cortex Phellodendri after cutting and carry out steaming and decocting, slowly heat when steaming and decocting starts, to boil and pressure remains between 35kPa to keeping micro-after boiling, steaming and decocting is advisable to well-done;
3) proceeded in Chinese medicine beater by well-done Radix Glycyrrhizae, the water adding well-done Radix Glycyrrhizae quality 1 times is pulled an oar, and obtains slurry;
4) in step 3) gained slurry, the ethanol that volume ratio is 45% is added, the volume ratio controlling slurry and ethanol is 1:5, soak 45 minutes at 20 ~ 25 DEG C, then ultrasonic Treatment 25 minutes, supersonic frequency 35kHz, ultrasonic power 550W, filter, obtain alcohol extract and filtering residue, filtering residue is squeezed fluid, be incorporated in alcohol extract, the filtering residue after squeezing is proceeded in step 3);
Said immersion carries out dynamic soaking in steeping tank, arranges eccentric rabbling mechanism respectively, to make coarse powder fully mix with water, be in suspended dispersion in the upper and lower of this steeping tank, is beneficial to infiltration and subsequent treatment.
5) by step 4) gained alcohol extract reclaim under reduced pressure ethanol to the greatest extent, at 25 DEG C, Al is utilized
2o
3ceramic membrane filter, the aperture of ceramic membrane used is 0.2 μm, and operation pressure reduction controls, at 0.06MPa, to obtain filtrate; When described filtrate being concentrated into 60 DEG C, relative density is the extractum of 1.12, and proceeded to by extractum in spray drying device and carry out spraying dry, obtain powder body, by powder body sterilizing, vacuum packaging, must exempt from fried dose.
Radix Glycyrrhizae described in the present embodiment is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L..Spring, Qiu Erji excavate, the medical material after removing fibrous root.
Embodiment 3
The present embodiment illustrates for Radix Puerariae the preparation method that fiber soft quality Chinese crude drug of the present invention exempts from fried dose, carries out according to the following steps:
1) by Radix Puerariae roguing, clean, drain, be then cut into the segment that greatest length is no more than 2 centimetres;
2) added in steaming pot by the Radix Puerariae after cutting and carry out steaming and decocting, slowly heat when steaming and decocting starts, to boil and pressure remains between 40kPa to keeping micro-after boiling, steaming and decocting is advisable to well-done;
3) proceeded in Chinese medicine beater by well-done Radix Puerariae, the water adding well-done Radix Puerariae quality 2 times is pulled an oar, and obtains slurry;
4) in step 3) gained slurry, the ethanol that volume ratio is 50% is added, the volume ratio controlling slurry and ethanol is 1:5 ~ 1:8, soak 40 minutes at 20 ~ 25 DEG C, then ultrasonic Treatment 30 minutes, supersonic frequency 50kHz, ultrasonic power 600W, filter, obtain alcohol extract and filtering residue, filtering residue is squeezed fluid, be incorporated in alcohol extract, the filtering residue after squeezing is proceeded in step 3);
Said immersion carries out dynamic soaking in steeping tank, arranges eccentric rabbling mechanism respectively, to make coarse powder fully mix with water, be in suspended dispersion in the upper and lower of this steeping tank, is beneficial to infiltration and subsequent treatment.
5) by step 4) gained alcohol extract reclaim under reduced pressure ethanol to the greatest extent, at 25 DEG C, Al is utilized
2o
3ceramic membrane filter, the aperture of ceramic membrane used is 0.2 μm, and operation pressure reduction controls, at 0.08MPa, to obtain filtrate; When described filtrate being concentrated into 60 DEG C, relative density is the extractum of 1.05, and proceeded to by extractum in spray drying device and carry out spraying dry, obtain powder body, by powder body sterilizing, vacuum packaging, must exempt from fried dose.
The present embodiment Radix Puerariae used is the tuber of leguminous plant Pueraria lobota, and spring, autumn excavate, and cleans, the medical material after removing crust.
Embodiment 4
The present embodiment illustrates for Radix Ginseng the preparation method that fiber soft quality Chinese crude drug of the present invention exempts from fried dose, carries out according to the following steps:
1) by Radix Ginseng roguing, clean, drain, be then cut into the segment that greatest length is no more than 2 centimetres;
2) added in steaming pot by the Radix Ginseng after cutting and carry out steaming and decocting, slowly heat when steaming and decocting starts, to boil and pressure remains between 42kPa to keeping micro-after boiling, steaming and decocting is advisable to well-done;
3) proceeded in Chinese medicine beater by well-done Radix Ginseng, the water adding well-done Ginseng Quality 1 times is pulled an oar, and obtains slurry;
4) in step 3) gained slurry, the ethanol that volume ratio is 40% is added, the volume ratio controlling slurry and ethanol is 1:8, soak 45 minutes at 20 ~ 25 DEG C, then ultrasonic Treatment 20 minutes, supersonic frequency 45kHz, ultrasonic power 580W, filter, obtain alcohol extract and filtering residue, filtering residue is squeezed fluid, be incorporated in alcohol extract, the filtering residue after squeezing is proceeded in step 3);
Said immersion carries out dynamic soaking in steeping tank, arranges eccentric rabbling mechanism respectively, to make coarse powder fully mix with water, be in suspended dispersion in the upper and lower of this steeping tank, is beneficial to infiltration and subsequent treatment.
5) by step 4) gained alcohol extract reclaim under reduced pressure ethanol to the greatest extent, at 25 DEG C, Al is utilized
2o
3ceramic membrane filter, the aperture of ceramic membrane used is 0.2 μm, and operation pressure reduction controls, at 0.07MPa, to obtain filtrate; When described filtrate being concentrated into 60 DEG C, relative density is the extractum of 1.10, and proceeded to by extractum in spray drying device and carry out spraying dry, obtain powder body, by powder body sterilizing, vacuum packaging, must exempt from fried dose.
The present embodiment Radix Ginseng used is the root of araliaceae ginseng plant's Radix Ginseng, the wild ginseng of excavating autumn.
Embodiment 5
The present embodiment illustrates for Folium Ilicis the preparation method that fiber soft quality Chinese crude drug of the present invention exempts from fried dose, carries out according to the following steps:
1) by Folium Ilicis roguing, clean, drain, be then cut into the sheet that greatest length is no more than 2 centimetres;
2) added in steaming pot by the Folium Ilicis after cutting and carry out steaming and decocting, slowly heat when steaming and decocting starts, to boil and pressure remains between 42kPa to keeping micro-after boiling, steaming and decocting is advisable to well-done;
3) proceeded in Chinese medicine beater by well-done Folium Ilicis, the water adding well-done Folium Ilicis quality 1.5 times is pulled an oar, and obtains slurry;
4) in step 3) gained slurry, the ethanol that volume ratio is 50% is added, the volume ratio controlling slurry and ethanol is 1:6, soak 35 minutes at 20 ~ 25 DEG C, then ultrasonic Treatment 28 minutes, supersonic frequency 40kHz, ultrasonic power 550W, filter, obtain alcohol extract and filtering residue, filtering residue is squeezed fluid, be incorporated in alcohol extract, the filtering residue after squeezing is proceeded in step 3);
Said immersion carries out dynamic soaking in steeping tank, arranges eccentric rabbling mechanism respectively, to make coarse powder fully mix with water, be in suspended dispersion in the upper and lower of this steeping tank, is beneficial to infiltration and subsequent treatment.
5) by step 4) gained alcohol extract reclaim under reduced pressure ethanol to the greatest extent, at 25 DEG C, Al is utilized
2o
3ceramic membrane filter, the aperture of ceramic membrane used is 0.2 μm, and operation pressure reduction controls, at 0.06MPa, to obtain filtrate; When described filtrate being concentrated into 60 DEG C, relative density is the extractum of 1.12, and proceeded to by extractum in spray drying device and carry out spraying dry, obtain powder body, by powder body sterilizing, vacuum packaging, must exempt from fried dose.
The said Folium Ilicis of the present embodiment is the leaf of holly plant Ilex cornuta Lindl. and Cortex Ilicis Rotundae, without the process of preparing Chinese medicine.
Below by experiment embodiment, beneficial effect of the present invention is described.Make up a prescription because traditional Chinese medicine formula is generally decoction, between each medicine, interactively is complicated, and adopts and exempt from fried dose and whether can obtain same or better effect, and applicant has done long-term clinical research to this, what the application enumerated is only certain embodiments.
Drug efficacy study
1) to treat the oral traditional Chinese medicine decoction of cervical spondylosis
Chinese medicine formula: Radix Puerariae 18g, Radix Paeoniae Alba 18g, Herba Ephedrae 6g, Ramulus Cinnamomi 9g, 3, Rhizoma Zingiberis Recens, 4 pieces, Fructus Jujubae.
Contrast method: get it filled with above-mentioned formula, adds in Decocting pot to decoct and makes decoction I.
The inventive method: get Radix Paeoniae Alba 18g, Herba Ephedrae 6g, Ramulus Cinnamomi 9g, 3, Rhizoma Zingiberis Recens, 4 pieces, Fructus Jujubae adds in Decocting pot to decoct makes decoction; By the inventive method, 18g Radix Puerariae is made Radix Puerariae and exempt from fried dose; Radix Puerariae being exempted from fried dose adds in the decoction that all the other Chinese medicines make, and heated and stirred is dissolved, and makes decoction II.
Lanqin oral solutions:
Choose Patients with Cervical Spondylopathy 84 example between 21 ~ 60 years old, all with aching pain of muscles after neck, rotary head inconvenience is chief complaint, exacerbation of symptoms after permanent seat work; Men and women does not limit; The regular further consultation of patient, omnidistance medication.
Above-mentioned 84 routine patients are divided into 2 groups at random, often organize 42 examples; Respectively by taking decoction I (matched group) and decoction II (experimental group) in identical dosage at one time section, decoction being taken warmly 1 time sooner or later, a 150ml, continuous use 1 week is 1 course for the treatment of, observes 4 courses for the treatment of.
Evaluation index: recovery from illness: subjective symptoms disappears, and cervical region activity is accessible, musculi colli tenderness disappears, and X sheet cervical vertebra is normal; Effective: most of transference cure, cervical region activity is normal, and X sheet cervical vertebra does not recover physiological camber; Invalid: symptom and sign does not improve, or increase the weight of.
Shown in statistical result sees the following form:
Table 1 liang group Clinical efficacy comparison
| Group | Number of cases | Recovery from illness | Effective | Invalid |
| Matched group | 42 | 38 | 3 | 1 |
| Experimental group | 42 | 39 | 2 | 1 |
Found out by table 1, experimental group is slightly better than matched group, and the drug effect adopting method of the present invention not reduce Radix Puerariae is described, Radix Puerariae namely prepared according to the methods of the invention is exempted from fried dose of its drug effect and maintained better, and active component obtains protection preferably and extracts.
2) to treat the Orally-administered decoction of ulcerative colitis
Chinese medicine formula: Radix Puerariae 20g, Fructus Mume 12g, Radix Sanguisorbae 15g, Cortex Phellodendri 9g, Radix Saposhnikoviae 9g, Radix Paeoniae Alba 12g, Rhizoma Atractylodis Macrocephalae 12g, Radix Codonopsis 20g, Radix Glycyrrhizae 9g.
Contrast method: the prepared slices of Chinese crude drugs taking above-mentioned formulation weight, adds in decocting for Chinese herbal medicine tank to decoct and makes decoction I.
The inventive method: get Fructus Mume 12g, Radix Sanguisorbae 15g, Radix Saposhnikoviae 9g, Radix Paeoniae Alba 12g, Rhizoma Atractylodis Macrocephalae 12g, Radix Codonopsis 20g, add in decocting for Chinese herbal medicine tank to decoct and make decoction, get Radix Puerariae 20g, Cortex Phellodendri 9g, Radix Glycyrrhizae 9g to be prepared into according to the inventive method respectively and to exempt from fried dose, then Radix Puerariae is exempted from fried dose, Cortex Phellodendri exempts from fried dose and Radix Glycyrrhizae and exempt from fried dose and add in the decoction made successively, stirring and dissolving, obtained granule II.
Lanqin oral solutions:
Choose 70 routine patients of ulcerative colitis, the age is all between 25 ~ 62 years old.Above-mentioned 70 routine patients are divided into 2 groups at random, often organize 35 examples; Respectively by taking granule I (matched group) and granule II (experimental group) in identical dosage at one time section, continuous use one week is 1 course for the treatment of, observes 5 courses for the treatment of.
Criterion of therapeutical effect: effective: diarrhoea blood, pus and mucus just disappear, or colonoscope check comparatively mucosa rehabilitation healing 80% before treatment; Improvement: diarrhoea stomachache basic controlling, or the colonoscope check comparatively front mucosa rehabilitation healing 60% for the treatment of; Invalid: symptom and sign is without improvement.
Shown in statistical result sees the following form:
Table 2 liang group Clinical efficacy comparison
| Group | Number of cases | Effective | Take a turn for the better | Invalid |
| Matched group | 35 | 22 | 10 | 3 |
| Experimental group | 35 | 22 | 12 | 1 |
As can be seen from Table 2; experimental group curative effect is compared to matched group; although the preparation method of medicine is different; but curative effect does not go down; and have the trend of well matched group; this illustrates that prepared according to the methods of the invention fried dose of its drug effect of exempting from maintains better, and active component obtains protection preferably and extracts.
Above-mentioned clinical research can obviously be found out, fiber soft quality Chinese crude drug prepared by the present invention is exempted from fried dose and can be applied to and prepare compound preparation, namely the Chinese medicine decoction comprising fiber soft quality Chinese crude drug fat/fiber soft quality Chinese medicinal material extract can be prepared into, same, also can be prepared into granule, tablet, capsule, injection, powder, unguentum, pill, not enumerate in this application.
Claims (7)
1. fiber soft quality Chinese crude drug exempts from the preparation method of fried dose, it is characterized in that, comprises the following steps:
1) by Chinese crude drug roguing, clean, drain, then cutting or section;
2) added in steaming pot and carry out steaming and decocting by the Chinese crude drug after cutting or section, steaming and decocting is to well-done;
3) proceed in beater by well-done Chinese crude drug, add water making beating, obtains slurry;
4) in step 3) gained slurry, the ethanol that volume ratio is 40 ~ 50% is added, the volume ratio controlling slurry and ethanol is 1:5 ~ 1:8, soak 30 ~ 45 minutes at 20 ~ 25 DEG C, then ultrasonic Treatment 20 ~ 30 minutes, filter, obtain alcohol extract and filtering residue, filtering residue is squeezed fluid, be incorporated in alcohol extract, the filtering residue after squeezing is proceeded in step 3);
5) by step 4) gained alcohol extract reclaim under reduced pressure ethanol to the greatest extent, utilize inorganic ceramic membrane filtration at 25 DEG C, obtain filtrate; When described filtrate being concentrated into 60 DEG C, relative density is the extractum of 1.05 ~ 1.12, and proceeded in spray drying device by described extractum and carry out spraying dry, obtain powder body, by powder body sterilizing, vacuum packaging, obtains fiber soft quality Chinese crude drug and exempt from fried dose.
2. fiber soft quality Chinese crude drug as claimed in claim 1 exempts from the preparation method of fried dose, it is characterized in that: Chinese crude drug be cut into section or the sheet that greatest length is no more than 2 centimetres in described cutting or section.
3. fiber soft quality Chinese crude drug as claimed in claim 1 exempts from the preparation method of fried dose, it is characterized in that: adding water described in step 3) is the water adding well-done Chinese crude drug quality 1 ~ 2 times.
4. fiber soft quality Chinese crude drug as claimed in claim 1 exempts from the preparation method of fried dose, it is characterized in that: soaking described in step 4) is carry out dynamic soaking in steeping tank.
5. fiber soft quality Chinese crude drug as claimed in claim 1 exempts from the preparation method of fried dose, it is characterized in that: the process conditions of ultrasonic Treatment described in step 4) are: supersonic frequency 35 ~ 50kHz, ultrasonic power 500 ~ 600W.
6. fiber soft quality Chinese crude drug as claimed in claim 1 exempts from the preparation method of fried dose, it is characterized in that: inorganic ceramic film described in step 5) is Al
2o
3ceramic membrane, aperture is 0.2 μm, and operation pressure reduction is 0.06 ~ 0.08MPa.
7. fiber soft quality Chinese crude drug prepared by the preparation method as described in any one of claim 1 ~ 6 exempts from the application of fried dose, it is characterized in that: described fiber soft quality Chinese crude drug is exempted from fried dose and directly adds in compound preparation, make pharmaceutically acceptable dosage form, comprise decoction, granule, tablet, capsule, injection, powder, unguentum, pill.
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