CN103520298A - Traditional Chinese medicine granules having effects of harmonizing liver and spleen, resisting inflammation and alleviating pains and preparation method thereof - Google Patents
Traditional Chinese medicine granules having effects of harmonizing liver and spleen, resisting inflammation and alleviating pains and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to traditional Chinese medicine granules having effects of harmonizing liver and spleen, resisting inflammation and alleviating pains. The traditional Chinese medicine granules comprise the raw materials: 3 parts by weight of white peony root stir-fried with vinegar and bran, and 2 parts by weight of honey moistened licorice root. The invention also provides a preparation method of the traditional Chinese medicine granules. The traditional Chinese medicine granules prepared by the method have outstanding effects of harmonizing liver and spleen, resisting inflammation and alleviating pains. Pharmacology experiments and clinical application results show that the granules have liver protective effect, digestive system inflammation resisting effect, and emergency relieving and pains alleviating effect and other efficacies. In addition, because of selection of the specific processed products and the specific proportion of the raw materials and with addition of improvement of the refining method, the granules have simple and feasible whole method and low cost, and are more suitable for industrialized mass production; and moreover, the granules have the advantages of convenient taking and good taste because of retention of more active ingredients.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of Chinese medicine granules with regulating the liver and spleen, anti-inflammatory analgesic effect and preparation method thereof.
Background technology
Incoordination between the liver and spleen card is the liver failing to maintain the normal flow of QI, dysfunction of the spleen in transportation, two dirty relations imbalances, the disease due to dysfunction.How unsuccessful by feelings will, strongly fragrant impairing the liver of a specified duration, or drinking and eating irregularly, overstrain impairing the spleens etc. cause.The clinical manifestation of incoordination between the liver and spleen is: fullness and distention in the chest and hypochondrium or alter pain, time want large breath, depressed emotion or being irritable and getting angry easily, inappetence, abdominal distention loose stool, or ictal abdominal pain diarrhea, tongue fur is white or greasy, stringy pulse.Fullness and distention in the chest and hypochondrium is altered pain, sighing frequently, depressed emotion; Or being irritable and getting angry easily, indigestion and loss of appetite abdominal distention, loose stool is not well, and gas is vowed in borborygmus; Or suffer from abdominal pain and want to rush down, rush down rear alleviation of pain; Tongue fur is white or greasy, stringy pulse.Incoordination between the liver and spleen card, alters pain with fullness and distention in the chest and hypochondrium, and indigestion and loss of appetite abdominal distention loose stool is dialectical main points.
Modern is along with the quickening of the increase of life stress and life speed, and the symptom of the incoordination between the liver and spleen causing because of reasons such as operating pressure is large, it is irregular to live, drinking and eating irregularly emerges in an endless stream; The lighter's gastrointestinal upset, severe one can cause acute abdomen because of incoordination between the liver and spleen, the intestines and stomach spasm, even life-threatening.
At present, chemicals or health product in regulating the liver and spleen, the treatment of anti-inflammatory analgesic disease are less, and all have toxic and side effects in various degree, as GI irritation, renal dysfunction etc., and may cause related complication.Studies confirm that, adopt Chinese medicine regulating the liver and spleen, spasmolytic antiinflammatory, relieving spasm to stop pain to there is obvious advantage, be day by day subject to the generally attention of Chinese scholars.
Nearly tens kinds of the conventional Chinese crude drugs with regulating the liver and spleen, anti-inflammatory analgesic effect.Wherein, peony and licorice decoction comes from Eastern Han Dynasty's Zhang Zhongjing treatise on Febrile Diseases TAI YANG syndrome piece of writing, each four liang, Radix Paeoniae Radix Glycyrrhizae, consists of, and pharmaceutical formulation is simple, is but the classics recipe of easing the affected liver yin fluid astringing, relieving spasm to stop pain.Later age, doctor very praised highly we, attached great importance to this side's change and cut out utilization.Along with the development of modern pharmacology and clinical research, for we, carried out research many-sided, multi-angle, comprise the adjustment of medical material compatibility consumption, effective ingredient screening, pharmacological effect checking etc., obtained a large amount of achievements.For example the superfine people of Zheng Fu has carried out experimentation to the analgesic activity of the different proportion compatibilities of peony and licorice decoction, the people such as Zhong Zhiyong have carried out the checking of orthogonal experiment to the best proportioning of peony and licorice decoction, the people such as Zhang Zhaowang are studied the impact of drug effect the material processing mode of peony and licorice decoction, the people such as Zhang Jingze take orthogonal experiment to carry out preferably to the extraction process of peoniflorin in peony and licorice decoction, etc.
But, present inventor is surprised to find that at laboratory, by selecting crude drug, concoct the new combination of mode, obtained the more significant product of effect, the inventor has further screened applicable preparation method, and its effect has been confirmed in chamber pharmacological evaluation and clinical experiment by experiment, and then obtained the present invention.Product of the present invention has excellent synergistic function, has retained more active component, and meanwhile, preparation method is simple and easy, is suitable for industrialized great production, and good mouthfeel is suitable for taking.
Summary of the invention
An object of the present invention is to provide a kind of Chinese medicine granules with regulating the liver and spleen, anti-inflammatory analgesic effect, this granule determined curative effect, taking convenience, good mouthfeel.
Another object of the present invention is to provide the preparation method of above-mentioned regulating the liver and spleen, anti-inflammatory analgesic effect Chinese medicine granules.
The crude drug of Chinese medicine granules of the present invention is as follows:
The vinegar parched with bran Radix Paeoniae Alba 1～4 weight portion, honey profit Radix Glycyrrhizae 0.5～4 weight portion.
Further, the vinegar parched with bran Radix Paeoniae Alba 2～4 weight portions, honey profit Radix Glycyrrhizae 1～3 weight portion.
Further, the vinegar parched with bran Radix Paeoniae Alba 2～3 weight portions, honey profit Radix Glycyrrhizae 1～2 weight portion.
More specifically, the vinegar parched with bran Radix Paeoniae Alba 3 weight portions, honey profit Radix Glycyrrhizae 2 weight portions.
Wherein, the vinegar parched with bran Radix Paeoniae Alba, for Radix Paeoniae Alba sheet is with after rice vinegar spray, fries to micro-Huang with slow fire with bran, and sieve removes Testa Tritici, dries in the air cool, obtains.The consumption of rice vinegar is for making the pouring time of Radix Paeoniae Alba surface.
Honey profit Radix Glycyrrhizae, for getting Radix Glycyrrhizae sheet, adds Mel-water (1-2:1), mixes thoroughly, and moistening is complete to absorbing, and takes out coolingly, obtains (part by weight of Radix Glycyrrhizae sheet and mulse is 10:2-4).
The present invention also provides the above-mentioned preparation method with the Chinese medicine granules of regulating the liver and spleen, anti-inflammatory analgesic effect, comprises the following steps:
(1) weighting raw materials in proportion, mixes;
(2) to water saturated n-butyl alcohol-75% alcohol mixed solvent of use (2:1) that adds 4-6 times of weight in crude drug, extract twice, each 1-3 hour, filters at every turn, and merging filtrate, is concentrated into 0.15-0.25g crude drug/ml;
(3) by the upper NKA-9 macroporous resin column of filtrate, use 80% ethanol elution, collect eluent;
(4) in eluent, add 0.1% activated carbon and 0.1%EDTA(disodiumedetate by weight), remove pigment and heavy metal, to filter, filtrate is concentrated, obtains concentrated solution;
(5) get cyclodextrin-sucrose (1:1) mixture and drop in fluid bed, send into hot-air pre-heating, when temperature reaches 30-40 ℃, spray into concentrated solution and 2% Gonak of step (4), complete spray granulation step;
(6) after having granulated, continue to pass into hot blast and make particle drying, to the moisture of granule, below 2%, granulate, makes granule of the present invention.
Wherein, in step (2), with in water saturated n-butyl alcohol-75% alcohol mixed solvent, the weight proportion of water saturated n-butyl alcohol-75% ethanol is 2:1.
Wherein, in step (3), NKA-9 macroporous resin is through methanol pretreatment, and the consumption of mobile phase is 3-5 times of upper prop liquid.
Wherein, in step (5), the temperature of air inlet is 60-70 ℃; The consumption of cyclodextrin-sucrose is 2-4 times of concentrated solution weight, preferably 3 times; The consumption of 2% Gonak is the 0.3-0.6% of concentrated solution weight, preferably 0.5%.
Instructions of taking: get 1 bag of granule of the present invention, add 80-100ml water, stirring and dissolving, oral once a day, within 5 days, be a course for the treatment of.
The inventor is devoted to classical prescription research always, has spent the processed product of plenty of time and work research classical prescription crude drug for the impact of classical prescription effect, have been surprisingly found that the vinegar parched with bran Radix Paeoniae Alba and honey profit Radix Glycyrrhizae combination results more significant cooperative compensating effect; On this basis, the inventor is further studied screening to preparation method, in the hope of obtain a kind of method easy, be more suitable for industrialized great production and the product active constituent content that makes is high, the significant preparation method of effect, the present invention has been proposed thus.Below will introduce in detail R&D process of the present invention and beneficial effect.
(1), the selection of crude drug concocting method
The Radix Paeoniae Alba is the root of dicotyledon medicine ranunculaceae plant Radix Paeoniae (cultigen).The Radix Paeoniae Alba is cool in nature, and bitter in the mouth acid, is slightly cold, and has the easing the affected liver of enriching blood, suppressing the hyperactive liver pain relieving.Common processed product has several as follows:
Radix Paeoniae Alba, for former medicine decontamination, runs through section, raw with the person of being used as medicine.
The parched with bran Radix Paeoniae Alba, fries to micro-Huang with slow fire with bran for Radix Paeoniae Alba sheet, and slightly focal spot, sieves and remove Testa Tritici, the cool person of being used as medicine of drying in the air.
Radix Paeoniae Alba has another name called Radix Paeoniae Alba (parched with wine), Radix Paeoniae Alba preparata.For Radix Paeoniae Alba sheet is mixed thoroughly with yellow wine sprinkle, the fried dry person of being used as medicine then.Cold alleviation, the effect of invigorating blood circulation strengthens.
Radix Paeoniae Alba (processed with vinegar) has another name called vinegar Radix Paeoniae Alba (parched), vinegar Chinese herbaceous peony.For Radix Paeoniae Alba sheet sprays with rice vinegar, with the micro-stir-fry of the slow fire person of being used as medicine.Relatively hold back liver pain relieving, nourishing blood and hemoslasis.
Radix Glycyrrhizae is dicotyledon pulse family Leguminosae Radix Glycyrrhizae Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. G.inflata Bat., or the root and rhizome of Glycyrrhiza glabra L. G.glabra L..Conventional processed product is as follows:
Radix Glycyrrhizae: for crude drug is removed impurity, clean, run through section, obtain.Be partial to heat-clearing and toxic substances removing.
Fry Radix Glycyrrhizae: get Radix Glycyrrhizae sheet, put in frying pan and fry with slow fire, complete to moisture evaporation, taking-up cools.
Honey profit Radix Glycyrrhizae: get Radix Glycyrrhizae sheet, add Mel-water (1-2:1), mix thoroughly, moistening is complete to absorbing, takes out coolingly, obtains (part by weight of Radix Glycyrrhizae sheet and mulse is 10:2-4).
Radix Glycyrrhizae (processed with honey): get Radix Glycyrrhizae sheet, add Mel-water (1-2:1), mix thoroughly, moistening is complete to absorbing, put in pot and fry to or be placed in oven for baking with slow fire, become buff, tack-free be degree, take out and cool (part by weight of Radix Glycyrrhizae sheet and mulse is 10:2-4).
The inventor has sprayed into rice vinegar unintentionally before the parched with bran Radix Paeoniae Alba, then carries out Testa Tritici stir-fry, has obtained the vinegar parched with bran Radix Paeoniae Alba, and then finds when with the various processed product compatibility of Radix Glycyrrhizae, and when the Radix Paeoniae Radix Glycyrrhizae combination of the employing vinegar parched with bran Radix Paeoniae Alba is extracted, the rate of transform of index components is higher.
Test the impact of a concocting method on index components stripping
1, experiment material
Radix Glycyrrhizae sheet, Radix Paeoniae Alba sheet are all purchased from Beijing Tongrentang.Make according to the method described above respectively the parched with bran Radix Paeoniae Alba, Radix Paeoniae Alba, Radix Paeoniae Alba (processed with vinegar), the vinegar parched with bran Radix Paeoniae Alba, fry Radix Glycyrrhizae, honey profit Radix Glycyrrhizae, Radix Glycyrrhizae (processed with honey), pulverize respectively, dry its moisture that makes is lower than after 3%, standby.
Peoniflorin standard substance, glycyrrhizic acid standard substance.
2, experimental technique
Get respectively various raw material 100g, add 6 times, water, soak after 30 minutes, boil 30 minutes, be condensed into respectively the single medical material decocting liquid containing former medicine 30%, standby.
Get respectively each processed product of the 50g Radix Paeoniae Alba and Radix Glycyrrhizae processed product, after combination of two (100g altogether), add 6 times, water, soak after 30 minutes, boil 30 minutes, be condensed into respectively containing the Radix Paeoniae Alba, each Radix Paeoniae Licorice root of 30% of Radix Glycyrrhizae, standby.
The standard curve of preparing peoniflorin and glycyrrhizic acid, measures respectively the content of peoniflorin and glycyrrhizic acid in each 20mL decocting liquid by thin layer quantitative method.The results are shown in Table 1 and table 2.
3, experimental result
In the various decocting liquid of table 1, the content (μ g/mL) of peoniflorin (n=3)
In the various decocting liquid of table 2, the content (μ g/mL) of glycyrrhizic acid (n=3)
By table 1 and table 2, can be found out, the combination of Radix Paeoniae Radix Glycyrrhizae has promoted the stripping of peoniflorin and glycyrrhizic acid, wherein, before not using vinegar parched with bran Radix Paeoniae Alba processed product, the combination of Radix Paeoniae Alba (processed with vinegar) and Radix Glycyrrhizae (processed with honey) should be the most reasonable and preferred, but, use after vinegar parched with bran Radix Paeoniae Alba processed product, having promoted on the contrary the more stripping of multi-target ingredient with the combination of honey profit Radix Glycyrrhizae, is obviously that forefathers expect.
Test the experimentation of two different processed product compositions analgesic activities
Present inventor further studies the pharmacological effect of the processed product combination of this new proposition of stripping.
1, experiment material
50 of Kunming mouses, male and female half and half, body weight 18-20g.
Vinegar parched with bran Radix Paeoniae Alba 50g+ honey profit Radix Glycyrrhizae 50g; Radix Paeoniae Alba (processed with vinegar) 50g+ Radix Glycyrrhizae (processed with honey) 50g; Vinegar parched with bran Radix Paeoniae Alba 50g+ Radix Glycyrrhizae (processed with honey) 50g; Radix Paeoniae Alba (processed with vinegar) 50g+ honey profit Radix Glycyrrhizae 50g, medicinal material composition decocting twice, collecting decoction, is concentrated into 50% concentration.
2, experimental technique
Mice is divided into 5 groups at random, and adaptability is raised after 3d, according to twice of the ratio gastric infusion of 1mL/10g, interval 1h, after administration 20min, press the number of times solution of 0.1mL/10g lumbar injection 0.5% acetic acid for the second time, the writhing number of times that observed and recorded mice occurs in 15min.Blank is organized gavage normal saline twice in proportion, presses the number of times solution of 0.1mL/10g lumbar injection 0.5% acetic acid, the writhing number of times that observed and recorded mice occurs in 15min.
3, experimental result
In Table 3.
The impact of the different processed product compositionss of table 3 on pain mice
| Group | Writhing number of times |
| Blank group | 40.1±7.91 |
| Vinegar parched with bran Radix Paeoniae Alba 50g+ honey profit Radix Glycyrrhizae 50g | 22.5±6.21** |
| Radix Paeoniae Alba (processed with vinegar) 50g+ Radix Glycyrrhizae (processed with honey) 50g | 30.7±8.04* |
| Vinegar parched with bran Radix Paeoniae Alba 50g+ Radix Glycyrrhizae (processed with honey) 50g | 29.3±7.18** |
| Radix Paeoniae Alba (processed with vinegar) 50g+ honey profit Radix Glycyrrhizae 50g | 34.2±8.32* |
With the comparison of blank group, * P < 0.05, * * P < 0.01.
From table 3, each group all can obviously reduce mouse writhing number of times, relatively has statistical significance with blank group.Vinegar parched with bran Radix Paeoniae Alba 50g+ honey profit Radix Glycyrrhizae 50g group is compared with other compositions groups, has more obvious effect, shows that the vinegar parched with bran Radix Paeoniae Alba and the combination of honey profit Radix Glycyrrhizae have not only significantly promoted the rate of transform of index components, also produce more significant actual therapeutic effect.
(2) screening of crude drug proportion relation
The consumption proportion of peony and licorice decoction in former book is equivalent proportioning, also have and report that the compositions of Radix Paeoniae Radix Glycyrrhizae (3:1) can obtain better analgesic effect, therefore,, because the present invention has adopted new processed product, inventor attempts obtaining preferred consumption proportion relation by screening.
Experiment three, peony and licorice decoction cause the impact of acute liver on carbon tetrachloride
1, experiment material
Kunming mouse, male and female half and half, 18-22g, 80.
The vinegar parched with bran Radix Paeoniae Alba, honey profit Radix Glycyrrhizae, carbon tetrachloride.
2, experimental technique
Mice is divided into 8 groups at random, 10 every group, establishes 1 of Normal group, 1 of model group.According to 200mg/kg(medical material proportioning, be 1:1,1:2,1:3; 2:1,3:1,3:2, after proportioning preparation, get respectively the medical material after 20g combination, water extraction twice, merging filtrate, concentrated making) dosage gastric infusion, every day 1 time, for three days on end, half an hour with 0.5% carbon tetrachloride Emulsion subcutaneous injection of 0.1ml/10g dosage once before the 3rd administration, after injection, 20h eye socket is got blood, and separation of serum is measured ALT and AST.
3, experimental result
Table 4 peony and licorice decoction causes the impact of acute liver on carbon tetrachloride
| Group (the vinegar parched with bran Radix Paeoniae Alba: honey profit Radix Glycyrrhizae) | ALT(IU/L) | AST(U/L) |
| Normal group | 34.43±17.82 | 128.63±40.17 |
| Model group | 462.53±92.22 | 649.87±187.23 |
| 1:1 | 321.05±85.17* | 401.28±39.47** |
| 1:2 | 330.17±39.89* | 487.33±59.26* |
| 1:3 | 351.28±59.25* | 511.16±92.31* |
| 2:1 | 305.84±61.57** | 389.11±54.12** |
| 3:1 | 251.72±41.03** | 356.28±60.82** |
| 3:2 | 185.29±67.21** | 281.09±40.12** |
With model group comparison, * P < 0.05, * * P < 0.01.
Can find out; compare with model group, all compositionss all have obvious liver protection, and wherein the vinegar parched with bran Radix Paeoniae Alba-honey profit Radix Glycyrrhizae 3:2 group is compared with other compositions groups; all there is statistical significance, be different from the view of thinking in prior art that the consumption of Radix Paeoniae is the bigger the better in peony and licorice decoction.Results suggest, during the vinegar parched with bran Radix Paeoniae Alba-honey profit Radix Glycyrrhizae 3:2, liver protection is more remarkable, and synergistic function occurs after compatibility between the two.
(3) process for purification of peony and licorice decoction screening
Test the screening of four macroporous resin kinds
1, instrument and reagent
High performance liquid chromatograph, electronic balance, the vinegar parched with bran Radix Paeoniae Alba-honey profit Radix Glycyrrhizae 3:2, peoniflorin standard substance, glycyrrhizic acid standard substance, liquirtin standard substance, methanol, 70% ethanol, 80% ethanol, acetonitrile, 0.1% phosphoric acid solution
Macroporous resin HPD200, AB-8, HPD600, D101, NKA-9
2, experimental technique
(1) high-efficient liquid phase chromatogram condition: flow velocity 0.8mL/min, column temperature: 25 ℃; Mobile phase: acetonitrile (peoniflorin), wavelength 230nm; Acetonitrile (liquirtin), wavelength 276nm; Methanol (glycyrrhizic acid), wavelength 250nm.
(2) preparation of upper prop liquid: take the vinegar parched with bran Radix Paeoniae Alba, honey profit Radix Glycyrrhizae in the ratio of 3:2, soak after half an hour, decoct with water 2 times, add 8 times of water gagings at every turn, decoct 1 hour.Collecting decoction, filters, concentrated, concentration be the water extraction liquid of 0.05g crude drug/mL.
(3) pretreatment of macroporous resin: select HPD200, AB-8, HPD600, D101, NKA-9 resin, after fully soaking with methanol, make wet method dress post after resin swelling, and use methanol pretreatment, by massive laundering to having no irritating odor.
(4) resin elution: respectively get upper prop liquid 150ml, with the flow velocity of 1.0mL/min by processed good resin.Use 200ml80% ethanol elution, collect eluent, measure respectively the content of three kinds of compositions, take retention rate as evaluation index, screening resin.
3, experimental result
5 kinds of macroporous resins of table 5 are to the retention rate of index components (%)
From table 5, D101 is the highest for the retention rate of peoniflorin, and HPD200 is the highest to the retention rate of liquirtin, and NKA-9 is the highest to the retention rate of glycyrrhizic acid, but considers the retention rate of three kinds of index components, finally selects NKD-9.
Test the screening of five eluant
1, instrument and reagent
High performance liquid chromatograph, electronic balance, the vinegar parched with bran Radix Paeoniae Alba-honey profit Radix Glycyrrhizae 3:2, peoniflorin standard substance, glycyrrhizic acid standard substance, liquirtin standard substance, methanol, acetonitrile, 70% ethanol, 80% ethanol, 0.1% phosphoric acid solution, macroporous resin NKA-9
2, experimental technique
(1) high-efficient liquid phase chromatogram condition: flow velocity 0.8mL/min, column temperature: 25 ℃; Mobile phase: acetonitrile (peoniflorin), wavelength 230nm; Acetonitrile (liquirtin), wavelength 276nm; Methanol (glycyrrhizic acid), wavelength 250nm.
(2) preparation of upper prop liquid: take the vinegar parched with bran Radix Paeoniae Alba, honey profit Radix Glycyrrhizae in the ratio of 3:2, soak after half an hour, decoct with water 2 times, add 8 times of water gagings at every turn, decoct 1 hour.Collecting decoction, filters, concentrated,
Concentration be the water extraction liquid of 0.05g crude drug/mL.
(3) pretreatment of macroporous resin: select NKA-9 resin, after fully soaking with methanol, make wet method dress post after resin swelling, and use methanol pretreatment, by massive laundering to having no irritating odor.
(4) resin elution: respectively get upper prop liquid 150ml, with the flow velocity of 1.0mL/min by processed good resin.Use respectively 200ml methanol, acetonitrile, 70% ethanol, 80% ethanol elution, collect eluent, measure the content of three kinds of compositions, take eluting rate as evaluation index, screening eluant.
3, experimental result
4 kinds of eluant are to the eluting rate of index components (%)
| Index composition | Methanol | Acetonitrile | 70% ethanol | 80% ethanol |
| Peoniflorin | 85.6 | 75.3 | 92.1 | 98.2 |
| Liquirtin | 79.8 | 73.9 | 95.6 | 96.7 |
| Glycyrrhizic acid | 97.6 | 80.1 | 82.9 | 92.9 |
From table 5, for glycyrrhizic acid composition, the eluting rate of methanol is the highest; For peoniflorin and liquirtin, the eluting rate of 80% ethanol is the highest, the eluting rate of 70% ethanol is also higher; Consider the eluting rate of three kinds of index components, finally select 80% ethanol to use as eluant.
(3), the checking of clinical efficacy
1, the therapeutic effect of pain patients
Case selection: choose pain-suffered patient 300 examples, wherein, 200 examples of having a stomachache, lower limb spasm and pain 60 examples, dysmenorrhea 40 examples.
The granule product of Therapeutic Method: administration embodiment 1, each one bag, every day, each once, 7 days was a course for the treatment of sooner or later.
Curative effect judging standard:
Pain disappears for effective; Pain relief is effective; In 3 days, pain is the same or to add severe one be invalid.
Experimental result:
The product of the visible embodiment of the present invention 1 has good regulating the liver and spleen, the effect of relieving spasm to stop pain.
2, the therapeutic effect of digestive system inflammatory patients
Case selection: choose digestive system inflammatory patients 150 examples, wherein, 50 Cases of Ulcerative Colitis, chronic atrophic gastritis 50 examples, cholecystitis 50 examples.
The granule product of Therapeutic Method: administration embodiment 1, each one bag once a day, 5 days is a course for the treatment of, observed result after 3 courses for the treatment of of medication.
Curative effect judging standard:
Inflammation disappears, pain disappears for effective; Inflammation alleviates, pain disappears for effective; Inflammation alleviates, pain relief is effectively; After 3 courses for the treatment of pain the same ulcer surface expands or inflammation index not change person into invalid.
Experimental result: after 3 courses for the treatment of, effective 89 examples, account for 59.33%; Effective 35 examples, account for 23.33%; Partial rcsponse 20 examples, account for 13.33%; Invalid 6 examples, account for 4%; Treatment total effective rate is 96%.Show that product of the present invention has good antiinflammatory action for digestive system inflammation.
Generally speaking; Chinese medicine granules of the present invention has remarkable regulating the liver and spleen, anti-inflammatory analgesic effect, through pharmacological experiment and clinical practice result, shows: this granule has the multiple efficacies effects such as liver protection, opposing digestive system inflammatory effect, relieving spasm to stop pain effect.In addition, this granule is owing to having selected the specific proportioning of specific processed product and raw material, and adds the improvement of process for purification, and whole method is simple, with low cost, is more suitable for industrialized great production; Also owing to having retained more effective ingredient, there is taking convenience, good mouthfeel.
The specific embodiment
Below in conjunction with embodiment, this Chinese medicine granules is described further.Those skilled in the art should be able to understand, these embodiment are also not intended to invention protection domain to make restriction, and those skilled in the art can obtain by the change of conventional means similar scheme on the basis of the application's disclosure.
Embodiment 1
A Chinese medicine granules with regulating the liver and spleen, anti-inflammatory analgesic effect, it makes by the following method:
(1) weighting raw materials (the vinegar parched with bran Radix Paeoniae Alba-honey profit Radix Glycyrrhizae 3:2) in proportion, mixes;
(2) to water saturated n-butyl alcohol-75% alcohol mixed solvent of use (2:1) that adds 5 times of weight in crude drug, extract twice, each each 2 hours, filter, merging filtrate, is concentrated into 0.2g crude drug/ml;
(3) by the upper NKA-9 macroporous resin column of filtrate, use 80% ethanol elution,, collect eluent;
(4) in eluent, add 0.1% activated carbon and 0.1%EDTA by weight, remove pigment and heavy metal, filter, filtrate is concentrated, obtains concentrated solution;
(5) get cyclodextrin-sucrose (1:1) mixture and drop in fluid bed, send into hot-air pre-heating, when temperature reaches 35 ℃, spray into concentrated solution and 2% Gonak of step (4), complete spray granulation step; Wherein, the temperature of air inlet is 60-70 ℃; The consumption of cyclodextrin-sucrose is 3 times of concentrated solution weight; The consumption of 2% Gonak is 0.5% of concentrated solution weight.
(6) after having granulated, continue to pass into hot blast and make particle drying, to the moisture of granule, below 2%, granulate, makes granule of the present invention.
Embodiment bis-
(1) weighting raw materials (the vinegar parched with bran Radix Paeoniae Alba-honey profit Radix Glycyrrhizae 3:2) in proportion, mixes;
(2) to water saturated n-butyl alcohol-75% alcohol mixed solvent of use (2:1) that adds 6 times of weight in crude drug, extract twice, each each 1 hour, filter, merging filtrate, is concentrated into 0.15g crude drug/ml;
(3) by the upper NKA-9 macroporous resin column of filtrate, use 80% ethanol elution, collect eluent;
(4) in eluent, add 0.1% activated carbon and 0.1%EDTA by weight, remove pigment and heavy metal, filter, filtrate is concentrated, obtains concentrated solution;
(5) get cyclodextrin-sucrose (1:1) mixture and drop in fluid bed, send into hot-air pre-heating, when temperature reaches 40 ℃, spray into concentrated solution and 2% Gonak of step (4), complete spray granulation step; Wherein, the temperature of air inlet is 70 ℃; The consumption of cyclodextrin-sucrose is 4 times of concentrated solution weight; The consumption of 2% Gonak is 0.5% of concentrated solution weight.
(6) after having granulated, continue to pass into hot blast and make particle drying, to the moisture of granule, below 2%, granulate, makes granule of the present invention.
Claims (9)
1. a Chinese medicine granules with regulating the liver and spleen, anti-inflammatory analgesic effect, is characterized in that its crude drug is: the vinegar parched with bran Radix Paeoniae Alba 1～4 weight portion, honey profit Radix Glycyrrhizae 0.5～4 weight portion.
2. Chinese medicine granules according to claim 1, is characterized in that its crude drug more preferably: the vinegar parched with bran Radix Paeoniae Alba 2～4 weight portions, honey profit Radix Glycyrrhizae 1～3 weight portion.
3. Chinese medicine granules according to claim 2, is characterized in that its crude drug more preferably: the vinegar parched with bran Radix Paeoniae Alba 2～3 weight portions, honey profit Radix Glycyrrhizae 1～2 weight portion.
4. Chinese medicine granules according to claim 3, is characterized in that its crude drug more preferably: the vinegar parched with bran Radix Paeoniae Alba 3 weight portions, honey profit Radix Glycyrrhizae 2 weight portions.
5. the preparation method of the Chinese medicine granules of claim 1-4 any one, is characterized in that comprising the following steps:
(1) weighting raw materials in proportion, mixes;
(2) to water saturated n-butyl alcohol-75% alcohol mixed solvent of the use 2:1 that adds 4-6 times of weight in crude drug, extract twice, each 1-3 hour, filters at every turn, and merging filtrate, is concentrated into 0.15-0.25g crude drug/ml;
(3) by the upper NKA-9 macroporous resin column of filtrate, use 80% ethanol elution, collect eluent;
(4) in eluent, add 0.1% activated carbon and 0.1%EDTA by weight, remove pigment and heavy metal, filter, filtrate is concentrated, obtains concentrated solution;
(5) get cyclodextrin-sucrose 1:1 mixture and drop in fluid bed, send into hot-air pre-heating, when temperature reaches 30-40 ℃, spray into concentrated solution and 2% Gonak of step (4), complete spray granulation step;
(6) after having granulated, continue to pass into hot blast and make particle drying, to the moisture of granule, below 2%, granulate, obtains.
6. preparation method according to claim 5, is characterized in that the weight proportion of water saturated n-butyl alcohol-75% ethanol is 2:1 with in water saturated n-butyl alcohol-75% alcohol mixed solvent.
7. according to the preparation method described in claim 5 or 6, it is characterized in that NKA-9 macroporous resin is through methanol pretreatment, the consumption of mobile phase is 3-5 times of upper prop liquid.
8. according to the preparation method described in claim 5 or 6 any one, the temperature that it is characterized in that air inlet is 60-70 ℃; The consumption of cyclodextrin-sucrose is 2-4 times of concentrated solution weight; The consumption of 2% Gonak is the 0.3-0.6% of concentrated solution weight.
9. according to the preparation method described in claim 5 or 6 any one, the consumption that it is characterized in that cyclodextrin-sucrose is 3 times of concentrated solution weight; The consumption of 2% Gonak is 0.5% of concentrated solution weight.
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| CN115040633A (en) * | 2022-07-25 | 2022-09-13 | 中国中医科学院中医基础理论研究所 | New use of protein extract of peony and licorice decoction |
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