CN102600281A - Traditional Chinese medicine composition for promoting digestion as well as preparation method and use - Google Patents
Traditional Chinese medicine composition for promoting digestion as well as preparation method and use Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for promoting digestion as well as a preparation method and use. The composition is prepared by the following raw materials in ratios by weight: 20-40% of fructus aurantii, 20-40% of pericarpium citri reticulatae, 10-35% of atractylodes rhizome, and 10-20% of radix aucklandiae. The preparation method comprises the following steps of: adding water of 5-9 times to soak fructus aurantii, pericarpium citri reticulatae, atractylodes rhizome and radix aucklandiae for 0.5-2 hours, decocting and extracting for 3-6 hours, then extracting, and collecting volatile oil for the future use simultaneously; filtering the extract to obtain a filtrate for the future use, adding water of 5-9 times to decoct and extract dregs for 2-4 hours, and filtering to obtain a filtrate; and combining the filtrates, standing for 6-24 hours, filtering, concentrating to obtain a thick paste having a relative density of 1.35-1.38 (60 DEG C) at a reduced pressure, and preparing various preparation forms by the thick paste, the volatile oil and a pharmaceutically acceptable excipient. The traditional Chinese medicine composition for promoting digestion can be used for preparing a medicine for treating the epigastralgia, poor appetite and functional dyspepsia symptoms caused by the qi stagnation of spleen and stomach.
Description
Technical field
The present invention relates to a kind of digestion promoting Chinese medicine composition and Preparation method and use.
Background technology
Functional dyspepsia is a kind of common, frequently-occurring disease, and the western medical treatment functional dyspepsia mainly is to be main with some short digestive tract powers, gastric acid inhibitory secretion medicine.Like motilium, cisapride, mosapride etc.; But can produce certain side effect behind these medicine life-time service; Many patients the Q-T interval occurs and prolong and arrhythmia after using cisapride, serious adverse reaction such as torsades de pointes type chamber speed particularly, even cause death.The motilium life-time service can cause headache, and mammary gland increases; The cimetidine life-time service can cause impotence, hyposexuality, breast increase etc.Synthetic digestion promoting medicine can only reach the purpose of relief of symptoms, and can not thoroughly cure when clinical use, and easy relapse.Because the effect of heavy dose of medicine often has side effects in patient's body, endocrine is seriously lacked of proper care in addition, aggravate disease.
The objective of the invention is the shortcoming to above-mentioned existing medicine, develop a kind of fully by oral drugs of prepared from traditional Chinese medicines and preparation method thereof.
Summary of the invention
The purpose of this invention is to provide the digestion promoting Chinese medicine composition that a kind of determined curative effect and flavour of a drug are simplified; Said composition is made up of effective ingredient and/or pharmaceutically acceptable excipient, and wherein said effective ingredient is processed by following materials of weight proportions: Fructus Aurantii 20～40%, Pericarpium Citri Reticulatae 20～40%, the Rhizoma Atractylodis Macrocephalae 10～35%, the Radix Aucklandiae 10～20%.
Preferably, described effective ingredient is processed by following materials of weight proportions: Fructus Aurantii 28～33%, Pericarpium Citri Reticulatae 25～36%; The Rhizoma Atractylodis Macrocephalae 18～30%, the Radix Aucklandiae respectively are 13～18%.
Preferably, described effective ingredient is processed by following materials of weight proportions: Fructus Aurantii 31.6%, Pericarpium Citri Reticulatae 31.6%; The Rhizoma Atractylodis Macrocephalae 21.0%, the Radix Aucklandiae respectively are 15.8%.
Another object of the present invention provides the method for preparing of described a kind of digestion promoting Chinese medicine composition; May further comprise the steps: decoct extraction extraction after 3～6 hours after Fructus Aurantii, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae and the Radix Aucklandiae are added 5～9 times of water gagings immersion 0.5～2h; Collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 5～9 times of water gagings again and decoct extraction 2～4 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 6～24 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil are processed various dosage forms with pharmaceutically acceptable excipient again.
Preferably, the method for preparing of described a kind of digestion promoting Chinese medicine composition may further comprise the steps: Fructus Aurantii, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae and the Radix Aucklandiae are added 8 times of water gagings immersions decoct extraction 4 hours after 1 hour, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 8 times of water gagings again and decoct extraction 3 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 12 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil are processed various dosage forms with pharmaceutically acceptable excipient again.
Another object of the present invention provides the abdominal distention of said compositions due to preparation treatment stagnation of QI in spleen and stomach that a kind of described method for preparing obtains, the purposes of the medicine of anorexia, functional dyspepsia symptom.
Preferably, said compositions is used to promote dopamine to cause the low mouse small intestine progradation of intestinal function.
Preferably, said compositions is used to promote atropine to cause the low mouse small intestine progradation of intestinal function.
Preferably, said compositions is used to promote the effect of rat gastric secretion and total acid output.
Preferably, said compositions is used to promote the pancreatic secretion effect.
Preferably, said compositions is used to suppress the autonomous contraction of rats in vitro intestinal tube.
Wherein said raw material of Chinese medicine is:
Fructus Aurantii is the dry immature fruit of rutaceae Citrus aurantium Linn. Citrus aurantium L. and variety thereof.The hot hardship of loosing of Fructus Aurantii is fallen, and cold nature is longer than regulating the flow of QI to ease the stomach, and the stagnant relieving distension of row is usually used in treating the breast abdomen stagnation of QI, feeling of fullness distending pain, accumulation of food in the stomach and intes tine due to indigestion, gastroptosis etc. clinically.
The dry immaturity peel of Pericarpium Citri Reticulatae rutaceae orange Citrus reticulata Blanco and variety thereof.Pericarpium Citri Reticulatae belongs to type of regulating the flow of vital energy Chinese medicine, effects such as tool circulation of qi promoting, soothing the liver, spleen invigorating, pain relieving preventing or arresting vomiting, antidiarrheal, the clinical abdominal distention that is usually used in due to the stagnation of QI in spleen and stomach, diseases such as anorexia.Fructus Aurantii and Pericarpium Citri Reticulatae all contain materials such as volatile oil and flavonoid glycoside.
The Rhizoma Atractylodis Macrocephalae is the dry rhizome regulating qi-flowing for strengthening spleen of feverfew Rhizoma Atractylodis Macrocephalae Atractylodes macrocephala Koidz., drying dampness to eliminate phlegm, and invigorating the spleen and benefiting QI, the dampness diuretic ends the Chinese, and is antiabortive.Be used for insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.Contain volatile oil 1.4%, main component is atractylol (Atractylol), atractylone (Atractylon) etc., and contains vitamin A.Rhizome contains volatile oil about 1.4%; Contain atractylone (a-tractylone) in the oil; Still contain butenolide A, second (butenolide A, B), celery alkane dienone [selina-4 (14), 7 (11)-dien-8-one], β-celery oil alkene (β-Se-linene), Eucalyptus terpene (aromaden-drene); Other contains oxygen Coumarins (oxicoumarines), saccharide and resin etc.
The Radix Aucklandiae is the dry root of feverfew Radix Aucklandiae Aucklandia lappa Decne..Promoting the circulation of QI to relieve pain, strengthening the spleen to promote digestion is used for the breast side of body, abdominal distention, and heavy behind the dysentery, food stagnation does not disappear, anorexia.Contain volatile oil. contain myrcene, p-cymene, linalool, beta-elemene, Flos Caryophylli alkene, humulene, cedrene, alpha, beta-lonone, cedrol, α-costol, (1 in the oil; 8; 11,14 positive 17 tetraenes and constuslactone, dihydrocostulactone, dehydrocostuslactone, costunolide, dihydro costunolide, 12-melonia costunolide and 12-melonia dehydrocostuslactone. other contains α-costic acid and 24 seed amino acids.
Compositions provided by the present invention is main with Fructus Aurantii, Pericarpium Citri Reticulatae, is equipped with the Rhizoma Atractylodis Macrocephalae, the Radix Aucklandiae, because the determined curative effect of compositions does not almost have side reaction.In addition, Chinese medicine is taken general employing decocting and is boiled, and the present invention combines modern science and technology; Adopt and extract volatile oil component with facilitating digestion effect; Decoct on the basis in traditional water, optimize extraction process with orthogonal experiment, obtain the optimum extraction process of the present invention: promptly: the decoction extraction was extracted in 4 hours after Fructus Aurantii, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae and the Radix Aucklandiae were added 8 times of water gagings immersion 1h; Collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 8 times of water gagings again and decoct extraction 3 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 12 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃).
Contrast can be known through experimental data; In old treated animal of trifoliate orange in dose groups 2.0g (crude drug)/kg, high dose group 4.0g (the crude drug)/kg stomach phenol red residual rate be lower than the normal control group; Middle dose groups, high dose group small intestinal prepared Chinese ink propelling rate are higher than the normal control group, but all do not have significant difference (P＞0.05); Show that old of trifoliate orange is not to having influence to normal mouse gastric emptying, intestinal propulsion function.
Contrast can be known through experimental data; Old of trifoliate orange does not have influence to normal mouse gastric emptying, intestinal propulsion function; In old treated animal of trifoliate orange in dose groups, the high dose group stomach phenol red residual rate be lower than the normal control group; Middle dose groups, high dose group small intestinal prepared Chinese ink propelling rate are higher than the normal control group, but all do not have significant difference; And dopamine is caused the low mice of intestinal function the intestinal progradation is arranged; Compare with the blank group; High dose group 4.0g (the crude drug)/kg of old group of trifoliate orange, middle dose groups 2.0g (crude drug)/kg small intestinal carbon art propelling all have effect, and the high dose group effect is (P＜0.01) very significantly.Explain that old of trifoliate orange has the dopamine of promotion and causes the low intestinal propulsion functions of mice intestinal function.
Contrast can be known through experimental data; Old of trifoliate orange causes the low mice of intestinal function to atropine has the intestinal progradation; Compare with the blank group; High dose group 4.0g (the crude drug)/kg of old group of trifoliate orange, middle dose groups 2.0g (crude drug)/kg, low dose group 1.0g (crude drug)/kg small intestinal carbon powder propelling all have effect, and three dose groups cause the low mice of intestinal function to atropine has the intestinal progradation that a certain amount of effect relationship is arranged.The high dose group effect is (P＜0.01) very significantly.Explain that old of trifoliate orange has the atropine of promotion and causes the low intestinal propulsion functions of mice intestinal function.
Contrast can be known through experimental data; Old high dose group 4.0g of trifoliate orange (crude drug)/kg, middle dose groups 2.0g (crude drug)/kg and GUIPI WAN 4.0g (crude drug)/kg have obvious facilitation (P＜0.05) to rat gastric secretion, total acidity and total acid output, and the pepsin vigor is also apparently higher than matched group in the gastric juice.
Contrast can be known through experimental data; Old high dose group 4.0g of trifoliate orange (crude drug)/kg, middle dose groups 2.0g (crude drug)/kg, low dose group 4.0g (crude drug)/kg and GUIPI WAN are to the obviously influence of rat bile secretion nothing; But old above-mentioned three dose groups of trifoliate orange and GUIPI WAN have pancreatic juice and extremely significantly promote secretory action; Reach the secretion peak in the time of 30 minutes, and after continuing to 90 minutes.
Contrast can know that old shrinkage amplitude to the autonomous contractile motion of rats in vitro intestinal tube of trifoliate orange has obvious inhibitory action through experimental data, and its inhibition strength is relevant with drug level, and the high inhibitory action of drug level is strong.Ach can cause rat intestinal tube tonic spasm; Add can cause after old of the trifoliate orange after the of short duration contraction of intestinal tube lax again; And old concentration of relexation intensity and trifoliate orange is relevant, and the lax greatly intestinal tube effect of concentration is strong, shows the intestinal tube tonic spasm that old ability antagonism of trifoliate orange Ach causes.
The specific embodiment
Embodiment 1
Get Fructus Aurantii 300g, Pericarpium Citri Reticulatae 300g, Rhizoma Atractylodis Macrocephalae 200g and Radix Aucklandiae 200g, add 6 times of water gagings and soak to decoct behind the 1h and extracted 3 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 6 times of water gagings again and decoct extraction 2 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 12 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil again with right amount of auxiliary materials, process tablet.
Embodiment 2
Get Fructus Aurantii 300g, Pericarpium Citri Reticulatae 300g, Rhizoma Atractylodis Macrocephalae 150g and Radix Aucklandiae 150g, add 6 times of water gagings and soak to decoct behind the 0.5h and extracted 4 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 5 times of water gagings again and decoct extraction 3 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 6 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil add adjuvant, process granule.
Embodiment 3
Get Fructus Aurantii 280g, Pericarpium Citri Reticulatae 300g, Rhizoma Atractylodis Macrocephalae 170g and Radix Aucklandiae 100g, add 7 times of water gagings and soak to decoct behind the 1.5h and extracted 5 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 6 times of water gagings again and decoct extraction 3.5 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 24 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil add appropriate amount of auxiliary materials, process flexible glue and assist agent.
Embodiment 4
Get Fructus Aurantii 300g, Pericarpium Citri Reticulatae 320g, Rhizoma Atractylodis Macrocephalae 180g and Radix Aucklandiae 160g, add 7 times of water gagings and soak to decoct behind the 0.5h and extracted 4 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 6 times of water gagings again and decoct extraction 2 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 18 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil add appropriate amount of auxiliary materials, process glue and assist agent.
Embodiment 5
Get Fructus Aurantii 320g, Pericarpium Citri Reticulatae 280g, Rhizoma Atractylodis Macrocephalae 200g and Radix Aucklandiae 150g, add 8 times of water gagings and soak to decoct behind the 1h and extracted 3 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 7 times of water gagings again and decoct extraction 2 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 12 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil add appropriate amount of auxiliary materials, process tablet.
Embodiment 6
Get Fructus Aurantii 320g, Pericarpium Citri Reticulatae 300g, Rhizoma Atractylodis Macrocephalae 220g and Radix Aucklandiae 130g, add 9 times of water gagings and soak to decoct behind the 2h and extracted 4.5 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 8 times of water gagings again and decoct extraction 3 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 18 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil add appropriate amount of auxiliary materials, process mixture.
Embodiment 7
Get Fructus Aurantii 290g, Pericarpium Citri Reticulatae 320g, Rhizoma Atractylodis Macrocephalae 180g and Radix Aucklandiae 130g, add 8 times of water gagings and soak to decoct behind the 0.5h and extracted 3 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 8 times of water gagings again and decoct extraction 2 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 24 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil add appropriate amount of auxiliary materials, process drop pill.
Embodiment 8
Get Fructus Aurantii 300g, Pericarpium Citri Reticulatae 290g, Rhizoma Atractylodis Macrocephalae 190g and Radix Aucklandiae 140g, add 7 times of water gagings and soak to decoct behind the 2h and extracted 3.5 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 6 times of water gagings again and decoct extraction 2.5 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 12 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil add appropriate amount of auxiliary materials, process syrup.
Embodiment 9
Get Fructus Aurantii 320g, Pericarpium Citri Reticulatae 290g, Rhizoma Atractylodis Macrocephalae 220g and Radix Aucklandiae 160g, add 9 times of water gagings and soak to decoct behind the 0.5h and extracted 4 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 7 times of water gagings again and decoct extraction 3 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 12 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil add appropriate amount of auxiliary materials, process granule.
Embodiment 10
Get Fructus Aurantii 280g, Pericarpium Citri Reticulatae 320g, Rhizoma Atractylodis Macrocephalae 200g and Radix Aucklandiae 160g, add 7 times of water gagings and soak to decoct behind the 1h and extracted 4 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 6 times of water gagings again and decoct extraction 2 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 24 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil add appropriate amount of auxiliary materials, process pill.
Embodiment 11
Get Fructus Aurantii 280g, Pericarpium Citri Reticulatae 300g, Rhizoma Atractylodis Macrocephalae 180g and Radix Aucklandiae 150g, add 8 times of water gagings and soak to decoct behind the 1.5h and extracted 3.5 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 7 times of water gagings again and decoct extraction 3 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 18 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil add appropriate amount of auxiliary materials, process glue and assist agent.
Embodiment 12
Get Fructus Aurantii 310g, Pericarpium Citri Reticulatae 300g, Rhizoma Atractylodis Macrocephalae 210g and Radix Aucklandiae 150g, add 9 times of water gagings and soak to decoct behind the 2h and extracted 5.5 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 8 times of water gagings again and decoct extraction 4 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 18 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil add appropriate amount of auxiliary materials, process dispersible tablet.
Embodiment 13
Get Fructus Aurantii 300g, Pericarpium Citri Reticulatae 310g, Rhizoma Atractylodis Macrocephalae 180g and Radix Aucklandiae 170g, add 7 times of water gagings and soak to decoct behind the 1h and extracted 4.5 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 9 times of water gagings again and decoct extraction 3 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 18 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil add appropriate amount of auxiliary materials, process effervescent tablet.
Embodiment 14
Get Fructus Aurantii 320g, Pericarpium Citri Reticulatae 320g, Rhizoma Atractylodis Macrocephalae 180g and Radix Aucklandiae 180g, add 8 times of water gagings and soak to decoct behind the 1.5h and extracted 4 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 6 times of water gagings again and decoct extraction 2 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 12 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil add appropriate amount of auxiliary materials, process granule.
Embodiment 15
Get Fructus Aurantii 300g, Pericarpium Citri Reticulatae 300g, Rhizoma Atractylodis Macrocephalae 200g and Radix Aucklandiae 150g, add 8 times of water gagings and soak to decoct behind the 1h and extracted 4 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 8 times of water gagings again and decoct extraction 3 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 12 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil add appropriate amount of auxiliary materials, process tablet.
One, extraction process confirms
Monarch drug Fructus Aurantii, Pericarpium Citri Reticulatae all contain flavone compound in the prescription; The flavonoid main chemical compositions is a neohesperidin in the Fructus Aurantii, and naringin, (version in 2010) Fructus Aurantii item of Chinese Pharmacopoeia are measured neohesperidin down; The content of naringin, with it as its quality of index property Composition Control; The Pericarpium Citri Reticulatae item is measured Determination of Hesperidin Content down, as index property Composition Control Pericarpium Citri Reticulatae quality; Therefore, the content that extraction process is investigated with Hesperidin, neohesperidin, naringin is test index, and the flavone compound great majority are main with water solublity, so we adopt water boiling and extraction; Fructus Aurantii, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, the Radix Aucklandiae all contain volatile oil in the prescription, and its volatile oil also is the effective ingredient of facilitating digestion, and therefore, we adopt water boiling and extraction, collect volatile oil simultaneously; Get a prescription medical material water boiling and extraction and collect volatile oil simultaneously.
1. the extraction of volatile oil
1.1 the selection of extraction process condition: as the investigation factor, adopt L4 (2 with pulverizing medicinal materials degree and water-soaking time
3) orthogonal table (seeing table 1); As investigating index, the extraction process condition of preferred volatile oil, take by weighing medical material, with the volatile oil extraction ratio by data shown in the positive quadraturing design test (seeing table 2); Extract 5h with version Chinese Pharmacopoeia method in 2005; Read the amount of volatile oil after leaving standstill, calculate extraction ratio, the result sees table 2,3.
Table 1. volatile oil extraction process orthogonal test factor level
Table 2. volatile oil extraction process orthogonal test table L4 (2
3)
The variance analysis of table 3 volatile oil extraction process
Condition checking is 3 batches in view of the above, and the result: the extraction ratio of sample 1,2,3 is respectively 1.32%, 1.30% and 1.32%, X=1.31, and RSD=0.88% shows that the method stablizes feasible.
According to above-mentioned variance analysis arranged intuitively, factor A (medical material granularity) has the influence of utmost point significance, K value A to result of the test
1＞A
2, best with coarse granule, factor B (soak time) is minimum to the result of the test influence, is put into error, from time-saving angle, selects for use and soaks 1h (B1).So draw best volatile oil extraction process condition: A thus
1, B
1, promptly use 10 purpose medical materials, soak 1h.
2.2 the investigation of volatile oil extraction time: consider from the energy savings that saves time, again the relation of volatile oil extraction time and extraction ratio is investigated, get the medical material of a prescription; It was pulverized 10 mesh sieves, get 2 parts, every part takes by weighing 200g; Soak 1h, heating and refluxing extraction.Respectively at 0.5,1.0,1.5,2.0,2.5,3.0,3.5,4.0,4.5,5.0h reads the volume of the volatile oil of carrying, the result sees table 4.
Experimental result shows when extraction time reaches 4h that volatile oil is carried to the greatest extent basically, so from producing reality, volatile oil extracts 4h and gets final product.
The relation of table 4 volatile oil extraction time and extraction ratio
2. decocting boils Study of optimization
Influence the principal element that decocting boils and amount of water is arranged, decoct number of times, decocting time 2.1 decocting boils factor and design levels, therefore, we have investigated above-mentioned three factors to extracting result's influence with orthogonal experiment, use orthogonal table L
9(3
4) make an experiment, experiment is carried out with half recipe quantity, and scheme is seen table 5, and experimental technique and result see table 6.
Table 5 decocting boils the arrangement of technological factor level
2.2 detection index: prescription monarch drug Fructus Aurantii, Pericarpium Citri Reticulatae all contain flavone compound, and therefore, the content that technology is investigated with Hesperidin, neohesperidin, naringin is test index.
2.3 content of hesperidin is measured in the medical material: get Fructus Aurantii, Pericarpium Citri Reticulatae medical material are measured flavone according to the High Performance Liquid Chromatography method content.
2.4 the preparation of need testing solution and mensuration: get 1 prescription medical material for every group, press table 6 orthogonal experiment and arrange technology to extract, the extracting solution of collecting is measured volume respectively, subsequent use.
[assay] measured according to HPLC (appendix VID of Chinese Pharmacopoeia version in 2010).
Chromatographic condition and system suitability test use octadecylsilane chemically bonded silica to be filler; Methanol-0.1% phosphoric acid (35: 65) is mobile phase; Detect wavelength 283nm; Number of theoretical plate should be not less than 3000 by the naringin peak.
The preparation precision of reference substance solution takes by weighing at 105 ℃ of Hesperidin, naringin, neohesperidin reference substances that are dried to constant weight an amount of, adds methanol and processes the solution that every 1ml contains Hesperidin 40 μ g, contains naringin and each 80 μ g of neohesperidin, promptly gets.
The extracting solution that is equivalent to 1.0g Fructus Aurantii, Pericarpium Citri Reticulatae medical material is got in the preparation of need testing solution, puts in the 50ml measuring bottle, adds methanol to scale, filters, and subsequent filtrate filters with microporous filter membrane (0.45 μ m), promptly gets.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, and the result sees table 6.
2.5 experimental result and data analysis
Table 6 decocting boils engineer testing design and result
The analysis of variance table of table 7 Hesperidin, naringin, neohesperidin summation
F
0.05(2，2)＝19.0 F
0.01(2，2)＝99.0
Content with Hesperidin, naringin, neohesperidin in the extract serves as to investigate index; The results of analysis of variance shows: the influence of factor B has utmost point significance meaning (P＜0.05); A, C value there was no significant difference, extreme difference R value size shows that the primary and secondary of each factor effect is B＞A＞C in the table 6; But K in the B factor
3And K
2There was no significant difference is considered the cost problem, with A
3B
2C
3The best is promptly intended and is added 8 times of water gagings and decoct and extract secondaries, and each 3 hours, but the data of investigating according to the volatile oil extraction process, we adopted and add 8 times of water gagings and soak to decoct behind the 1h and extracted 4 hours, collect volatile oil simultaneously, and volatile oil is subsequent use; Medicinal residues add 8 times of water gagings again and decoct extraction 3 hours.
Below experiment is with embodiment 15 (hereinafter to be referred as old of the trifoliate orange) sample that method for preparing was obtained.The experimental data that other embodiment obtained is approaching basically, repeats no more.
Two, the old stomach power of trifoliate orange sheet pharmacodynamics test data
2.1 influence to the normal mouse gastric emptying
Get 60 of kunming mices, press the random packet of group shown in the table 8.The administration group is irritated the above-mentioned relative medicine of clothes, and the administration volume is 0.20ml/10g, and matched group is irritated clothes equal-volume distilled water, every day 1 time, logotype 3 days.Fasting is 12 hours before the last administration, presses dosed administration shown in the table 8, and matched group is given the equal-volume normal saline, and every mice is irritated stomach with 0.04% phenol red solution (containing 10% gelatin) 0.20mL, puts to death animal after 20 minutes, takes out stomach and small intestinal simultaneously.Small intestinal is tiled on the blank sheet of paper, multiply by 100% with the percentage ratio of phenol red divide a word with a hyphen at the end of a line distance and small intestinal total length in small intestinal and estimate intestinal propulsion speed as the intestinal propulsion percentage rate; Stomach places 0.5NaOH solution 30mI; Cut off along greater gastric curvature, fully clean gastric content. get washing liquid 5ml centrifugal (3000r/min, 10 minutes); Suct clear liquid with ultraviolet spectrophotometer in 560nm wavelength colorimetric; Surveying its absorbance, calculate the phenol red residual rate of stomach, is index evaluation gastric emptying speed with the phenol red residual rate of stomach.
Old influence to normal mouse gastric emptying, intestinal propulsion function of table 8. trifoliate orange (X ± S)
" * " expression administration group and matched group compare, P＜0.05, and " * * " P＜0.01, down together;
Table 8 is the result show: in old treated animal of trifoliate orange in dose groups 2.0g (crude drug)/kg, high dose group 4.0g (the crude drug)/kg stomach phenol red residual rate be lower than the normal control group; Middle dose groups, high dose group small intestinal prepared Chinese ink propelling rate are higher than the normal control group, but all do not have significant difference; Show that old of trifoliate orange is not to having influence to normal mouse gastric emptying, intestinal propulsion function.
2.2 old influence that dopamine is caused the low mice of intestinal function of trifoliate orange
Get 50 of mices, body weight 19～22g is divided into 7 groups at random: matched group, model group (GUIPI WAN), long-pending old (4.0,2.0,3 dose groups of 1.0g (crude drug)/kg), 10 every group, male and female half and half.Each is organized the mice fasting and can't help water 16 hours, next day single administration, matched group is irritated the stomach distilled water, other groups give relative medicine and irritate stomach.Except that matched group, all the other mices give 1.8mgkg to each mouse stomach after 30 minutes
-1The modeling of dopamine hydrochloride inj subcutaneous injection, 50 mices are irritated respectively and obey 2% sodium carboxymethyl cellulose carbon powder suspension 0.25ml10g after 20 minutes
-1, mice takes off neck execution after 20 minutes, takes out gastrointestinal immediately, tiling, and the distance and the small intestinal total length of mensuration carbon powder front end to pylorus are calculated the propelling percentage rate with ratio between two.
Old intestinal propelling influence
that dopamine is caused the low mice of intestinal function of table 9. trifoliate orange
Table 9 is the result show: old of trifoliate orange causes the low mice of intestinal function to dopamine has the intestinal progradation; Compare with the blank group; High dose group 4.0g (the crude drug)/kg of old group of trifoliate orange, middle dose groups 2.0g (crude drug)/kg small intestinal carbon art propelling all have effect, and the high dose group effect is (P＜0.01) very significantly.Explain that old of trifoliate orange has the dopamine of promotion and causes the low intestinal propulsion functions of mice intestinal function.
2.3 old influence that atropine is caused the low mice of intestinal function of trifoliate orange
50 of mices, body weight 19～22g is divided into 5 groups at random: old of matched group, model group, trifoliate orange (1.0,2.0,4 dose groups of 4.0g (crude drug)/kg) and positive drug group (motilium 50mgkg-1), 10 every group, male and female half and half.Each is organized the mice fasting and can't help water 16 hours, next day single administration, matched group is irritated the stomach distilled water, other groups give relative medicine and irritate stomach.Except that matched group, all the other mices give the atropine subcutaneous injection modeling of 2.5mgkg-1 to each mouse stomach after 30 minutes, and 70 mices are irritated respectively and obey 2% sodium carboxymethyl cellulose carbon powder suspension 0.2ml10g after 20 minutes
-1, mice takes off neck execution after 20 minutes, takes out gastrointestinal immediately, tiling, and the distance and the small intestinal total length of mensuration carbon art front end to pylorus are calculated the propelling percentage rate with ratio between two.
Old of table 10. trifoliate orange causes the propulsive influence of the low mice intestinal of intestinal function
to atropine
Table 10 is the result show: old of trifoliate orange causes the low mice of intestinal function to atropine has the intestinal progradation; Compare with the blank group; High dose group 4.0g (the crude drug)/kg of old group of trifoliate orange, middle dose groups 2.0g (crude drug)/kg, low dose group 1.0g (crude drug)/kg small intestinal carbon powder propelling all have effect, and three dose groups cause the low mice of intestinal function to atropine has the intestinal progradation that a certain amount of effect relationship is arranged.The high dose group effect is (P＜0.01) very significantly.Explain that old of trifoliate orange has the atropine of promotion and causes the low intestinal propulsion functions of mice intestinal function.
2.4 influence to rat gastric secretion and pepsin vigor
Get 50 random packet of SD rat, press the gastric infusion of dosage shown in the table 10, every day 1 time, 7d continuously; Water 24h is can't help in the animal fasting after the last administration, the 8th day with animal with etherization after the row pyloric ligation, in duodenal administration 1 time; Sew up incision of abdominal wall, cover wound, behind the 4h; The fu jie of taking out stitches out is pricked cardia and is got stomach, and inclining gastric content, centrifugal back record gastric juice total amount.Draw supernatant 2.0ml, adding distil water 20.0ml adds 2 of phenol red indicators, uses the 20mmol/LNaOH acid-base titration, and record NaOH solution consumption amount is calculated total acidity and total acid output.Other gets the supernatant 0.50ml after centrifugal, gets 0.04ml after adding the homogenate medium by 1: 1 volume, carries out the pepsin vitality test by operation table.The result sees table 12.
Old of table 11. trifoliate orange is to the excretory influence of rat gastric juice
Old influence of table 12. trifoliate orange to the rat stomach protein vigor
The result shows: old high dose group 4.0g of trifoliate orange (crude drug)/kg, middle dose groups 2.0g (crude drug)/kg and GUIPI WAN have obvious facilitation to rat gastric secretion, total acidity and total acid output, and the pepsin vigor is also apparently higher than matched group (P＜0.05) in the gastric juice.
2.5 influence to rat bile, pancreatic secretion
50 of Wistar rats, body weight 240～250g, male and female are regardless of, and are divided into 5 groups at random.Fasting is 24 hours before the experiment, and during experiment, lumbar injection calmine anesthesia (60mg/kg) is cut open the belly thereafter; Find out pancreatic duct and bile duct, insert catheter drainage respectively, stablized earlier 20 minutes, collect bile in 30 minutes then; The secretory volume of pancreatic juice (with the full length computation of diameter 1.2mm vinyl tube), as normal value, from duodenal administration once, dosage is seen table 13; Behind 30 clocks, with 30 minutes be a unit, collect the secretory volume of 3 bile and pancreatic juice altogether.The result sees table 13,14.
Rat bile, pancreatic secretion amount before table 13. administration
After table 14. administration to the influence of rat bile, pancreatic secretion
Table 13,14 shows: old high dose group 4.0g of trifoliate orange (crude drug)/kg, middle dose groups 2.0g (crude drug)/kg, low dose group 4.0g (crude drug)/kg and GUIPI WAN are to the obviously influence of rat bile secretion nothing; But old above-mentioned three dose groups of trifoliate orange and GUIPI WAN have pancreatic juice and extremely significantly promote secretory action; Reach the secretion peak in the time of 30 minutes, and after continuing to 90 minutes.
2.6 old influence of trifoliate orange to the isolated rat intestinal movement
Get rat and put to death, preparation rat small intestine in vitro, every section about 2cm of intestinal tube; Put into the smooth muscle specimen tube that tyrode is housed respectively, wherein tyrode's solution is 37 ℃, bubbling air; Connect tonotransducer and connect bio signal collection and processing system, write down one section normal contraction curve, add the various dose medicine respectively; Observation reaches the antagonism that acetylcholine (Ach 5ug/ml-0.02ml) is caused the contraction of tetanic property to intestinal tube shrinkage amplitude variation effect, and the result sees table 15, and 16.
Old of table 15. trifoliate orange is to the paleocinetic influence of rat intestinal tube
Old of table 16. trifoliate orange is to the paleocinetic influence of rat intestinal tube
Table 15 result shows: old shrinkage amplitude to the autonomous contractile motion of rats in vitro intestinal tube of trifoliate orange has obvious inhibitory action, and its inhibition strength is relevant with drug level, and the high inhibitory action of drug level is strong.Table 16 result shows: Ach can cause rat intestinal tube tonic spasm; Add can cause after old of the trifoliate orange after the of short duration contraction of intestinal tube lax again; And old concentration of relexation intensity and trifoliate orange is relevant, and the lax greatly intestinal tube effect of concentration is strong, shows the intestinal tube tonic spasm that old ability antagonism of trifoliate orange Ach causes.
Claims (11)
1. digestion promoting Chinese medicine composition; It is made up of effective ingredient and/or pharmaceutically acceptable excipient, and wherein said effective ingredient is processed by following materials of weight proportions: Fructus Aurantii 20～40%, Pericarpium Citri Reticulatae 20～40%, the Rhizoma Atractylodis Macrocephalae 10～35%, the Radix Aucklandiae 10～20%.
2. Chinese medicine composition according to claim 1, wherein said effective ingredient is processed by following materials of weight proportions: Fructus Aurantii 28～33%, Pericarpium Citri Reticulatae 25～36%; The Rhizoma Atractylodis Macrocephalae 18～30%, the Radix Aucklandiae respectively are 13～18%.
3. Chinese medicine composition according to claim 2, wherein said effective ingredient is processed by following materials of weight proportions: Fructus Aurantii 31.6%, Pericarpium Citri Reticulatae 31.6%; The Rhizoma Atractylodis Macrocephalae 21.0%, the Radix Aucklandiae respectively are 15.8%.
4. the method for preparing of claim 1,2 or 3 described digestion promoting Chinese medicine compositions; May further comprise the steps: decoct extraction extraction after 3～6 hours after Fructus Aurantii, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae and the Radix Aucklandiae are added 5～9 times of water gagings immersion 0.5～2h; Collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 5～9 times of water gagings again and decoct extraction 2～4 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 6～24 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil are processed various dosage forms with pharmaceutically acceptable excipient again.
5. the method for preparing of the described digestion promoting Chinese medicine composition of claim 4 may further comprise the steps: Fructus Aurantii, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae and the Radix Aucklandiae are added 8 times of water gagings soak to decoct after 1 hour and extracted 4 hours, collect volatile oil simultaneously, volatile oil is subsequent use; Said extracted liquid filters, filtrate for later use, and medicinal residues add 8 times of water gagings again and decoct extraction 3 hours, filter, and must filtrate; Above-mentioned filtrating is merged, left standstill 12 hours, filter, be evaporated to the thick paste of relative density 1.35～1.38 (60 ℃), thick paste and volatile oil are processed various dosage forms with pharmaceutically acceptable excipient again.
6. claim 1, the 2 or 3 described digestion promoting Chinese medicine compositions abdominal distention due to preparation treatment stagnation of QI in spleen and stomach, the purposes of the medicine of anorexia, functional dyspepsia symptom.
7. medicinal usage as claimed in claim 6, said compositions are used to promote dopamine to cause the low mouse small intestine progradation of intestinal function.
8. medicinal usage as claimed in claim 6, said compositions are used to promote atropine to cause the low mouse small intestine progradation of intestinal function.
9. medicinal usage as claimed in claim 6, said compositions is used to promote the effect of rat gastric secretion and total acid output.
10. medicinal usage as claimed in claim 6, said compositions is used to promote the pancreatic secretion effect.
11. medicinal usage as claimed in claim 6, said compositions are used to suppress the autonomous effect of shrinking of rats in vitro intestinal tube.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103071010A (en) * | 2013-01-17 | 2013-05-01 | 白长川 | Traditional Chinese medicine preparation for treating disorders of gastrointestinal motility |
| CN103463257A (en) * | 2013-08-12 | 2013-12-25 | 中国科学院广州生物医药与健康研究院 | Fructus aurantii immaturus or fructus aurantii extract, its preparation method and application |
| CN108653432A (en) * | 2017-04-01 | 2018-10-16 | 北京盈科瑞创新药物研究有限公司 | A kind of Chinese medicine composition and its preparation |
| CN114081934A (en) * | 2022-01-20 | 2022-02-25 | 江西省中医药研究院 | Traditional Chinese medicine composition and quality detection method thereof |
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| CN101524511A (en) * | 2008-03-07 | 2009-09-09 | 天科仁祥技术（北京）有限责任公司 | Chinese medicinal composition for treating indigestion for children and preparation method thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103071010A (en) * | 2013-01-17 | 2013-05-01 | 白长川 | Traditional Chinese medicine preparation for treating disorders of gastrointestinal motility |
| CN103071010B (en) * | 2013-01-17 | 2015-06-17 | 白长川 | Traditional Chinese medicine preparation for treating disorders of gastrointestinal motility |
| CN103463257A (en) * | 2013-08-12 | 2013-12-25 | 中国科学院广州生物医药与健康研究院 | Fructus aurantii immaturus or fructus aurantii extract, its preparation method and application |
| CN108653432A (en) * | 2017-04-01 | 2018-10-16 | 北京盈科瑞创新药物研究有限公司 | A kind of Chinese medicine composition and its preparation |
| CN108653432B (en) * | 2017-04-01 | 2021-11-19 | 盈科瑞（天津）创新医药研究有限公司 | Traditional Chinese medicine composition and preparation thereof |
| CN114081934A (en) * | 2022-01-20 | 2022-02-25 | 江西省中医药研究院 | Traditional Chinese medicine composition and quality detection method thereof |
| CN114081934B (en) * | 2022-01-20 | 2022-04-12 | 江西省中医药研究院 | Traditional Chinese medicine composition and quality detection method thereof |
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