CN100396324C - Medicine composition for treating functional indigestion and its prepn - Google Patents
Medicine composition for treating functional indigestion and its prepn Download PDFInfo
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- CN100396324C CN100396324C CNB2005101149438A CN200510114943A CN100396324C CN 100396324 C CN100396324 C CN 100396324C CN B2005101149438 A CNB2005101149438 A CN B2005101149438A CN 200510114943 A CN200510114943 A CN 200510114943A CN 100396324 C CN100396324 C CN 100396324C
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Abstract
The present invention discloses a medicine composition for curing functional dyspepsia, which comprises the following raw materials (wt%) of medicine: 11.65 wt. % of combined spicebush root, 11.65 wt. % of areca seed, 9.30 wt. % of finger citron, 9.30 wt. % of curcuma root, 2.34 wt. % of agilawood, 23.23 wt. % of dandelion, 23.23 wt. % of calcined concha arcae and 9.30 wt. % of codonopsis pilosula. The present invention can be prepared into a conventional dosage form such as oral medicinal liquid, tablets, capsules, granules, injections, etc. The present invention also provides an improved preparation method for a medicine composition. The medicine composition can cure functional dyspepsia and can be mainly used for symptoms of stomach distention or stomachache, eructation, acid regurgitation, nausea, loss of appetite, dry mouth, bitter taste, dyschezia or colonic stasis, etc. caused by qi stagnation in the spleen and the stomach and internal heat.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of functional dyspepsia and preparation method thereof, particularly relating to a kind of is the pharmaceutical composition of the treatment functional dyspepsia made of raw material with the vegetable Chinese herbal medicine.
Background technology
Chinese medicine is thought: The spleen and stomach provide the material basis of the acquired, occupy Central Region, be the pivot of rising and falling of QI, splenic qi tending to ascend, stomach-QI being apt to descend, oppose each other and yet also complement each other, temper rises then essence of water and grain and is failed cloth, and gastric qi is fallen, then water paddy and waste matter thereof are able to descending, so "guide to clinical practice with medical record" cloud: " the normal function of the spleen tending to ascent, stomach should fall then and ", if the taste abnormal ascending-descending of QI, spleen-QI failing to rise up, failure of stomach-QI to descend, Central Region mechanism of qi hinge is ineffective, causes epigastric fullness, the chest and diaphragm unhappiness, all diseases such as distension and fullness in the abdomen or distending pain discomfort, " so element asks YIN YANG classification of natural phenomena big opinion " day: " clear QI in the lower part of the body; then give birth to and let out, turbid QI failing to descend is then given birth to and expanded ".If the stagnation of QI with the passing of time, then easily strongly fragrant and fire-transformation is given birth to heat, pathogenic heat Central Region of being jammed causes diseases such as xerostomia, hardship, noisy, constipation with dry stool more.
The treatment of feeling of fullness disease, key are to transfer the regulating the function of middle-JIAO mechanism of qi.Study carefully the cause of disease of feeling of fullness disease, have invasion of pathogenic factor from the exterior into the interior, eating accumulation, mental disorder fight knot, turbid damp internal resistance, seven emotions are become estranged and weakness of the spleen and stomach etc., except that invasion of pathogenic factor from the exterior into the interior, all relevant with dysfunction of spleen and stomach, in burnt ascending or descending movement of vital Qi be obstructed, clear YANG failing to ascend, turbid YIN failing to descend, and must not cause declare logical.Its sick position is dirty at spleen, stomach, liver three, thus distinguish and control feeling of fullness, emphasis spleen, stomach, liver, most important.Painful abdominal mass has the branch of deficiency and excess, and cold and heat are not, and stuffiness syndrome of excess type is based on eliminating evil, and stuffy sensation of deftciency type is an elder generation to set upright, no matter right eliminating evil or set upright, always not from conditioning spleen, stomach, liver three dirty functions, make spleen rise stomach and fall, liver catharsis function is normal, and middle burnt mechanism of qi is unobstructed, and then feeling of fullness can be healed.
The Chinese patent medicine for the treatment of this class disease at present clinically is more, as adds flavor lenitive pill, Aurantii Immaturi and Atractylodis Pill, oral mushroom liquor etc.But old person, child's physiological characteristics is that internal organs are tender and lovely, weakness of the spleen and stomach particularly, to drug reaction than health adult sensitivity.So children's, particularly preschool children's, when using medicines such as adding flavor lenitive pill, Aurantii Immaturi and Atractylodis Pill, oral mushroom liquor, just more outstanding to adverse effect.
Wherein, the most common oral mushroom liquor is an extremely brown supernatant liquid of pale brown color, gas fragrance, sweet, the little hardship of flavor.Its Main Ingredients and Appearance is: the Radix Aucklandiae, Fructus Aurantii, the Radix Linderae, Semen Arecae.But there is following problem in this product in clinical use: 1, have hypertension, heart disease, hepatopathy, diabetes, nephropathy chronic diseases severe patient generally can not take.2, old person generally can not take.3, cause child's allergy easily, the child generally can not use.
Therefore, need a kind of medicine that uses safer, more effective treatment functional dyspepsia clinically.
Summary of the invention
On the one hand, the object of the present invention is to provide a kind of pharmaceutical composition of novel treatment functional dyspepsia, the weight proportion of its each crude drug is: Radix Linderae 6.51wt.%-16.67wt.%, Semen Arecae 6.51wt.%-16.67wt.%, Fructus Citri Sarcodactylis 6.51wt.%-15.33wt.%, Radix Curcumae 6.51wt.%-15.33wt.%, Concha Arcae (calcined) 20.00wt.%-28.67wt.%, Herba Taraxaci 20.00wt.%-28.67wt.%.
On the other hand, the object of the present invention is to provide the method for this pharmaceutical composition of preparation, it contains following steps:
(1) get the crude drug Radix Linderae, Semen Arecae, Fructus Citri Sarcodactylis, Radix Curcumae according to the weight proportion of claim 1 earlier, the soak with ethanol that adds 50wt.%-80wt.% is spent the night; Reflux, extract, secondary then, each 1-2.5 hour, filter medicinal residues I and medicinal liquid I;
(2) get crude drug Herba Taraxaci, Concha Arcae (calcined) according to the weight proportion of claim 1 again, soaked 1 hour, add the medicinal residues I in the step (1) then, the mixture decocting that obtains boils secondary, each 1-2.5 hour; After the filtration filtrate being concentrated into proportion is 1.0-1.3; Put and be chilled to room temperature, ethanol to the concentration of alcohol that adds 80wt.%-95% again is 50%; Placement is spent the night; The supernatant concentration that obtains is obtained the concentrated solution B that proportion d is 1.0-1.3;
(3) the concentrated solution B that obtains in the medicinal residues I that obtains in the step (1) and the step (2) is merged, obtain each described pharmaceutical composition among the claim 1-3.
Technical scheme of the present invention is to establish for stagnation of QI in spleen and stomach, wherein the concrete prescription of pharmaceutical composition is Radix Linderae 6.51wt.%-16.67wt.%, Semen Arecae 6.51wt.%-16.67wt.%, Fructus Citri Sarcodactylis 6.51wt.%-15.33wt.%, Radix Curcumae 6.51wt.%-15.33wt.%, Concha Arcae (calcined) 20.00wt.%-28.67wt.%, Herba Taraxaci 20.00wt.%-28.67wt.%.
The weight proportion of the crude drug of pharmaceutical composition of the present invention is preferably: Radix Linderae 6.51wt.%-15.33wt.%, Semen Arecae 6.51wt.%-15.33wt.%, Fructus Citri Sarcodactylis 6.51wt.%-13.33wt.%, Radix Curcumae 6.51wt.%-13.33wt.%, Concha Arcae (calcined) 20.00wt.%-26.67wt.%, Herba Taraxaci 20.00wt.%-26.67wt.%, Radix Codonopsis 6.51wt.%-13.33wt.%, Lignum Aquilariae Resinatum 0-6.51wt.%.
The weight proportion of the crude drug of pharmaceutical composition of the present invention most preferably is: the Radix Linderae (radixlinderae) 11.65wt.%, Semen Arecae (semen arecae) 11.65wt.%, Fructus Citri Sarcodactylis (fructus citrisarcodactylis) 9.30wt.%, Radix Curcumae (radixcurcumae) 9.30wt.%, Concha Arcae (calcined) (concha arcae) 23.23wt.%, Herba Taraxaci (herba taraxaci) 23.23wt.%, Radix Codonopsis (radlx codonopsis) 9.30wt.%, Lignum Aquilariae Resinatum (lignum aquilariaeresinatum) 2.34wt.%.
Pharmaceutical composition of the present invention can be prepared into the step of said dosage form on any pharmaceutics according to the conventional production method of pharmaceutical field.For example that pharmaceutical composition of the present invention and one or more are conventional pharmaceutical carrier mixes, and is prepared into required dosage form then.
Technical scheme of the present invention also comprises the method for preparing this pharmaceutical composition, and it contains following steps:
(1) get the crude drug Radix Linderae, Semen Arecae, Fructus Citri Sarcodactylis, Radix Curcumae according to the weight proportion of claim 1 earlier, the soak with ethanol that adds 50wt.%-80wt.% is spent the night; Reflux, extract, secondary then, each 1-2.5 hour, filter medicinal residues I and medicinal liquid I;
(2) get crude drug Herba Taraxaci, Concha Arcae (calcined) according to the weight proportion of claim 1 again, soaked 1 hour, add the medicinal residues I in the step (1) then, the mixture decocting that obtains boils secondary, each 1-2.5 hour; After the filtration filtrate being concentrated into proportion is 1.0-1.3; Put and be chilled to room temperature, ethanol to the concentration of alcohol that adds 80wt.%-95% again is 50%; Placement is spent the night; The supernatant concentration that obtains is obtained the concentrated solution B that proportion d is 1.0-1.3;
(3) the concentrated solution B that obtains in the medicinal residues I that obtains in the step (1) and the step (2) is merged, obtain each described pharmaceutical composition among the claim 1-3.
Further contain Lignum Aquilariae Resinatum in the crude drug in the step in this preparation method (1), and may further include the medicinal liquid I that will obtain and place the concentrating under reduced pressure pot, 50-80 ℃ concentrate concentrated solution A, its proportion d is 1.0-1.3; Further contain Radix Codonopsis in the crude drug in the step (2).
This preparation method preferably contains following steps:
(1) earlier 70wt.% ethanol is added soaked overnight among Radix Linderae 179g, Semen Arecae 179g, Fructus Citri Sarcodactylis 143g, Radix Curcumae 143g, the Lignum Aquilariae Resinatum 36g; The reflux, extract, secondary, each 1.5 hours, filter medicinal residues I and medicinal liquid I, medicinal liquid I places the concentrating under reduced pressure pot then, 60 ℃ concentrate concentrated solution A, d=1.07;
(2) soaked 1 hour first water for injection is added among 3200ml Herba Taraxaci 357g, Concha Arcae (calcined) 357g, the Radix Codonopsis 143g; Add the medicinal residues I in the step (1), and then add 3200ml water for injection decoction secondary, each 1.5 hours; After the filtration 70 ℃ of filtrates being concentrated into proportion is 1.08, puts and is chilled to room temperature; It is 50% that the ethanol of slow adding 95% makes concentration of alcohol; Placement is spent the night; Get the concentrated solution B that the supernatant concentration supernatant gets d=1.08;
(3) with the starch oven dry, sieve, mannitol sieves, and is standby; Take by weighing concentrated solution A described in the step (1) of recipe quantity and the concentrated solution B described in the step (2) and mannitol 500g, starch 150g mix homogeneously, conventional method is prepared into granule.
Preparation method of the present invention obtains the step that pharmaceutical composition can be prepared into said dosage form on any pharmaceutics according to the conventional production method of pharmaceutical field.For example that pharmaceutical composition of the present invention and one or more are conventional pharmaceutical carrier mixes, and is prepared into required dosage form then.
Pharmaceutical composition of the present invention can by oral, snuffing is gone into, the mode of rectum or parenteral is applied to the patient who needs.Be used for when oral, can be made into conventional solid preparation, as tablet, powder, granule, capsule etc.; Or make liquid preparation, as water or oil-suspending agent, or other liquid preparations, as syrup, elixir etc.; When being used for parenteral, can be made into solution, lyophilized injectable powder of injection etc.
The amount of application of pharmaceutical composition of the present invention can be according to variations such as the type of route of administration, patient's age, body weight, disease and the orders of severity.
According to theory of Chinese medical science, the Radix Linderae in the pharmaceutical composition of the present invention, broken stagnant, the pleasant merit of sending down the abnormal ascending QI of the equal tool circulation of qi promoting of Semen Arecae, wherein the hot Wen Xiang of the Radix Linderae scurries, be the good medicine of regulating QI to relieve pain, and yellow palace embroidery thinks that " the genus QI rising in reverse order of all diseases and see the unhappy person of breast abdomen all should be used this.The merit and the Radix Aucklandiae, Rhizoma Cyperi are all a class ".The hot hardship of loosing of Semen Arecae is let out, again can cathartic and relieving constipation.Two medicines share, and make mechanism of qi mediation, internal organs stop up to stagnate and are able to Xuan Li, thereby reach the effect of relieving distension pain relieving, alleviating distention in middle-JIAO relieving constipation, and two medicines are monarch drug altogether; Fructus Citri Sarcodactylis, Radix Curcumae, Lignum Aquilariae Resinatum are strengthened the merit of monarch drug activating qi for lowering adverse qi, relieving distension pain relieving.Wherein Fructus Citri Sarcodactylis abnormal smells from the patient delicate fragrance, and the appetizing of being amusing, relieving diaphragm and removing stagnancy, pleasant the chest stuffiness relieving be to be pleased the quality goods of spleen, and Radix Curcumae again can blood circulation promoting and blood stasis dispelling, make QI movement being in harmonious way.Lignum Aquilariae Resinatum can activating qi for lowering adverse qi the power of pain relieving very strong, the auxiliary monarch drug of three medicines with the breast abdominal distention of controlling stagnation of QI QI rising in reverse order vexedly have a pain, the vexed disease such as not well of not eating, defecate of QI rising in reverse order belch, gastral cavity, be ministerial drug altogether; The stagnation of QI with the passing of time, many easily heat-transformation and see dry mouth with bitter taste, acid regurgitation, noisy, disease such as unhappiness is not relaxed, thus with Herba Taraxaci with hot and suffocating in the clearing stomach.Forge the Concha Arcae relieving gastric hyperacidity to alleviate stomachache, help the monarch and his subjects to control the acid regurgitation belch.Gastropathy with the passing of time, the gas that injures one's stomach more, thus again with Radix Codonopsis first tonify deficiency set upright, the capable medicine that stagnates of second anti-dispelling the stagnated QI is sent an expedition against too, gas instead more injures one's stomach.More than three medicines its for the assistant make.All medicines share, and gather the merit of activating qi for lowering adverse qi, relieving distension pain relieving, clearing heat to ease the stomach altogether.We are cold, heat, attack, mend and usefulness, row and do not let out, tonify without causing stagnation, real for controlling the good recipe of painful abdominal mass.
According to the doctor trained in Western medicine theory, under normal circumstances, the physics of various foods and chemical factor, gastric acid, pepsic Digestion all can not damage gastric mucosa in the gastric juice.This is because normal gastric mucosa has the series of defence function, comprising: gastric mucus barrier, the updating ability that mucomembranous cell is vigorous, gastric mucosa blood supply etc.Especially the abundant supply of blood flow of coat of the stomach, the adaptive cytoprotection of the synthetic endogenous prostaglandin that discharges of gastric mucosa when gastric mucosa suffers from various damage, can be strengthened the defensive enginery of body, and gastric mucosa is protected.
Bibliographical information according to Chinese scholars: Herba Taraxaci can significantly reduce the pyloric ligation ulcers rat tolerance secretion, and reduction gastric juice is free and spend inhibition pepsin activity, anti-pyloric ligation ulcers rat gastric ulcer at long last.Semen Arecae, Fructus Citri Sarcodactylis can be synthesized and the release prostaglandin by the stimulation in rats gastric mucosa; thereby its cell is protected, can be promoted the secretion of gastric mucus and bicarbonate, strengthen mucosal barrier; stimulate gastric mucosal cell to upgrade and improve the effect of gastric mucosal blood flow, resist downright bad actor.As the corrosion function of ethanol, strong acid, highly basic etc., thereby stop gastric mucosal damage.Radix Codonopsis, Lignum Aquilariae Resinatum two flavor medical materials also have certain inhibitory action to the gastric acid increase due to the histamine etc. except reducing pyloric ligation ulcers rat tolerance secretion and pepsin activity.Simultaneously, it also can increase the synthetic of prostaglandin and aminohexose and discharge, and [1 in addition, and according to discovering in recent years, a large amount of oxygen-derived free radicals can cause cells injury in the intravital accumulation of machine in the defence of reinforcement gastric mucosa.This plays an important role in gastric mucosa injury.Its effect may be relevant with mechanism such as lipid oxidation damage and covalent bonds damages.And Radix Codonopsis can reduce the level of lipoxygenase in the rat serum (LPO), suppresses lipid peroxidation, reduces the accumulation of oxygen-derived free radicals, reduces the damage of gastric mucosal cell.
The inventor is through testing with stripped digestive tract power in the body, and the peptic ulcer model, the gastric mucosa injury model that use different onset mechanism, observe stomach and intestine dynamics effect, antiulcer effect and the effect of protection gastric mucosa of pharmaceutical composition of the present invention, find that pharmaceutical composition of the present invention has the good active effect of promotion gastrointestinal tract dynamia when the treatment functional dyspepsia; Simultaneously gastric mucosa injury is had significant protective effect, multiple ulcer model is all had excellent protection or therapeutical effect, curative effect obviously is better than Aurantii Immaturi and Atractylodis Pill, oral mushroom liquor.Concrete experimental evidence, toxicity data and stability data are as follows:
(1) experimental evidence
One, the stomach and intestine dynamics effect of pharmaceutical composition of the present invention
1. zoology test:
Medication preparation: preparation in accordance with the present invention is mixed with injection with the Radix Linderae, Semen Arecae, Fructus Citri Sarcodactylis, Radix Curcumae, Lignum Aquilariae Resinatum, Herba Taraxaci, Concha Arcae (calcined), Radix Codonopsis.
Mice selects for use Zhongshan University drug study chamber that 80 of white mice are provided.All white mouse all promptly begin the subcutaneous injection atropine the last week in experiment.Be divided into each 20 of A, B, C groups (A:6.1g/kg, B:12.1g/kg, C:30.4g/kg) then and all injected the above-mentioned injection that makes 7 days; Normal control group injection " Decoction of Four-Drug Juice injection ", the cycle is the same.
Table 1. relative analysis table
| Title | The methyl orange Emptying Rate | Zhou Xianxiao |
| A | 45.41wt.％ | 33.66wt.％ |
| B | 56.24wt.％ | 46.79wt.％ |
| C | 68.29wt.％ | 51.60wt.％ |
| Matched group | 23.58wt.％ | 19.83wt.％ |
As can be seen from Table 1, pharmaceutical composition of the present invention has tangible antagonism, and is obvious dose-effect relationship because of the emptying of the caused mice stomach of subcutaneous injection atropine (0.22mg/kg) to methyl orange suppresses, and the big more effect of dosage is obvious more; And effect obviously is better than " Decoction of Four-Drug Juice injection ".
2. clinical trial
What implement is simple open group clinical trial, self cross-reference test, and observing case is 80 examples.
Test method: (1) medication preparation: weight proportion according to the present invention is prepared into granule with the Radix Linderae, Semen Arecae, Fructus Citri Sarcodactylis, Radix Curcumae, Lignum Aquilariae Resinatum, Herba Taraxaci, Concha Arcae (calcined), Radix Codonopsis with the conventional method in the field of Chinese medicines.
(2) observational technique: when qualified experimenter enters test, promptly use granule, take after mixing it with water half an hour ante cibum, each 1 bag (7 gram), every day 3 times.Viewing duration plays the medicine of therapeutical effect without other to primary symptom.Observe for two groups and be 7 days the course of treatment.
Table 2. tcm symptom grading curative effect situation relatively
As can be seen from Table 2, pharmaceutical composition of the present invention has good curative effect to treatment stagnation of QI in spleen and stomach type functional dyspepsia, to improving the gastric emptying obstacle curative effect is preferably arranged, and effect safety, no obvious adverse reaction can be used as the medicine of stagnation of QI in spleen and stomach type functional dyspepsia.
Two, the anti-stick membrane damage effect of pharmaceutical composition of the present invention
1.1 laboratory animal
Adopt the purebred rat of SD one-level, body weight 140～160g.Male and female are regardless of.Zhongshan University's Experimental Animal Center provides.
1.2 the preparation of medicine
Preparation in accordance with the present invention makes A solution with the Radix Linderae, Semen Arecae, Fructus Citri Sarcodactylis, Radix Curcumae, Lignum Aquilariae Resinatum, Herba Taraxaci, Concha Arcae (calcined), Radix Codonopsis.
Preparation in accordance with the present invention makes B solution with the Radix Linderae, Semen Arecae, Fructus Citri Sarcodactylis, Radix Curcumae, Herba Taraxaci, Concha Arcae (calcined).
1.3 the preparation of animal model and grouping
1.3.1 gastric mucosa injury model
Rat fasting 24h before the experiment can't help water.Stomach raise above-mentioned A solution after 1 hour stomach raise the 2ml dehydrated alcohol, put to death animal after 1 hour, dissect and to get stomach, cut off coat of the stomach along greater gastric curvature, clean up the back and launch to measure damage index.
1.3.2 animal grouping and medication
Adopt the random packet principle, 40 rat are divided into I, II, III, IV group at random, promptly test A, B, C group and matched group, 10 every group.Group I stomach is raised the above-mentioned A solution 10g/kg of 100wt.%, and stomach is raised a dehydrated alcohol 2ml/ modeling after 1 hour; Group II stomach is raised the above-mentioned B solution 10g/kg of 100wt.%, and stomach is raised a dehydrated alcohol 2ml/ modeling after 1 hour; Group III stomach is raised " the Decoction of Four-Drug Juice electuary " of the 10gl/kg of 100wt.%, and stomach is raised a dehydrated alcohol 2ml/ modeling after 1 hour; Group IV stomach is raised the distilled water of the 10ml/kg of 100wt.%, and stomach is raised a dehydrated alcohol 2ml/ modeling after 1 hour.
1.4 damage index measuring method and statistical procedures
1.4.1 damage index measuring method
Damage slivering rope person surveys its length, and in 1mm 1 minute, if width＞1mm, then score doubled; Hemorrhagely be point-like person (length and width is meter 0.5 minute all＜1mm); The hemorrhage person that is the speckle (length and width all＞2mm) measure its area, score with area.Above results added is damage index.
1.4.2 statistical procedures
Each is organized damage index and represents with " means standard deviation ".The average differences is checked with t.
Damage suppression ratio=(the average damage index of the average damage index-experimental group of matched group) x100wt.%
The average damage index of matched group
2 the results are shown in Table 3
Table 3.I, II, III, IV group damage index and statistical procedures result
| Group | Damage index | The damage suppression ratio |
| Experiment A group | 41.0±20.5 | 85.7 |
| Experiment B group | 62.0±9.5 | 64.1 |
| Experiment C group | 87.7±5.3 | 36.7 |
| Matched group | 286.2±83.7 |
P＜0.001, there were significant differences.
The Radix Linderae of recipe quantity, Semen Arecae, Fructus Citri Sarcodactylis, Radix Curcumae, Herba Taraxaci, Concha Arcae (calcined) have protective effect to the gastric mucosa of dehydrated alcohol damage as can be seen from Table 3.Radix Codonopsis, Lignum Aquilariae Resinatum add in the prescription, make drug effect more gentle, more can give play to the effect of all the other 6 flavor medical materials.
Three, adopt medicine composite for curing constipation of the present invention
1, treatment group adopts pharmaceutical composition of the present invention, patient's 42 examples.10 examples＜＜2 years old, each 3～5 grams; 10 examples 2～7 years old, each 6～10 grams, 3/ day, mixing in water for oral taking; 10 examples＞＞60 years old; Each 10～15 grams more than 7 years old, 3 times/day, mixing in water for oral taking. 7 days courses of treatment, 2 courses of treatment of logotype.Matched group adopts oral mushroom liquor, patient's 40 examples, and the course of treatment is the same.
2, result
2.1 pharmaceutical composition of the present invention and Simo Decoction Treatment Acute infantile constipation curative effect are relatively
| The example number | Zhou Zhiyu | Zhou Xianxiao | Zhou Wuxiao | The moon cures | Is the moon invalid? | |
| The treatment group | 42 | 14 | 8 | 10 | 25 | 12 |
| Matched group | 40 | 8 | 5 | 20 | 16 | 19 |
P＜0.05＜0.05
2.2 the defecation situation compares after pharmaceutical composition of the present invention and the Simo Decoction Treatment Acute infantile constipation, (X-± S)
| The improvement time | Defecation cycle during 1 week | Defecation cycle during January | |
| The treatment group (my god) | 3.636±0.935 | 1.349±0.767 | 1.621±1.374 |
| Matched group (my god) | 4.260±0.857 | 1.970±0.812 | 3.682±1.746 |
U?3.826?4.295?7.1107，P＜0.01＜0.01＜0.001
Above-mentioned experiment shows that pharmaceutical composition of the present invention has advantage in functional dyspepsia diseases such as treatment constipation, and cure rate at a specified future date is high and cheap, does not find side effect in therapeutic process.Effective percentage 58/66 (87.9wt.%) during 1 week, effective percentage 54/66 (81.8wt.%) in the time of 1 month, short term effect and late result pharmaceutical composition group of the present invention all is better than the Decoction of Four-Drug Juice group.
(2) clinical preceding toxicity summary
Pharmaceutical composition of the present invention has been done systematic study and experiment by Guangzhou Traditional Chinese Medicine College's clinical pharmacology institute and group embryo teaching and research room to its acute toxicity, long term toxicity and toxicity, the result shows: acute toxicity test adopts pharmaceutical composition 440g/kg of the present invention (daily dose) to give mouse gavaging, observed seven days continuously, the mice ordinary circumstance is normal, weight increase, each major organs perusal shows no obvious abnormalities, and can not survey LD
50Long term toxicity test adopts pharmaceutical composition 88.0g/kg of the present invention, 66.5g/kg and three dosage groups of 33.1g/kg (be respectively clinical consumption 80 times, 55 times, 30 times) to take to rat, result of the test shows: below the pharmaceutical composition 88.0g/kg of the present invention, took for a long time through 90 days and not see toxic reaction.
The toxicological experiment histological examination is the result show: basic, normal, high three the dosage groups of matched group and pharmaceutical composition of the present invention, each organizes the heart, liver, spleen, lung, kidney, adrenal gland, the ovary of rat, the organizational structure of testis all belongs to normally, except that mild hyperaemia or the infiltration of focal inflammation that haveing nothing to do with medicine appears in the minority animal viscera, do not have tangible pathomorphology and change.
(3) stable data
The component of pharmaceutical composition of the present invention and chemical analysis are comparatively complicated, for guaranteeing the preparation inherent quality pharmaceutical composition of the present invention is carried out study on the stability (40 ℃ ± 2 ℃, relative humidity are accelerated test 6 months under the condition of 75wt.% ± 5wt.%, and the sample room temperature study on the stability that keeps sample and placed 3 years) under the terms of packing in listing.1. experimental group:
A: the Radix Linderae, Semen Arecae, Fructus Citri Sarcodactylis, Radix Curcumae, Lignum Aquilariae Resinatum, Herba Taraxaci, Concha Arcae (calcined), Radix Codonopsis
2. following is the matched group data:
B: the Radix Astragali, Radix Notoginseng, Radix Curcumae, Lignum Aquilariae Resinatum, Herba Taraxaci, Concha Arcae (calcined), Radix Codonopsis, Fructus Schisandrae Chinensis
C: Radix Ginseng, Radix Notoginseng, Radix Curcumae, Lignum Aquilariae Resinatum, the Rhizoma Pinelliae, Semen Arecae, Fructus Citri Sarcodactylis, the Radix Astragali
D: Radix Adenophorae (Radix Glehniae), Radix Codonopsis, Radix Scutellariae, Ganoderma, Cordyceps, Semen Arecae, Fructus Citri Sarcodactylis, the Radix Astragali
E: Radix Codonopsis, Radix Angelicae Sinensis, the Radix Astragali, Radix Angelicae Sinensis Tabellae, Radix Sophorae Flavescentis, Radix Glycyrrhizae, Radix Isatidis, the Rhizoma Pinelliae
Table 4
Pharmaceutical composition of the present invention as can be seen from Table 4 is accelerated test 6 months under the condition of 75wt.% ± 5wt.% through 40 ℃ ± 2 ℃, relative humidity, reach the study on the stability that room temperature keeps sample and placed 3 years, outward appearance and content have no significant change, differentiate and all be positive reaction, granularity inspection, melting and moisture content are qualified, and health examination is up to specification; Accelerated test shows, following 40 ℃ of double-deck aluminum film terms of packing, relative humidity 75% experiment 6 months, and sample is stable, and according to pertinent regulations, effect duration can be decided to be 3 years.
The specific embodiment
Further specify the present invention below in conjunction with the specific embodiment, but do not limit the present invention in any way.
Pharmaceutical composition of the present invention can further be processed into multiple dosage forms such as oral liquid, tablet, capsule, granule and injection according to actual needs.Above-mentioned dosage form all can be according to the conventional method preparation of pharmaceutical field.Prepare as pill: prescription according to the present invention is got each crude drug and is ground into fine powder, crosses the 120-140 mesh sieve, adds the water mixing, pill, and drying, promptly.
The preparation technology of tablet is: prescription according to the present invention is got each crude drug and is decocted with water three times, and 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, and filtrate is condensed into thick paste; Recipe quantity Radix Codonopsis, Lignum Aquilariae Resinatum are ground into fine powder, and with above-mentioned thick paste uniform mixing, drying is made granule, is pressed into 1000, the bag film-coat, promptly.
In addition, the improvement extracting method of pharmaceutical composition of the present invention is:
(1) Radix Linderae 179g, Semen Arecae 179g, Fructus Citri Sarcodactylis 143g, Radix Curcumae 143g, Lignum Aquilariae Resinatum 36g are added 70wt.% ethanol in multi-function extractor, soaked overnight; The reflux, extract, secondary, each 1.5 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I, medicinal liquid I places the concentrating under reduced pressure pot, 60 ℃ concentrate concentrated solution A, d=1.07;
(2) Herba Taraxaci 357g, Concha Arcae (calcined) 357g, Radix Codonopsis 143g are added water for injection 3200ml and soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1.5 hours, filter merging filtrate, the reject medicinal residues are put amalgamation liquid in the triple effect concentrator, and 70 ℃ stop to concentrate when being concentrated into proportion 1.08, put and be chilled to room temperature, the concentration that slowly adds amount of calculation is the neutralization of 95% ethanol, makes concentration of alcohol reach 50%, and placement is spent the night, extract supernatant, discard precipitate; Concentrated supernatant gets concentrated solution B, d=1.08;
(3) with the starch oven dry, sieve, mannitol sieves, and is standby; Take by weighing the extractum of recipe quantity and mannitol 500g, starch 150g mix homogeneously, conventional method is prepared into granule.
As everyone knows, ethanol is the semi-polarity solvent, dissolubility between polarity and nonpolar between, solubilized alkaloid and its esters, glycosides, sugar, amaroid etc., more dissolved compositions of solubilized non-polar solven again are as resin, volatile oil, lactone, aromatic compound etc.The dissolubility of the chemical constituent of various medical materials in ethanol changes with concentration of alcohol, and determining alcohol is higher, and the dissolubility of volatile oil, free alkaloid, resin etc. is bigger.By document as can be known: general ethanol content is suitable for lixiviate volatile oil, organic acid, resin, chlorophyll etc. when 90wt.% is above; Ethanol content is suitable for lixiviate alkaloid, glycoside etc. when 50wt.%-70wt.%.
The Radix Linderae, Semen Arecae, Fructus Citri Sarcodactylis, Radix Curcumae and Lignum Aquilariae Resinatum Chinese medicine of the five flavours mainly contain compositions (seeing Pharmacopoeia of People's Republic of China 2005 editions for details) such as volatile oil, alkaloid in the pharmaceutical composition of the present invention.The inventor finds can destroy compositions such as the volatile oil that mainly contains in the Radix Linderae, Semen Arecae, Fructus Citri Sarcodactylis, Radix Curcumae and the Lignum Aquilariae Resinatum in the pharmaceutical composition of the present invention, alkaloid according to the preparation conventional method that document discloses in experiment, causes yield to descend.
For the effective ingredient in the medical material can fully be extracted, reduce simultaneously and destroy and loss, the inventor has at first done contrast test to the concentration of alcohol of reflux, extract,, under the time of the reflux, extract, condition identical with the ethanol consumption, investigates concentration of alcohol to becoming the influence of cream amount and arecoline extraction ratio.According to bibliographical information, Chinese crude drug is generally 70～90% with the selected concentration of alcohol reflux.In the experience aspect other Chinese medicine extraction, selected 70%, 80%, 90% 3 kind of concentration of alcohol done the reflux, extract, test in conjunction with the inventor.Experiment condition is: reflux, extract, once, the time is 1.5 hours, add alcohol multiple be 10 times.Experimental result sees Table 5.
The extraction result of three kinds of concentration ethanol of table 5.
Annotate: 1. arecoline content is 0.32wt.% in the Semen Arecae medical material that feeds intake.
2. Semen Arecae alkali number in Semen Arecae alkali number in the arecoline extraction ratio=extractum/medical material Semen Arecae that feeds intake.
As can be seen from Table 5, along with concentration of alcohol by 90wt.% → 80wt.% → 70wt.%, extractum amount, extractum yield progressively improve, yield is by 12.60wt.% → 13.10wt.% → 13.70wt.%, though the content of arecoline descends to some extent in the extractum, but the extraction ratio of arecoline is along with the decline of concentration of alcohol increases, by 87.50wt.% → 88.13wt.% → 88.54wt.%.Inferring reason, may be in certain range of alcohol concentration, and the water content of proper proportion helps the extraction of some composition in the Chinese crude drug.
In order to reduce cost, improve yield, guarantee effective ingredient not by or few destroyed factors prerequisite under, the inventor determines to select the solvent of 70wt.% ethanol as reflux, extract.
And the inventor finds to compare with common process, and the improved preparation technology that the present invention proposes improves a lot aspect yield.Experimental results show that as follows:
The A group directly is prepared 8 herbal medicines for conventional water extract-alcohol precipitation method.
The B group is the new preparation process method
Embodiment 1:
Extraction is prepared into high-capacity injection with separating
Radix Linderae 250g, Semen Arecae 250g, Fructus Citri Sarcodactylis 230g, Radix Curcumae 230g are added 70wt.% ethanol in multi-function extractor, soaked overnight.The reflux, extract, secondary, each 1.5 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I, medicinal liquid I places the concentrating under reduced pressure pot, concentrate concentrated solution A (80 ℃, d=1.10), label, indicate the name of an article, lot number, date etc.
Herba Taraxaci 300g, Concha Arcae (forging) 300g, Radix Codonopsis 200g are added water for injection 3200ml soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1.5 hours, filter merging filtrate, the reject medicinal residues are put amalgamation liquid in the triple effect concentrator, stop when being concentrated into proportion 1.12 concentrating, put and be chilled to room temperature, slowly add 95% ethanol of amount of calculation, make concentration of alcohol reach 50%, placement is spent the night, extract supernatant, discard precipitate.Concentrated supernatant gets concentrated solution B (d=1.12), and device is placed in addition, labels, and indicates the name of an article, lot number, date etc.
The concentrated solution B that the concentrated solution A and the water of above-mentioned alcohol extraction are carried fully mixes, get above-mentioned concentrated solution and add water for injection 440ml, heated and boiled 20 minutes, stir and add active carbon 0.8g down, continued to boil 10 minutes, take out cooling, filter carbon removal, add water for injection to nearly 400ml, NaOH solution adjust pH with 10wt.% is 6.5, coarse filtration, the elementary 3um of fine straining (adopting three grades of microfiltration technology), secondary 0.45um, three grades of 0.22um, embedding in the ampoule of 20ml 100 ℃, sterilization in 30 minutes promptly gets injection after the passed examination.
Embodiment 2:
Radix Linderae 100g, Semen Arecae 100g, Fructus Citri Sarcodactylis 100g, Radix Curcumae 100g are added 70wt.% ethanol in multi-function extractor, soaked overnight.The reflux, extract, secondary, each 2.0 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I, medicinal liquid I places the concentrating under reduced pressure pot, concentrate concentrated solution A (80 ℃, d=1.10), label, indicate the name of an article, lot number, date etc.
Herba Taraxaci 458g, Concha Arcae (forging) 458g, Radix Codonopsis 200g, Lignum Aquilariae Resinatum 100g are added water for injection 3200ml soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1.5 hours, filter merging filtrate, the reject medicinal residues are put amalgamation liquid in the triple effect concentrator, stop when being concentrated into proportion 1.12 concentrating, put and be chilled to room temperature, slowly add 95% ethanol of amount of calculation, make concentration of alcohol reach 50%, placement is spent the night, extract supernatant, discard precipitate.Concentrated supernatant gets concentrated solution B (d=1.12), and device is placed in addition, labels, and indicates the name of an article, lot number, date etc.
The concentrated solution B that the concentrated solution A and the water of above-mentioned alcohol extraction are carried fully mixes, get above-mentioned concentrated solution and add water for injection 440ml, heated and boiled 20 minutes, stir and add active carbon 0.8g down, continued to boil 10 minutes, take out cooling, filter carbon removal, add water for injection to nearly 400ml, NaOH solution adjust pH with 10wt.% is 6.5, coarse filtration, the elementary 3um of fine straining (adopting three grades of microfiltration technology), secondary 0.45um, three grades of 0.22um, embedding in the ampoule of 20ml 100 ℃, sterilization in 30 minutes promptly gets injection after the passed examination.
Embodiment 3
The preparation of the lyophilized injectable powder of 20ml
(1) get Radix Linderae 200g, Semen Arecae 200g, Fructus Citri Sarcodactylis 100g, Radix Curcumae 100g, more than 7 times of 60wt.% ethanol of each component gross weight, heating and refluxing extraction 2 times, each 2.0 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I.
(2) Herba Taraxaci 300g, Concha Arcae (forging) 300g, Radix Codonopsis 100g are added water for injection 3200ml and soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1.5 hours, filter, merging filtrate obtains extracting compositions.Get and extract compositions 10g, add the injection water and make dissolving in right amount, add sodium chloride 2.25g, adjust volume to 250ml with water for injection, add an amount of injection charcoal, boiled 20 minutes, and put coldly, filter, sterilization, irritate in low boron glass ampoule bottle by 1ml volume branch, cool drying promptly gets the lyophilized injectable powder sample.
Embodiment 4
The preparation of the lyophilized injectable powder of 20ml
(1) get Radix Linderae 200g, Semen Arecae 200g, Fructus Citri Sarcodactylis 100g, Radix Curcumae 100g, more than 5 times of 60wt.% ethanol of each component gross weight, heating and refluxing extraction 2 times, each 2.5 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I.
(2) Herba Taraxaci 400g, Concha Arcae (forging) 400g, Radix Codonopsis 100g are added water for injection 3200ml and soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1.5 hours, filter, merging filtrate obtains extracting compositions.Get and extract compositions 10g, add the injection water and make dissolving in right amount, add sodium chloride 2.25g, adjust volume to 250ml with water for injection, add an amount of injection charcoal, boiled 20 minutes, and put coldly, filter, sterilization, irritate in low boron glass ampoule bottle by 1ml volume branch, cool drying promptly gets the lyophilized injectable powder sample.
Embodiment 5:
The preparation method of granule
Five tastes medical materials such as Radix Linderae 179g, Semen Arecae 179g, Fructus Citri Sarcodactylis 143g, Radix Curcumae 143g, Lignum Aquilariae Resinatum 36g are added 70wt.% ethanol in multi-function extractor, soaked overnight.The reflux, extract, secondary, each 1.5 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I, medicinal liquid I places the concentrating under reduced pressure pot, concentrate concentrated solution A (60 ℃, d=1.07), label, indicate the name of an article, lot number, date etc.
Herba Taraxaci 357g, three flavor medical materials such as Concha Arcae (forging) 357g, Radix Codonopsis 143g are added water for injection 3200ml and soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1.5 hours, filter merging filtrate, the reject medicinal residues are put amalgamation liquid in the triple effect concentrator, stop to concentrate when being concentrated into proportion 1.0 (70 ℃), put and be chilled to room temperature, slowly add 95% ethanol of amount of calculation, make concentration of alcohol reach 50%, placement is spent the night, extract supernatant, discard precipitate.Concentrated supernatant gets concentrated solution B (d=1.0), and device is placed in addition, labels, and indicates the name of an article, lot number, date etc.
With the starch oven dry, sieve, mannitol sieves, and is standby.Take by weighing the extractum of recipe quantity and mannitol 500g, starch 150g mix homogeneously, on granulation machine, granulate with 12 order stainless steel meshs, boiled bed drying, 12 mesh sieve granulate are measured particulate content and moisture, packing, every packed 7g, sealing is preserved in shady and cool dry place
Embodiment 6: sheet preparation technology
1. Radix Linderae 230g, Semen Arecae 200g, Fructus Citri Sarcodactylis 200g, Radix Curcumae 200g, Lignum Aquilariae Resinatum 100g are added 60wt.% ethanol in multi-function extractor, soaked overnight.The reflux, extract, secondary, each 1.0 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I, medicinal liquid I places the concentrating under reduced pressure pot, concentrate concentrated solution A (d=1.06), label, indicate the name of an article, lot number, date etc.
Herba Taraxaci 400g, Concha Arcae (forging) 400g, Radix Codonopsis 200g are added water for injection 3200ml soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1 hour, filter merging filtrate, the reject medicinal residues are put amalgamation liquid in the triple effect concentrator, stop to concentrate when being concentrated into proportion 1.08 (70 ℃), put and be chilled to room temperature, slowly add 95% ethanol of amount of calculation, make concentration of alcohol reach 50%, placement is spent the night, extract supernatant, discard precipitate.Concentrated supernatant gets concentrated solution B, and (70 ℃, d=1.08), device is placed in addition, labels, and indicates the name of an article, lot number, date etc.
Get A, B uniform mixing, add filler 200g, mix homogeneously; Mixture is put in the granulator, added 30wt.% ethanol 60ml, granulate, drying gets final product.
2. get vitamin 50 grams, add filler 120g, mix homogeneously; Mixture is put in the granulator, added 6wt.% binding agent 35ml, granulate, drying gets final product.
3. even by the prescription mixed with two groups, survey content, 33 towards the rotary tablet machine tabletting, and packing gets final product.
Embodiment 7: the preparation technology of capsule
(1) get Radix Linderae 230g, Semen Arecae 200g, Fructus Citri Sarcodactylis 200g, Radix Curcumae 200g, more than 7 times of 50wt.% ethanol of each component gross weight, heating and refluxing extraction 2 times, each 2.0 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I.
(2) Herba Taraxaci 400g, Concha Arcae (forging) 400g, Radix Codonopsis 200g are added water for injection 3200ml and soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1 hour, filter merging filtrate, reclaim under reduced pressure is to there not being the ethanol flavor, and being condensed into thick extractum, proportion is 1.30 (revising) relatively, places vacuum drying oven, 80 ℃ of drying under reduced pressure 96 hours, take out, pulverize, cross 80 mesh sieves;
(3) with medicated powder and adjuvant mix homogeneously, sieve, granulate, oven dry, granulate adds the magnesium stearate mix homogeneously, filled capsules, promptly.
Embodiment 8: the preparation technology of capsule
(1) get Radix Linderae 250g, Semen Arecae 250g, Fructus Citri Sarcodactylis 100g, Radix Curcumae 100g, more than 7 times of 80wt.% ethanol of each component gross weight, heating and refluxing extraction 2 times, each 2.0 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I.
(2) Herba Taraxaci 300g, Concha Arcae (forging) 300g, Radix Codonopsis 100g are added water for injection 3200ml and soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1.5 hours, filter merging filtrate, reclaim under reduced pressure is to there not being the ethanol flavor, and being condensed into thick extractum, proportion is 1.0 (revising) (60 ℃ of surveys) relatively, places vacuum drying oven, 50 ℃ of drying under reduced pressure 48 hours, take out, pulverize, cross the 60-80 mesh sieve;
(3) with medicated powder and adjuvant mix homogeneously, sieve, granulate, oven dry, 20 mesh sieve granulate add the magnesium stearate mix homogeneously, filled capsules, promptly.
Embodiment 9: the preparation technology of capsule
(1) get Radix Linderae 250g, Semen Arecae 250g, Fructus Citri Sarcodactylis 100g, Radix Curcumae 100g, more than 7 times of 60wt.% ethanol of each component gross weight, heating and refluxing extraction 2 times, each 2.0 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I.
(2) Herba Taraxaci 400g, Concha Arcae (forging) 300g, Radix Codonopsis 100g being added water for injection 3200ml soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 2.5 hours, filter, merging filtrate, reclaim under reduced pressure is to there not being the ethanol flavor, and being condensed into thick extractum, proportion is 1.30 relatively., place vacuum drying oven, 80 ℃ drying under reduced pressure 48-96 hour, take out, pulverize, cross the 60-80 mesh sieve;
(3) with medicated powder and adjuvant mix homogeneously, cross 60 mesh sieves, granulate, oven dry, granulate adds the magnesium stearate mix homogeneously, filled capsules, promptly.
Embodiment 10:
The preparation of the lyophilized injectable powder of 10ml
(1) get Radix Linderae 250g, Semen Arecae 250g, Fructus Citri Sarcodactylis 100g, Radix Curcumae 100g, more than 7 times of 60wt.% ethanol of each component gross weight, heating and refluxing extraction 2 times, each 2.0 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I.
(2) Herba Taraxaci 400g, Concha Arcae (forging) 300g, Radix Codonopsis 100g are added water for injection 3200ml and soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1.5 hours, filter, merging filtrate obtains extracting compositions.Get and extract compositions 10g, add the injection water and make dissolving in right amount, add sodium chloride 2.25g, adjust volume to 125ml with water for injection, add an amount of injection charcoal, boiled 20 minutes, and put coldly, filter, sterilization, irritate in low boron glass ampoule bottle by 1ml volume branch, cool drying promptly gets the lyophilized injectable powder sample.
Embodiment 11:
Radix Linderae 100g, Semen Arecae 100g, Fructus Citri Sarcodactylis 200g, Radix Curcumae 200g are added 70wt.% ethanol in multi-function extractor, soaked overnight.The reflux, extract, secondary, each 2.0 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I, medicinal liquid I places the concentrating under reduced pressure pot, concentrate concentrated solution A (80 ℃, d=1.10), label, indicate the name of an article, lot number, date etc.
Herba Taraxaci 300g, Concha Arcae (forging) 400g, Radix Codonopsis 200g are added water for injection 3200ml soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1.5 hours, filter merging filtrate, the reject medicinal residues are put amalgamation liquid in the triple effect concentrator, stop to concentrate when being concentrated into proportion 1.12 (60 ℃), put and be chilled to room temperature, slowly add 95% ethanol of amount of calculation, make concentration of alcohol reach 50%, placement is spent the night, extract supernatant, discard precipitate.Concentrated supernatant gets concentrated solution B, and (60 ℃, d=1.12), device is placed in addition, labels, and indicates the name of an article, lot number, date etc.
The concentrated solution B that the concentrated solution A and the water of above-mentioned alcohol extraction are carried fully mixes, get above-mentioned concentrated solution and add water for injection 440ml, heated and boiled 20 minutes, stir and add active carbon 0.8g down, continued to boil 10 minutes, take out cooling, filter carbon removal, add water for injection to nearly 400ml, NaOH solution adjust pH with 10wt.% is 6.5, coarse filtration, the elementary 3um of fine straining (adopting three grades of microfiltration technology), secondary 0.45um, three grades of 0.22um, embedding in the ampoule of 20ml 100 ℃, sterilization in 30 minutes promptly gets injection after the passed examination.
Claims (10)
1. pharmaceutical composition for the treatment of functional dyspepsia, the weight proportion that it is characterized in that each crude drug is: Radix Linderae 6.51wt.%-16.67wt.%, Semen Arecae 6.51wt.%-16.67wt.%, Fructus Citri Sarcodactylis 6.51wt.%-15.33wt.%, Radix Curcumae 6.51wt.%-15.33wt.%, Concha Arcae (calcined) 20.00wt.%-28.67wt.%, Herba Taraxaci 20.00wt.%-28.67wt.%.
2. according to the pharmaceutical composition described in the claim 1, it is characterized in that further containing the compositions of Radix Codonopsis or Radix Codonopsis and Lignum Aquilariae Resinatum, and the weight proportion of each crude drug is: Radix Linderae 6.51wt.%-15.33wt.%, Semen Arecae 6.51wt.%-15.33wt.%, Fructus Citri Sarcodactylis 6.51wt.%-13.33wt.%, Radix Curcumae 6.51wt.%-13.33wt.%, Concha Arcae (calcined) 20.00wt.%-26.67wt.%, Herba Taraxaci 20.00wt.%-26.67wt.%, Radix Codonopsis 6.51wt.%-13.33wt.%, Lignum Aquilariae Resinatum 0-6.51wt.%.
3. according to the pharmaceutical composition described in the claim 2, the weight proportion that it is characterized in that each crude drug is: Radix Linderae 11.65wt.%, Semen Arecae 11.65wt.%, Fructus Citri Sarcodactylis 9.30wt.%, Radix Curcumae 9.30wt.%, Concha Arcae (calcined) 23.23wt.%, Herba Taraxaci 23.23wt.%, Radix Codonopsis 9.30wt.%, Lignum Aquilariae Resinatum 2.34wt.%.
4. according to each described pharmaceutical composition among the claim 1-3, the dosage form that it is characterized in that said pharmaceutical composition is a said dosage form on any pharmaceutics.
5. method for preparing the described pharmaceutical composition of claim 1 is characterized in that containing following steps:
(1) get the crude drug Radix Linderae, Semen Arecae, Fructus Citri Sarcodactylis, Radix Curcumae according to the weight proportion of claim 1 earlier, the soak with ethanol that adds 50wt.%-80wt.% is spent the night; Reflux, extract, secondary then, each 1-2.5 hour, filter medicinal residues I and medicinal liquid I;
(2) get crude drug Herba Taraxaci, Concha Arcae (calcined) according to the weight proportion of claim 1 again, soaked 1 hour, add the medicinal residues I in the step (1) then, the mixture decocting that obtains boils secondary, each 1-2.5 hour; After the filtration filtrate being concentrated into proportion is 1.0-1.3; Put and be chilled to room temperature, ethanol to the concentration of alcohol that adds 80wt.%-95% again is 50%; Placement is spent the night; The supernatant concentration that obtains is obtained the concentrated solution B that proportion d is 1.0-1.3;
(3) the concentrated solution B that obtains in the medicinal residues I that obtains in the step (1) and the step (2) is merged, obtain the described pharmaceutical composition of claim 1.
6. method for preparing claim 2 or 3 described pharmaceutical compositions is characterized in that containing following steps:
(1) get the crude drug Radix Linderae, Semen Arecae, Fructus Citri Sarcodactylis, Radix Curcumae, Lignum Aquilariae Resinatum according to the weight proportion of claim 2 or 3 earlier, the soak with ethanol that adds 50wt.%-80wt.% is spent the night; Reflux, extract, secondary then, each 1-2.5 hour, filter medicinal residues I and medicinal liquid I;
(2) get crude drug Herba Taraxaci, Concha Arcae (calcined), Radix Codonopsis according to the weight proportion of claim 2 or 3 again, soaked 1 hour, add the medicinal residues I in the step (1) then, the mixture decocting that obtains boils secondary, each 1-2.5 hour; After the filtration filtrate being concentrated into proportion is 1.0-1.3; Put and be chilled to room temperature, ethanol to the concentration of alcohol that adds 80wt.%-95% again is 50%; Placement is spent the night; The supernatant concentration that obtains is obtained the concentrated solution B that proportion d is 1.0-1.3;
(3) the concentrated solution B that obtains in the medicinal residues I that obtains in the step (1) and the step (2) is merged, obtain claim 2 or 3 described pharmaceutical compositions.
7. according to the method described in claim 5 or 6, it is characterized in that further comprising in the step (1) that the medicinal liquid I that will obtain places the concentrating under reduced pressure pot, 50-80 ℃ concentrate concentrated solution A, its proportion d is 1.0-1.3.
8. according to the method described in the claim 7, it is characterized in that further comprising that step (4) mixes the described concentrated solution A of claim 7 and claim 5 or 6 described concentrated solution B, further concentrating and obtaining proportion d is 1.10～1.50 extractum C.
9. according to the method described in claim 5 or 6, it is characterized in that further will obtaining the step that preparation of pharmaceutical compositions becomes said dosage form on any pharmaceutics.
10. according to the method described in the claim 6, it is characterized in that containing following steps:
(1) earlier 70wt.% ethanol is added soaked overnight among Radix Linderae 179g, Semen Arecae 179g, Fructus Citri Sarcodactylis 143g, Radix Curcumae 143g, the Lignum Aquilariae Resinatum 36g; The reflux, extract, secondary, each 1.5 hours, filter medicinal residues I and medicinal liquid I, medicinal liquid I places the concentrating under reduced pressure pot then, 60 ℃ concentrate concentrated solution A, d=1.07;
(2) will soak 1 hour among 3200ml water for injection adding Herba Taraxaci 357g, Concha Arcae (calcined) 357g, the Radix Codonopsis 143g earlier; Add the medicinal residues I in the step (1), and then add 3200ml water for injection decoction secondary, each 1.5 hours; After the filtration 70 ℃ of filtrates being concentrated into proportion is 1.08, puts and is chilled to room temperature; It is 50% that the ethanol of slow adding 95% makes concentration of alcohol; Placement is spent the night; Get the concentrated solution B that the supernatant concentration supernatant gets d=1.08;
(3) with the starch oven dry, sieve, mannitol sieves, and is standby; Take by weighing concentrated solution A described in the step (1) of recipe quantity and the concentrated solution B described in the step (2) and mannitol 500g, starch 150g mix homogeneously, conventional method is prepared into granule.
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| CN1406593A (en) * | 2001-08-27 | 2003-04-02 | 刘河广 | Medicine |
| CN1628710A (en) * | 2003-12-18 | 2005-06-22 | 于志朋 | Method for preparing stomach benefiting powder |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1406593A (en) * | 2001-08-27 | 2003-04-02 | 刘河广 | Medicine |
| CN1628710A (en) * | 2003-12-18 | 2005-06-22 | 于志朋 | Method for preparing stomach benefiting powder |
Non-Patent Citations (2)
| Title |
|---|
| 中医药治疗功能性消化不良的研究进展. 武敬等.现代消化及介入诊疗，第9卷第1期. 2004 |
| 中医药治疗功能性消化不良的研究进展. 武敬等.现代消化及介入诊疗，第9卷第1期. 2004 * |
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