CN1248715C - Stomachic medication and preparation method - Google Patents
Stomachic medication and preparation method Download PDFInfo
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- CN1248715C CN1248715C CN 200410007237 CN200410007237A CN1248715C CN 1248715 C CN1248715 C CN 1248715C CN 200410007237 CN200410007237 CN 200410007237 CN 200410007237 A CN200410007237 A CN 200410007237A CN 1248715 C CN1248715 C CN 1248715C
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Abstract
The present invention relates to a stomachic medication which comprises an active ingredient composed of an effective extract of hawthorn fruit, enucleate Chinese date, cablin patchouli herb, perilla stem and coloured malt. A preparation method of the medicament comprises: soaking the raw materials for extraction in 5 to 10 times of water for 0.5 to 2 hours, decocting the medicinal liquid for three times with 1 to 2 hours each time, filtering, combining the filter liquor, concentrating the filter liquor, adding alcohol while stirring the concentrate until alcohol content reaches 50 to 90%, sufficiently stirring, settling for 12 to 36 hours at room temperature, filtering by suction, concentrating the filter liquor, adding alcohol to the concentrated liquor for ethanol precipitation, carrying out the ethanol precipitation twice, measuring the total flavonoid content of the dry extract of the concentrated filter liquor of the last time with an ultraviolet-visible spectrophotometer not to be lower than 35 mg measured by rutin in each gram of the dry extract, and preparing the concentrated extract as the active ingredient of the medication; finally, mixing the obtained active ingredient with auxiliary materials to prepare various oral preparations. The total flavonoid content of each gram of the preparations is not lower than 8% measured by rutin.
Description
Technical field
The present invention relates to a kind of medicine and preparation method thereof that is good for the stomach, belong to the field of Chinese medicines.
Background technology
The situation of existing like product
Existing like product situation sees Table 1.
Table 1 and the similar Chinese medicinal formulae of curative effect of medication of the present invention
| Title | Prescription is formed | Dosage form | Effect | Range of application |
| Kaixiong Shunqi Wan | 8 flavors such as Semen Arecae, Semen Pharbitidis, Pericarpium Citri Reticulatae, the Radix Aucklandiae | Pill | Removing food stagnancyization stagnates | The costa sternales distension, gastralgia |
| JIANWEI XIAOSHI PIAN | Radix Pseudostellariae, Pericarpium Citri Reticulatae, Rhizoma Dioscoreae, Fructus Hordei Germinatus, Fructus Crataegi | Tablet | Invigorating the stomach and promoting digestion | Weakness of the spleen and stomach, dyspepsia |
| Lenitive pill | 8 flavors such as Fructus Crataegi, Massa Medicata Fermentata, the Rhizoma Pinelliae, Poria | Pill | Dyspepsia and intestinal stasis relieving | Food stagnation is stagnated, dyspepsia |
| Medicated leaven | 17 flavors such as Massa Medicata Fermentata, Fructus Hordei Germinatus, Fructus Crataegi, Herba Pogostemonis | Electuary | Invigorating the stomach and promoting digestion | Dyspepsia, abdominalgia with improper diet |
| Digestion pill of betel nut | 6 flavors such as Semen Arecae, Radix Et Rhizoma Rhei, Semen Pharbitidis, Fructus Gleditsiae Abnormalis | Pill | Dyspepsia and intestinal stasis relieving, circulation of qi promoting removing water retention by purgation | Dyspepsia |
| ANSHEN BUXIN WAN | Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Rhizoma Acori Graminei, tranquilization paste | Pill | Tranquilizing by nourishing the heart | Palpitation and insomnia, dizziness and tinnitus |
| Mind-easing tonic bolus with arborvitate seed | 13 flavor Chinese medicines such as Semen Platycladi, Radix Codonopsis, Radix Astragali Preparata, Rhizoma Chuanxiong, Radix Angelicae Sinensis | Honeyed pill | QI invigorating, nourish blood, calm the nerves | Motive deficiency and coldness, palpitation with fear insomnia |
The problem that existing product exists
Existing like product all adopts traditional Chinese medicinal preparation method to make, and fabricating technology falls behind, and active constituent content is low, and the extractum moisture absorption is strong, and preparation stability is poor; Each dose is big.The present invention uses technology such as water extract-alcohol precipitation, spray drying farthest to preserve active component, and granule is carried out coating, has improved preparation stability greatly.
Summary of the invention
The object of the present invention is to provide a kind of medicine that is good for the stomach, this clinical drug effect is clearer and more definite than existing similar better drug curative effect, therapeutical effect.
Another object of the present invention is to provide a kind of manufacturing method for above mentioned medicine, this method is used the refining and spray drying technology of modern advanced extraction, and art for coating, realizes extraction and preservation to effective ingredient, improve the quality of the pharmaceutical preparations and stability, reduced each dosage.
Above-mentioned purpose of the present invention is achieved in that
The active component of medicine of the present invention is made up of the effective extract of Fructus Crataegi, Fructus Jujubae (enucleation), Herba Pogostemonis, Caulis Perillae, Fructus Hordei Germinatus (parched), and the crude drug that wherein is used to extract forms and part by weight is: 3～20 parts of Fructus Crataegis, 5～20 parts in Fructus Jujubae, 1～12 part of Herba Pogostemonis, 2～15 parts of Caulis Perillaes, 2～20 parts of Fructus Hordei Germinatus (parched)s.The crude drug proportion optimization is: 5 parts of Fructus Crataegis, 5 parts in Fructus Jujubae (enucleation), 5 parts of Herba Pogostemonis, 5 parts of Caulis Perillaes, 5 parts of Fructus Hordei Germinatus (parched)s.
The preparation method of medicine of the present invention is as follows:
Crude drug soaked 0.5～2 hour in the water of 5 ~ 10 times of amounts after, decoct three times, each 1～2 hour, filter, merging filtrate, filtrate concentrates, add ethanol while stirring until containing alcohol amount 50～90% in concentrate, fully stir, room temperature left standstill 12～36 hours, sucking filtration, concentrated filtrate carries out precipitate with ethanol with adding ethanol in the concentrated solution again, and precipitate with ethanol is twice so altogether, last spissated filtrate must not be lower than 35mg in rutin in every gram through ultraviolet-visible spectrophotometer assay dry extract general flavone content, and this concentrated extract is the active ingredient of described medicine; At last the gained active ingredient is made various oral formulations, the general flavone content of every restraint agent must not be lower than 8% in rutin.
The adjuvant commonly used that adds various oral formulations in the active component extractum of the present invention can be made various oral formulations.Adopt tablet and its better efficacy of capsule of following method preparation.The preparation tablet: with active component extractum and microcrystalline cellulose excipients, Pulvis Talci, magnesium stearate, behind the micropowder silica gel spray granulation, tabletting forms tablet with coating material coatings such as HPMC alcoholic solution or acrylic resin aqueous dispersions again.Preparation capsule: with active component extractum and microcrystalline cellulose excipients, Pulvis Talci, magnesium stearate, micropowder silica gel is through spray granulation, again with coating material coatings such as HPMC alcoholic solution or acrylic resin aqueous dispersions, incapsulate at last in the shell and make capsule preparations.Employed adjuvant percentage by weight is in the preparation: microcrystalline Cellulose 20-97%, Pulvis Talci 1-6%, magnesium stearate 0.5-2%, micropowder silica gel 0.5-4%.Be preferably: microcrystalline Cellulose 96%, Pulvis Talci 2%, magnesium stearate 1%, micropowder silica gel 1%.
The medicine and preparation method thereof that is good for the stomach provided by the present invention has following advantage:
1. we use Fructus Crataegi, sweet acid all eating accumulations that can disappear, and outstanding kind carnivorous greasy the amassing that disappear is monarch drug.Transferring of taste, the fortuneization of the damp all relies the operation in gas, the easy air resister of condition food stagnation rises heat of wetting and causes taste and become estranged, and with Herba Pogostemonis, Caulis Perillae, gets its fragrance and changes turbid damp in the lining in the side, ascending the clear and descending the turbid helps the hawthorn digesting eliminate indigestion, ward off dirty and in be minister.Assistant is long-pending with Fructus Hordei Germinatus rapid digestion of food blood stasis expelling, Fructus Jujubae stomach reinforcing gas, and nourishing stomach-YIN is for making.Close the side of forming, have that alleviating distention in middle-JIAO is regulated the flow of vital energy, a merit of eliminating turbid pathogen with aromatics, strengthening the spleen and stomach.
2. preparation process has adopted water decoction-alcohol sedimentation technology, adopts spray drying technology, and granule is carried out coating, active preservation of effective ingredient and raising preparation stability are given security, and then improve the quality of products, overcome the deficiencies in the prior art, obtained the medicine that is good for the stomach of better efficacy.
Description of drawings
Fig. 1 is for treating the process chart of the medication preparation that is good for the stomach.
The specific embodiment
Below by embodiment the present invention is specifically described, and further set forth the beneficial effect of described medicine.Be necessary to be pointed out that at this present embodiment only is used for the present invention is further specified; can not be interpreted as limiting the scope of the invention, the person skilled in the art in this field can make some nonessential improvement and adjustment according to the content of the invention described above.
Embodiment 1-11 is the preparation embodiment of medicine of the present invention.
Embodiment 1
With raw material Fructus Crataegi 8 grams, Fructus Jujubae (enucleation) 6 grams, Herba Pogostemonis 4 grams, Caulis Perillae 2 grams, Fructus Hordei Germinatus (parched) 3 grams, after soaking 1 hour in the water of 10 times of amounts, decoct three times, each 1～2 hour, filter merging filtrate, filtrate concentrates, and adds 95% ethanol to containing alcohol amount 80%, fully stirs, room temperature left standstill 24 hours, sucking filtration, concentrated filtrate carries out precipitate with ethanol with adding 95% ethanol in the concentrated solution again, precipitate with ethanol twice concentrates last filtrate so altogether.Concentrated extract adds the adjuvant spray granulation, with coating material coatings such as HPMC alcoholic solution or acrylic resin (Eudragit) aqueous dispersions, makes 4 capsules.
Embodiment 2
With raw material Fructus Crataegi 10 grams, Fructus Jujubae (enucleation) 5 grams, Herba Pogostemonis 5 grams, Caulis Perillae 2 grams, Fructus Hordei Germinatus (parched) 3 grams, after soaking 2 hours in the water of 5 times of amounts, decoct three times, each 1～2 hour, filter merging filtrate, filtrate concentrates, and adds ethanol to containing alcohol amount 60%, fully stirs, room temperature left standstill 36 hours, sucking filtration, concentrated filtrate carries out precipitate with ethanol with adding ethanol in the concentrated solution again, precipitate with ethanol twice concentrates last filtrate so altogether.Concentrated extract adds adjuvant (microcrystalline Cellulose 1g, Pulvis Talci 0.02g, magnesium stearate 0.01g, micropowder silica gel 0.01g) spray granulation, 4 of compressed tabletses, with coating material coatings such as HPMC alcoholic solution or Eudragit aqueous dispersions promptly.
Embodiment 3
With raw material Fructus Crataegi 20 grams, Fructus Jujubae (enucleation) 10 grams, Herba Pogostemonis 10 grams, Caulis Perillae 10 grams, Fructus Hordei Germinatus (parched) 8 grams, after soaking 0.5 hour in the water of 10 times of amounts, decoct three times, each 1～2 hour, filter merging filtrate, filtrate concentrates, and adds ethanol to containing alcohol amount 90%, fully stirs, room temperature left standstill 12 hours, sucking filtration, concentrated filtrate carries out precipitate with ethanol with adding ethanol in the concentrated solution again, precipitate with ethanol twice concentrates last filtrate so altogether.The concentrated extract spray granulation adds sucrose, lactose, the blank granule that correctives etc. are made, and mix homogeneously, 4 bags of packing promptly get granule.
Embodiment 4
With raw material Fructus Crataegi 15 grams, Fructus Jujubae (enucleation) 10 grams, Herba Pogostemonis 10 grams, Caulis Perillae 8 grams, Fructus Hordei Germinatus (parched) 6 grams, after soaking 1.5 hours in the water of 9 times of amounts, decoct three times, each 1～2 hour, filter merging filtrate, filtrate concentrates, and adds ethanol to containing alcohol amount 70%, fully stirs, room temperature left standstill 18 hours, sucking filtration, concentrated filtrate carries out precipitate with ethanol with adding ethanol in the concentrated solution again, precipitate with ethanol twice concentrates last filtrate so altogether.The concentrated extract spray granulation adds sucrose, lactose, the blank granule that correctives etc. are made, and mix homogeneously, 4 bags of packing promptly get granule.
Embodiment 5
With raw material Fructus Crataegi 8 grams, Fructus Jujubae (enucleation) 6 grams, Herba Pogostemonis 4 grams, Caulis Perillae 2 grams, Fructus Hordei Germinatus (parched) 3 grams, after soaking 1 hour in the water of 10 times of amounts, decoct three times, each 1～2 hour, filter merging filtrate, filtrate concentrates, and adds ethanol to containing alcohol amount 80%, fully stirs, room temperature left standstill 30 hours, sucking filtration, concentrated filtrate carries out precipitate with ethanol with adding ethanol in the concentrated solution again, precipitate with ethanol twice concentrates last filtrate so altogether.Concentrated extract and adjuvant (microcrystalline Cellulose 1g, Pulvis Talci 0.02g, magnesium stearate 0.01g, micropowder silica gel 0.01g) spray granulation with coating material coatings such as HPMC alcoholic solution or acrylic resin (Eudragit) aqueous dispersions, is made 4 capsules.
Embodiment 6
With raw material Fructus Crataegi 4 grams, Fructus Jujubae (enucleation) 10 grams, Herba Pogostemonis 2 grams, Caulis Perillae 4 grams, Fructus Hordei Germinatus (parched) 5 grams, after soaking 1 hour in the water of 10 times of amounts, decoct three times, each 1～2 hour, filter merging filtrate, filtrate concentrates, and adds 95% ethanol to containing alcohol amount 85%, fully stirs, room temperature left standstill 24 hours, sucking filtration, concentrated filtrate carries out precipitate with ethanol with adding ethanol in the concentrated solution again, precipitate with ethanol twice concentrates last filtrate so altogether.The concentrated extract spray granulation with coating material coatings such as HPMC alcoholic solution or acrylic resin (Eudragit) aqueous dispersions, is made 4 capsules.
Embodiment 7
With raw material Fructus Crataegi 10 grams, Fructus Jujubae (enucleation) 5 grams, Herba Pogostemonis 1 gram, Caulis Perillae 2 grams, Fructus Hordei Germinatus (parched) 2 grams, after soaking 1 hour in the water of 10 times of amounts, decoct three times, each 1～2 hour, filter merging filtrate, filtrate concentrates, and adds ethanol to containing alcohol amount 65%, fully stirs, room temperature left standstill 36 hours, sucking filtration, concentrated filtrate carries out precipitate with ethanol with adding ethanol in the concentrated solution again, precipitate with ethanol twice concentrates last filtrate so altogether.The concentrated extract spray granulation adds adjuvant (microcrystalline Cellulose 1g, Pulvis Talci 0.02g, magnesium stearate 0.01g, micropowder silica gel 0.01g), 4 of compressed tabletses, with coating material coatings such as HPMC alcoholic solution or Eudragit aqueous dispersions promptly.
Embodiment 8
With raw material Fructus Crataegi 10 grams, Fructus Jujubae (enucleation) 15 grams, Herba Pogostemonis 9 grams, Caulis Perillae 15 grams, Fructus Hordei Germinatus (parched) 20 grams, after soaking 2 hours in the water of 5 times of amounts, decoct three times, each 1～2 hour, filter merging filtrate, filtrate concentrates, and adds ethanol to containing alcohol amount 70%, fully stirs, room temperature left standstill 36 hours, sucking filtration, concentrated filtrate carries out precipitate with ethanol with adding ethanol in the concentrated solution again, precipitate with ethanol twice concentrates last filtrate so altogether.Concentrated extract adds adjuvant (microcrystalline Cellulose 1g, Pulvis Talci 0.02g, magnesium stearate 0.01g, micropowder silica gel 0.01g) spray granulation, 4 of compressed tabletses, with coating material coatings such as HPMC alcoholic solution or Eudragit aqueous dispersions promptly.
Embodiment 9
With raw material Fructus Crataegi 3 grams, Fructus Jujubae (enucleation) 20 grams, Herba Pogostemonis 12 grams, Caulis Perillae 10 grams, Fructus Hordei Germinatus (parched) 3 grams, after soaking 2 hours in the water of 10 times of amounts, decoct three times, each 1～2 hour, filter merging filtrate, filtrate concentrates, and adds ethanol to containing alcohol amount 85%, fully stirs, room temperature left standstill 24 hours, sucking filtration, concentrated filtrate carries out precipitate with ethanol with adding ethanol in the concentrated solution again, precipitate with ethanol twice concentrates last filtrate so altogether.Concentrated extract adds adjuvant (microcrystalline Cellulose 1g, Pulvis Talci 0.02g, magnesium stearate 0.01g, micropowder silica gel 0.01g) spray granulation, 4 of compressed tabletses, with coating material coatings such as HPMC alcoholic solution or Eudragit aqueous dispersions promptly.
Embodiment 10
With raw material Fructus Crataegi 5 grams, Fructus Jujubae (enucleation) 6 grams, Herba Pogostemonis 4 grams, Caulis Perillae 5 grams, Fructus Hordei Germinatus (parched) 3 grams, after soaking 1 hour in the water of 10 times of amounts, decoct three times, each 1～2 hour, filter merging filtrate, filtrate concentrates, and adds 95% ethanol to containing alcohol amount 80%, fully stirs, room temperature left standstill 24 hours, sucking filtration, concentrated filtrate carries out precipitate with ethanol with adding 95% ethanol in the concentrated solution again, precipitate with ethanol twice concentrates last filtrate so altogether.Concentrated extract adds the adjuvant spray granulation, with coating material coatings such as HPMC alcoholic solution or acrylic resin (Eudragit) aqueous dispersions, makes 4 capsules.
Produce the result as a trial among the embodiment 11
Compatibility raw material with 250 times embodiment 7 carries out pilot scale, and the extractum yield is about 6～15%, general flavone content 17mg/g.It is stable to make end product quality, makes 1000 capsules, and each dose is 2, every day 2 times.
Produce 3 batches altogether, the result is as follows:
| Lot number | Inventory (Kg) | Medicated powder amount (Kg) | General flavone content (mg/g) |
| 20020217 20020218 20020219 | 100 100 100 | 10.04 9.98 10.12 | 17.3 17.7 17.8 |
The pharmacological research of embodiment 12, medicine of the present invention
1. materials and methods
1.1 given the test agent: the active constituents of medicine for preparing gained according to the proportioning of the embodiment of the invention 1.
1.2 experimental animal: 60 of SPF level Kunming kind female mices, other have 10 standby, body weight 18-20 gram, the wistar male rat, 60 of body weight 140-150 grams, in addition 10 standby, the animal approval number is Hubei Province moving pipe word 19-082 number and 19-084 number.
1.3 animal grouping and dosage design: according to people's daily intaking amount 0.03g/kg.bw, (promptly 0.3,0.6,0.9g/kg.bw) conduct is tried the basic, normal, high dosage group of thing to enlarge 10,20,30 times respectively.Other establishes the blank group, and each dosage group will be tried thing and be mixed with corresponding dosage per os filling stomach with distilled water.Continuous irrigation stomach 20 and carry out every test after 28 days.
1.4 test method and observation index:
1.4.1 body weight and food utilization are measured: adopt the Wistar rat, body weight and food utilization are 28 days observed results.
1.4.2 intestinal propulsion test
Adopt SPF level Kunming mouse, divide blank group and basic, normal, high dosage group, 10 every group, each dosage treated animal continuous irrigation stomach was tried thing 20 days, and the blank treated animal gives the equivalent distilled water simultaneously.Tried thing before the experiment and respectively organized the mice fasting 12 hours, each dosage group gives compound diphenoxylate (about 5mg/kg.bw), irritate stomach by the 0.15ml/10g.bw per os and give (except the normal control group), after 30 minutes more simultaneously per os irritate stomach and tried thing and carbon powder glue 0.2ml/10g.bw (being tried thing can prepare with the carbon powder glue), each experimental group is put to death animal by irritating stomach order (every group five minutes at interval) cervical vertebra dislocation after 25 minutes, the separation mesentery of cutting open the belly, the clip upper end is to pylorus, the lower end is to the intestinal tube of ileocecus, gently small intestinal is paved stretching, measure the carbon powder glue from sphincter of pylorus to propulsive length of small intestinal ileocecus and small intestinal total length.Intestinal motility is represented with intestinal propulsion rate (%):
1.4.3 digestive enzyme is measured:
Adopt SPF level wistar male rat, animal is divided blank group and basic, normal, high dosage group, 10 every group.Each dosage treated animal continuous irrigation stomach was tried thing 28 days, and the blank group gives the equivalent distilled water simultaneously.After each treated animal fasting 24 hours before being tried (during freely drink water), lumbar injection 100mg/kg.bw dosage penthiobarbital anesthetized rat, row pyloric ligation are collected 5 hours gastric juice outputs, gastric juice output analytical unit time, pepsin activity calculates the protease output; Determination of peptic activity adopts the MettShi method, promptly select internal diameter 1.5mm glass tubing for use, inject fresh Ovum Gallus domesticus album, put to keep flat in the hot bath and take out after making protein coagulating, discard alveolate protein pipe, putting refrigerator preserves, face with before making 3cm length, select 100ml band plug ground triangular flask simultaneously for use, gastric juice eliminating amount adds 0.05mol hydrochloric acid 15ml by 1ml and puts mixing in the triangular flask, every bottle adds 2 of 3cm length protein pipe, and sealing is put in the calorstat and taken out after 24 hours, length (mm) with vernier caliper measurement protein pipe two ends transparent part, value with four ends is averaged, pepsin activity unit (U)=meansigma methods 2 * 16, and calculate pepsin output (U/hr).
1.4.4 statistical method: adopt variance analysis and t-test.
2. result
2.1 body weight, food-intake and food utilization result:
As seen from Table 1, medicine of the present invention does not have obvious influence to the weight of animals and food utilization.
Table 1 male rat body weight, food-intake and food utilization result (X ± S)
| Group | Dosage (g/kg.bw) | Number of animals (only) | Initial weight (g) | Eventually heavy (g) | Weightening finish (g) | Total foodstuff utilization rate (%) |
| Dosage group high dose group in the blank low dose group | 0 0.35 0.70 1.10 | 10 10 10 10 | 148±2.77 149±2.46 150±3.03 150±2.37 | 234±5.66 235±9.25 242±9.33 235±9.78 | 85±6.48 86±10.28 93±9.58 85±10.06 | 20.7±1.64 22.2±2.73 24.7±2.78 23.5±2.70 |
2.2 tried thing to the intestinal propulsion motion effects: see Table 2.As seen from Table 2, the intestinal propulsion rate of the basic, normal, high dosage group of medicine of the present invention mice is all apparently higher than model control group, and credit is analysed basic, normal, high dosage and compared with model control group by statistics, and difference has utmost point significance (P＜0.01).
" medicine of the present invention is " to the influence of mouse small intestine mechanical movement (X ± S) for table 2
| Group | Dosage (g/kg .bw) | Number of animals (only) | Initial weight (g) | Eventually heavy (g) | Small intestinal total length (cm) | Advance length (cm) | Propelling rate (%) |
| Dosage group high dose group in the Normal group control group low dose group | 0 0 0.35 0.70 1.10 | 10 10 10 10 10 | 18.4±1.8 18.2±0.8 18.0±0.9 18.3±1.0 18.0±1.2 | 34.1±2.3 34.4±2.1 34.1±2.1 33.9±1.7 34.0±1.7 | 45.4±3.6 41.5±4.4 45.2±4.0 41.8±4.9 21.2±2.5 | 30.9±6.5 18.0±3.7 17.4±3.0 20.2±4.9 47.2±5.7 | 68.2 ± 14.0 model 45.2 ± 8.2 39.0 ± 9.0 48.7 ± 12.8 45.3 ± 7.0 |
Compare * * with model control group: P＜0.01
2.3 digestive enzyme activity is influenced:
See Table 3.As seen from Table 3, each test group of medicine of the present invention is compared with matched group, and basic, normal, high dosage group gastric juice output difference does not have significance (P＞0.05).But compare with matched group, middle and high dosage group can obviously increase pepsin activity, and difference has significance (P＜0.01, P＜0.05), and per hour difference has utmost point significance (P＜0.01) to middle dosage group apparently higher than matched group the endoproteinase output.
Table 3 male rat determination of peptic activity result (X ± S)
| Group | Dosage (g/kg.bw) | Number of animals (only) | Gastric juice amount (ml) | Pepsin activity (U) | Pepsin output (U/hr) |
| Dosage group high dose group in the normal control group low dose group | 0 0.35 0.70 1.10 | 10 10 10 10 | 3.8±1.30 3.2±1.35 4.9±1.52 3.9±1.61 | 254±115.6 316±182.8 504±130.2** 396±121.3* | 207±163.2 238±263.6 505±239.5** 333±200.4 |
Compare *: P＜0.05, * *: P＜0.01 with matched group
3. conclusion:
Recommend daily intaking amount 1.8g/60kg.bw according to the crowd, enlarge 10,20,30 times (promptly 0.3,0.6,0.9g/kg.bw) respectively as being tried the basic, normal, high dosage group of thing, adopt SPF level Kunming mouse and Wistar rat, tried thing 20 and 28 days continuously, facilitating digestion effect result of the test shows: 1) this is tried the small intestinal mechanical movement that thing can obviously strengthen mice, three dosage treated animal intestinal propulsion rates all obviously raise, and with the model control group comparing difference utmost point significance (p＜0.01) are arranged.2) this is tried thing does not have obviously the weight of animals and food utilization and influences.Each test group is compared with matched group, and basic, normal, high dosage group gastric juice output difference does not have significance (P＞0.05).Middle and high dosage group can obviously increase pepsin activity, and difference has significance (P＜0.01, P＜0.05), and per hour difference has utmost point significance (P＜0.01) to middle dosage group apparently higher than matched group the endoproteinase output.Above experimental result shows: this is tried thing and is had certain facilitating digestion function; Medicine has the effect that increases gastric secretion; This invention medicine can be transferred the gastrointestinal activity of dysfunction, reaches the effect of spleen invigorating relieving dyspepsia.
The checking of embodiment 13 clinical efficacies
1 material and method
The capsule of 1.1 sample: embodiment 11 preparations; Placebo: the mixture of starch, caramel color.
Digestive problems such as 1.2 subjects: selective body focuses in 1 standard deviation of normal type value, and is poor with appetite, and appetite reduces, monophagia and do not have 100 of 4-6 year children of other bad performances.
1.3 test grouping and amount: double-blind method is adopted in this test, at random the experimenter is divided into two groups, test group 50 examples, and matched group 50 examples, each organizes the men and women half-and-half.Test group eats medicine of the present invention, and matched group eats placebo, and according to amount and the eating method that production unit provides, every day 3 times, each 2, the test-meal cycle is 30 days.
1.4 statistical analysis technique: adopt the T check.
2 observation index
2.1 overview index
2.1.1 subjective sensation index: diet, sleep and the mental status.Observe by the head of a family and the doctor in charge and to be tried the daily current status of child and by good, difference narration.
2.1.2 physical examination index: height, body weight, heart rate, skin, liver, spleen, electrocardiogram and Chest X-rays.Physical examination method is routinely undertaken by the doctor in charge.
2.1.3 physiochemical indice: hemoglobin, red blood cell count(RBC), from cell counting, Clinical Laboratory method is routinely carried out.
2.2 changes in diet index
2.2.1 appetite is improved: appetite is improved and is adopted experimenter and child head of a family's narration, and the doctor in charge observes, be divided into appetite good (3 minutes), in (2 minutes) and poor (1 minute) three kinds.
2.2.2 monophagia improves: monophagia improves with experimenter and child head of a family's narration, and the doctor in charge observes, and is divided into three kinds of no monophagia (3 minutes), medium monophagia (2 minutes) and monophagias (1 minute).
2.2.3 food-intake is improved: tried child's total food-intake (comprising staple food, non-staple foodstuff, beverage and fruit) on the one before the accurate recording test and after the test, be viewed as a measurement unit and staple food food-intake (three daily means) is carried out statistical analysis with continuous three days.
3 results
3.1 the edible general index situation of change of medicine of the present invention
3.1.1 ordinary circumstance
Ordinary circumstance before the edible medicine test-meal of the present invention of table 1 (X ± S)
| Group | The example number | Sex | Age (year) | Body weight (Kg) | Hemoglobin (g%) | ||||
| The man | The woman | The man | The woman | The man | The woman | The man | The woman | ||
| The test group matched group | 50 50 | 25 25 | 25 25 | 5.4±0 .7 5.4±0 .7 | 5.3±0 .5 5.3±0 .9 | 18.5± 1.6 18.5± 1.2 | 17.7± 1.3 17.6± 1.5 | 11.9± 0.6 12.0± 0.6 | 11.9± 0.5 11.9± 0.7 |
3.1.2 subjective sensation and health check-up index situation of change
Experimenter's test-meal medicine of the present invention and placebo all had no adverse reaction after 30 days, and its height, body weight, heart rate, skin, spleen, lung and Electrocardioscopy all belong to normally.And experimenter's diet, sleep and the mental status all have improvement to a certain degree.
3.1.3 hematological indices situation of change
Table 2 medicine hematological indices comparison edible of the present invention (X ± S)
| Index | Sex | Test group | Matched group | ||
| Before the test-meal | After the test-meal | Before the test-meal | After the test-meal | ||
| Erythrocyte (10 12/ L) leukocyte (10 9/L) | The men and women men and women | 4.04±0.1 9 3.98±0.1 5 6.61±1.0 9 6.85±1.3 3 | 4.10±0.13 4.07±0.23 6.82±0.68 6.72±0.73 | 4.00±0.23 4.03±0.21 7.34±1.15 6.89±1.26 | 4.00±0.1 8 4.01±0.1 9 7.62±0.9 4 7.13±1.0 0 |
The above results shows that the RBC number after the test group test-meal has increase trend, and the RBC number before and after the matched group test-meal does not have significant change.Test group and matched group leukocyte count test-meal front and back are all in normal range.
3.2 edible medicine changes in diet situation of the present invention
All experimenters are observed test-meal front and back appetite, food-intake and monophagia situation of change, and its result is as table 3-5.
Table 3 medicine appetite improvement situation comparison edible of the present invention (score, X ± S)
| Group | The example number | Before the test-meal | After the test-meal |
| The test group matched group | 50 50 | 1.2±0.5 1.4±0.6 | 2.3±0.5* 1.3±0.7 |
With before the test-meal and matched group relatively, * P＜0.01
Table 4 eats medicine food-intake of the present invention (staple food) situation of change (X ± S, g/ day)
| Sex | The test-meal group | Matched group | ||||
| The example number | Before the test-meal | After the test-meal | The example number | Before the test-meal | After the test-meal | |
| The men and women | 25 25 | 247.1±25. 4 239.2±30. 9 | 290.4±35.3 * 281.3±31.5 * | 25 25 | 241.5±26.9 240.6±31.5 | 242.3±38.7 241.1±37.2 |
With comparison before the test-meal, * P＜0.01
Table 5 medicine monophagia situation of change comparison edible of the present invention (score, X ± S)
| Group | The example number | Before the test-meal | After the test-meal |
| The test group matched group | 50 50 | 1.5±0.6 1.8±0.7 | 2.2±0.6* 1.8±0.8 |
With before the test-meal and matched group relatively, * P＜0.01
Show that from table 3,4,5 experimenter is after test-meal, the appetite of test group and monophagia improve obviously, with before the test-meal and the matched group comparing difference highly significant (P＜0.01) is arranged; The test group food-intake is significantly increased, and with comparing difference before the test-meal highly significant (P＜0.01) is arranged; Matched group does not have significant change.
3.3 body weight and hemoglobin situation of change before and after the medicine edible of the present invention
Body weight situation of change before and after the table 6 medicine test-meal edible of the present invention (X ± S, Kg)
| Sex | Test group | Matched group | ||||
| The example number | Before the test-meal | After the test-meal | The example number | Before the test-meal | After the test-meal | |
| The man | 25 | 18.5±1.6 | 19.0±1.6* | 25 | 18.5±1.2 | 18.7±1.2* |
| The woman | 25 | 17.7±1.3 | 18.1±1.4* | 25 | 17.6±1.5 | 17.9±1.5* |
Relatively preceding with test, * P＜0.01
Hemoglobin situation of change before and after the table 7 medicine test-meal edible of the present invention (X ± S, g%)
| Sex | Test group | Matched group | ||||
| The example number | Before the test-meal | After the test-meal | The example number | Before the test-meal | After the test-meal | |
| The man | 25 | 11.9±0.6 | 12.1±0.4* | 25 | 12.0±0.6 | 12.0±0.6 |
| The woman | 25 | 11.9±0.5 | 12.0±0.5* | 25 | 11.9±0.6 | 11.9±0.5 |
Relatively preceding with test, * P＜0.01
Show that from table 6 experimenter's body weight all has in various degree to be increased, test group test-meal forebody-afterbody irrespective of sex anharmonic ratio has highly significant (p＜0.01) than difference.Show that from table 7 the hemoglobin comparing difference has highly significant (p＜0.01) matched group experimenter hemoglobin not have significant change before and after test group experimenter's test-meal.
4 conclusions
The continuous edible medicine capsule of experimenter is after 30 days, the appetite of test group and monophagia index be improved significantly, with before the test-meal and the matched group comparing difference highly significant (P＜0.01) is arranged, the food-intake of test group obviously increases, with comparing difference before the test-meal highly significant (P＜0.01) is arranged, the test group weight increase is obvious, with comparing difference before the test-meal highly significant is arranged, and the hemoglobin comparing difference has highly significant (p＜0.01) before and after test group experimenter's test-meal.Subjective sensation, physical examination and all no abnormal variation of other index of correlation simultaneously.Standard by " facilitating digestion function human feeding trial method " judges that this medicament capsule has the facilitating digestion function.
Claims (9)
1, a kind of medicine that is good for the stomach is characterized in that, it is made by following bulk drugs: 3～20 parts of Fructus Crataegis, 5～20 parts in Fructus Jujubae, 1～12 part of Herba Pogostemonis, 2～15 parts of Caulis Perillaes, 2～20 parts of Fructus Hordei Germinatus (parched)s.
2, medicine according to claim 1 is characterized in that, the consumption of each crude drug is: 5 parts of Fructus Crataegis, 5 parts in Fructus Jujubae, 5 parts of Herba Pogostemonis, 5 parts of Caulis Perillaes, 5 parts of Fructus Hordei Germinatus (parched)s.
3, medicine according to claim 1 is characterized in that, this medicine is an oral formulations.
4, a kind of method for preparing the described medicine of claim 1, it is characterized in that, the above-mentioned raw materials medicine soaked 0.5～2 hour in the water of 5～10 times of amounts after, decoct three times, each 1～2 hour, filter merging filtrate, filtrate concentrates, add ethanol while stirring until containing alcohol amount 50～90% in concentrate, fully stir, room temperature left standstill 12～36 hours, sucking filtration, concentrated filtrate carries out precipitate with ethanol with adding ethanol in the concentrated solution again, and precipitate with ethanol is twice so altogether, last spissated filtrate must not be lower than 35mg in rutin in every gram through ultraviolet-visible spectrophotometer assay dry extract general flavone content, and this concentrated extract is the active ingredient of described medicine; At last the gained active ingredient is made various oral formulations, the general flavone content of every restraint agent must not be lower than 8% in rutin.
5. method according to claim 4 is characterized in that, after described active component extractum drying, the granulation, carries out the preparation of various oral formulations again.
6. method according to claim 5 is characterized in that, described active component extractum adds microcrystalline cellulose excipients, Pulvis Talci, magnesium stearate is behind the micropowder silica gel spray granulation, tabletting forms tablet with coating material coatings such as HPMC alcoholic solution or acrylic resin aqueous dispersions again.
7. method according to claim 5, it is characterized in that, described active component extractum adds microcrystalline cellulose excipients, Pulvis Talci, magnesium stearate, behind the micropowder silica gel spray granulation,, reinstall and make capsule preparations in the capsule shells with coating material coatings such as HPMC alcoholic solution or acrylic resin aqueous dispersions.
8. according to claim 6 or 7 described methods, it is characterized in that described adjuvant percentage by weight is: microcrystalline Cellulose 20-90%, Pulvis Talci 1-6%, magnesium stearate 0.5-2%, micropowder silica gel 0.5-4%.
9. method according to claim 8 is characterized in that, described adjuvant percentage by weight is: microcrystalline Cellulose 96%, Pulvis Talci 2%, magnesium stearate 1%, micropowder silica gel 1%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410007237 CN1248715C (en) | 2004-02-27 | 2004-02-27 | Stomachic medication and preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410007237 CN1248715C (en) | 2004-02-27 | 2004-02-27 | Stomachic medication and preparation method |
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| Publication Number | Publication Date |
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| CN1660159A CN1660159A (en) | 2005-08-31 |
| CN1248715C true CN1248715C (en) | 2006-04-05 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 200410007237 Expired - Lifetime CN1248715C (en) | 2004-02-27 | 2004-02-27 | Stomachic medication and preparation method |
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| CN (1) | CN1248715C (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102698144B (en) * | 2012-06-15 | 2014-01-22 | 徐州金牌药业有限公司 | Traditional Chinese medicine composition for treating gasteremphraxis |
| CN103652099A (en) * | 2012-09-01 | 2014-03-26 | 宁国红楼梦旅游产品开发有限公司 | Semen boitae tea and preparation method thereof |
| CN103055208B (en) * | 2013-01-08 | 2015-02-04 | 洛阳本草生物制药股份有限公司 | Spleen invigorating and appetite promoting tablet and its making method |
| CN116019217A (en) * | 2021-10-26 | 2023-04-28 | 内蒙古蒙牛乳业（集团）股份有限公司 | Stomach strengthening composition, nutrition composition and nutrition bar |
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2004
- 2004-02-27 CN CN 200410007237 patent/CN1248715C/en not_active Expired - Lifetime
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| Publication number | Publication date |
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| CN1660159A (en) | 2005-08-31 |
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