CN103520620B - A kind of Chinese medicine preparation and preparation method for the treatment of due to weakness of spleen and stomach chronic gastritis - Google Patents

A kind of Chinese medicine preparation and preparation method for the treatment of due to weakness of spleen and stomach chronic gastritis Download PDF

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CN103520620B
CN103520620B CN201310500574.0A CN201310500574A CN103520620B CN 103520620 B CN103520620 B CN 103520620B CN 201310500574 A CN201310500574 A CN 201310500574A CN 103520620 B CN103520620 B CN 103520620B
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刘守梅
冯伟
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刘守梅
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Abstract

The invention provides a kind of Chinese medicine preparation and preparation method for the treatment of due to weakness of spleen and stomach chronic gastritis, each raw medicinal material of Chinese medicine preparation comprises: Herba Limonii Gmelinii, Monas cuspurpureus Went, Semen Alpiniae Katsumadai, Radix Glycyrrhizae Preparata, Amylum Metroxyli sagu, Flos dolichoris, Radix Codonopsis, Folium Perillae, Radix Mimosae Pudicae, Herba Paederiae and Fructus Citri Sarcodactylis.Chinese medicine preparation warming middle-JIAO and strengthening the spleen of the present invention, QI invigorating stomach function regulating, determined curative effect, side effect is little.

Description

A kind of Chinese medicine preparation and preparation method for the treatment of due to weakness of spleen and stomach chronic gastritis
Technical field
The present invention relates to the medicinal preparation containing deriving from plant, animal or mineral component, particularly relating to a kind of Chinese medicine preparation and preparation method for the treatment of due to weakness of spleen and stomach chronic gastritis.
Background technology
Chronic gastritis means the various chronic gastric Mucosal inflammatory pathological changes that different pathogeny causes, and be a kind of commonly encountered diseases, its sickness rate ranks first in various gastropathy.Since fiberendoscope extensive use, primary disease understanding is significantly improved.Common chronic superficial gastritis, chronic erosive gastritis and chronic atrophic gastritis.The intestinal epithelial metaplasia of the latter's mucosa, often involves cardia, reduces, also can involve body of stomach, with the forfeiture of secreting acid gland, cause gastric acid, the minimizing of pepsin and endogenous factors with G cell loss and gastrin secretion.
The main disease of chronic gastritis syndrome of dampness-heat of spleen and stomach is: the scorching hot distending pain of gastral cavilty, and noisy, gastral cavity abdomen painful abdominal mass is vexed, dry mouth with bitter taste, thirst but no desire to drink, and heavy sensation of the body limb is tired, yellowish urine, red tongue, yellow and greasy fur, rolling pulse.Characteristic wet in theory of Chinese medical science is: deep, viscous, under becoming.Its pathogenic characteristic is: (1) damage yang-energy damp pathogen obstructing the spleen, hypoactivity of spleen-YANG, and water is wet to stop gathering, therefore oliguria.(2) mechanism of qi taste abnormal ascending-descending of QI then anorexia and loose stool is hindered, oliguria with reddish urine.(3) course of disease is touching not easily fully recovers.(4) common autopodium is tired heavy.Thermal property is: burn bright, in inflammation, urgently.Its pathogenic characteristic is: (1) shows as thermal imagery high fever, flushed complexion, irritated etc.(2) impairment of body fluid consumption gas thirst and liking drink is relevant with secondary.(3) easy raw pneumatic blood.(4) easily invade human upper and cause laryngopharynx swelling and pain gingival hemorrhage etc.The traditional Chinese medical science is thought, chronic gastritis many because of long-term feelings will unsuccessful, eating and drinking without temperance, work and rest is not normal, causes depression of liver-QI, dysfunction of the spleen in transportation, and gastral cavilty is become estranged, and gas virtual loss with the passing of time, thus causes all symptoms.Determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs should be given clinically according to the practical situation of patient.Syndrome Differentiation of Chronic Gastritis typing is with Types Below by Chinese medicine: spleen and stomach damp-heat type, spleen-deficiency qi-stagnation type, due to weakness of spleen and stomach, liver-stomach disharmony type and type of deficiency of stomach yin.All types of disease is as follows: (1) spleen and stomach damp-heat type: the scorching hot distending pain of gastral cavilty, and gastral cavity abdomen painful abdominal mass is vexed, thirst but no desire to drink, bitter taste halitosis, yellowish urine, red tongue, and limit point is dark red, yellow fur is thick or greasy, stringy pulse or cunning.(2) spleen-deficiency qi-stagnation type: vague epigastralgia or distending pain, after food, gastral cavity is vexed, appetite stimulator belch, just sugar diarrhoea, limbs fatigue, and the light red or enlarged tongue limit of body of the tongue has tooth print, white and thin fur or in vain; Thready and soft pulse is unable.(3) due to weakness of spleen and stomach: vague epigastralgia, the happiness of stomachache pain relieved by pressing is warm, feeling of distension and oppression, feeling of fullness after food, appetite stimulator, loose stool or diarrhoea, and weak, extremity are aching and limp, pale tongue or light red, white and thin fur or have indentation, deep-thready pulse.(4) liver-stomach disharmony type: epigastric distending pain or pain alter both sides of the chest, and belch is done frequently, and noisy pantothenic acid, often send out because of feelings will, body of the tongue is light red, white and thin fur or thick in vain, stringy pulse.(5) type of deficiency of stomach yin: the scorching hot pain of gastral cavilty or dull pain, mouthfeel dryness of the tongue, indigestion and loss of appetite lack of appetite, constipation with dry stool, red tongue with a little fluid has crackle suddenly, and tongue is few, thready pulse fire string.
Summary of the invention
Technical problem to be solved by this invention is, provides a kind of Chinese medicine preparation and preparation method for the treatment of due to weakness of spleen and stomach chronic gastritis, Chinese medicine preparation warming middle-JIAO and strengthening the spleen of the present invention, QI invigorating stomach function regulating, and have definite curative effect to treatment due to weakness of spleen and stomach chronic gastritis, side effect is little.
In order to solve the problems of the technologies described above, the invention provides a kind of Chinese medicine preparation for the treatment of due to weakness of spleen and stomach chronic gastritis, each raw medicinal material of described Chinese medicine preparation comprises: Herba Limonii Gmelinii, Monas cuspurpureus Went, Semen Alpiniae Katsumadai, Radix Glycyrrhizae Preparata, Amylum Metroxyli sagu, Flos dolichoris, Radix Codonopsis, Folium Perillae, Radix Mimosae Pudicae, Herba Paederiae and Fructus Citri Sarcodactylis.
Wherein, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Herba Limonii Gmelinii 30 ~ 40 parts, 20 ~ 30 parts, Monas cuspurpureus Went, Semen Alpiniae Katsumadai 10 ~ 20 parts, Radix Glycyrrhizae Preparata 30 ~ 40 parts, Amylum Metroxyli sagu 20 ~ 30 parts, Flos dolichoris 10 ~ 20 parts, Radix Codonopsis 25 ~ 35 parts, Folium Perillae 15 ~ 25 parts, Radix Mimosae Pudicae 20 ~ 30 parts, Herba Paederiae 20 ~ 30 parts and Fructus Citri Sarcodactylis 30 ~ 40 parts.
Wherein, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Herba Limonii Gmelinii 35 ~ 40 parts, 20 ~ 25 parts, Monas cuspurpureus Went, Semen Alpiniae Katsumadai 10 ~ 15 parts, Radix Glycyrrhizae Preparata 30 ~ 35 parts, Amylum Metroxyli sagu 25 ~ 30 parts, Flos dolichoris 10 ~ 15 parts, Radix Codonopsis 30 ~ 35 parts, Folium Perillae 15 ~ 20 parts, Radix Mimosae Pudicae 25 ~ 30 parts, Herba Paederiae 20 ~ 25 parts and Fructus Citri Sarcodactylis 30 ~ 35 parts.
Wherein, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Herba Limonii Gmelinii 40 parts, 22 parts, Monas cuspurpureus Went, Semen Alpiniae Katsumadai 12 parts, Radix Glycyrrhizae Preparata 32 parts, Amylum Metroxyli sagu 28 parts, Flos dolichoris 13 parts, Radix Codonopsis 31 parts, Folium Perillae 16 parts, Radix Mimosae Pudicae 28 parts, Herba Paederiae 24 parts and Fructus Citri Sarcodactylis 32 parts.
Wherein, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Herba Limonii Gmelinii 37 parts, 24 parts, Monas cuspurpureus Went, Semen Alpiniae Katsumadai 13 parts, Radix Glycyrrhizae Preparata 34 parts, Amylum Metroxyli sagu 26 parts, Flos dolichoris 11 parts, Radix Codonopsis 34 parts, Folium Perillae 18 parts, Radix Mimosae Pudicae 25 parts, Herba Paederiae 22 parts and Fructus Citri Sarcodactylis 35 parts.
Wherein, when the dosage form of described Chinese medicine preparation is tablet, its preparation method comprises the following steps:
The first step, by Herba Limonii Gmelinii, Monas cuspurpureus Went, Semen Alpiniae Katsumadai, Radix Glycyrrhizae Preparata, Amylum Metroxyli sagu and Flos dolichoris mixing, add relative to mixture 3 ~ 5 times amount determining alcohol be at every turn 60% ~ 70% alcohol reflux 2 ~ 4 times, each 2 ~ 4 hours, filter respectively, each time filtrate merges, and reclaims ethanol, being concentrated into 70 DEG C of relative densities is the mastic of 1.30 ~ 1.32, for subsequent use;
Second step, is mixed in proportion surplus stock medical material, adds relative to mixture 3 ~ 5 times of water gagings, decocts 2 ~ 4 hours, and filter, being concentrated into 70 DEG C of relative densities is the mastic of 1.27 ~ 1.29;
3rd step, the mastic mixing that the first step, second step are obtained, 60 DEG C ~ 65 DEG C reduced vacuum dryings, get dry extract powder;
4th step, carries out mixing by described dried cream powder and starch and processes, obtain mastic mixture; The weight ratio of described dried cream powder and described starch is 1: 0.01 ~ 0.02; Described mastic mixture is carried out pelletization treatment, dried, obtains mastic compound particles;
5th step, described mastic compound particles and Pulvis Talci, magnesium stearate are carried out successively mixing processes, tabletting process, Cotton seeds, obtain Chinese medicine preparation tablet finished product; The weight ratio of described mastic compound particles, described Pulvis Talci and described magnesium stearate is 100: 1 ~ 3: 0.15 ~ 0.3.
Wherein, when the dosage form of described Chinese medicine preparation is syrup, its preparation method comprises the following steps:
The first step, by Herba Limonii Gmelinii, Monas cuspurpureus Went, Semen Alpiniae Katsumadai and Radix Glycyrrhizae Preparata mix in described ratio, add relative to the determining alcohol of 5 ~ 10 times, mixture is the ethanol of 80% ~ 90% at every turn, heating and refluxing extraction 2 ~ 4 times, each reflux, extract, 3 ~ 5 hours, merge each extracting solution, with the centrifugal remove impurity of tube centrifuge, when the extracting solution after remove impurity being evaporated under the condition of 60 DEG C ~ 70 DEG C 60 DEG C, relative density is the medicinal liquid of 1.12 ~ 1.15, by dry with spray dryer for the concentrated solution after concentrated, be ground into 100 ~ 200 orders subsequently, obtain dry powder;
Second step, by Amylum Metroxyli sagu, Flos dolichoris, Radix Codonopsis and Folium Perillae mix in described ratio, are ground into powder, are that the ethanol of 85% ~ 95% is as solvent with determining alcohol, flood 20 hours ~ 40 hours, adopt percolation with the speed of 1 ~ 3ml per minute slowly percolation, collect percolate, when being concentrated into 60 DEG C, relative density is the mastic of 1.26 ~ 1.28, dry with spray dryer, be ground into 100 ~ 200 orders subsequently, obtain dry powder, the quality of the ethanol added is 4 ~ 7 times of second step mixture quality;
3rd step, surplus stock medical material is mixed in described ratio, add relative to mixture 4 ~ 6 times amount determining alcohol is the ethanol of 70% ~ 80% at every turn, heating and refluxing extraction 2 ~ 4 times, each 2 ~ 4 hours, merges each extracting solution, reclaim ethanol, when being concentrated into 60 DEG C, relative density is the mastic of 1.22 ~ 1.25, in 55 DEG C ~ 65 DEG C reduced vacuum dryings, obtains dry powder;
4th step, by the dry powder blend that the first step obtains to the 3rd step, add the water dissolution relative to mixture quality 3 ~ 5 times, by 40% sodium hydroxide solution adjust ph to 7.0, add sucrose and potassium sorbate mix homogeneously subsequently, obtain syrup, the sucrose added and the potassium sorbate content in medicine: sucrose 20 ~ 45%, potassium sorbate 0.15 ~ 0.4%.
Beneficial effect of the present invention: Chinese medicine preparation warming middle-JIAO and strengthening the spleen of the present invention, QI invigorating stomach function regulating, have definite curative effect to treatment due to weakness of spleen and stomach chronic gastritis, side effect is little.
Detailed description of the invention
The invention provides a kind of Chinese medicine preparation for the treatment of due to weakness of spleen and stomach chronic gastritis, each raw medicinal material of described Chinese medicine preparation comprises: Herba Limonii Gmelinii, Monas cuspurpureus Went, Semen Alpiniae Katsumadai, Radix Glycyrrhizae Preparata, Amylum Metroxyli sagu, Flos dolichoris, Radix Codonopsis, Folium Perillae, Radix Mimosae Pudicae, Herba Paederiae and Fructus Citri Sarcodactylis.
In described Chinese medicine preparation, the pharmacology of each raw medicinal material is as follows:
Herba Limonii Gmelinii: sweet, salty, temperature.Promoting blood circulation and hemostasis, warming middle-JIAO and strengthening the spleen, strengthening by means of tonics.For menoxenia, dysfunctional uterine hemorrhage, bleeding hemorrhoids, gastric ulcer, insufficiency of the spleen edema.
Monas cuspurpureus Went: sweet, temperature.Return liver, spleen, stomach, large intestine channel.Blood circulation promoting and blood stasis dispelling, strengthening the spleen to promote digestion.Main eating accumulation, distension and fullness in the abdomen, red white dysentery, lochia is more than, traumatic injury.Principle of Correct Diet: spleen invigorating, QI invigorating, warming middle-JIAO." Amplification on Materia Medica addendum ": invigorate blood circulation and help digestion, spleen invigorating warming the stomach, water paddy under dysentery with red and white feces.
Semen Alpiniae Katsumadai: pungent, temperature.Return lung, spleen, stomach warp.Removing dampness disappears painful abdominal mass, circulation of qi promoting warming middle-JIAO, appetite-stimulating indigestion-relieving.For turbid damp obstructing in middle-JIAO, anorexia, hygropyrexia from the beginning of, uncomfortable in chest not hungry, cold-damp vomiting, chest and abdomen swelling and pain, food stagnation does not disappear." not Lu ": main warming middle-JIAO, cardiac and abdominal pain, vomiting, removes halitosis gas." book on Chinese herbal medicine is original ": tonifying the spleen and stomach, mill is stagnant, and adjust cold scattering gas very fast, it is the most suitable that weakness can not drink trencherman, alcoholic intoxication of holding concurrently.
Radix Glycyrrhizae Preparata: sweet is flat.GUIXIN, lung, spleen, stomach warp.Spleen reinforcing stomach function regulating, Yiqi and vein recovery.For weakness of the spleen and stomach, fatigue and weakness, severe palpitation, irregularly intermittent and regularly intermittent pulse, can separate Radix Aconiti Lateralis Preparata poison.
Amylum Metroxyli sagu: sweet, temperature.Warming middle-JIAO and strengthening the spleen.Control weakness of the spleen and stomach, dyspepsia." Haiyao Bencao, Oversea Materia Medica ": main tonify deficiency is cold, helps digestion." the little knowledge in Citrus chachiensis Hort. garden ": spleen invigorating fortune stomach, the empty weary person of prolonged illness, food of cooking congee is the most suitable.
Flos dolichoris: flat, sweet, light.Return spleen, stomach, large intestine channel.Expelling summer-heat and damp, and middle spleen invigorating.Main summer Sunstroke wets, and heating, has loose bowels, dysentery, leucorrhea with red and white discharge, and traumatic injury wound is swollen." Traditional Chinese Medicine in Sichuan will ": stomach function regulating spleen invigorating, removing damp-heat.To relieve summer heat hot coma, burnt in humidity hysteresis, dysentery pus and blood, summer diarrhoea and leucorrhea with red and white discharge.
Radix Codonopsis: property is put down, sweet in the mouth, micro-acid.Return spleen, lung meridian.Invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.For deficiency of the spleen and lung, cardiopalmus of breathing hard, anorexia and loose stool, dyspnea due to deficiency is coughed, and interior-heat is quenched one's thirst." Bencao Congxin ": invigorating the spleen and replenishing QI, and taste relieving thirst and restlessness." Chinese crude drug handbook ": control asthenia internal injury, intestinal cold in the stomach, slides and rushes down chronic dysentery, asthma excessive thirst, and heating spontaneous perspiration, metrorrhagia, tire produce all diseases.
Folium Perillae: acrid in the mouth, tepor.Return spleen, lung meridian.Deliver, cold expelling, regulate the flow of vital energy, and battalion.Cure cold wind and cold, fever with aversion to cold, and cough, has a headache lossless, asthma, distension and fullness of the chest and abdomen, and vomiting and nausea is suffered from diarrhoea, and blocks, pregnancy reactions, frequent fetal movement in pharynx.And energy solving toxin of fish and crab, carbuncle skin ulcer snake venom." Japan hanako materia medica ": invigorating the spleen and replenishing QI.Control trusted subordinate's distension, only cramp caused by acute vomiting and diarrhea, whetting the appetite, and (controlling) all cold air, only beriberi." Bencao Tujing ": logical heart channel, strengthening the spleen stomach.
Radix Mimosae Pudicae: puckery, micro-hardship, temperature.Relieving cough and resolving phlegm, dampness removing dredging collateral, stomach function regulating removing food stagnancy.Control chronic bronchitis, rheumatalgia, chronic gastritis, infantile dyspepsia.
Herba Paederiae: sweet in the mouth, acid, property is put down.GUIXIN, liver, spleen, kidney channel.Expelling wind and removing dampness, promoting digestion and removing stagnation, removing toxic substances and promoting subsidence of swelling, promoting blood circulation and stopping pain.Cure mainly rheumatic arthralgia, dyspeptic abdominal distention, infantile malnutrition, diarrhoea, dysentery, heatstroke, jaundice, hepatitis, hepatosplenomegaly." vegetation is side just ": tonify deficiency labor, function of spleen and stomach regulating vigour, edema due to deficiency, tinnitus after curing the disease." south of the Five Ridges herbal ": pre-sunstroke prevention poison, the intestines and stomach that disappears stagnates, and changes five types of stranguria; Gu cloudy QI consumed is fallen apart.For dysentery, jaundice, pulmonary tuberculosis hemoptysis, cough, pertussis, stomachache, stool hematochezia, the hernia swelling and hanging down of either of the testes, anemofrigid-damp arthralgia, burn and scald, venom.
Fructus Citri Sarcodactylis: pungent, bitter, acid, temperature.Return liver, spleen, lung meridian.Liver-smoothing, qi-regulating, and stomach and alleviating pain.For stagnation of liver-QI and stomach-QI, distending pain in the chest and hypochondrium, gastral cavilty feeling of fullness, lack of appetite is vomitted." the southern regions of the Yunnan Province book on Chinese herbal medicine ": tonifying liver warming the stomach, anti-nausea, the cold syndrome of the stomach that disappears expectorant, controls gastric qi pain, the only cold pain in face, and middle circulation of qi promoting." book on Chinese herbal medicine is new again ": control gas soothing liver-QI, stomach function regulating reduces phlegm, removing mass controls dysphagia and regurgitation, eliminating mass abdominal mass scrofula.
Wherein, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Herba Limonii Gmelinii 30 ~ 40 parts, 20 ~ 30 parts, Monas cuspurpureus Went, Semen Alpiniae Katsumadai 10 ~ 20 parts, Radix Glycyrrhizae Preparata 30 ~ 40 parts, Amylum Metroxyli sagu 20 ~ 30 parts, Flos dolichoris 10 ~ 20 parts, Radix Codonopsis 25 ~ 35 parts, Folium Perillae 15 ~ 25 parts, Radix Mimosae Pudicae 20 ~ 30 parts, Herba Paederiae 20 ~ 30 parts and Fructus Citri Sarcodactylis 30 ~ 40 parts.
Wherein, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Herba Limonii Gmelinii 35 ~ 40 parts, 20 ~ 25 parts, Monas cuspurpureus Went, Semen Alpiniae Katsumadai 10 ~ 15 parts, Radix Glycyrrhizae Preparata 30 ~ 35 parts, Amylum Metroxyli sagu 25 ~ 30 parts, Flos dolichoris 10 ~ 15 parts, Radix Codonopsis 30 ~ 35 parts, Folium Perillae 15 ~ 20 parts, Radix Mimosae Pudicae 25 ~ 30 parts, Herba Paederiae 20 ~ 25 parts and Fructus Citri Sarcodactylis 30 ~ 35 parts.
Wherein, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Herba Limonii Gmelinii 40 parts, 22 parts, Monas cuspurpureus Went, Semen Alpiniae Katsumadai 12 parts, Radix Glycyrrhizae Preparata 32 parts, Amylum Metroxyli sagu 28 parts, Flos dolichoris 13 parts, Radix Codonopsis 31 parts, Folium Perillae 16 parts, Radix Mimosae Pudicae 28 parts, Herba Paederiae 24 parts and Fructus Citri Sarcodactylis 32 parts.
Wherein, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Herba Limonii Gmelinii 37 parts, 24 parts, Monas cuspurpureus Went, Semen Alpiniae Katsumadai 13 parts, Radix Glycyrrhizae Preparata 34 parts, Amylum Metroxyli sagu 26 parts, Flos dolichoris 11 parts, Radix Codonopsis 34 parts, Folium Perillae 18 parts, Radix Mimosae Pudicae 25 parts, Herba Paederiae 22 parts and Fructus Citri Sarcodactylis 35 parts.
Wherein, when the dosage form of described Chinese medicine preparation is tablet, its preparation method comprises the following steps:
The first step, by Herba Limonii Gmelinii, Monas cuspurpureus Went, Semen Alpiniae Katsumadai, Radix Glycyrrhizae Preparata, Amylum Metroxyli sagu and Flos dolichoris mixing, add relative to mixture 3 ~ 5 times amount determining alcohol be at every turn 60% ~ 70% alcohol reflux 2 ~ 4 times, each 2 ~ 4 hours, filter respectively, each time filtrate merges, and reclaims ethanol, being concentrated into 70 DEG C of relative densities is the mastic of 1.30 ~ 1.32, for subsequent use;
Second step, is mixed in proportion surplus stock medical material, adds relative to mixture 3 ~ 5 times of water gagings, decocts 2 ~ 4 hours, and filter, being concentrated into 70 DEG C of relative densities is the mastic of 1.27 ~ 1.29;
3rd step, the mastic mixing that the first step, second step are obtained, 60 DEG C ~ 65 DEG C reduced vacuum dryings, get dry extract powder;
4th step, carries out mixing by described dried cream powder and starch and processes, obtain mastic mixture; The weight ratio of described dried cream powder and described starch is 1: 0.01 ~ 0.02; Described mastic mixture is carried out pelletization treatment, dried, obtains mastic compound particles;
5th step, described mastic compound particles and Pulvis Talci, magnesium stearate are carried out successively mixing processes, tabletting process, Cotton seeds, obtain Chinese medicine preparation tablet finished product; The weight ratio of described mastic compound particles, described Pulvis Talci and described magnesium stearate is 100: 1 ~ 3: 0.15 ~ 0.3.
Wherein, when the dosage form of described Chinese medicine preparation is syrup, its preparation method comprises the following steps:
The first step, by Herba Limonii Gmelinii, Monas cuspurpureus Went, Semen Alpiniae Katsumadai and Radix Glycyrrhizae Preparata mix in described ratio, add relative to the determining alcohol of 5 ~ 10 times, mixture is the ethanol of 80% ~ 90% at every turn, heating and refluxing extraction 2 ~ 4 times, each reflux, extract, 3 ~ 5 hours, merge each extracting solution, with the centrifugal remove impurity of tube centrifuge, when the extracting solution after remove impurity being evaporated under the condition of 60 DEG C ~ 70 DEG C 60 DEG C, relative density is the medicinal liquid of 1.12 ~ 1.15, by dry with spray dryer for the concentrated solution after concentrated, be ground into 100 ~ 200 orders subsequently, obtain dry powder;
Second step, by Amylum Metroxyli sagu, Flos dolichoris, Radix Codonopsis and Folium Perillae mix in described ratio, are ground into powder, are that the ethanol of 85% ~ 95% is as solvent with determining alcohol, flood 20 hours ~ 40 hours, adopt percolation with the speed of 1 ~ 3ml per minute slowly percolation, collect percolate, when being concentrated into 60 DEG C, relative density is the mastic of 1.26 ~ 1.28, dry with spray dryer, be ground into 100 ~ 200 orders subsequently, obtain dry powder, the quality of the ethanol added is 4 ~ 7 times of second step mixture quality;
3rd step, surplus stock medical material is mixed in described ratio, add relative to mixture 4 ~ 6 times amount determining alcohol is the ethanol of 70% ~ 80% at every turn, heating and refluxing extraction 2 ~ 4 times, each 2 ~ 4 hours, merges each extracting solution, reclaim ethanol, when being concentrated into 60 DEG C, relative density is the mastic of 1.22 ~ 1.25, in 55 DEG C ~ 65 DEG C reduced vacuum dryings, obtains dry powder;
4th step, by the dry powder blend that the first step obtains to the 3rd step, add the water dissolution relative to mixture quality 3 ~ 5 times, by 40% sodium hydroxide solution adjust ph to 7.0, add sucrose and potassium sorbate mix homogeneously subsequently, obtain syrup, the sucrose added and the potassium sorbate content in medicine: sucrose 20 ~ 45%, potassium sorbate 0.15 ~ 0.4%.
Below adopt embodiment to describe embodiments of the present invention in detail, fully understand how application technology means solve technical problem in the present invention whereby, reach technique effect and implement according to this.
Embodiment 1: tablet
Get Herba Limonii Gmelinii 370g, Monas cuspurpureus Went 240g, Semen Alpiniae Katsumadai 130g, Radix Glycyrrhizae Preparata 340g, Amylum Metroxyli sagu 260g, Flos dolichoris 110g, Radix Codonopsis 340g, Folium Perillae 180g, Radix Mimosae Pudicae 250g, Herba Paederiae 220g and Fructus Citri Sarcodactylis 350g.
Its preparation method comprises the following steps:
The first step, by Herba Limonii Gmelinii, Monas cuspurpureus Went, Semen Alpiniae Katsumadai, Radix Glycyrrhizae Preparata, Amylum Metroxyli sagu and Flos dolichoris mixing, add relative to mixture 4 times amount determining alcohol be at every turn 65% alcohol reflux 3 times, each 3 hours, filter respectively, each time filtrate merges, and reclaims ethanol, being concentrated into 70 DEG C of relative densities is the mastic of 1.31, for subsequent use;
Second step, is mixed in proportion surplus stock medical material, adds relative to mixture 5 times of water gagings, decocts 3 hours, and filter, being concentrated into 70 DEG C of relative densities is the mastic of 1.28;
3rd step, the mastic mixing that the first step, second step are obtained, 65 DEG C of reduced vacuum dryings, get dry extract powder;
4th step, carries out mixing by dried cream powder and starch and processes, obtain mastic mixture; The weight ratio of dried cream powder and starch is 1: 0.02; Mastic mixture is carried out pelletization treatment, dried, obtains mastic compound particles;
5th step, mastic compound particles and Pulvis Talci, magnesium stearate are carried out successively mixing processes, tabletting process, Cotton seeds, obtain Chinese medicine preparation tablet finished product; The weight ratio of mastic compound particles, Pulvis Talci and magnesium stearate is 100: 3: 0.3.
Embodiment 2: syrup
Herba Limonii Gmelinii 400g, Monas cuspurpureus Went 220g, Semen Alpiniae Katsumadai 120g, Radix Glycyrrhizae Preparata 320g, Amylum Metroxyli sagu 280g, Flos dolichoris 130g, Radix Codonopsis 310g, Folium Perillae 160g, Radix Mimosae Pudicae 280g, Herba Paederiae 240g and Fructus Citri Sarcodactylis 320g.
Its preparation method comprises the following steps:
The first step, by Herba Limonii Gmelinii, Monas cuspurpureus Went, Semen Alpiniae Katsumadai and Radix Glycyrrhizae Preparata mix in described ratio, and add relative to the determining alcohol of 7 times, mixture is the ethanol of 90% at every turn, heating and refluxing extraction 3 times, each reflux, extract, 4 hours, merge each extracting solution, reclaim ethanol, with the centrifugal remove impurity of tube centrifuge, when the extracting solution after remove impurity being evaporated under the condition of 60 DEG C 60 DEG C, relative density is the medicinal liquid of 1.14, by dry with spray dryer for the concentrated solution after concentrated, be ground into 200 orders subsequently, obtain dry powder;
Second step, by Amylum Metroxyli sagu, Flos dolichoris, Radix Codonopsis and Folium Perillae mix in described ratio, are ground into powder, are that the ethanol of 90% is as solvent with determining alcohol, flood 30 hours, adopt percolation with the speed of 3ml per minute slowly percolation, collect percolate, reclaim ethanol, when being concentrated into 60 DEG C, relative density is the mastic of 1.27, dry with spray dryer, is ground into 200 orders subsequently, obtain dry powder, the quality of the ethanol added is 6 times of second step mixture quality;
3rd step, surplus stock medical material is mixed in described ratio, add relative to mixture 5 times amount determining alcohol is the ethanol of 75% at every turn, heating and refluxing extraction 4 times, each 3 hours, merges each extracting solution, reclaim ethanol, when being concentrated into 60 DEG C, relative density is the mastic of 1.23, in 65 DEG C of reduced vacuum dryings, obtains dry powder;
4th step, by the dry powder blend that the first step obtains to the 3rd step, add the water dissolution relative to mixture quality 4 times, by 40% sodium hydroxide solution adjust ph to 7.0, add sucrose and potassium sorbate mix homogeneously subsequently, obtain syrup, the sucrose added and the potassium sorbate content in medicine: sucrose 35%, potassium sorbate 0.35%.
Toxicity test:
Acute toxicity testing: application mice 80, male and female half and half, body weight 18 ~ 26g, carries out acute toxicity test.Mice is divided into two groups at random, i.e. matched group and administration group, before experiment, fasting 12 hours, is dissolved in water by Chinese medicinal tablet prepared by embodiments of the invention 1, (concentration is 6.48g crude drug/ml, maximum concentration) gavage, gavage volume is 5ml/kg (namely unit dosage form is 32.4 crude drugs/kg), and matched group gives normal saline, administration in one day 2 times, delivery time 6 hours, Continuous Observation 14 days after administration, and record mice toxic reaction and death toll.Experimental result shows: compare with matched group, and after administration, mice has no notable difference, and experiment Continuous Observation 14 days, mouse systemic situation, diet, drinking-water, body weight increase all normal.Mouse oral gavage tablet of the present invention and LD50>32.4 crude drug/kg, every day, maximum dosage-feeding was 64.8 crude drugs/kg/ day.Chinese medicine preparation clinical application amount of the present invention be 5.2g crude drug/day/people, adult body weight in 60KG, average dosage is 0.087g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight is in 22g) oral administration gavage Chinese medicine preparation of the present invention is 745 times of quantity.Therefore Chinese medicine preparation acute toxicity of the present invention is extremely low, clinical drug safety.
Long term toxicity test: Chinese medicine preparation embodiment 1 tablet of the present invention presses 14.28,22.56 and 38.62g crude drug/kg continuous use 15 weeks (1.0ml/100g body weight to mice, every day 2 times) and drug withdrawal after 3 weeks, result shows: the index such as hair, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat of Chinese medicine preparation of the present invention to mice all has no significant effect, internal organs naked eyes do not find that difference change and histological indications show, medication 15 weeks and drug withdrawal are after 3 weeks, and Organs of Mice is all without obviously changing.Illustrate that Chinese medicine preparation of the present invention is little to toxicity after mice long-term prescription, also there is no difference reaction after drug withdrawal, application safety.
Clinical data:
Case selection: whole 84 routine cases are my Out-patient Department or inpatient.Be divided into treatment group and matched group at random.Wherein treatment group 44 people, male 24 people, women 20 people, 25 ~ 61 years old age, chronic superficial gastritis patient 28 example, Chronic Atrophic Gastritis Patients 16 example; Matched group 40 people, male 22 people, women 18 people, 27 ~ 59 years old age, chronic superficial gastritis patient 26 example, Chronic Atrophic Gastritis Patients 14 example.Two groups in age, sex, clinical manifestation etc. through statistical analysis there was no significant difference (p>0.05).
Diagnostic criteria:
Western medicine diagnose standard: gastroscopy turns out to be the HP positive, by histopathology biopsy, finds that Grastiodudenal mucosa inflammatory pathologies changes, and gets rid of the organic disease such as gastric ulcer, tumor.Clinical that to show as gastral cavilty portion pain uncomfortable is more, the symptoms such as normal companion's painful abdominal mass vexed or distension, nausea and vomiting, belch, pantothenic acid.Visible point-like, lamellar erythema under chronic superficial gastritis gastroscope, and visible petechia, the coarse injustice of mucosa, there is edema, oozes out in mucosa.Under chronic atrophic gastritis gastroscope, visible mucosa fold disappears, red and white, exposed vessel and present nodositas or graininess.
Tcm diagnosis standard: main disease: the scorching hot distending pain of (1) gastral cavilty; (2) bitter taste halitosis; (3) gastral cavity abdomen painful abdominal mass is vexed, thirst but no desire to drink; (4) red tongue, limit point is dark red, and yellow fur is thick or greasy.Secondary disease: the acute Active inflammation of (1) gastric mucosa is congested obviously rotten to the corn; (2) yellow urine; (3) rolling pulse or moisten number.Disease type is determined: possess main disease 2 and add secondary disease 1.
Meet above-mentioned Western medicine diagnose standard and tcm diagnosis standard, meet the Syndrome Differentiation of Traditional Chinese Medicine disease of due to weakness of spleen and stomach chronic gastritis simultaneously.
Therapeutic Method: treatment group: the tablet taking Chinese medicine preparation embodiment 1 of the present invention, each 3, every day 3 times.It within 30 days, is a course for the treatment of.
Matched group: treatment in oral omeprazole 40mg/ days, amoxicillin 1.5g/ days, the WEISU CHONGJI of coupling simultaneously (Yangzijiang Pharmaceutical Group produces, the accurate word z10930002 of traditional Chinese medicines) 45g/ days.It within 30 days, is a course for the treatment of.
Curative effect judging standard:
Clinical cure: (1) clinical cardinal symptom disappears; minor symptom substantially disappear or disappear (2) gastroscope check Active inflammation substantially disappear; chronic inflammatory disease passs on well slight (3) biopsy proved by pathology gastroscope finding; body of gland atrophy, intestinal and dysplasia again normal or (4) gastric acid that disappears recover normal substantially, and bile reflux disappears.
Effective: (1) clinical cardinal symptom disappears, minor symptom disappears substantially (2), and gastroscope check mucosa acute inflammation disappears, chronic inflammatory disease improvement (3) biopsy proved by pathology gastroscope finding, body of gland atrophy, intestinal and dysplasia recover or alleviate to reach more than two level degree (containing two level degree) (4) Acid Secretion and bile reflux improvement, and former exceptional value reduces more than 2/3.
Effective: (1) clinical cardinal symptom obviously alleviates (2) gastroscope check non-cancer lesion range shorter more than 1/2, biopsy proved by pathology gastroscope finding that inflammation alleviates to some extent (3), Acute and chronic inflammation alleviates more than a level degree, body of gland atrophy, intestinal and dysplasia alleviate (4) Acid Secretion and bile reflux is improved, and former exceptional value reduces more than 1/2.
Invalid: clinical symptoms is without improvement, and indices is without improvement.
Therapeutic outcome: two groups treat 1 course for the treatment of respectively after, statistical result is see table 1 and table 2.As can be seen from Table 1, adopt treatment by Chinese herbs due to weakness of spleen and stomach chronic gastritis of the present invention, relative to Western medicine on therapeutic effect, there is significant improvement; As can be seen from Table 2, adopt treatment by Chinese herbs due to weakness of spleen and stomach chronic gastritis of the present invention, relative to Western medicine, treatment the course for the treatment of on significantly shorten.
After table 1 liang group treats 1 course for the treatment of respectively, Clinical efficacy comparison is routine
Group n Cure Effective Effectively Invalid Effectively total
Treatment group 44 10 24 8 2 42(95.5%)
Matched group 40 2 20 11 7 33(82.5%)
Table 2 liang group is cured after treating 1 course for the treatment of respectively and effective number and time comparative example (%)
Group Number of cases Medication 15 days Medication 20 days Medication 25 days Medication 30 days
Treatment group 34 6(17.6%) 14(41.2%) 12(35.3%) 2(5.9%)
Matched group 22 0(0%) 4(18.2%) 10(45.5%) 8(36.4%)
According to the clinical statistics in above table, Chinese medicine provided by the invention have rapid-action, effective percentage is high, determined curative effect, safety are high, the advantage that has no side effect; Cure treatment group and 34 effective routine patients and matched group are cured and 22 effective routine patients follow up a case by regular visits to 1 year respectively, result statistics, the routine patient for the treatment of group 34 is without recurring or aggravation, and relapse rate is 0% simultaneously; The routine patient of matched group 22, without recurrence, aggravation 4 people, relapse rate 18.2%.
Concrete case: Wei, man, 50 years old, symptom: vague epigastralgia, feeling of distension and oppression after food, have loose bowels in loose stool, weak, and body of the tongue is light red, and tongue has indentation, deep-thready pulse; Gastroscopy is visible: erythema, and mucus is thin and many.Be diagnosed as chronic superficial gastritis, traditional Chinese medical science disease type is due to weakness of spleen and stomach chronic gastritis.Take Chinese medicine preparation embodiment 1 tablet of the present invention, each 3, every day 3 times, take recovery from illness in 25 days.Follow up a case by regular visits to and do not recur for 1 year.
The above is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.

Claims (4)

1. treat the Chinese medicine preparation of due to weakness of spleen and stomach chronic gastritis for one kind, it is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Herba Limonii Gmelinii 30 ~ 40 parts, 20 ~ 30 parts, Monas cuspurpureus Went, Semen Alpiniae Katsumadai 10 ~ 20 parts, Radix Glycyrrhizae Preparata 30 ~ 40 parts, Amylum Metroxyli sagu 20 ~ 30 parts, Flos dolichoris 10 ~ 20 parts, Radix Codonopsis 25 ~ 35 parts, Folium Perillae 15 ~ 25 parts, Radix Mimosae Pudicae 20 ~ 30 parts, Herba Paederiae 20 ~ 30 parts and Fructus Citri Sarcodactylis 30 ~ 40 parts;
The dosage form of described Chinese medicine preparation is tablet, and its preparation method comprises the following steps:
The first step, by Herba Limonii Gmelinii, Monas cuspurpureus Went, Semen Alpiniae Katsumadai, Radix Glycyrrhizae Preparata, Amylum Metroxyli sagu and Flos dolichoris mixing, add relative to mixture 3 ~ 5 times amount determining alcohol be at every turn 60% ~ 70% alcohol reflux 2 ~ 4 times, each 2 ~ 4 hours, filter respectively, each time filtrate merges, and reclaims ethanol, being concentrated into 70 DEG C of relative densities is the mastic of 1.30 ~ 1.32, for subsequent use;
Second step, is mixed in proportion surplus stock medical material, adds relative to mixture 3 ~ 5 times of water gagings, decocts 2 ~ 4 hours, and filter, being concentrated into 70 DEG C of relative densities is the mastic of 1.27 ~ 1.29;
3rd step, the mastic mixing that the first step, second step are obtained, 60 DEG C ~ 65 DEG C reduced vacuum dryings, get dry extract powder;
4th step, carries out mixing by described dried cream powder and starch and processes, obtain mastic mixture; The weight ratio of described dried cream powder and described starch is 1: 0.01 ~ 0.02; Described mastic mixture is carried out pelletization treatment, dried, obtains mastic compound particles;
5th step, described mastic compound particles and Pulvis Talci, magnesium stearate are carried out successively mixing processes, tabletting process, Cotton seeds, obtain Chinese medicine preparation tablet finished product; The weight ratio of described mastic compound particles, described Pulvis Talci and described magnesium stearate is 100: 1 ~ 3: 0.15 ~ 0.3.
2. Chinese medicine preparation as claimed in claim 1, it is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Herba Limonii Gmelinii 35 ~ 40 parts, 20 ~ 25 parts, Monas cuspurpureus Went, Semen Alpiniae Katsumadai 10 ~ 15 parts, Radix Glycyrrhizae Preparata 30 ~ 35 parts, Amylum Metroxyli sagu 25 ~ 30 parts, Flos dolichoris 10 ~ 15 parts, Radix Codonopsis 30 ~ 35 parts, Folium Perillae 15 ~ 20 parts, Radix Mimosae Pudicae 25 ~ 30 parts, Herba Paederiae 20 ~ 25 parts and Fructus Citri Sarcodactylis 30 ~ 35 parts.
3. Chinese medicine preparation as claimed in claim 1, it is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Herba Limonii Gmelinii 40 parts, 22 parts, Monas cuspurpureus Went, Semen Alpiniae Katsumadai 12 parts, Radix Glycyrrhizae Preparata 32 parts, Amylum Metroxyli sagu 28 parts, Flos dolichoris 13 parts, Radix Codonopsis 31 parts, Folium Perillae 16 parts, Radix Mimosae Pudicae 28 parts, Herba Paederiae 24 parts and Fructus Citri Sarcodactylis 32 parts.
4. Chinese medicine preparation as claimed in claim 1, it is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine preparation is as follows: Herba Limonii Gmelinii 37 parts, 24 parts, Monas cuspurpureus Went, Semen Alpiniae Katsumadai 13 parts, Radix Glycyrrhizae Preparata 34 parts, Amylum Metroxyli sagu 26 parts, Flos dolichoris 11 parts, Radix Codonopsis 34 parts, Folium Perillae 18 parts, Radix Mimosae Pudicae 25 parts, Herba Paederiae 22 parts and Fructus Citri Sarcodactylis 35 parts.
CN201310500574.0A 2013-10-22 2013-10-22 A kind of Chinese medicine preparation and preparation method for the treatment of due to weakness of spleen and stomach chronic gastritis Expired - Fee Related CN103520620B (en)

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* Cited by examiner, † Cited by third party
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CN101708304A (en) * 2009-12-14 2010-05-19 张晨 Oral herbal decoction for treating chronic gastritis
CN101791387A (en) * 2010-04-12 2010-08-04 汤永顺 Traditional Chinese medicine preparation for treating chronic gastritis
CN102847047A (en) * 2012-09-26 2013-01-02 张永红 Medicine for treating chronic gastritis and preparation method thereof
CN103182059A (en) * 2013-03-18 2013-07-03 上海中医药大学附属岳阳中西医结合医院 Traditional Chinese medicine composition for treating chronic gastritis, and application thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101708304A (en) * 2009-12-14 2010-05-19 张晨 Oral herbal decoction for treating chronic gastritis
CN101791387A (en) * 2010-04-12 2010-08-04 汤永顺 Traditional Chinese medicine preparation for treating chronic gastritis
CN102847047A (en) * 2012-09-26 2013-01-02 张永红 Medicine for treating chronic gastritis and preparation method thereof
CN103182059A (en) * 2013-03-18 2013-07-03 上海中医药大学附属岳阳中西医结合医院 Traditional Chinese medicine composition for treating chronic gastritis, and application thereof

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