CN108653432B - Traditional Chinese medicine composition and preparation thereof - Google Patents
Traditional Chinese medicine composition and preparation thereof Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/285—Aucklandia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/57—Magnoliaceae (Magnolia family)
- A61K36/575—Magnolia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A—HUMAN NECESSITIES
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- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Alternative & Traditional Medicine (AREA)
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- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
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- Veterinary Medicine (AREA)
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Abstract
The invention discloses a traditional Chinese medicine composition for regulating middle warmer, relieving stuffiness, strengthening spleen and stomach and treating gastroparesis. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 6-20 parts of bran-fried bighead atractylodes rhizome, 3-15 parts of bran-fried fructus aurantii, 3-15 parts of mangnolia officinalis, 1-6 parts of elecampane and 1-6 parts of dried orange peel. The invention has scientific formula, exact curative effect, quick response, no adverse reaction, safety, no toxic or side effect, low cost and extremely high clinical application value, and can treat both symptoms and root causes.
Description
Technical Field
The invention belongs to the technical field of pure traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for regulating middle warmer, relieving distension and fullness, strengthening spleen and stomach and treating gastroparesis and a preparation thereof.
Background
The spleen and stomach diseases are the most common diseases related to the most extensive clinical practice in the internal medicine of traditional Chinese medicine, and the traditional Chinese medicine considers that the spleen belongs to Taiyin damp soil, more yin is damp, more yin is shaoyang, dryness is favored, dampness is disliked, and transportation, transformation and blood governing are preferably carried out in a rising manner; the stomach is yang-clearing and dryness-earth, qi-fire-yang-yin-deficiency, and prefers to dampness and dislike dryness, mainly receives, assimilates and decomposes, descending and regulating yin and yang of the stomach into two mutually dependent yin and yang, dryness and dampness complement each other, and the functions of receiving and transporting food and food essence are completed by the same reason of ascending and descending and the opposite, and the stomach is the source of qi and blood generation and transformation and the acquired root.
The pathological features of the spleen are deficiency and dampness. The excessive deficiency of spleen disease indicates the deficiency of spleen qi and spleen yang. Spleen-qi deficiency is often seen in: transportation and transformation are lack of strength. Food retention can lead to loose stool, abdominal distension, fatigue, lassitude, pale tongue and weak pulse; edema and oliguria are caused by water retention; the function of ascending clear and losing the function; the clear yang is not ascending, turbid yin is not descending, manifested as dizziness, nausea, vomiting, etc., and the viscera drooping is caused by the inability to ascend.
Spleen yang deficiency can cause dysfunction of warming, manifested as cold sensation or cold pain in the abdomen, vomiting of clear water, poor appetite, or indigestion, loose stool, white face and cold limbs. Excessive dampness in spleen disease manifests as cold-dampness encumbering the spleen and damp-heat accumulating in the spleen, both of which can cause nausea, abdominal distension, loose stool, heaviness of the head and body, greasy tongue coating, slippery pulse, etc.
The pathological features of the stomach are excessive heat, excessive excess, no absorption and no reduction, and the pathological features of spleen and stomach diseases, such as stomach heat exuberance, stomach qi adverse rising, stomach yin deficiency and the like, are that the spleen diseases are deficient and damp, namely spleen qi deficiency and spleen yang deficiency, and the spleen diseases are mainly manifested by failure of blood circulation without rising and failing to transport; stomach diseases are excessive and hot, and the excessive and hot stomach diseases usually affect each other on the basis of the pathological changes of the stomach, such as the same spleen and stomach, mixed cold and heat, and disorder of ascending and descending.
The clinical manifestations of the spleen and stomach diseases are as follows: abdominal paresthesia, characterized by fullness, fullness and pain; loose stool can occur due to failure of the spleen to transport and transform; fullness in the epigastrium, no desire for food, lassitude, hypodynamia, difficult defecation, greasy and yellowish fur, and wiry pulse.
Although western medicines have quick response for treating the spleen and stomach diseases, the western medicines have great side effects, do not fundamentally treat and condition the body, treat the symptoms and do not treat the root causes, and are easy to attack repeatedly. The traditional Chinese medicine composition is used for treating and regulating spleen and stomach, has mild drug effect and small side effect on human body, can regulate and improve fundamentally and is not easy to attack repeatedly.
The traditional Chinese medicine composition for treating spleen and stomach related diseases at present comprises the following components: the disclosure number is CN105999028A, and the invention name is 17 traditional Chinese medicine compositions comprising 5-15 parts of fried bighead atractylodes rhizome, 10-30 parts of rhizoma atractylodis, 5-30 parts of fructus aurantii, 5-20 parts of mangnolia officinalis, 5-15 parts of elecampane, 5-15 parts of dried orange peel, 5-30 parts of fried radish seed, 5-30 parts of white paeony root, 5-15 parts of radix bupleuri, 5-15 parts of cortex moutan, 5-30 parts of scorched hawthorn fruit, 5-15 parts of betel nut, 5-15 parts of cardamom, 5-15 parts of amomum tsao-ko, 10-30 parts of salvia miltiorrhiza, 5-15 parts of trogopterus dung, 5-20 parts of rhizoma corydalis and the like; the invention discloses 18 traditional Chinese medicine compositions of rhizoma atractylodis, mangnolia officinalis, dried orange peel, liquorice, endothelium corneum gigeriae galli, fried hawthorn, fructus aurantii, medicated leaven, fructus toosendan, radix aucklandiae, fructus amomi, mirabilite, immature bitter orange, rhizoma atractylodis macrocephalae, malt, white hyacinth bean, fructus amomi koenii, radix pseudostellariae and the like, and the disclosure number is CN 101912562B. The two pharmaceutical compositions in the prior art have more raw material medicine components and large prescription amount, and also increase the difficulty of matching the formula and the difficulty of realizing industrialization. Therefore, there is a need to develop a Chinese medicinal composition for treating spleen and stomach disharmony, which has the advantages of simple components, small prescription amount, safety, effectiveness and wider treatment range.
Disclosure of Invention
In view of the above disadvantages, the first objective of the present invention is to provide a Chinese medicinal composition with the functions of regulating middle warmer, relieving stuffiness, strengthening spleen and stomach. The invention also provides a method for using the traditional Chinese medicine composition with a pharmaceutically effective amount and a preparation thereof. An "effective amount" refers to an amount of the composition sufficient to treat a disease as defined herein.
The traditional Chinese medicine composition provided by the invention is prepared by extracting the following traditional Chinese medicine raw materials: atractylodis rhizoma parched with bran, fructus Aurantii parched with bran, cortex Magnolia officinalis, radix aucklandiae and pericarpium Citri Tangerinae.
More importantly, the traditional Chinese medicine composition can also be used for treating gastroparesis.
The properties and the functions of the raw materials of the traditional Chinese medicine composition are as follows:
atractylodis rhizoma (Atractylodes macrocephala) parched with bran, and processed product thereof. The rhizoma Atractylodis Macrocephalae belongs to perennial herb of Compositae and Atractylodes, and is bitter in taste, sweet and warm in nature as root and rhizome. It enters spleen and stomach meridians. Is used for strengthening spleen, replenishing qi, eliminating dampness, promoting diuresis, arresting sweating and preventing miscarriage. Can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm retention, dizziness, palpitation, edema, spontaneous perspiration, and threatened abortion. Tu Bai Zhu strengthens spleen, harmonizes stomach and prevents abortion. Bighead atractylodes rhizome stir-baked with bran is used for treating incoordination between the spleen and the stomach, dysfunction of transportation and transformation, anorexia, fullness and distention, lassitude, hypodynamia, exterior deficiency and spontaneous perspiration.
Fructus Aurantii (Fructus aurantii) is dry immature fruit of Citrus aurantium L of Rutaceae and its cultivar, and has bitter, pungent, sour and warm properties, and has effects of regulating qi-flowing, relieving epigastric distention, activating stagnancy and relieving flatulence, and can be used for treating qi stagnation in chest and hypochondrium, fullness and pain, dyspepsia, and phlegm retention; gastroptosis, proctoptosis, uterine prolapse, etc.
Magnolia officinalis (Magnolia officinalis of Magnolia rehd. et Wils.) is a plant of Magnolia, magnoliaceae and Magnolia, commonly refers to two types of Magnolia officinalis (original subspecies) m.ofcinalis subsp.ofcinalis and Magnolia robusta (subspecies) m.ofcinalis subsp.bioloba, and the Chinese medicinal material is especially dry bark, root bark and branch bark of the plant. Bitter and pungent in taste, warm in nature, entering spleen channel, stomach channel and large intestine channel, and promoting qi circulation and removing food retention; drying dampness and removing fullness; descending adverse-rising energy and relieving asthma, mainly treating food stagnation and qi stagnation; abdominal distension and constipation; dampness obstructing the middle energizer, gastric fullness, vomiting and diarrhea; phlegm obstructing the adverse flow of qi; fullness in chest, dyspnea and cough.
Radix Aucklandiae (Radix Aucklandiae), a generic name of saussurea lappa and Radix Aucklandiae of Compositae, is prepared from root and stem, and has the following properties and tastes: pungent taste; bitter; and (4) temperature. The main treatment is as follows: promoting qi circulation and relieving pain; to regulate the middle energizer and remove food stagnation. Hypochondriac distention in the main cell is satisfied; abdominal distending pain; belching, vomiting and diarrhea; severe after dysentery. Can be used for treating chest and abdominal pain, dysentery, tenesmus, dyspepsia, and anorexia; the middle-jiao energy is not saved; sudden deafness; biting by snake and insect; toothache.
Pericarpium Citri Tangerinae, which is dried mature pericarp of Citrus reticulata Blanco of Rutaceae and its cultivar. Bitter and pungent in flavor and warm in nature. It enters lung and spleen meridians. Regulating qi-flowing, strengthening spleen, drying dampness and resolving phlegm, it is indicated for abdominal distention, poor appetite, vomiting and diarrhea, cough with profuse sputum.
The whole prescription has the advantages of good therapeutic effect, cold and heat, and embodies the compatibility characteristics of good therapeutic effect, pungent taste and bitter taste.
In order to achieve the purpose, the technical scheme of the invention is as follows:
the invention relates to a traditional Chinese medicine composition for regulating middle warmer, relieving distension and fullness, strengthening spleen and stomach, which is prepared from the following raw materials in parts by weight:
6-20 parts of bran-fried bighead atractylodes rhizome, 3-15 parts of bran-fried fructus aurantii, 3-15 parts of mangnolia officinalis, 1-6 parts of elecampane and 1-6 parts of dried orange peel;
preferably, the feed additive is prepared from the following raw materials in parts by weight:
10-14 parts of bran-fried bighead atractylodes rhizome, 4-8 parts of bran-fried fructus aurantii, 4-8 parts of mangnolia officinalis, 2-4 parts of elecampane and 2-4 parts of dried orange peel;
more preferably, the feed additive is prepared from the following raw materials in parts by weight:
12 parts of bran-fried bighead atractylodes rhizome, 6 parts of bran-fried fructus aurantii, 6 parts of mangnolia officinalis, 3 parts of elecampane and 3 parts of dried orange peel.
The invention also aims to provide a preparation method of the traditional Chinese medicine composition, which is prepared by adopting water extraction or ethanol extraction with different concentrations. The preparation method comprises the following steps:
the first scheme is as follows: mixing all the medicinal materials, adding water, extracting for 2-3 times, each time adding water amount 6-12 times of the total weight of the medicinal materials, each time extracting for 1-3 hr, mixing extractive solutions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, and pulverizing into fine powder.
Scheme II: mixing all the materials, reflux-extracting with 40-80% ethanol for 2-3 times, wherein the ethanol content is used as medicinal material each time
Extracting for 1-3 hr 4-10 times of the total amount, mixing extractive solutions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, and pulverizing into fine powder.
The third scheme is as follows: mixing all the medicinal materials, adding water, extracting for 2-3 times, wherein the water amount added each time is 6 times of the total weight of the medicinal materials
12 times of the amount of the extract, 1-3 hours of extraction each time, merging the extract, filtering, concentrating the filtrate to clear paste with the relative density of 1.15-1.20 at the temperature of 60-70 ℃, adding ethanol to ensure that the ethanol content is 40-70%, standing for 12-24 hours, filtering, concentrating the filtrate to clear paste with the relative density of 1.20-1.30 at the temperature of 60-70 ℃, drying and crushing into fine powder to obtain the traditional Chinese medicine.
The invention also provides a preparation of the traditional Chinese medicine composition, and the preparation can be granules, pills, capsules, tablets, suspensions, injections and syrups. The preparation comprises effective dose of the composition and acceptable pharmaceutical carriers, flavoring agents, diluents or excipients or the combination thereof,
the invention also aims to provide granules of the traditional Chinese medicine composition, which are prepared by the following steps:
step 1, decocting the traditional Chinese medicine composition with water for 2-3 times, wherein the weight of the water added for each time is 6-12 times of the total weight of the traditional Chinese medicine composition, the decocting time is 1-3 hours, combining the decoctions for each time, filtering out dregs of decoction, then concentrating under reduced pressure to obtain clear paste with the relative density of 1.25-1.35 at 60 ℃, drying and crushing into fine powder;
and 2, taking 1-4 parts of another excipient, uniformly mixing the excipient with the fine powder obtained in the step 1, adding a proper amount of a flavoring agent, adding a proper amount of a wetting agent, performing wet granulation, and drying to obtain the finished product.
The invention also provides the dosage of the prescription of the traditional Chinese medicine composition, the dosage of the traditional Chinese medicine composition is 6-20 g of raw material medicines of white atractylodes rhizome stir-fried with bran, 3-15 g of bitter orange stir-fried with bran, 3-15 g of officinal magnolia bark, 1-6 g of costustoot and 1-6 g of dried orange peel, and the traditional Chinese medicine composition is taken before three meals.
Preferably, the dosage of the prescription is one day, and the prescription is a granule equivalent to a traditional Chinese medicine composition prepared from 10-14 g of raw material medicines of bran-fried bighead atractylodes rhizome, 4-8 g of bran-fried bitter orange, 4-8 g of magnolia officinalis, 2-4 g of costustoot and 2-4 g of dried orange peel, and the granule is taken before three meals.
More preferably, the dosage of the prescription is one day, and the prescription is a granule equivalent to a traditional Chinese medicine composition prepared from raw material medicines of 12g of rhizoma atractylodis macrocephalae stir-fried with bran, 6g of fructus aurantii stir-fried with bran, 6g of cortex magnoliae officinalis, 3g of radix aucklandiae and 3g of pericarpium citri reticulatae, and the granule is taken before three meals.
The invention has the beneficial effects that: .
1. The invention combines the modern traditional Chinese medicine pharmacological research, mainly supplements qi and invigorates spleen, and simultaneously regulates qi and removes stasis, and digests food and clears heat as the treatment principle, has the efficacies of regulating the middle warmer and relieving distension and fullness, regulating qi and relieving pain, harmonizing stomach and lowering adverse qi, activating stagnancy and relieving distension, treats both symptoms and root causes, and regulates the internal and external.
2. The traditional Chinese medicine composition for treating gastroparesis has the advantages of high cure speed, no recurrence after cure, patient pain alleviation, good conditioning effect on body health, no side effect, flexible application and low cost.
3. The traditional Chinese medicine composition only contains 5 traditional Chinese medicine raw materials, still can achieve the same treatment effect as more than ten traditional Chinese medicine compositions, even better, and simultaneously reduces the cost of patients.
4. The Chinese medicinal composition is prepared into granules, has the advantages of remarkable curative effect, convenient use, small irritation, good patient compliance, wide applicable population and suitability for children.
5. The traditional Chinese medicine composition disclosed by the invention is scientific and rigorous in formula, simple in preparation method, low in preparation cost and great in clinical application value.
Detailed Description
The invention is illustrated below with reference to specific examples. It will be understood by those skilled in the art that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention in any way.
The experimental procedures in the following examples are conventional unless otherwise specified. The raw materials and reagents used in the following examples are all commercially available products unless otherwise specified.
Example 1
Mixing bran-fried bighead atractylodes rhizome 12g, bran-fried fructus aurantii 6g, mangnolia officinalis 6g, elecampane 3g and dried orange peel 3g, adding water for extraction for 3 times, wherein the water amount added for each time is 8 times of the total weight of the medicinal materials, the extraction time for each time is 2 hours, combining the extracting solutions, filtering, concentrating the filtrate to obtain clear paste with the relative density of about 1.25 at 70 ℃, drying, and crushing into fine powder to obtain the traditional Chinese medicine.
Example 2
Mixing bran-fried rhizoma Atractylodis Macrocephalae 10g, bran-fried fructus Aurantii 8g, cortex Magnoliae officinalis 8g, radix aucklandiae 3g and pericarpium Citri Reticulatae 3g, reflux-extracting with 60% ethanol for 3 times, each time with ethanol amount 6 times of the total amount of the medicinal materials for 1 hr, mixing extractive solutions, filtering, concentrating the filtrate to fluid extract with relative density of 1.25 at 65 deg.C, drying, and pulverizing into fine powder.
Example 3
Mixing bran-fried rhizoma Atractylodis Macrocephalae 10g, bran-fried fructus Aurantii 4g, cortex Magnolia officinalis 4g, radix aucklandiae 2g and pericarpium Citri Tangerinae 2g, reflux-extracting with 60% ethanol for 3 times, wherein the ethanol amount is 6 times of the total amount of the medicinal materials each time, the extraction time is 1 hr, mixing the extractive solutions, filtering, concentrating the filtrate to fluid extract with relative density of 1.25 at 65 deg.C, drying, and pulverizing into fine powder.
Example 4
Mixing 14g of bran-fried bighead atractylodes rhizome, 8g of bran-fried fructus aurantii, 8g of mangnolia officinalis, 4g of elecampane and 4g of dried orange peel, performing reflux extraction for 3 times by using 60% ethanol, wherein the amount of the ethanol is 6 times of the total amount of the medicinal materials each time, the extraction time is 1 hour, combining the extracting solutions, filtering, concentrating the filtrate to obtain clear paste with the relative density of about 1.25 at 65 ℃, drying, and crushing into fine powder to obtain the traditional Chinese medicine.
Example 5
Taking 10g of bran-fried bighead atractylodes rhizome, 8g of bran-fried fructus aurantii, 8g of mangnolia officinalis, 3g of elecampane and 3g of dried orange peel, mixing, adding water for extraction for 3 times, wherein the water amount is 10 times of the total weight of the medicinal materials, the extraction time is 2 hours, combining the extracting solutions, filtering, concentrating the filtrate to obtain clear paste with the relative density of 1.17 at 60 ℃, adding ethanol to ensure that the ethanol content is 50%, standing for 18 hours, filtering, concentrating the filtrate to obtain extract with the relative density of 1.25 at 68 ℃, drying, and crushing into fine powder to obtain the traditional Chinese medicine.
Example 6
Taking 12g of bran-fried bighead atractylodes rhizome, 6g of bran-fried fructus aurantii, 6g of mangnolia officinalis, 3g of elecampane and 3g of dried orange peel, adding water into the traditional Chinese medicine composition, decocting for 3 times, wherein the weight of the added water is 10 times of the total weight of the traditional Chinese medicine composition each time, decocting for 1 hour, combining the three decoctions, filtering out dregs of the decoction, concentrating under reduced pressure to obtain clear paste with the relative density of 1.25 at 60 ℃, drying, and crushing into fine powder; and mixing 3 parts of excipient (a mixture of dextrin and soluble starch in a weight ratio of 4: 1) with the fine powder, adding 1 part of sucrose, adding a wetting agent, granulating by a wet method, and drying to obtain the finished product.
Example 7
Taking 6g of bran-fried bighead atractylodes rhizome, 3g of bran-fried fructus aurantii, 3g of mangnolia officinalis, 1g of elecampane and 1g of dried orange peel, adding water into the traditional Chinese medicine composition, decocting for 2 times, wherein the weight of the added water is 6 times of the total weight of the traditional Chinese medicine composition each time, decocting for 2 hours, combining the two decoctions, filtering out dregs of the decoction, concentrating under reduced pressure to obtain clear paste with the relative density of 1.25 at 60 ℃, drying, and crushing into fine powder; and mixing excipient (mixture of dextrin and soluble starch at a weight ratio of 4: 1) 3 parts with the fine powder, adding aspartame 0.05 part, adding humectant, granulating by wet method, and drying.
Example 8
Taking 20g of bran-fried bighead atractylodes rhizome, 15g of bran-fried fructus aurantii, 15g of mangnolia officinalis, 6g of elecampane and 6g of dried orange peel, adding water into the traditional Chinese medicine composition, decocting for 3 times, wherein the weight of the added water is 8 times of the total weight of the traditional Chinese medicine composition each time, decocting for 1 hour, combining the two decoctions, filtering out dregs of the decoction, concentrating under reduced pressure to obtain clear paste with the relative density of 1.25 at 60 ℃, drying, and crushing into fine powder; and mixing 2 parts of excipient (mixture of dextrin and soluble starch at a weight ratio of 4: 1) with the fine powder, adding 0.03 part of aspartame, adding a wetting agent, performing wet granulation, and drying to obtain the product.
Clinical data
General data
The therapeutic effect of the present invention will be described with reference to 2016, 3 months to 2017, 1 month and ten months as examples. During this time, the applicant co-treated 52 patients, of which 27 were male, 25 female, aged 31-65 years, of which 6 were gastroparesis, with granules of the pharmaceutical composition of the invention.
Criteria for diagnosis and exclusion
The patients clinically show different degrees of spleen deficiency and qi stagnation, abdominal fullness, inappetence, early satiety, postprandial epigastric fullness, nausea, vomiting or paroxysmal retching, repeated hiccup, tiredness and hypodynamia, even vomit can contain food taken before 4-6h, the vomit can have fermentation odor, and the repeated vomiting can have the symptoms of emaciation, weight reduction, hypodynamia and the like; gastroscopes show red and white intervals of mucosa of the stomach body part with red as the main part, and mucosa of the antrum part is congested and edematous, and erosion and exudation are visible. Endoscope, digestive tract radiography, abdominal B-ultrasound for removing upper digestive tract or liver, gallbladder and pancreas organic lesions; exclusion of diabetes and systemic sclerosis, etc., may explain the primary onset of symptoms.
Method of treatment
The granule is prepared by using the extracts with the equivalent amount of 12g of bran-fried bighead atractylodes rhizome, 6g of bran-fried bitter orange, 6g of magnolia officinalis, 3g of costustoot and 3g of dried orange peel in a prescription daily amount, and is taken before three meals. Uncooked, cold, spicy, sweet and fat and fried foods are prohibited during the treatment period. Four weeks is a course of treatment, and the treatment course is one.
Standard of therapeutic effect
And (3) curing: clinical symptoms disappear, the stomach of the patient has no untoward reaction, the diet returns to normal, the diet level of normal people is reached, and the recurrence is avoided.
The method has the following advantages: most symptoms disappear, and slight discomfort still remains;
and (4) invalidation: the clinical symptoms are not obviously improved, and the gastroscope or B-ultrasonic examination has no obvious change with the examination before treatment.
Clinical results show that the applicant adopts the Chinese medicinal composition granules to treat patients with stomach diseases and gastroparesis, and the Chinese medicinal composition granules are all effective. Of these, 30 were relieved within 1 week, another 26 were relieved by day 15, and all but 1 were cured by day 28.
In the test cases, the number of healers reaches 51, the cure rate reaches 98%, the effective rate reaches 100%, and no toxic or side effect occurs in the treatment period.
Claims (13)
1. A traditional Chinese medicine composition for treating spleen deficiency and qi stagnation is characterized by being prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: 10-14 parts of bran-fried bighead atractylodes rhizome, 4-8 parts of bran-fried fructus aurantii, 4-8 parts of mangnolia officinalis, 2-4 parts of elecampane and 2-4 parts of dried orange peel.
2. The traditional Chinese medicine composition according to claim 1, which is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: 12 parts of bran-fried bighead atractylodes rhizome, 6 parts of bran-fried fructus aurantii, 6 parts of mangnolia officinalis, 3 parts of elecampane and 3 parts of dried orange peel.
3. The method for preparing a Chinese medicinal composition according to any one of claims 1 to 2, wherein the raw materials of the Chinese medicinal composition are obtained by decocting with water or extracting with ethanol of different concentrations.
4. The method according to claim 3, characterized by comprising the steps of: mixing all the medicinal materials, adding water, extracting for 2-3 times, each time adding water amount 6-12 times of the total weight of the medicinal materials, each time extracting for 1-3 hr, mixing extractive solutions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, and pulverizing to obtain dry extract powder.
5. The method according to claim 3, characterized by comprising the steps of: mixing all the medicinal materials, reflux-extracting with 40-80% ethanol for 2-3 times, each time the ethanol amount is 4-10 times of the total amount of the medicinal materials, extracting for 1-4 hr, mixing extractive solutions, filtering, concentrating the filtrate to fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, and pulverizing to obtain dry extract powder.
6. The method according to claim 3, characterized by comprising the steps of: mixing all the medicinal materials, adding water, extracting for 2-3 times, each time adding water amount 6-12 times of the total weight of the medicinal materials, each time extracting for 1-3 hr, mixing extractive solutions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.15-1.20 at 60-70 deg.C, adding ethanol to make ethanol content 40-70%, standing for 12-24 hr, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.20-1.30 at 60-70 deg.C, drying, and pulverizing to obtain dry extract powder.
7. A Chinese medicinal preparation for treating spleen deficiency and qi stagnation, which is characterized by being prepared from the Chinese medicinal composition for treating spleen deficiency and qi stagnation in any one of claims 1-2 and an acceptable medicinal carrier.
8. The preparation according to claim 7, wherein the preparation is granules, pills, capsules, tablets, suspensions, injections, syrups.
9. The formulation according to claim 8, characterized in that it is a granulate.
10. The formulation according to claim 8 or 9, characterized in that the granules are prepared as follows:
step 1, decocting the raw materials of the traditional Chinese medicine composition for 2-3 times by adding water, wherein the weight of the water added for each time is 6-12 times of the total weight of the traditional Chinese medicine composition, the decocting time is 1-3 hours, combining the decoctions for each time, filtering out dregs of decoction, then concentrating under reduced pressure to obtain clear paste with the relative density of 1.25-1.35 at the temperature of 60 ℃, drying, and crushing into fine powder;
and 2, taking 1-4 parts of another excipient, uniformly mixing the excipient with the fine powder obtained in the step 1, adding a proper amount of a flavoring agent, adding a proper amount of a wetting agent, performing wet granulation, and drying to obtain the finished product.
11. The use of the Chinese medicinal composition of any one of claims 1-2 in the preparation of a medicament for treating spleen and stomach diseases, wherein the medicament for treating spleen and stomach diseases has the following indications: spleen deficiency and qi stagnation, abdominal distention and fullness, and poor appetite.
12. The use of the Chinese medicinal composition of any one of claims 1-2 in the preparation of a medicament for treating spleen and stomach diseases, wherein the medicament for treating spleen and stomach diseases has the following indications: gastroparesis syndrome.
13. The Chinese medicinal composition according to any one of claims 1 to 2 or the preparation according to any one of claims 7 to 9, wherein the prescribed amount per day is an equivalent amount of the Chinese medicinal composition extracted from raw material herbs of bran-fried atractylodes macrocephala 12g, bran-fried bitter orange 6g, magnolia bark 6g, banksia rose 3g and dried orange peel 3g, and is taken before three meals.
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