CN113209194A - Composition for treating chronic gastritis and preparation method and application thereof - Google Patents
Composition for treating chronic gastritis and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a composition for treating chronic gastritis and a preparation method and application thereof, and belongs to the technical field of medicines. The composition for treating chronic gastritis is prepared from the following raw materials in parts by weight: 100-200 parts of aconitum sinomontanum, 100-200 parts of girald daphne bark, 100-150 parts of radix angelicae pubescentis, 50-150 parts of fried astragalus membranaceus, 50-100 parts of angelica sinensis, 50-100 parts of divaricate saposhnikovia root, 50-100 parts of radix achyranthis bidentatae, 30-80 parts of acanthopanax and 50-80 parts of honey-fried licorice root. The composition has obvious anti-inflammatory effect, good curative effect and quick response, and has obvious effect of treating chronic gastritis. The advantages of the single medicines are complementary, the medicines are combined, the synergistic effect among the medicines is fully exerted, the active ingredients of the product act together, and the aim of treating the chronic gastritis is achieved through multiple ways.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a composition for treating chronic gastritis and a preparation method and application thereof.
Background
Chronic gastritis is a chronic inflammation of the gastric mucosa caused by various etiologies. The disease occurs in all ages, is very common, accounts for about 80-90% of patients who receive gastroscopy, is more than female in males, and has gradually increased incidence rate along with the age. The chronic gastritis caused by helicobacter pylori is symptom-free in most patients, and the symptom-free patients show dyspepsia symptoms such as epigastric pain or discomfort, epigastric distention, early satiety, eructation, nausea and the like.
The traditional Chinese medicine always pays particular attention to diagnosis and treatment of stomach diseases. In traditional Chinese medicine, the spleen governs transportation and transformation, and governs receiving and transforming, so as to generate essence, so the spleen and stomach are called "acquired basis". The source of qi and blood generation indicates that the state of qi and blood is crucial to human health. During the treatment process, the protection of the stomach qi and the regulation of the spleen and the stomach are very emphasized, and the important treatment experiences of ' the spleen is vigorous without being affected by evil in four seasons ', ' one part of stomach qi is preserved, one part of the vitality is remained, and ' the stomach qi is generated ', and the like are summarized. The book Su Wen & Tan Tong Lun (Su Wen & Tan treatise on pain): cold qi is obstructed in the intestines and stomach, under the membrane, blood cannot disperse, and small collaterals are drawn rapidly, so it is painful. The stomach governs reception and has the function of promoting the flow of qi downward, the liver is rigid and rigid, the sexual pleasure is caused, the stomach is mainly dredged, worry and anger, emotional distress, liver loss and qi stagnation, the liver is depressed and qi stagnation is caused, so that the stomach qi is disharmony and the stomach qi is blocked, and the stomach pain can be caused. Gastritis is the most common gastric disease, and belongs to the categories of epigastric pain, fullness, acid regurgitation, gastric upset, anorexia and the like in traditional Chinese medicine. The traditional Chinese medicine considers that chronic gastritis causes various symptoms due to long-term emotional distress, improper diet and improper work and rest, liver qi stagnation, spleen dysfunction, gastric cavity disharmony and qi deficiency in middle-jiao for a long time.
Disclosure of Invention
One of the purposes of the invention is to provide a composition for treating chronic gastritis, which can treat symptoms such as stomachache, gastric acid, gastrectasia and the like caused by the chronic gastritis, regulate qi, regulate spleen and stomach, activate blood and remove stasis, and obviously relieve gastritis symptoms of patients.
The second object of the present invention is to provide a process for preparing the composition.
The invention also aims to provide application of the composition.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
the composition for treating chronic gastritis is prepared from the following raw materials in parts by weight: 100-200 parts of aconitum sinomontanum, 100-200 parts of girald daphne bark, 100-150 parts of radix angelicae pubescentis, 50-150 parts of fried astragalus membranaceus, 50-100 parts of angelica sinensis, 50-100 parts of divaricate saposhnikovia root, 50-100 parts of radix achyranthis bidentatae, 30-80 parts of acanthopanax and 50-80 parts of honey-fried licorice root.
In some embodiments of the invention, the composition is prepared from the following raw materials in parts by weight: 120-180 parts of aconitum sinomontanum, 120-180 parts of girald daphne bark, 110-140 parts of radix angelicae pubescentis, 80-120 parts of fried astragalus membranaceus, 70-90 parts of angelica sinensis, 60-80 parts of divaricate saposhnikovia root, 60-80 parts of radix achyranthis bidentatae, 40-60 parts of acanthopanax senticosus and 50-70 parts of honey-fried licorice root.
In some embodiments of the invention, the composition is prepared from the following raw materials in parts by weight: 150 parts of aconitum sinomontanum, 150 parts of daphne giraldii nitsche, 120 parts of radix angelicae pubescentis, 100 parts of fried astragalus mongholicus, 80 parts of angelica sinensis, 70 parts of radix sileris, 70 parts of radix achyranthis bidentatae, 50 parts of acanthopanax senticosus and 60 parts of honey-fried licorice root.
In some embodiments of the invention, the composition is a preparation prepared by adding pharmaceutically acceptable auxiliary materials into raw materials of aconitum sinomontanum, girald daphne bark, radix angelicae pubescentis, fried astragalus mongholicus, angelica sinensis, divaricate saposhnikovia root, radix achyranthis bidentatae, acanthopanax senticosus and radix glycyrrhizae preparata according to a conventional method.
In some embodiments of the invention, the preparation is prepared from aconitum sinomontanum nakai extract, girald daphne bark extract, and a mixed extract prepared from radix angelicae pubescentis, fried astragalus mongholicus, angelica sinensis, radix sileris, radix achyranthis bidentatae, acanthopanax and radix glycyrrhizae preparata.
In some embodiments of the present invention, the aconitum sinomontanum extract and the girald daphne bark extract are alcohol extracts, and the mixed extract is a water extract.
In some embodiments of the invention, the formulation is an oral formulation.
The invention relates to a preparation method of the composition, which comprises the following steps:
s1, preparing raw materials in parts by weight;
s2, percolating the aconitum sinomontanum nakai with ethanol, collecting percolate, and concentrating under reduced pressure to obtain an aconitum sinomontanum nakai extract I; or drying the aconitum sinomontanum nakai extract I, and crushing into aconitum sinomontanum nakai extract powder I;
s3, refluxing the girald daphne bark with ethanol, filtering, and concentrating the filtrate under reduced pressure to obtain a girald daphne bark extract II; or drying cortex Daphne Giraldii Nitsche extract II, and pulverizing into cortex Daphne Giraldii Nitsche extract powder II;
s4, decocting radix angelicae pubescentis, fried astragalus membranaceus, angelica sinensis, divaricate saposhnikovia root, radix achyranthis bidentatae, acanthopanax and radix glycyrrhizae preparata in water, filtering and concentrating to obtain an extract III; or drying the extract III, and crushing into extract powder III;
s5, mixing the aconitum sinomontanum extract I, the girald daphne bark extract II and the extract III, and concentrating under reduced pressure to obtain an extract IV; or mixing radix Aconiti Sinomontani extract powder I, cortex Daphne Giraldii Nitsche extract powder II and extract powder III uniformly to obtain extract powder IV;
s5, mixing the extract IV or the extract powder IV serving as an active ingredient with pharmaceutically acceptable auxiliary materials, and preparing a corresponding oral preparation according to a conventional preparation method.
In some embodiments of the present invention, in S2, percolating with 50% to 100% ethanol; preferably, soaking the aconitum sinomontanum nakai by 10-20 times of 60-95% ethanol for 24-48 hours, and collecting a soaking solution; percolating the soaked aconitum sinomontanum medicinal material with 1-2 times of 50-100% ethanol, combining soaking liquid and percolation, and concentrating to obtain an aconitum sinomontanum extract I;
or/and in the S3, adding 5-7 times of 50-70% ethanol into the girald daphne bark, performing reflux extraction for 1-3 times, each time for 2-4 hours, filtering, recovering ethanol from filtrate until no alcohol smell exists, and performing reduced pressure concentration to obtain a girald daphne bark extract II;
or/and in the S4, adding 2-8 times of water into the radix angelicae pubescentis, the fried astragalus mongholicus, the angelica sinensis, the divaricate saposhnikovia root, the radix achyranthis bidentatae, the acanthopanax senticosus and the honey-fried licorice root, decocting for 1-4 times, 0.5-3.0 hours each time, filtering, combining decoction liquids, and concentrating under reduced pressure at 65-75 ℃ to obtain an extract III with the relative density of 1.2-1.3.
The composition disclosed by the invention is applied to preparation of a medicine for treating chronic gastritis.
Pharmaceutically acceptable adjuvants as referred to herein refer to diluents, adjuvants, excipients or vehicles that are co-administered with the therapeutic agent and which are, within the scope of sound medical judgment, suitable for contact with the tissues of humans and/or other animals without excessive toxicity, irritation, allergic response or other problem or complication commensurate with a reasonable benefit/risk ratio.
The Aconitum sinomontanum Nakai is a dried rhizome of Aconitum sinomontanum Nakai of the Aconitum genus of the ranunculaceae family, has the functions of relieving swelling and pain, promoting blood circulation to remove blood stasis and dispelling wind, and is mainly used for treating fracture, rheumatic lumbocrural pain, sore and furuncle, syphilis, palpitation, stomachache and traumatic injury. The total alkaloids are effective components of radix Aconiti Sinomontani, wherein Lappaconitine is one of analgesic effective components extracted from radix Aconiti Sinomontani, and can be used as non-addictive analgesic clinically, with strong analgesic effect, and anti-inflammatory and repercussive effects.
The Daphne giraldii Nitsche in the invention is the stem bark and root bark of Daphne giraldii Nitsche, Daphne tandutina Maxim, and Daphne retusa Hemsl of Daphne retusa of Thymelaeaceae. Has the effects of dispelling pathogenic wind, dredging collaterals, removing blood stasis and relieving pain. It is commonly used for arthralgia due to wind-dampness, numbness of limbs, headache, stomach ache, lumbago and traumatic injury. Written in the national Chinese herbal medicine assembly: expelling wind, dredging collaterals, removing blood stasis and relieving pain. Mainly treats toothache, stomachache and liver diseases. "in Hubei Bingyao" (records of Chinese herbal medicine in Hubei): relaxing muscles and tendons, activating collateral flow, promoting blood circulation and relieving pain. Can be used for treating stomach ache, rheumatalgia, lumbago, traumatic injury, and fracture. In Shanxi Chinese medicine record: "Zhitong, dispel blood, enrich blood, have anesthetic action. Can be used for treating traumatic injury, general pain, headache, heart and stomach pain, lumbago, and skelalgia. It is also indicated for numbness of limbs. "
The pubescent Angelica root is the dried root of Angelica gigas Maxim.f. biservata Shan et Yuan of Umbelliferae plant. Du Huo is slightly warm in nature and pungent and bitter in flavor. Has effects of dispelling pathogenic wind, removing dampness, relieving arthralgia, and relieving pain. Animal experiments show that the alcohol extract has platelet aggregation resisting and antithrombotic effects, and the active ingredients are dihydrocarveol, dihydrocarveol acetate and the like. The water decoction or fluid extract has sedative, hypnotic, analgesic and antiinflammatory effects on rat. It also has blood pressure lowering and arrhythmia resisting effects; has effects in photosensitizing, relieving spasm, resisting tumor, resisting bacteria, promoting lipolysis, and exciting respiration. The pubescent angelica root contains bergapten which is a chemical substance with remarkable maintenance effect on gastritis.
The fried astragalus root is a processed product of astragalus root. The radix astragali is dried root of Astragalus membranaceus (Fisch.) Bge. of Leguminosae family or Astragalus membranaceus (Fisch.) Bge. of Hsiao. Radix astragali has effects in enhancing immunity, protecting liver, promoting urination, resisting aging, resisting stress, lowering blood pressure, and resisting bacteria. Stir-baked Huang Qi can tonify spleen and qi without stagnation, and can enhance the immunity of patients for abdominal distension, poor appetite and loose stool due to spleen deficiency. Modern researches show that astragalus contains saponin, sucrose, polysaccharide, various amino acids, folic acid, selenium, zinc, copper and other trace elements. Tests show that the astragalus extract has an inhibiting effect on gastric ulcer and can tonify spleen and stomach. The composition has obvious inhibition effect on the gastric mucosa injury of mice caused by 95% ethanol and the gastric mucosa injury caused by pylorus ligation of rats, can reduce the injury area and the injury index, but has no obvious influence on the gastric juice amount, gastric acidity and pepsin activity of rats.
Angelica sinensis is the dried root of Angelica sinensis (Oliv.) Diels of Umbelliferae, and is one of the most commonly used Chinese medicines. Has effects in nourishing blood, regulating menstruation, relieving pain, moistening dryness, smoothing intestine, resisting cancer, resisting aging, and enhancing immunity. Sweet, pungent and bitter in nature; and (4) temperature. It enters liver, heart and spleen meridians. Dang Gui is sweet and heavy in flavor, so it can tonify blood, and its qi is light and pungent, so it can also move blood, tonify middle energizer and tonify middle energizer, and is the essential herb in blood. Therefore, it can tonify blood, activate blood, dredge channels and activate collaterals.
Radix Saposhnikoviae is the dried root of Saposhnikovia divaricata (Turcz.) Schischk of Umbelliferae, also known as herba cistanches, herba Cistanchis, herba Moslae Cavaleriei, etc. Pungent and sweet in flavor, slightly warm in nature. It enters bladder, liver and spleen meridians. It can move liver qi and relieve liver qi stagnation. Preventing wind energy from raising the spleen and clearing yang. Li Gao said that Fang Feng is used to treat pain of the whole body, and it is also a humectant in wind-herbs. If tonifying the spleen and stomach, it can not be used. Modern pharmacological research proves that the divaricate saposhnikovia root contains volatile oil, picrin, mannitol and the like and has the effects of relieving pain, resisting bacteria and relieving fever. Prevent wind-evil and ease pain, can raise the pain threshold obviously, so it can obtain better curative effect when used for stomachache.
Achyranthis radix is dried root of Achyranthus bidentis Bl. belonging to Amaranthaceae. Mild in nature and taste, bitter and sour. It enters liver and kidney meridians. Achyranthes bidentata contains a large amount of alkaloids, and has the functions of tonifying liver and kidney, strengthening muscles and bones, dredging channels and collaterals and dissipating blood stasis. The radix achyranthis bidentatae has high drug effect, and the records of the Ming dynasty, Li Shizhen and Ben Cao gang mu are as follows: the nourishing effect is like the force of cattle. The achyranthes root, radix achyranthis bidentatae, with bitter and sour flavor, is mainly used for treating cold-dampness flaccidity arthralgia, limb spasm, gonalgia, difficulty in flexion and extension, blood and qi expelling, heat and fire erosion injury, weight reduction and aging resistance after long-term taking. It is good at tonifying liver and kidney, strengthening waist and knee joints, promoting blood circulation and inducing blood to flow downwards. Radix Achyranthis bidentatae is a meridian-inducing drug. It can induce blood to flow downward to lower the deficient fire of ascending inflammation, so it has the action of conducting heat and draining downward. Zhu Dan xi is indicated for all herbs descending and gout in tendons and bones. "Chinese herbs should be used to descend to the crux because many herbs do not go down over the knee. This is the unique action of achyranthes bidentata.
Acanthopanax senticosus is dried root, rhizome or stem of Acanthopanax senticosus (Rupr. et Maxim.) Harms belonging to Araliaceae. The property of the drug is sweet, slightly bitter and warm. It enters spleen, lung, heart and kidney meridians. Has effects of invigorating qi, invigorating spleen, invigorating kidney, and tranquilizing mind, and can be used for treating spleen and lung qi deficiency, kidney deficiency, soreness of waist and knees, heart and spleen deficiency, insomnia, and amnesia. Acanthopanax senticosus has a long history of being widely applied as a medicament in Chinese medicine and pharmacology, has the effects of tonifying middle-jiao and replenishing vital essence, strengthening muscles and bones and strengthening will, is light and durable after being taken for a long time, and can be eaten, invigorated and strengthened by strength and forgetfulness when being matched with other medicaments. Bai Pi has the function of making yin from yang and making yang from yin from Lei' er 25961from Liu Song of south North China. Compared with the systematic research on the ginseng and the acanthopanax which is a related plant in China, the acanthopanax and the ginseng are proved to have similar pharmacological action and clinical curative effect.
Radix Glycyrrhizae Preparata is processed product of radix Glycyrrhizae. The Glycyrrhrizae radix is dried root and rhizome of Glycyrrhiza uralensis Fisch, Glycyrrhiza inflata Bat, or Glycyrrhiza glabra L. The liquorice is also named as the old, sweet grass, Wula Er liquorice and the radix glycyrrhizae, and is a tonifying Chinese herbal medicine. The licorice root is the root and rhizome of perennial herb, and has wide action, sweet and mild property and flavor, and enters heart, lung, spleen and stomach meridians. In the compatibility of Chinese medicinal decoction and Chinese patent medicine, it is commonly indicated for tonifying qi and spleen, regulating the middle warmer and relieving urgency, and harmonizing the actions of all the herbs. The former is mainly to clear heat while the latter is mainly to tonify middle energizer. Stir-baked with honey is mainly indicated for hypofunction of spleen and stomach, loose stool, weakness, fever, cough, palpitation, etc. The licorice has the similar adrenocortical hormone-like effect, has the effect of inhibiting hyperacidity caused by histamine, has the effects of resisting acid and relieving gastrointestinal smooth muscle spasm, and can inhibit gastric ulcer caused by long-term gastric acid.
According to the formula, the aconitum sinomontanum nakai can relieve the pain of a patient caused by gastritis and reduce the pain of the patient. Experiments show that aconitum sinomontanum nakai has an inhibiting effect on organ injury. The girald daphne bark and the liquorice are used together, so that the medicine not only has a better effect on treating the pain in the heart and the stomach, but also can strengthen the anti-inflammatory and anti-inflammatory effects of the girald daphne bark and inhibit the influence caused by excessive gastric acid. Experiments show that the compatibility of daphne giraldii nitsche and liquorice has better anti-inflammatory and pain relieving effects. Du Huo is indicated for qi stagnation because it can soothe liver, raise yang, relieve qi stagnation and alleviate pain, and regulate liver-stomach disharmony. The stir-fried astragalus membranaceus has the effects of tonifying spleen and qi without stagnation, treating spleen deficiency and abdominal distension, poor appetite and loose stool, assisting in treatment and enhancing the immunocompetence of a patient. Prevent wind energy from raising the spleen and clearing yang, move liver qi and relieve liver depression, and tonify spleen and stomach. Radix Saposhnikoviae, in combination with radix astragali, is used to strengthen defensive qi in the recipe, so that radix Saposhnikoviae can eliminate pathogens without disturbing the exterior. Radix Saposhnikoviae, in combination with radix Angelicae Pubescentis, can dispel wind and dampness, ascend clear and stop diarrhea. Achyranthis radix has effects of regulating qi-flowing, dispelling cold, and dredging channels and collaterals. Radix Achyranthis bidentatae is used in combination with radix Angelicae sinensis to promote blood circulation, remove blood stasis, nourish liver blood, relieve liver depression, tonify deficiency cold and abdominal pain, and treat gastritis as adjuvant therapy. Radix Acanthopanacis Senticosi has effects of invigorating qi, invigorating spleen, invigorating kidney, tranquilizing, enhancing immunity, and improving gastric mucosa injury. The liquorice improves the anti-inflammatory effect of the girald daphne bark on one hand, and plays a role in harmonizing the medicines on the other hand. The liquorice processed by honey has the effects of warming the middle-jiao and strengthening the spleen, regulating the functions of the spleen and the stomach, improving the symptoms of gastritis, having good antacid effect and preventing gastric ulcer of a gastritis patient caused by overlong gastric acid cycle.
Clinically, most of chronic gastritis is caused by spleen and stomach internal injury due to long-term improper diet, the course of the chronic gastritis is many months or even tens of years, the fundamental pathogenesis of the chronic gastritis is marked by principal deficiency and excess, and the deficiency and excess are mixed with miscellaneous diseases. TCM summarizes the etiology and mechanism of the gastric diseases from the points of deficiency and excess through seven aspects. From the demonstration, the method is divided into five aspects. Cold evil attacks the stomach, cold qi belongs to one of six natural qi, and when the excessive cold qi is larger than the tolerance degree of a human body, cold evil can enter the body, and stomachache caused by cold evil is called as 'cold evil attacks the stomach'; the damp-heat in the body is excessive due to the heat-warm middle-warmer resistance caused by irregular diet and long-term environmental factors such as heavy moisture and the like, and the regulation of qi activity by the spleen and stomach is influenced, so that stomachache is caused; diet stagnation, which is recorded in Huangdi's Canon of medicine "the symptoms of gastritis caused by overeating and overeating are marked by the impairment of spleen and stomach; liver-qi attacking the stomach is the syndrome of liver loss, transverse flow affecting the stomach, stomach loss and descending, and is mostly the gastritis caused by emotional distress and qi stagnation transforming into fire; stagnant blood stopping stomach refers to stomach pain caused by chronic stomach diseases, failure of improving treatment after repeated administration, and chronic pain entering collaterals. From the viewpoint of deficiency, it is divided into two aspects. The deficiency of stomach yin and the function of spleen and stomach have different characteristics, the spleen belongs to yin earth, the stomach belongs to yang earth, and if the yin and yang decline occurs, the gastritis can be caused; the stomach belongs to yang earth, so that qi and blood are abundant, yin deficiency syndrome is easy to appear, and stomach pain can be caused by stomach malnutrition; the syndrome of deficient cold of spleen and stomach and exuberance of yin-cold is also called yang-deficiency cold syndrome of spleen, which is caused by stomach-ache due to spleen-qi deficiency.
In the formula, the Chinese medicinal composition combines the mechanism of treating chronic gastritis, takes aconitum sinomontanum, girald daphne bark and radix angelicae pubescentis as monarch drugs, mainly dispels cold evil to attack stomach, resists inflammation and relieves pain, relieves stagnation and relieves distension, strengthens spleen and appetizes, and inhibits regurgitation. The fried astragalus, the angelica and the divaricate saposhnikovia root are used as ministerial drugs, are mainly used for tonifying qi of spleen and stomach yin loss, are used as auxiliary monarch drugs, are used for dispersing blood stasis in stomach, and are used for replenishing blood and nourishing blood, so that the effects of dredging collaterals and relieving pain are achieved, and the immunity of patients with spleen deficiency and liver heat is enhanced. Achyranthes root and acanthopanax root are used as adjuvant drugs for soothing the liver and invigorating yang, and assisting the mediation of monarch drugs and ministerial drugs for regulating qi and regulating depression. The liquorice is a guiding drug, so that the effect of the girald daphne reaches the disease site on one hand, and the effects of the other hand are harmonized with the other hand, so that the effects of the other hand are combined to eliminate pathogenic factors. The medicine composition can be used for treating stomachache, gastric acid, gastrectasia and the like caused by chronic gastritis, regulating qi, regulating spleen and stomach, promoting blood circulation, removing blood stasis and obviously relieving gastritis of patients. The invention is obtained by long-term exploration and screening according to the traditional Chinese medicine compatibility theory and by referring to the research results of modern medicines. The modern medical and pharmacological research proves that the traditional Chinese medicine composition has an exact effect of treating the gastritis. The dosage of each component in the range has good curative effect and small toxic and side effect.
Compared with the prior art, the invention has the following beneficial effects:
the formula of the invention is reasonable, the design is scientific, the aconitum sinomontanum, the girald daphne bark and the radix angelicae pubescentis are monarch drugs, the invention has the effects of anti-inflammation, relieving fever and regulating qi-flowing for relieving epigastric distention; radix astragali, angelica and radix sileris are used as ministerial drugs for dispersing blood stasis in stomach, enriching and nourishing blood and dredging collaterals to relieve pain; radix cyathulae and acanthopanax are adjuvant drugs for soothing liver and invigorating yang; prepared licorice root, radix Glycyrrhizae Praeparata, as a guiding drug, is combined with Daphne giraldii Nitsche to treat stomach ache, and also to harmonize the other drugs, so as to combine the effects of the drugs to eliminate pathogenic factors.
Pharmacological experiments show that the composition has good anti-inflammatory and analgesic effects, can effectively treat gastric mucositis, and has low toxicity and safe medication.
The advantages of the medicines are complementary, the medicines are combined, the synergistic effect among the medicines is fully exerted, and the product can jointly act with various active ingredients, so that the aim of treating the chronic gastritis is fulfilled through various ways.
Detailed Description
The present invention will be described in further detail with reference to the following examples. It should not be understood that the scope of the above-described subject matter of the present invention is limited to the following examples.
Example 1
The embodiment discloses a preparation method of the composition, which specifically comprises the following steps:
(1) weighing 150g of aconitum sinomontanum nakai, cleaning, drying, crushing, soaking in 1500mL of 75% ethanol for 36 hours, and collecting soaking liquid; percolating the soaked Aconitum sinomontanum with 150ml of 80% ethanol, and collecting percolate; mixing the soaking solution and the percolate, recovering ethanol until no alcohol smell exists, concentrating under reduced pressure at 75 ℃ until the relative density of the aconitum sinomontanum nakai extract I is 1.2-1.3 (measured at 60 ℃), drying the aconitum sinomontanum nakai extract I under reduced pressure at 65 ℃, and crushing the obtained dry paste into fine powder to obtain aconitum sinomontanum nakai extract powder I for later use;
(2) weighing 150g of girald daphne bark, cleaning, drying, crushing, adding 65% ethanol, performing reflux extraction for 3 times, adding 900mL of 65% ethanol each time, performing reflux extraction for 3.5 hours each time, collecting and combining extracting solutions, recovering ethanol until no ethanol smell exists, performing reduced pressure concentration at 75 ℃ until a girald daphne bark extract II with the relative density of 1.2-1.3 (measured at 60 ℃), performing reduced pressure drying at 65 ℃ on the girald daphne bark extract II, and crushing the obtained dry extract into fine powder to obtain girald daphne bark extract powder II for later use;
(3) weighing 120g of radix angelicae pubescentis, 100g of fried astragalus membranaceus, 80g of angelica sinensis, 70g of radix sileris, 70g of radix achyranthis bidentatae, 50g of acanthopanax senticosus and 60g of honey-fried licorice root, cleaning, drying and crushing, then decocting with 3600mL of water for 3 hours for the first time, 2800mL of water for 2 hours for the second time, 1500mL of water for 1 hour for the third time, and combining decoction; concentrating under reduced pressure at 65-75 deg.C to obtain extract III with relative density of 1.2-1.3 (measured at 60 deg.C); drying the extract III at 65 deg.C under reduced pressure, and pulverizing the obtained dry extract into fine powder to obtain extract powder III;
(4) mixing radix Aconiti Sinomontani extract powder I, cortex Daphne Giraldii Nitsche extract powder II and extract powder III, mixing with starch 60g, granulating, drying, adding magnesium stearate 1g, mixing, and making into capsule. Specification: 0.4 g/pellet. The usage and dosage are as follows: 3 times a day, 3-5 grains at a time.
Experimental example 2
The embodiment discloses a preparation method of the composition, which specifically comprises the following steps:
(1) weighing 120g of aconitum sinomontanum nakai, cleaning, drying, crushing, soaking in 1300mL of 80% ethanol for 30 hours, and collecting soak solution; percolating the soaked aconitum sinomontanum medicinal material with 75% of 150mL ethanol, and collecting percolate; mixing the soaking solution and the percolate, recovering ethanol until no alcohol smell exists, concentrating under reduced pressure at 75 ℃ until an aconitum sinomontanum nakai extract I with the relative density of 1.2-1.3 (measured at 60 ℃), drying the aconitum sinomontanum nakai extract I under reduced pressure at 65 ℃, and crushing the obtained dry paste into fine powder to obtain aconitum sinomontanum nakai extract powder I for later use;
(2) weighing 120g of girald daphne bark, cleaning, drying, crushing, adding 65% ethanol, performing reflux extraction for 3 times, adding 700mL of 65% ethanol each time, performing reflux extraction for 3 hours each time, collecting and combining extracting solutions, recovering ethanol until no alcohol smell exists, performing reduced pressure concentration at 75 ℃ until a girald daphne bark extract II with the relative density of 1.2-1.3 (measured at 60 ℃), performing reduced pressure drying at 65 ℃ on the girald daphne bark extract II, and crushing the obtained dry extract into fine powder to obtain girald daphne bark extract powder II for later use;
(3) weighing 120g of radix angelicae pubescentis, 100g of fried astragalus membranaceus, 90g of angelica sinensis, 90g of radix sileris, 90g of radix achyranthis bidentatae, 60g of acanthopanax senticosus and 60g of honey-fried licorice root, cleaning, drying and crushing, then decocting for 3 hours by 4000mL of water for the first time, decocting for 2 hours by 3000mL of water for the second time, decocting for 1 hour by 1800mL of water for the third time, and combining the decoctions; concentrating under reduced pressure at 65-75 deg.C to obtain extract III with relative density of 1.2-1.3 (measured at 60 deg.C); drying the extract III at 65 deg.C under reduced pressure, and pulverizing the obtained dry extract into fine powder to obtain extract powder III;
(4) mixing the aconitum sinomontanum extract powder I, the girald daphne bark extract powder II and the extract powder III, mixing with 70g of starch and 14g of sodium carboxymethyl starch, granulating, drying at 65 ℃, adding 1g of magnesium stearate, and granulating and tabletting by using a 14-mesh sieve. Specification: piece weight: 0.4 g/tablet. The usage and dosage are as follows: 3 times a day, 3-5 tablets at a time.
Experimental example 3
The embodiment discloses a preparation method of the composition, which specifically comprises the following steps:
(1) weighing 140g of aconitum sinomontanum nakai, cleaning, drying, crushing, soaking in 1700mL of 65% ethanol for 40 hours, and collecting soaking liquid; percolating the soaked aconitum sinomontanum medicinal material with 75% of 150mL ethanol, and collecting percolate; mixing the soaking solution and the percolate, recovering ethanol until no alcohol smell exists, and concentrating under reduced pressure at 75 ℃ until an aconitum sinomontanum nakai extract I with the relative density of 1.2-1.3 (measured at 60 ℃) is obtained for later use;
(2) weighing 140g of girald daphne bark, cleaning, drying, crushing, adding 65% ethanol, performing reflux extraction for 3 times, adding 800mL of 65% ethanol each time, performing reflux extraction for 3 hours each time, collecting and combining extracting solutions, recovering ethanol until no alcohol smell exists, and performing reduced pressure concentration at 75 ℃ until a girald daphne bark extract II with the relative density of 1.2-1.3 (measured at 60 ℃) is obtained for later use;
(3) weighing 130g of radix angelicae pubescentis, 90g of fried astragalus membranaceus, 70g of angelica sinensis, 80g of radix sileris, 80g of radix achyranthis bidentatae, 50g of acanthopanax senticosus and 70g of honey-fried licorice root, cleaning, drying and crushing, decocting with 3800mL of water for 3 hours for the first time, 3000mL of water for 2 hours for the second time, 1500mL of water for 1 hour for the third time, and combining decoction; concentrating under reduced pressure at 65-75 deg.C to obtain extract III with relative density of 1.2-1.3 (measured at 60 deg.C);
(4) stirring and mixing Aconitum sinomontanum extract I, Daphne giraldii Nitsche extract II, extract III, soluble starch 80g, sucrose 120g, and dextrin 40g, adjusting humidity with 60% ethanol to obtain soft material, granulating, drying at 65 deg.C, grading, and packaging. Specification: 5g per bag. The usage and dosage are as follows: the preparation is administered 3 times a day, and 1 bag each time.
Experimental example 4
The embodiment discloses a preparation method of the composition, which specifically comprises the following steps:
(1) weighing 150g of aconitum sinomontanum nakai, cleaning, drying, crushing, soaking in 1650mL of 80% ethanol for 40 hours, and collecting soaking liquid; percolating the soaked aconitum sinomontanum medicinal material with 75% of 150mL ethanol, and collecting percolate; mixing the soaking solution and the percolate, recovering ethanol until no alcohol smell exists, and concentrating under reduced pressure at 75 ℃ until an aconitum sinomontanum nakai extract I with the relative density of 1.2-1.3 (measured at 60 ℃) is obtained for later use;
(2) weighing 130g of girald daphne bark, cleaning, drying, crushing, adding 65% ethanol, performing reflux extraction for 2 times, adding 750mL of 65% ethanol each time, performing reflux extraction for 3 hours each time, collecting and combining extracting solutions, recovering ethanol until no alcohol smell exists, and performing reduced pressure concentration at 75 ℃ until a girald daphne bark extract II with the relative density of 1.2-1.3 (measured at 60 ℃) is obtained for later use;
(3) weighing 140g of radix angelicae pubescentis, 80g of fried astragalus membranaceus, 80g of angelica sinensis, 90g of radix sileris, 60g of radix achyranthis bidentatae, 70g of acanthopanax senticosus and 50g of honey-fried licorice root, cleaning, drying and crushing, decocting with 3500mL of water for 2 hours for the first time, 2800mL of water for 1.5 hours for the second time, 1600mL of water for 1 hour for the third time, 1150mL of water for 0.5 hours for the fourth time, and combining decoction; concentrating under reduced pressure at 65-75 deg.C to obtain extract III with relative density of 1.2-1.3 (measured at 60 deg.C);
(4) mixing the aconitum sinomontanum extract I, the girald daphne bark extract II and the extract III, and concentrating under reduced pressure to obtain an extract IV with the specific gravity of 1.4-1.5 (measured at 60 ℃); mixing with starch 50g and sodium carboxymethyl starch 5g, drying at 65 deg.C, adding magnesium stearate 1.5g, sieving with 14 mesh sieve, and tabletting. Specification: piece weight: 0.4 g/tablet. The usage and dosage are as follows: 3 times a day, 3-5 tablets at a time.
EXAMPLE 5
The embodiment discloses a preparation method of the composition, which specifically comprises the following steps:
(1) weighing 100g of aconitum sinomontanum nakai, cleaning, drying, crushing, soaking in 2000mL of 95% ethanol for 24 hours, and collecting soaking liquid; percolating the soaked aconitum sinomontanum medicinal material with 150mL of 80% ethanol, and collecting percolate; mixing the soaking solution and the percolate, recovering ethanol until no alcohol smell exists, concentrating under reduced pressure at 75 ℃ until an aconitum sinomontanum nakai extract I with the relative density of 1.2-1.3 (measured at 60 ℃), drying the aconitum sinomontanum nakai extract I under reduced pressure at 65 ℃, and crushing the obtained dry paste into fine powder to obtain aconitum sinomontanum nakai extract powder I for later use;
(2) weighing 180g of girald daphne bark, cleaning, drying, crushing, adding 900mL of 70% ethanol, performing reflux extraction for 4 hours, collecting and combining extract, recovering ethanol until no alcohol smell exists, performing reduced pressure concentration at 75 ℃ until the relative density of the girald daphne bark extract II is 1.2-1.3 (measured at 60 ℃), performing reduced pressure drying at 65 ℃ on the girald daphne bark extract II, and crushing the obtained dry extract into fine powder to obtain girald daphne bark extract powder II for later use;
(3) weighing 150g of radix angelicae pubescentis, 50g of fried astragalus mongholicus, 100g of angelica sinensis, 80g of radix sileris, 80g of radix achyranthis bidentatae, 30g of acanthopanax senticosus and 80g of honey-fried licorice root, cleaning, drying and crushing, then decocting with 4600mL of water for 3 hours for the first time, 2800mL of water for 2 hours for the second time, and 1200mL of water for 0.5 hours for the third time, combining decoction liquids, and concentrating under reduced pressure at 65-75 ℃ to obtain extract III with the relative density of 1.2-1.3 (measured at 60 ℃); drying the extract III at 65 deg.C under reduced pressure, and pulverizing the obtained dry extract into fine powder to obtain extract powder III;
(4) mixing radix Aconiti Sinomontani extract powder I, cortex Daphne Giraldii Nitsche extract powder II and extract powder III, mixing with starch 55g, granulating, drying, adding magnesium stearate 1g, mixing, and making into capsule. Specification: 0.4 g/pellet. The usage and dosage are as follows: 3 times a day, 3-5 grains at a time.
EXAMPLE 6
The embodiment discloses a preparation method of the composition, which specifically comprises the following steps:
(1) weighing 180g of aconitum sinomontanum nakai, cleaning, drying, crushing, soaking in 2700mL of 60% ethanol for 48 hours, and collecting soaking liquid; percolating the soaked Aconitum sinomontanum with 80% 210ml ethanol, and collecting percolate; mixing the soaking solution and the percolate, recovering ethanol until no alcohol smell exists, and concentrating under reduced pressure at 75 ℃ until an aconitum sinomontanum nakai extract I with the relative density of 1.2-1.3 (measured at 60 ℃) is obtained for later use;
(2) weighing 200g of girald daphne bark, cleaning, drying, crushing, adding 50% ethanol, performing reflux extraction for 2 times, adding 1200mL of 50% ethanol each time, performing reflux extraction for 2 hours each time, collecting and combining extracting solutions, recovering ethanol until no alcohol smell exists, and performing reduced pressure concentration at 75 ℃ until a girald daphne bark extract II with the relative density of 1.2-1.3 (measured at 60 ℃) is obtained for later use;
(3) weighing 100g of radix angelicae pubescentis, 120g of fried astragalus mongholicus, 50g of angelica sinensis, 100g of radix sileris, 50g of radix achyranthis bidentatae, 80g of acanthopanax senticosus and 60g of honey-fried licorice root, cleaning, drying and crushing, then decocting with 3600mL of water for 3 hours for the first time, decocting with 2800mL of water for 2 hours for the second time, and combining the decoctions; concentrating under reduced pressure at 65-75 deg.C to obtain extract III with relative density of 1.2-1.3 (measured at 60 deg.C);
(4) mixing the aconitum sinomontanum extract I, the girald daphne bark extract II and the extract III, and concentrating under reduced pressure to obtain an extract IV with the specific gravity of 1.4-1.5 (measured at 60 ℃); mixing with 45g of starch and 7g of sodium carboxymethyl starch, drying at 65 ℃, adding 1.3g of magnesium stearate, granulating with a 14-mesh sieve, and tabletting. Specification: piece weight: 0.4 g/tablet. The usage and dosage are as follows: 3 times a day, 3-5 tablets at a time.
EXAMPLE 7
The embodiment discloses a preparation method of the composition, which specifically comprises the following steps:
(1) weighing 200g of aconitum sinomontanum nakai, cleaning, drying, crushing, soaking in 2000mL of 75% ethanol for 36 hours, and collecting soaking liquid; percolating the soaked Aconitum sinomontanum with 80% 150ml ethanol, and collecting percolate; mixing the soaking solution and the percolate, recovering ethanol until no alcohol smell exists, and concentrating under reduced pressure at 75 ℃ until an aconitum sinomontanum nakai extract I with the relative density of 1.2-1.3 (measured at 60 ℃) is obtained for later use;
(2) weighing 100g of girald daphne bark, cleaning, drying, crushing, adding 65% ethanol, refluxing and extracting for 3 times, adding 700mL of 65% ethanol each time, 3.5 hours each time, collecting and combining extracting solutions, recovering ethanol until no alcohol smell exists, and concentrating under reduced pressure at 75 ℃ until the girald daphne bark extract II with the relative density of 1.2-1.3 (measured at 60 ℃) is obtained for later use; (ii) a
(3) Weighing 110g of radix angelicae pubescentis, 150g of fried astragalus membranaceus, 90g of angelica sinensis, 50g of radix sileris, 100g of radix achyranthis bidentatae, 40g of acanthopanax senticosus and 40g of honey-fried licorice root, cleaning, drying and crushing, then decocting with 3600mL of water for 3 hours for the first time, 2800mL of water for 2 hours for the second time, 1500mL of water for 1 hour for the third time, and combining the decoctions; concentrating under reduced pressure at 65-75 deg.C to obtain extract III with relative density of 1.2-1.3 (measured at 60 deg.C);
(4) stirring and mixing the aconitum sinomontanum extract I, the daphne giraldii extract II, the extract III, 78g of soluble starch, 117g of cane sugar and 39g of dextrin, adjusting the humidity with 60% ethanol to prepare soft materials, granulating, drying at 65 ℃, grading and subpackaging. Specification: 5g per bag. The usage and dosage are as follows: the preparation is administered 3 times a day, and 1 bag each time.
The main pharmacodynamic experiments and results performed on the present invention are as follows:
1. writhing analgesia experiment:
the tested drugs are: taking the content of the capsule prepared by the method of example 1, adding fresh distilled water to dilute the content to prepare suspension with the concentration of 5 wt%;
control drugs: physiological saline;
experimental animals: 24 Kunming mice with the weight of 20 +/-2 g;
the mice are numbered 1-24 at room temperature and 20 ℃, and are randomly divided into 12 groups of 2 mice each. The drug is administrated by gastric lavage, the single number is a control group, and the double number is an experimental group. The control group is injected with 0.1mL/10g of normal saline in the abdominal cavity, and the experimental group is injected with 0.1mL/10g of test drug in the abdominal cavity. . After 20min, all mice were injected intraperitoneally with 0.8% acetic acid 0.2mL/10 g. The number of writhing times and the time of the first writhing of the mice were observed and recorded within 15 min.
Table 2 mouse writhing situation recording table
Therefore, the traditional Chinese medicine composition has the obvious effect of inhibiting pain and has good analgesic effect.
2 anti-inflammatory assay:
2.1, test of the effect of paraxylene on mouse ear swelling:
the tested drugs are: taking the content of the capsule prepared by the method of example 1, adding fresh distilled water to dilute the content to prepare suspension with the concentration of 5 wt%;
positive control drug: indomethacin tablets (manufactured by kaifeng Yongkang pharmaceutical Co., Ltd.);
blank control drug: physiological saline;
an inflammation-causing agent: xylene, analytical reagent produced by the chemical reagent factory of Tongli district, Tianjin.
Experimental animals: a clean grade healthy adult Kunming male mouse with the weight of 20 +/-2 g;
dose selection and subject administration regimen: a blank control group, a positive control group, a sample low dose group and a sample high dose group are arranged, and each group comprises 10 animals.
The blank control group is perfused with the normal saline at a concentration of 0.2mL/10g, the positive control group is perfused with the indometacin at a concentration of 10mg/kg, and the sample low-dose group is perfused with the drug of the invention at a concentration of 0.80mL/10 g; the sample high dose group was gavaged with 1.3ml of the inventive drug. The stomach is drenched for three times every day and continuously drenched for three days.
Two hours after the completion of the third day of drug administration, 20. mu.L of xylene was evenly applied to both sides of the left ear and not to the right ear of each mouse as a control. The time for xylene application was recorded, and after 40 minutes the mice were sacrificed, both ears were cut along the base of the auricle, circular ears were punched out of the same portions of the left and right ears, respectively, using a punch with a diameter of 9mm, and weighed. And calculating the weight difference of the left ear and the right ear of the same mouse as swelling degree, comparing the swelling degree of each group of ears, performing statistical significance test, and calculating the swelling inhibition rate.
TABLE 3 mouse ear swelling degree recording table
| Group of | n | Dosage form | Degree of ear swelling (mg) | Inhibition rate |
| Blank control group | 10 | 0.2mL/10g | 5.55±2.51 | － |
| Control group of yang sample | 10 | 10mg/kg | 3.38±1.62* | 32.4％ |
| Sample Low dose group | 10 | 0.80mmol/kg | 3.26±1.57* | 58.40％ |
| Sample high dose group | 10 | 1.3mmol/kg | 2.78±1.35** | 78.25％ |
Statistical significance tests showed that positive control group (. SP <0.05), low dose group (. SP <0.05) and high dose group (. SP <0.01) had significant inhibition of xylene-induced swelling of mouse pinna compared to the blank control group. Therefore, the traditional Chinese medicine composition has better anti-inflammatory effect.
2.2, effect experiment of mouse cotton ball granuloma:
the tested drugs are: taking the content of the capsule prepared by the method of example 1, adding fresh distilled water to dilute the content to prepare suspension with the concentration of 5 wt%;
positive control drug: the ibuprofen raw material drug is provided by Hubeixin Galaxy chemical Co., Ltd;
blank control drug: physiological saline;
ampicillin: produced by Huaxing pharmaceutical factory in New county of Henan.
Experimental animals: a clean grade healthy adult Kunming male mouse with the weight of 20 +/-2 g;
dose selection and subject administration regimen: a blank control group, a positive control group, a sample low dose group and a sample high dose group are arranged, and each group comprises 10 animals.
Mice were fasted for 5h at room temperature 20 ℃ before the experiment. Under aseptic condition, a small opening is opened on the chest of the mouse, two sterilized cotton balls (each cotton ball is 10mg in weight, is autoclaved and is added with a small amount of ampicillin) are respectively implanted into the underarm subcutaneous parts on the two sides of the mouse, and then the chest is sutured. The intragastric administration is started on the same day of the experiment, wherein the blank control group is intragastric saline of 0.2mL/10g, the positive control group is intragastric ibuprofen of 130mg/kg, and the sample low-dose group is intragastric drug of the invention of 0.80mL/10 g; the sample high dose group was gavaged with 1.3ml/10g of the drug of the present invention. The gavage is carried out once a day and continuously for one week. And on the eighth day, dislocating the cervical vertebra of the mouse to death, taking out the cotton balls, placing the cotton balls in an oven at 65 ℃ for 12 hours, weighing, subtracting the weight of the original cotton balls, and converting the weight into the weight of granulation per 100g according to the weight to obtain the granuloma net weight.
TABLE 4 mouse granuloma condition record sheet
| Group of | n | Dosage form | Granuloma cleaner (mg/100g) |
| Blank control group | 10 | 0.2mL/10g | 157.88±41.69 |
| Positive control group | 10 | 130mg/kg | 103.47±38.13 |
| Sample Low dose group | 10 | 0.80mL/10g | 123.36±45.82* |
| Sample high dose group | 10 | 1.3mL/10g | 112.55±41.66** |
From the results, the sample high dose group had a significant inhibitory effect on the formation of granuloma in the mouse tampon (. about.p <0.01), and the sample low dose group had a significant difference in comparison with the blank control group (. about.p < 0.05). Therefore, the traditional Chinese medicine composition has a good anti-inflammatory effect.
3. Toxicology experiments:
3.1, animal acute toxicology experiment:
the contents of the capsule prepared as in example 1 were diluted with distilled water at room temperature of 20 ℃ to prepare a suspension having a concentration of 5 wt%. 20 mice of 20 +/-2 g are selected, and the mice are half female and half male for gastric lavage experiment. The preparation is administered once in the morning and afternoon, with a dose of 0.5ml/10g, and is administered continuously for 7 days. As a result, none of the mice died, the skin and hair of the mice were smooth, the activity was as usual, the excretion was normal, and no abnormal secretion was observed in the eyes.
The experiment was repeated several times and no LD50 value was measured. According to the requirements in the research guidelines of toxicology of new traditional Chinese medicines, the maximum tolerance of the capsule for intragastric administration of mice in one day is 280 times of the daily dosage of clinical adults, so the administration dosage range of the capsule is safe and reliable.
3.2, animal long-term toxicology experiment:
the tested drugs are: taking the content of the capsule prepared by the method of example 1, adding fresh distilled water to dilute the content to prepare suspensions with the concentration of 5 wt% and 25 wt%;
blank control drug: physiological saline;
experimental animals: healthy SD rats with half male and female bodies and weight of 200-240 g;
dose selection and subject administration regimen: a blank control group, a sample low dose group and a sample high dose group were set, and each group had 20 animals.
The rats are continuously gazed for 90 days by two dosage groups of high and low according to the dosage which is 10 times and 50 times of the clinical daily dosage of adults respectively. The blank control group was gavaged with physiological saline, wherein 3 ml/time of the test drug at a concentration of 5 wt% was given to the low dose group, and 3 ml/time of the test drug at a concentration of 25 wt% was given to the high dose group. The results show that the hemogram and various biochemical indexes of the serum of the rats in the sample low-dose group and the sample high-dose group are in a normal range, and have no obvious difference with a blank control group. The pathological anatomy examination shows that no obvious difference is found when the main organs are compared with a blank control group. No obvious pathological morphological change is observed in the histological observation of each organ, the hair color, diet, excretion and activity of the rat are normal after the test, and the dynamic observation of the body weight and the like show no obvious difference from the control group. The high dose group used in the experiment is as high as nearly 50 times of the clinical dosage of adults, no toxic or side effect is shown after 90 continuous days, and no abnormality is found in any index. It is therefore believed that the compositions of the present invention are safe and reliable for use within the prescribed dosage range.
4. Pharmacodynamic experiments:
the tested drugs are: taking the content of the capsule prepared by the method of example 1, adding fresh distilled water to dilute the content to prepare suspension with the concentration of 5 wt%;
blank control drug: physiological saline;
positive control drug: stomach nourishing granule, diluting with fresh distilled water to obtain 5 wt% suspension; produced by Zhengda youth medicine industry limited company;
experimental animals: healthy SD rats with half male and female bodies and weight of 200-240 g;
dose selection and subject administration regimen: a blank control group, a positive control group, a sample low dose group and a sample high dose group are arranged, and each group comprises 20 animals.
Molding: in the first month, 2mL of 60% ethanol is administered to each rat every 10 days, and 20mmol/L sodium deoxycholate solution is used as a beverage to drink at will and is prepared from distilled water. In the second and third months, 30% ethanol and 10mmmol/L deoxysodium cholate solution are respectively used as beverage, and the beverage is alternately drunk every seven days. After the molding is finished, one rat is randomly extracted for the pathological histology examination of the gastric mucosa, and whether the molding is successful is confirmed.
After the molding is successful, the samples are randomly divided into a blank control group, a positive control group, a sample low-dose group and a sample high-dose group. The administration is carried out twice a day, once in the morning and at night, and the administration is carried out continuously for one week. Wherein the dosage of the positive control group is 1ml/10g
The dosage of the sample low dose group was 3.16ml/10g
The dosage of the sample high-dose group is 10ml/10 g;
the blank control group was given an equal volume of saline.
After the gastric lavage drug therapy is finished, the patient is not forbidden to eat water for 24 hours. The animals were sacrificed by cervical dislocation, the whole stomach was harvested and the gastric cavity was dissected open along the greater curvature of the stomach. The gastric cavity was rinsed with 5mL of distilled water, the rinsing mixture was collected, the free acid was determined by titration, and the pepsin activity was determined by the Matt's method. The full thickness stomach wall was taken from anterior stomach to pylorus along the lesser curvature of the stomach, fixed with 10% formalin, sectioned by conventional paraffin embedding, HE stained, and examined with a light microscope. According to literature data, after observation, the degree of inflammation was graded for observation and the thickness of the mucosal muscle was measured.
TABLE 5 gastritis rats treated with gastritis titrates the change in acid, pepsin activity (x + -s)
As can be seen from the table, the difference between the gastric juice titrating acid and the pepsin activity group of the traditional Chinese medicine reagent group is obvious (P is less than 0.05) compared with the contrast group, which shows that the traditional Chinese medicine composition can obviously improve the pepsin activity, and the gastric juice titrating acid of the stomach nourishing granules is improved to some extent compared with the contrast group, but has no statistical significance (P is more than 0.05).
TABLE 6 inflammation changes (x + -s) of gastric mucosa after treatment of gastritis rats
From the analysis of the table, the inflammation degree of the traditional Chinese medicine composition dosage group at the junction of sinus, sinus body, forestomach and glandular stomach is statistically different (P is less than 0.05) compared with that of a control group, which shows that the traditional Chinese medicine composition has obvious anti-inflammatory effect.
TABLE 7 inflammation changes (x + -s) of gastric mucosa after treatment of gastritis rats
From the table, it can be seen that the statistical treatment (P <0.01) performed on the control group and the invention group has significant differences, which indicates that the traditional Chinese medicine composition has a better effect on the treatment of the gastric mucositis.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.
Claims (10)
1. The composition for treating chronic gastritis is characterized by being prepared from the following raw materials in parts by weight: 100-200 parts of aconitum sinomontanum, 100-200 parts of girald daphne bark, 100-150 parts of radix angelicae pubescentis, 50-150 parts of fried astragalus membranaceus, 50-100 parts of angelica sinensis, 50-100 parts of divaricate saposhnikovia root, 50-100 parts of radix achyranthis bidentatae, 30-80 parts of acanthopanax and 50-80 parts of honey-fried licorice root.
2. The composition according to claim 1, characterized by being prepared from the following raw materials in parts by weight: 120-180 parts of aconitum sinomontanum, 120-180 parts of girald daphne bark, 110-140 parts of radix angelicae pubescentis, 80-120 parts of fried astragalus membranaceus, 70-90 parts of angelica sinensis, 60-80 parts of divaricate saposhnikovia root, 60-80 parts of radix achyranthis bidentatae, 40-60 parts of acanthopanax senticosus and 50-70 parts of honey-fried licorice root.
3. The composition according to claim 2, characterized by being prepared from the following raw materials in parts by weight: 150 parts of aconitum sinomontanum, 150 parts of daphne giraldii nitsche, 120 parts of radix angelicae pubescentis, 100 parts of fried astragalus mongholicus, 80 parts of angelica sinensis, 70 parts of radix sileris, 70 parts of radix achyranthis bidentatae, 50 parts of acanthopanax senticosus and 60 parts of honey-fried licorice root.
4. The composition according to any one of claims 1 to 3, wherein the composition is a preparation prepared by using aconitum sinomontanum, daphne giraldii nitsche, radix angelicae pubescentis, fried astragalus mongholicus, angelica sinensis, radix sileris, radix achyranthis bidentatae, acanthopanax senticosus and radix glycyrrhizae preparata as raw material medicines and adding pharmaceutically acceptable auxiliary materials according to a conventional method.
5. The composition of claim 4, wherein the preparation is prepared from Aconitum sinomontanum nakai extract, Daphne giraldii Nitsche extract, and mixed extracts of radix Angelicae Pubescentis, radix astragali Preparata, radix Angelicae sinensis, radix Saposhnikoviae, radix Achyranthis bidentatae, radix Et caulis Acanthopanacis Senticosi, and radix Glycyrrhizae Preparata.
6. The composition as claimed in claim 5, wherein the Aconitum sinomontanum extract and the girald daphne bark extract are alcohol extracts, and the mixed extract is an aqueous extract.
7. The composition of claim 4, wherein the formulation is an oral formulation.
8. A process for the preparation of a composition according to any one of claims 1 to 7, characterized in that it comprises the following steps:
s1, preparing raw materials in parts by weight;
s2, percolating the aconitum sinomontanum nakai with ethanol, collecting percolate, and concentrating under reduced pressure to obtain an aconitum sinomontanum nakai extract I; or drying the aconitum sinomontanum nakai extract I, and crushing into aconitum sinomontanum nakai extract powder I;
s3, refluxing the girald daphne bark with ethanol, filtering, and concentrating the filtrate under reduced pressure to obtain a girald daphne bark extract II; or drying cortex Daphne Giraldii Nitsche extract II, and pulverizing into cortex Daphne Giraldii Nitsche extract powder II;
s4, decocting radix angelicae pubescentis, fried astragalus membranaceus, angelica sinensis, divaricate saposhnikovia root, radix achyranthis bidentatae, acanthopanax and radix glycyrrhizae preparata in water, filtering and concentrating to obtain an extract III; or drying the extract III, and crushing into extract powder III;
s5, mixing the aconitum sinomontanum extract I, the girald daphne bark extract II and the extract III, and concentrating under reduced pressure to obtain an extract IV; or mixing radix Aconiti Sinomontani extract powder I, cortex Daphne Giraldii Nitsche extract powder II and extract powder III uniformly to obtain extract powder IV;
s5, mixing the extract IV or the extract powder IV serving as an active ingredient with pharmaceutically acceptable auxiliary materials, and preparing a corresponding oral preparation according to a conventional preparation method.
9. The method according to claim 8, wherein in S2, the solution is percolated with 50% to 100% ethanol; preferably, soaking the aconitum sinomontanum nakai by 10-20 times of 60-95% ethanol for 24-48 hours, and collecting a soaking solution; percolating the soaked aconitum sinomontanum medicinal material with 1-2 times of 50-100% ethanol, combining soaking liquid and percolation, and concentrating to obtain an aconitum sinomontanum extract I;
or/and in the S3, adding 5-7 times of 50-70% ethanol into the girald daphne bark, performing reflux extraction for 1-3 times, each time for 2-4 hours, filtering, recovering ethanol from filtrate until no alcohol smell exists, and performing reduced pressure concentration to obtain a girald daphne bark extract II;
or/and in the S4, adding 2-8 times of water into the radix angelicae pubescentis, the fried astragalus mongholicus, the angelica sinensis, the divaricate saposhnikovia root, the radix achyranthis bidentatae, the acanthopanax senticosus and the honey-fried licorice root, decocting for 1-4 times, 0.5-3.0 hours each time, filtering, combining decoction liquids, and concentrating under reduced pressure at 65-75 ℃ to obtain an extract III with the relative density of 1.2-1.3.
10. Use of a composition according to any one of claims 1 to 7 for the manufacture of a medicament for the treatment of chronic gastritis.
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