CN114984160A

CN114984160A - Mongolian medicine for treating alcoholic liver disease

Info

Publication number: CN114984160A
Application number: CN202210630805.9A
Authority: CN
Inventors: 陈桂花; 周慧斌
Original assignee: Individual
Current assignee: Individual
Priority date: 2022-06-06
Filing date: 2022-06-06
Publication date: 2022-09-02
Anticipated expiration: 2042-06-06
Also published as: CN114984160B

Abstract

The invention discloses a Mongolian medicine for treating alcoholic liver diseases, which comprises the following components: stigma croci, calculus bovis, fel Ursi powder, cornu Saigae Tataricae, Carthami flos, Saviae Miltiorrhizae radix, fructus Chebulae, radix Puerariae, fructus Schisandrae chinensis, lignum Pterocarpi Indici, radix Ranunculi Ternati, herba Silybi Mariani, semen Nelumbinis, fructus Toosendan, semen Cassiae, folium Ginkgo, radix aucklandiae, radix Ophiopogonis, fructus Gardeniae, fructus Amomi rotundus, and Ginseng radix. The Mongolian medicine adopts Mongolian medicine 'clearing liver heat, aiding digestion, detoxifying and reinforcing kidney' to treat alcoholic liver disease, can effectively improve liver function and improve life quality of patients; can reduce or prevent the alcoholic hepatitis from developing into alcoholic cirrhosis; the Mongolian medicine has the advantages of low price, easy popularization, no toxic or side effect after long-term use, good treatment effect and low recurrence rate; solves the problems of extremely deficient and drug-free selection of the current alcoholic hepatitis drug therapy, and provides a new drug selection for clinic.

Description

Mongolian medicine for treating alcoholic liver disease

The technical field is as follows:

the invention relates to the field of pharmaceutical compositions, in particular to a Mongolian medicine for treating alcoholic liver diseases.

Background art:

along with the development of socioeconomic, the number of drinkers is increasing, and alcohol abuse, alcohol dependence and alcoholism become common public health problems in all countries of the world. Liver is the main part of alcohol metabolism and the main target organ of alcohol toxicity, the clinical incidence of Alcoholic Liver Disease (ALD) caused by long-term drinking is increased year by year, and it becomes another major cause of liver injury following viral hepatitis. The clinical diagnosis of alcoholic liver disease can be divided into the following types according to liver function, imaging and histopathological examination results: mild alcoholic liver disease, alcoholic fatty liver, alcoholic hepatitis, alcoholic hepatic fibrosis and alcoholic cirrhosis.

The common treatment methods in modern medicine mainly include alcohol withdrawal, nutrition support, medication, liver transplantation and the like. However, the curative effect is still lack, and the curative medicine which can be recommended for ALD is very deficient, especially the alcoholic hepatitis drug therapy is extremely deficient, the situation that no medicine can be selected is existed, the overall curative effect is not ideal, the toxic and side effects are large, the cost is high, and the liver and kidney injury can be caused by long-term use.

The invention content is as follows:

the invention aims to provide a Mongolian medicine for treating alcoholic liver diseases, which has the advantages of definite curative effect, low cost and no side effect after long-term administration.

The invention is implemented by the following technical scheme: a Mongolian medicine for treating alcoholic liver diseases comprises the following components in parts by weight: 0.1-0.5 part of saffron, 0.5-1 part of bezoar, 0.1-0.5 part of bear gall powder, 1-2 parts of antelope horn, 3-4 parts of safflower, 3-4 parts of salvia miltiorrhiza, 3-4 parts of myrobalan, 3-4 parts of kudzu root, 3-4 parts of schisandra chinensis, 2-4 parts of sandalwood, 2-3 parts of ternate buttercup root, 2-3 parts of silybum marianum, 2-3 parts of semen nelumbinis, 2-3 parts of szechwan chinaberry fruit, 1-2 parts of cassia occidentalis, 1-2 parts of ginkgo leaf, 1-2 parts of costus root, 1-2 parts of dwarf lilyturf root, 1-2 parts of cape jasmine, 1-2 parts of round cardamon seed and 1-2 parts of ginseng.

Preferably, the Mongolian medicine for treating alcoholic liver diseases is characterized by comprising the following components in parts by weight: 0.36 part of saffron, 0.72 part of bezoar, 0.45 part of bear gall powder, 1.2 parts of antelope horn, 3.6 parts of safflower, 3.6 parts of salvia miltiorrhiza, 3.6 parts of myrobalan, 3.6 parts of kudzuvine root, 3.6 parts of Chinese magnoliavine fruit, 2.4 parts of sandalwood, 2.4 parts of ternate buttercup root, 2.4 parts of silybum marianum, 2.4 parts of lotus seed, 2.4 parts of szechwan chinaberry fruit, 1.8 parts of cassia occidentalis, 1.8 parts of ginkgo leaf, 1.8 parts of costus root, 1.8 parts of dwarf lilyturf tuber, 1.8 parts of cape jasmine, 1.8 parts of cardamon seed and 1.8 parts of ginseng.

Further, the Mongolian medicine for treating alcoholic liver diseases is any one of powder, water-paste pills, honeyed pills, capsules or granules.

The Mongolian medicine takes saffron, safflower, bezoar, bear gall powder and antelope horn as main medicines, and the saffron and the safflower have sweet, slightly bitter, cold, blunt, soft, moderate, heavy and solid tastes, and have the effects of pulse locking, liver heat clearing, nourishing, body building and pain relieving; calculus bovis is slightly bitter and sweet, and has effects of clearing heat, removing toxic substance, and tranquilizing; bear gall powder is bitter in taste, cool, dull, coarse and mobile in nature, and has the effects of locking pulse, stopping bleeding, clearing away xila, improving eyesight, preventing corrosion, promoting vitality and stopping diarrhea; ling Yang jiao is salty in taste and neutral in nature, and has the actions of drying out pus, breaking blood and relieving diarrhea.

The red sage root, the myrobalan, the kudzuvine root and the Chinese magnoliavine fruit are taken as adjuvant drugs, and the red sage root is bitter in taste, light, dull and strong in property and has the effects of clearing blood heat, drying and bleeding and stopping bleeding; the myrobalan is astringent in taste, mild, sharp and dry in nature, and has the effects of removing pathological changes, detoxifying and harmonizing voxels; the kudzu root is sweet and pungent in taste and cool in nature, and has the effects of relieving muscles and reducing fever, and promoting the production of body fluid to quench thirst; the schisandra chinensis is sweet and sour, neutral in nature, dry, light, firm and coarse, and has the effects of stopping vomiting, stopping diarrhea and stimulating appetite.

The sandalwood is astringent, salty, cool and blunt in nature, and has the effects of clearing blood heat, calming qi and blood, relieving swelling and the like; the radix ranunculi ternati is sweet and pungent in flavor, warm and mild in nature and has the effect of detoxifying; silybum marianum is bitter in taste and cool in nature, and has the effects of clearing heat, promoting diuresis, soothing liver and benefiting gallbladder; the Jian Lian Zi is pungent, astringent and warm in nature, and has the effects of tonifying the kidney, dispelling stomach and kidney cold, stopping diarrhea and drying yellow water; fructus Toosendan is astringent and bitter, and has effects of dispelling bara and dry Hiragana, improving eyesight, and relieving pain.

The guiding drug is semen Cassiae, folium Ginkgo, radix aucklandiae, radix Ophiopogonis, fructus Gardeniae, fructus Amomi rotundus, Ginseng radix, semen Cassiae is bitter and astringent in stomach, cool, coarse, dry, and sharp, and has effects of drying yellow water and nourishing; folium Ginkgo is sweet, bitter and astringent, and has effects of promoting blood circulation for removing blood stasis, dredging collaterals, relieving pain, eliminating turbid pathogen and reducing blood lipid; the costus root is pungent and bitter in taste, warm, greasy, coarse and light in nature, and has the effects of removing the damp and dry heat, calming qi and blood, breaking the distension and fullness, regulating the body weight, preventing corrosion and relieving pain; the dwarf lilyturf tuber is bitter in taste and cool in nature, and has the effects of dispelling Shela, detoxifying, clearing heat and reducing swelling; fructus Gardeniae is bitter, cool, dull and coarse, and has effects of clearing blood heat, improving eyesight, removing dryness, nourishing and harmonizing voxel; fructus Amomi rotundus is pungent and bitter, warm, greasy, sharp, light and dry, and has effects of dispelling kidney cold, relieving Heryi, promoting stomach fire, resolving food stagnation, promoting appetite and relieving vomit; ginseng is sweet and slightly bitter in taste, warm in nature, and has nourishing and tranquilizing effects.

The formula takes saffron, safflower, bezoar, bear gall powder and antelope horn as main medicines, and has the effects of clearing liver heat, detoxifying, protecting liver and improving eyesight; the auxiliary materials comprise salvia miltiorrhiza, myrobalan, radix puerariae and schisandra chinensis, and have the effects of clearing blood heat, removing aversion to blood, regulating voxel, stopping vomiting and diarrhea and stimulating appetite; the Chinese medicinal composition is supplemented with lignum Pterocarpi Indici, radix Ranunculi Ternati, herba Silybi Mariani, semen Nelumbinis, and fructus Toosendan, and has effects of clearing blood heat, removing toxic substances, calming qi and blood, clearing heat, promoting diuresis, dispersing stagnated liver qi, promoting bile flow, and dispelling stomach and kidney cold; the guiding drugs are cassia occidentalis, ginkgo leaf, costus root, dwarf lilyturf tuber, gardenia, round cardamon seed and ginseng, the dry yellow water has the effects of nourishing, activating blood circulation to dissipate blood stasis, dredging collaterals to relieve pain, removing the damp-heat, helping stomach fire, promoting digestion, stimulating appetite and preventing vomiting.

The invention has the advantages that: the Mongolian medicine adopts Mongolian medicine 'clearing liver heat, aiding digestion, detoxifying and reinforcing kidney' to treat alcoholic liver disease, can effectively improve liver function and improve life quality of patients; can reduce or prevent the alcoholic hepatitis from developing into alcoholic cirrhosis; the Mongolian medicine has the advantages of low price, easy popularization, no toxic or side effect after long-term use and good treatment effect; solves the problems of extremely deficient and drug-free selection of the current alcoholic hepatitis drug therapy, and provides a new drug selection for clinic.

The specific implementation mode is as follows:

the technical solutions of the present invention will be described clearly and completely with reference to the following embodiments of the present invention, and it should be understood that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example 1: a Mongolian medicine for treating alcoholic liver diseases is prepared by weighing the following raw material medicines in parts by weight: 0.72kg of saffron, 1.44kg of bezoar, 0.9kg of bear gall powder, 2.4kg of antelope horn, 7.2kg of safflower, 7.2kg of salvia miltiorrhiza, 7.2kg of myrobalan, 7.2kg of kudzuvine root, 7.2kg of Chinese magnoliavine fruit, 4.8kg of sandalwood, 4.8kg of ternate buttercup root, 4.8kg of silybum marianum, 4.8kg of semen nelumbinis, 4.8kg of szechwan chinaberry fruit, 3.6kg of cassia occidentalis, 3.6kg of ginkgo leaf, 3.6kg of costus root, 3.6kg of dwarf lilyturf tuber, 3.6kg of gardenia, 3.6kg of round cardamon seed and 3.6kg of ginseng. Processing the weighed raw materials into watered pills with the specification of 200 mg/pill by entrusting the international Mongolian medicine preparation center of the internal Mongolian international Mongolian medical hospital.

Example 2: a Mongolian medicine for treating alcoholic liver diseases is prepared by weighing the following raw material medicines in parts by weight: 0.7kg of saffron, 1.4kg of bezoar, 0.8kg of bear gall powder, 3kg of antelope horn, 6kg of safflower, 6kg of salvia miltiorrhiza, 6kg of myrobalan, 6kg of kudzuvine root, 6kg of Chinese magnoliavine fruit, 7kg of santalum album, 5.6kg of ternate buttercup root, 5.6kg of silybum marianum, 5.6kg of lotus seed, 5.6kg of szechwan Chinaberry fruit, 2kg of cassia occidentalis, 2kg of ginkgo leaf, 2kg of costus root, 2kg of dwarf lilyturf tuber, 2kg of cape jasmine, 2kg of cardamon seed and 2kg of ginseng. Processing the weighed raw materials into watered pills with the specification of 200 mg/pill by entrusting the international Mongolian medicine preparation center of the internal Mongolian international Mongolian medical hospital.

The Mongolian medicine prepared in examples 1 and 2 can also be prepared into powder, honeyed pills, capsules or granules by adopting the conventional method.

Clinical research on treatment of alcoholic hepatitis by Mongolian medicine (Gurigoumu liver-clearing pill) for treating alcoholic liver disease

The research mainly aims to discuss the effectiveness and safety of the Mongolian medicine Gurigumu liver-clearing pill on the alcoholic hepatitis patients by observing the clinical curative effect of the Mongolian medicine Gurigumu liver-clearing pill on the alcoholic hepatitis patients, and provide scientific basis for future clinical application of the Mongolian medicine Gurigumu liver-clearing pill. The study protocol was a randomized, controlled clinical study. 138 subjects were from the department of outpatient service and living quarters in the institute of health of taimen, township, west philosophy, n.g., the inner mongolian Xingan Jiangan union.

2.1 methods of investigation

2.1.1 name and Specification of test drugs

Observation group one drug: the Mongolian medicine Gurigumu liver-clearing pill prepared according to the formula of the embodiment 1 of the invention has the following dosage forms: watered pill (200 mg/pill) is provided by International Mongolian medicine preparation center of International Mongolian Hospital of inner Mongolia.

Observation group two-purpose medicine: the Mongolian medicine Gurigumu liver-clearing pill prepared according to the formula of the embodiment 2 of the invention has the following dosage forms: watered pill (200 mg/pill) is provided by International Mongolian medicine preparation center of International Mongolian Hospital of inner Mongolia.

The drug administration of the control group is as follows: the liver protection tablet has the following dosage forms: tablets, (0.35 g/tablet) were provided by Heilongjiang sunflower pharmacy Ltd (national Standard Z20003336).

2.1.2 random dispensing

The experimental study has the specific operations that: and in the experimental research process, the patients meeting the grouping standard are sequentially assigned with the drug numbers according to the qualified screening sequence, the drug administrator or researcher dispenses the drugs according to the drug numbers, and the rest drugs are handed over to the researcher or drug administrator.

2.1.3 application method and treatment course

Observation group one: orally taking 15 pills at a time, 2 times a day, and taking warm boiled water after breakfast and supper, wherein each treatment course is 6 weeks, and 3 treatment courses are performed;

and (4) observation group II: orally taking 15 pills at a time, 2 times a day, and taking warm boiled water after breakfast and supper, wherein each treatment course is 6 weeks, and 3 treatment courses are performed;

control group: the liver-protecting tablet is taken 4 tablets at a time, 2 times a day, and is taken with warm boiled water after breakfast and supper, each treatment course is 6 weeks, and 3 treatment courses are performed;

2.1.4 Observation index

2.1.4.1 liver fibrosis index: the indices of liver function, blood lipid and hepatic fibrosis including serum Hyaluronic Acid (HA), Laminin (LN), type III Procollagen (PCIV) and type IV Collagen (CIV) are examined after and after morning fasting blood sampling.

2.1.4.2B ultrasonic: before and after treatment, B-ultrasonography was performed once and was classified into normal (-), mild (+), moderate (+ +), and severe (+ +++).

2.1.5 therapeutic Standard

Refer to the national administration of traditional Chinese medicine 2002 "clinical research guidelines (trial) for new Chinese medicine" and the relevant literature data:

and (3) curing: clinical symptoms completely disappear, liver echo basically returns to normal in B ultrasonic examination, liver function returns to normal, serum Total Cholesterol (TC) is reduced by more than 20%, and Triglyceride (TG) is reduced by more than 40%; the effect is shown: clinical symptoms basically or completely disappear, the echo state of liver is graded and reduced by grade 1 in B ultrasonic examination, the liver function is recovered to be normal, the Total Cholesterol (TC) in serum is reduced by more than 10-20 percent, and the Triglyceride (TG) is reduced by more than 20-40 percent; the method has the following advantages: clinical symptoms are obviously improved, the echo state of liver is graded and reduced by 1 grade or improved by B ultrasonic examination, the liver function is basically normal, and (or) the serum Total Cholesterol (TC) is reduced by 10-20 percent, and the Triglyceride (TG) is reduced by 20-40 percent; and (4) invalidation: the clinical symptoms and various examination results do not meet the standards.

2.1.6 statistical treatment

Statistical analysis is carried out by SPSS 18.0 statistical software, t test is adopted for comparing the liver function curative effect data of the group, and X is used for comparing B ultrasonic and total curative effect data ² Inspection of P<0.05, which shows that the difference is significant and has statistical significance.

2.2 results

2.2.1 clinical Total curative effects of Mongolian medicine dialectical treatment on alcoholic hepatitis

After 3 treatment courses, 40 cases are cured in 46 cases, 4 cases are obviously effective, 1 case is ineffective and the total effective rate is 97.83%; 38 cases are cured in the observation group II 46, 2 cases are obviously effective, 4 cases are effective, 2 cases are ineffective, and the total effective rate is 95.65%; in the control group, 46 cases are cured for 10 cases, 8 cases are obviously effective, 15 cases are effective, 13 cases are ineffective, and the total effective rate is 71.74% (P is less than 0.01). The Mongolian medicine is prompted to remarkably improve the clinical curative effect when the Mongolian medicine is used for dialectically treating the alcoholic hepatitis (see table 1).

TABLE 1 comparison of the three groups

Comparing the observed group I with the control group, wherein P is less than 0.01; comparing the observation group II with the control group, wherein P is less than 0.01; % observed group one compared to observed group two, P < 0.05.

2.2.2 effects of Mongolian dialectical treatment on alcoholic liver disease and fibrosis

After 3 treatment courses, each group can improve alcoholic hepatitis and hepatic fibrosis, but the improvement effect of the observation group I and the observation group II is obviously better than that of the control group, and the difference compared with the control group has statistical significance (P is less than 0.01); and the improvement effect of the observation group I is better than that of the observation group II, and the difference has statistical significance (P is less than 0.05). Prompting that the Mongolian medicine dialectical treatment of alcoholic hepatitis can obviously improve hepatic fibrosis of patients with alcoholic hepatitis (see table 2), wherein data before and after treatment of a control group in the table 2 are mean values of examination results of the patients with the control group; the data before and after the treatment of the observation group I are mean values of the examination results of the patient of the observation group I; the data before and after the treatment in the observation group II are the mean values of the examination results of the patients in the observation group II.

TABLE 2 Effect of three groups on hepatic fibrosis

Comparison before and after treatment: p < 0.05, P < 0.01, P < 0.001; comparison of observation group one with control group: ^※ p is less than 0.01; observation group two was compared with the control group: # P < 0.01; comparison of observation group one with observation group two: the% P < 0.05.

2.2.3 Effect of Mongolian medicine dialectical treatment on the curative effect of alcoholic hepatitis B ultrasonic

After 3 treatment courses, each group can improve the imaging index of alcoholic hepatitis, but the improvement effect of the observation group I and the observation group II is obviously better than that of the control group, and the difference compared with the control group has statistical significance (P is less than 0.01); and the improvement effect of the observation group I is better than that of the observation group II, and the difference has statistical significance (P is less than 0.05). The Mongolian medicine is prompted to carry out dialectical treatment, so that the change of the liver imaging of the alcoholic hepatitis patient can be obviously improved (see table 3).

TABLE 3 Effect of the three groups on the curative effect of liver B-ultrasonic

Comparison before and after treatment: p < 0.05, P < 0.01, P < 0.001; comparison of observation group one with control group: ^※ p is less than 0.01; observation group two was compared with the control group: # P < 0.01; comparison of observation group one with observation group two: % P < 0.05

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, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims

1. The mongolian medicine for treating the alcoholic liver disease is characterized by comprising the following components in parts by weight: 0.1-0.5 part of saffron, 0.5-1 part of bezoar, 0.1-0.5 part of bear gall powder, 1-2 parts of antelope horn, 3-4 parts of safflower, 3-4 parts of salvia miltiorrhiza, 3-4 parts of myrobalan, 3-4 parts of kudzu root, 3-4 parts of Chinese magnoliavine fruit, 2-4 parts of sandalwood, 2-3 parts of ternate buttercup root, 2-3 parts of silybum marianum, 2-3 parts of medicinal lotus seed, 2-3 parts of szechwan chinaberry fruit, 1-2 parts of cassia occidentalis, 1-2 parts of ginkgo leaf, 1-2 parts of costus root, 1-2 parts of dwarf lilyturf root, 1-2 parts of cape jasmine, 1-2 parts of round cardamon seed and 1-2 parts of ginseng.

2. The Mongolian medicine for treating alcoholic liver diseases as claimed in claim 1, which is characterized by comprising the following components in parts by weight: 0.36 part of saffron, 0.72 part of bezoar, 0.45 part of bear gall powder, 1.2 parts of antelope horn, 3.6 parts of safflower, 3.6 parts of salvia miltiorrhiza, 3.6 parts of myrobalan, 3.6 parts of kudzuvine root, 3.6 parts of Chinese magnoliavine fruit, 2.4 parts of sandalwood, 2.4 parts of ternate buttercup root, 2.4 parts of silybum marianum, 2.4 parts of lotus seed, 2.4 parts of szechwan chinaberry fruit, 1.8 parts of cassia occidentalis, 1.8 parts of ginkgo leaf, 1.8 parts of costus root, 1.8 parts of dwarf lilyturf tuber, 1.8 parts of cape jasmine, 1.8 parts of cardamon seed and 1.8 parts of ginseng.

3. The Mongolian medicine for treating alcoholic liver diseases according to claim 1 or 2, which is any one of powder, watered pill, honeyed pill, capsule or granule.