DE102022102077A1 - Drug used to treat fatty liver - Google Patents

Abstract

The invention discloses a composition of traditional Chinese medicine for treating fatty liver, which is composed of turmeric, hawthorn, dandelion, fried gardenia, rhubarb, rhizoma pinelliae, and licorice by weight ratio. The invention has a heat-dissolving effect, moisturizing and promotes qi and blood circulation, and is mainly used for the treatment of fatty liver.

Description

TECHNICAL FIELD

The invention relates to a medicament for the treatment of fatty liver. The drug is a composition of traditional Chinese medicine, and belongs to the field of pharmacy.

BACKGROUND

)) usw. eingesetzt. Obwohl es viele der oben erwähnten Medikamente gibt, müssen die meisten von ihnen noch weiter auf ihre Wirksamkeit und Sicherheit überprüft werden.To date, there are no effective medications in western medicine to prevent or treat fatty liver. Traditional Chinese medicine can be recommended by experienced Chinese medicine practitioners. In general, fatty liver can be cured in this way within one to three months, with the B-ultrasound forming the basis for testing the effect. Western drugs to protect liver cells, fat-depleting drugs and antioxidants such as vitamins B, C, E, lecithin, ursodeoxycholic acid, silymarin, inosine, coenzyme A, reduced glutathione, taurine, carnitinorotate, gluconolactone and certain lipid-lowering drugs (e.g. Wholehiqing (

)) etc. used. While there are many of the drugs mentioned above, most of them still need further validation for their effectiveness and safety.

Traditional Chinese medicine believes that fatty liver is mainly caused by overeating, obesity, excessive alcohol consumption, epidemic poisonous feeling of hot and humid epidemic poison, emotional disturbances, chronic diseases and physical weakness, as well as the accumulation of food, stagnation of qi and epidemic qi is caused. The disease, the lesion of which is in the liver, is closely related to the liver, gallbladder, spleen, stomach, kidney and other internal organs. Many scholars believe that the pathogenesis of the disease is liver failure, spleen failure, internal accumulation of Damp-Heat and phlegm opacity and stagnation, congestion, and finally the formation of dampness, phlegm and congestion, causing the liver to become blocked and become fatty liver forms. In addition to the pathological products of phlegm, dampness and congestion, some believe that fatty liver is related to lack of qi and blood in the body, liver dysregulation and loss of kidney essence and non-woody water. Traditional Chinese medicine treats fatty liver primarily by eliminating phlegm and dampness, promoting blood circulation and congestion, calming the liver and relieving depression, strengthening the spleen, and eliminating dampness. Depending on the condition, it may also be supplemented with heat elimination, detoxification, choleretics, congestion, strengthening the kidneys, and nourishing the liver.

After years of research and practice, the inventor improved the original fatty liver treatment drug based on the theory of traditional Chinese medicine and developed a new fatty liver treatment drug.

SUMMARY

The purpose of the present invention is to provide a medicament for treating fatty liver, which is a composition of traditional Chinese medicine.

Another object of the present invention is to provide a process for preparing the above-mentioned medicament for treating fatty liver. The process uses raw traditional Chinese medicines as raw material and is carried out with modern pharmaceutical technology.

Another object of the present invention is to provide the method of using the above drug in the treatment of fatty liver.

According to the theory of traditional Chinese medicine, the medicine of the present invention provides treatments according to the syndrome differentiation and has achieved good therapeutic effects.

In summary, although the prior art discloses Western medicines for treating fatty liver, there has been no report documenting the specific raw material ratio of the medicine of the present invention, and no one has disclosed the clinical therapeutic effect of the medicine obtained by selecting the raw material ratio of the of the present invention.

DETAILED DESCRIPTION

) als Hauptarzneimittel und wird mit rohen Arzneimitteln wie gebratener Gardenie (

), Weißdorn (

), Kurkuma (

), Rhabarber (

), Löwenzahn (

), Süßholz (

) und dergleichen zubereitet. Das Zusammensetzungsverhältnis der rohen Medizin aus den Rohstoffen ist wie folgt, bezogen auf das Gewicht: 20-60 Teile Kurkuma, 20-60 Teile Weißdorn, 6-26 Teile Löwenzahn, 60-100 Teile gebratene Gardenie, 4-44 Teile Rhabarber, 20-60 Teile Süßholz und 44-84 Teile Rhizoma pinelliae; vorzugsweise 40 Teile Kurkuma, 40 Teile Weißdorn, 16 Teile Löwenzahn, 80 Teile gebratene Gardenie, 24 Teile Rhabarber, 40 Teile Süßholz und 64 Teile Rhizoma pinelliae.The present invention uses Rhizoma pinelliae (

) as the main medicinal and is mixed with raw medicinals such as roasted gardenia (

), hawthorn (

), turmeric (

), rhubarb (

), Dandelion (

), licorice (

) and the like prepared. The composition ratio of the raw medicine from the raw materials is as follows by weight: 20-60 parts turmeric, 20-60 parts hawthorn, 6-26 parts dandelion, 60-100 parts fried gardenia, 4-44 parts rhubarb, 20- 60 parts licorice and 44-84 parts Rhizoma pinelliae; preferably 40 parts turmeric, 40 parts hawthorn, 16 parts dandelion, 80 parts roasted gardenia, 24 parts rhubarb, 40 parts liquorice and 64 parts Rhizoma pinelliae.

According to the purpose of the present invention, the present invention also provides a method for preparing the drug for treating fatty liver, which comprises the steps of mixing raw drugs in proportion to make a clear ointment and granulating.

In a specific embodiment, the preparation process of the above drug includes adding each raw drug to water and decoction, preferably three times, combining the decoction, filtering, concentrating the filtrate to obtain a clear ointment, mixing with other medicinal excipients and mixing thoroughly to produce an oral preparation.

More specifically, the manufacturing process of the drug is as follows: decoction of each raw medicine in water three times: the first time for 3 hours, and the second time and the third time for 2 hours each, combining and filtering the decoction, concentrating the filtrate into one clear ointment with each gram for 3g of raw medicines and a specific gravity of 1.20, with a reasonable number of medicinal excipients mixed, granulated and dried.

Another object of the present invention is to provide the method of using the above drug in the treatment of fatty liver.

The fatty liver of the present invention includes obese fatty liver, alcoholic fatty liver, malnutrition-induced fatty liver, diabetic fatty liver, gestational fatty liver, drug-induced fatty liver and other disease-induced fatty liver.

After many years of clinical medical practice, it has been found that when the raw medicines of the present invention are selected to form a medicinal product, unexpected therapeutic effects are produced and the side effects of the medicines are minimized, especially when the weight of each raw material is 40 parts turmeric, 40 parts hawthorn, 16 parts dandelion, 80 parts roasted gardenia, 24 parts rhubarb, 40 parts licorice and 64 parts Rhizoma pinelliae.

Example

Example 1: Granules

Weigh 40 g turmeric, 40 g hawthorn, 16 g dandelion, 80 g fried gardenia, 24 g rhubarb, 40 g licorice and 64 g Rhizoma pinelliae. They are boiled in water three times for 3, 2 and 2 hours each. The decoction is combined and filtered. The filtrate is concentrated to a clear ointment, each gram representing 3 g of crude drug and having a specific gravity of 1.20. The clear ointment is mixed with white powdered sugar and cyclodextrin in a ratio of 2:1:1. The mixture is stirred uniformly, granulated by the spray granulation method, dried, graded and divided into packs to produce the granules.

Example 2: Tablets

The dried powder prepared according to the method of the example above is compressed according to the usual method to prepare the tablets.

Example 3: capsules

The granules prepared by the above process are packed in gelatin capsules to prepare the capsules.

Experiment 1: Quality Standard Study (granules)

[Features] This product is light yellow granules.

Fried Gardenia: Taking 10 g of this material, adding 15 ml of water to dissolve it, extracting with ethyl acetate three times, 15 ml each time, combining the ethyl acetate solution and concentrating it to 2 ml, as a test solution. Separately, 1 g of fried gardenia reference drug is taken, 15 ml of water is added for ultrasonic extraction for 30 minutes, filtered, and the filtrate is extracted three times with ethyl acetate, 15 ml each time. The ethyl acetate solution is combined and concentrated to 2 ml as a reference drug solution. For the thin-layer chromatography test, 10 µl of each of the two solutions mentioned above are taken and applied to the same silica gel G thin-layer plate. Using ethyl acetate-chloroform-formic acid (6:4:2) as a developing agent, developed, taken out and dried, sprayed with 5% vanillin-sulfuric acid test solution and heated at 105°C for about 5 minutes. In the chromatogram of the test product, spots of the same color appear at the corresponding position of the chromatogram of the control drug.

Licorice: Taking 10 g of this material, adding 15 ml of water to dissolve it, extracting twice with petroleum ether, 1 ml each time, combining the ethyl acetate solution and concentrating it to 2 ml, like the test solution. Separately, 0.5 g of licorice is taken as a medicinal reference material, 1 ml of water is added for ultrasonic extraction for 30 min, filtered, and the filtrate is filtered with petroleum ether twice, 1 ml each time, combining the ethyl acetate solution, and to 2 ml concentrated, as a reference drug solution. According to the thin layer chromatography test, 5 µl of each of the above two solutions are taken and applied to the same silica gel G thin layer plate. Chloroform-methanol-water (6:4:2) is used as the developing agent, developed, taken out and dried, sprayed with 5% vanillin-sulfuric acid test solution and heated at 105°C for about 5 minutes. In the chromatogram of the test product, spots of the same color appear at the corresponding position of the chromatogram of the control drug.

Experiment 2: Acute Toxicity Experiment (granules)

Experimental Method: Take 30 Kunming mice, half male and half female, and rear 5 mice per cage. The ambient temperature is 18±2°C and the relative humidity is 70±5%. Granules are fed to the rats and drunk freely. According to the results of the preliminary test, after 16 hours of fasting (without water), the test drug is administered by nasogastric tube, namely 1.2g/20g body weight each time, once every 6 hours, twice in a row, the total dose is 60g/kg. After administration, eating and drinking are free. The responses of the animals should be closely observed and recorded on the day of administration and once daily in the morning and afternoon for 7 consecutive days thereafter.

Experimental results: No toxic reactions observed for 7 days after administration.

Conclusion: The maximum tolerated dose of this granule for Kunming mice is 60 g/kg. This corresponds to 100 times the human consumption.

Experiment 3: Observation of treatment of fatty liver (granules)

From 2003 to 2007, 200 patients with fatty liver and hyperlipidemia were treated with the above granules. The effect was significant. The mechanism is related to the fact that the recipe promotes qi, aids blood circulation, eliminates heat and promotes dampness. With these granules and some tools as a basic prescription, 100 cases of patients with fatty liver diagnosed by B-ultrasound were treated, 90 cases were alleviated, and 10 cases were ineffective. The efficacy rate in patients with hyperlipidemia and atherosclerosis was 91.3% and 85.2%, respectively. Of the remission cases, 85 cases were followed up for one to two years. Only 5 cases of fatty liver experienced a slow remission, while the others improved markedly. Of the 60 patients with hyperlipidemia, 50 had a 16% drop in total cholesterol and a 30% drop in triglycerides after taking the drug for a year.

The above granules have a significant therapeutic effect on fatty liver and have no obvious effects on the normal functions of the heart, brain, liver, kidney and blood. There is some improvement trend in electrocardiogram and cerebral blood flow diagram. As a new drug for reducing fatty liver and blood lipid levels, it therefore has certain clinical advantages.

Claims (5)

Medicament for the treatment of fatty liver, characterized in that it is prepared by extracting active ingredients from the following raw materials in parts by weight: 20-60 parts turmeric, 20-60 parts hawthorn, 6-26 parts dandelion, 60-100 parts burnt gardenia, 4 -44 parts rhubarb, 20-60 parts licorice and 44-84 parts Rhizoma pinelliae. Medication for the treatment of fatty liver after claim 1 , characterized in that it is prepared by extracting active ingredients from the following raw materials in parts by weight: 40 parts turmeric, 40 parts hawthorn, 16 parts dandelion, 80 parts burnt gardenia, 24 parts rhubarb, 40 parts licorice and 64 parts Rhizoma pinelliae. Process for the manufacture of the medicament for the treatment of fatty liver according to any one of Claims 1 until 2 , which involves mixing raw materials in proportion to produce a clear ointment and granulating. procedure after claim 3 , which involves adding each raw drug to water and decoction, combining the decoction, filtering, concentrating the filtrate to obtain a clear ointment, mixing with other medicinal excipients, and mixing well to produce an oral preparation. procedure after claim 4 , whereby the raw medicines are boiled three times with water.