CN111643636A - Traditional Chinese medicine granules for treating liver disease enterogenic endotoxemia and preparation method thereof - Google Patents

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine granule for treating intestinal endotoxemia of liver disease and a preparation method thereof. The traditional Chinese medicine granules are made from the following raw materials in parts by weight: 15-30 parts of Yin Chen, 10-20 parts of Scutellaria baicalensis, 15-30 parts of red peony, 6-12 parts of comfrey, 15-30 parts of goldenseal, 8 parts of turmeric ‑15 servings, 5‑15 servings of rhubarb. The traditional Chinese medicine granules of the present invention have reasonable and precise compatibility, conform to the principle of "the ruler, ministers and assistants" and the pathogenesis of intestinal endotoxemia of liver disease.

Description

A kind of traditional Chinese medicine granule for treating liver disease intestinal-derived endotoxemia and preparation method thereof

technical field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine granule for treating intestinal endotoxemia of liver disease and a preparation method thereof.

Background technique

Endotoxin is the outer layer component of the cell wall of gram-negative bacteria, and its main chemical substance and the component that has a toxic effect on the human body is lipopolysaccharide (LPS). In patients with acute, chronic and severe hepatitis, liver cirrhosis, etc., due to the weakening of gastrointestinal barrier function and/or the damage of the liver mononuclear macrophage system, especially the liver Kupffer cells, the intestinal flora microecological imbalance is often combined. Intestinal endotoxemia (IETM), data show that 35%-65% of viral hepatitis patients are accompanied by IETM, 70%-100% of severe hepatitis patients, and 79% of patients with liver cirrhosis. %-92%, endotoxin can cause direct damage to the liver, and can also activate Kupffer cells to release a variety of cytokines, such as tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1), interleukin- 6 (IL-6), transforming growth factor-β1 (TGF-β1), platelet activating factor (PAF) and other cytokines and inflammatory mediators, causing secondary damage to the liver, causing mitochondrial dysfunction in liver cells, Cell energy metabolism disorder and oxygen free radical damage promote the aggravation and chronicity of liver disease, eventually leading to liver failure. Therefore, seeking the best methods and means to intervene or block liver damage caused by endotoxin, effectively control/relieve liver damage, and prevent its further deterioration is an important topic in the research on the prevention and treatment of liver diseases by traditional Chinese and Western medicine.

At present, there is a lack of effective drugs for endotoxemia in clinical practice. Clinical treatment of endotoxin generally adopts comprehensive measures, mainly including liver protection treatment, use of antibiotics for intestinal decontamination, and microecological preparations to correct intestinal flora. Disorders, gastrointestinal motility drugs to improve intestinal content stasis, enteral nutrition and other treatments to protect intestinal mucosa, immunotherapy, etc., but the clinical effect is not satisfactory.

Although there is no synonymous name for endotoxemia in traditional Chinese medicine, it is generally believed that there is a certain correlation between the "poison" of traditional Chinese medicine and the "endotoxin" of modern medicine. One of the foundations is that endotoxemia of liver disease is equivalent to the category of "heat-toxin syndrome" in traditional Chinese medicine. The mutual accumulation of heat toxin and blood stasis and stagnation in the intestines are its basic pathogenesis. Therefore, the treatment method of "clearing heat and detoxifying, removing blood stasis and dredging the fu-organs" is theoretically It can help to clear the "heat poison".

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a traditional Chinese medicine granule for treating liver disease intestinal endotoxemia and a preparation method thereof, which can effectively reduce the level of endotoxin and reduce the release of inflammatory factors such as TNF-a, IL-1, and IL-6. , Improve the clinical symptoms of patients, reduce bilirubin, reduce liver damage, and effectively prevent further damage to various organs of the body.

To achieve the above object, the present invention adopts the following technical solutions:

A traditional Chinese medicine granule for treating liver disease intestinal-derived endotoxemia is prepared from the following raw materials:

15-30 parts of Yin Chen, 10-20 parts of skullcap, 15-30 parts of red peony, 6-12 parts of comfrey, 15-30 parts of money grass, 8-15 parts of turmeric, 5-15 parts of rhubarb.

Further, the preparation method of described Chinese medicine granule, comprises the steps:

S1, take by weight 15-30 parts of Yin Chen, 10-20 parts of Scutellaria baicalensis, 15-30 parts of red peony, 6-12 parts of comfrey, 15-30 parts of money grass, 8-15 parts of turmeric, 5 parts of rhubarb -15 copies, each API is cleaned and dried;

S2, the dried raw materials are superfinely pulverized, passed through a 200-mesh sieve, and the obtained medicinal powder is mixed and stirred to obtain a mixed traditional Chinese medicine composition;

S3, the Chinese medicine composition is boiled with water, and the concentrated filtrate obtains the extract;

S4. Mix the extract with sucrose and dextrin in a mass ratio of 1:3:1, stir evenly to make soft materials, granulate and dry to obtain finished Chinese medicine granules.

Pharmacological effects of various raw materials of traditional Chinese medicine granules of the present invention:

Yin Chen: Bitter, acrid in taste, slightly cold in nature, returns to the spleen, stomach, liver and gallbladder meridians, has the effect of clearing away dampness and heat, promoting gallbladder and relieving jaundice. It is used for jaundice, oliguria, dampness, heat and dampness, and itching of eczema.

Scutellaria baicalensis: bitter, cold. Return lung, gallbladder, spleen, stomach, large intestine, small intestine meridian. Clearing away heat and dampness, purging fire and detoxifying, hemostasis, anti-abortion, lowering blood pressure. It is used for damp-heat, heat-warming, chest tightness and nausea, damp-heat fullness, dysentery, jaundice, cough due to lung heat, high fever and polydipsia, blood heat and vomiting, carbuncle, swollen sore and uneasy fetal movement.

Comfrey: sweet, salty, cold, returning to the heart and liver meridians. Cooling blood, promoting blood circulation, detoxification and rash. It is used for blood heat toxin, rash purple-black, measles opaque, sores, eczema, water and fire scalds. Warm rash, damp-heat jaundice, purpura, vomiting, epistaxis, hematuria, stranguria, heat constipation, burns, eczema, erysipelas, carbuncle ulcers.

Red peony: bitter in taste, slightly cold in nature. Return to the liver meridian. It has the effect of clearing heat and cooling blood, dissipating blood stasis and relieving pain. It is used for warm people to nourish blood, warm toxin to form spots, vomiting blood and epistaxis, red eyes and swelling and pain, liver depression and hypochondrium pain, amenorrhea dysmenorrhea, abdominal pain due to addiction, fall injury, carbuncle, swollen and sore. After frying, the medicinal properties tend to ease, promote blood circulation and relieve pain without injury, and can be used for stasis pain. Wine red peony is better for promoting blood circulation and dissipating blood stasis, but it has a weak effect of clearing heat and cooling blood. Mostly used for amenorrhea or dysmenorrhea, bruises.

Money grass: sweet, salty, slightly cold. Returns liver, gallbladder, kidney, bladder meridian. Dampness and yellowing, diuresis and stranguria, detoxification and swelling. It is used for damp-heat jaundice, gallbladder distention and hypochondral pain, stone stranguria, hot stranguria, astringent urination, carbuncle swollen boils, and snake and insect bites.

Turmeric: hard, bitter, cold. Returns the liver, heart and lung meridians. Activating blood and relieving pain, promoting Qi and relieving depression, clearing heart and cooling blood, promoting gallbladder and relieving jaundice. It is used for tingling pain in the chest and flank, chest pain and heartache, amenorrhea, dysmenorrhea, breast tenderness, fever, dizziness, epilepsy, epilepsy, vomiting and epistaxis, jaundice and red urine.

Rhubarb: Nature and taste: bitter, cold. Return to the spleen, stomach, large intestine, liver, pericardium meridian. Efficacy: attack accumulated stagnation; clear damp-heat; purify fire; cool blood; remove blood stasis; detoxify Indications: constipation due to excess heat;

In the formula of the present invention, Yinchen reduces bitterness and cold, and Gongzhuo clears dampness and heat toxins, so it is the monarch medicine; Scutellaria baicalensis clears heat and detoxifies, and Lithospermum detoxifies and cools blood, and helps Yinchen detoxify and remove jaundice; the two together are the minister medicine; Gallbladder, dehumidification and yellowing; Turmeric activates Qi and activates blood, cools blood and dissipates blood stasis; Chishao clears heat, cools blood and removes stasis, helps Turmeric to remove dampness and remove jaundice. Turmeric works on the two channels of liver and gallbladder. power. It is supplemented with rhubarb to relieve heat and remove blood stasis, and to clear the stool;

Positive beneficial effects of the present invention:

1. The traditional Chinese medicine granules of the present invention are reasonable and precise in compatibility, conform to the principle of "jun, minister and assistant", and conform to the pathogenesis of intestinal endotoxemia of liver disease.

2. The traditional Chinese medicine granules for treating liver disease and intestinal endotoxemia of the present invention have remarkable therapeutic effect, and the total effective rate is as high as 76.3%.

Detailed ways

The present invention will be described in detail below in conjunction with specific embodiments, but should not be construed as a limitation of the present invention. Unless otherwise specified, the technical means used in the following examples are conventional means well known to those skilled in the art, and the materials, reagents, etc. used in the following examples can be obtained from commercial sources unless otherwise specified.

Example 1

A traditional Chinese medicine granule for treating liver disease intestinal-derived endotoxemia is prepared from the following raw materials:

15 parts of Yin Chen, 10 parts of skullcap, 15 parts of red peony, 6 parts of comfrey, 15 parts of money grass, 8 parts of turmeric, and 5 parts of rhubarb.

The preparation method of above-mentioned Chinese medicine granule comprises the steps:

S1, take by weight 15-30 parts of Yin Chen, 10-20 parts of Scutellaria baicalensis, 15-30 parts of red peony, 6-12 parts of comfrey, 15-30 parts of money grass, 8-15 parts of turmeric, 5 parts of rhubarb -15 copies, each API is cleaned and dried;

S2, the dried raw materials are superfinely pulverized, passed through a 200-mesh sieve, and the obtained medicinal powder is mixed and stirred to obtain a mixed traditional Chinese medicine composition;

S3, the Chinese medicine composition is boiled with water, and the concentrated filtrate obtains the extract;

S4. Mix the extract with sucrose and dextrin in a mass ratio of 1:3:1, stir evenly to make soft materials, granulate and dry to obtain finished Chinese medicine granules.

Example 2

A traditional Chinese medicine granule for treating liver disease intestinal-derived endotoxemia is prepared from the following raw materials:

20 parts of Yin Chen, 15 parts of skullcap, 25 parts of red peony, 10 parts of comfrey, 20 parts of money grass, 12 parts of turmeric, and 9 parts of rhubarb.

The preparation method of the traditional Chinese medicine granules described in this example is the same as that in Example 1.

Example 3

A traditional Chinese medicine granule for treating liver disease intestinal-derived endotoxemia is prepared from the following raw materials:

30 parts of Yin Chen, 20 parts of skullcap, 30 parts of red peony, 12 parts of comfrey, 30 parts of money grass, 15 parts of turmeric, 15 parts of rhubarb.

The preparation method of the traditional Chinese medicine granules described in this example is the same as that in Example 1.

Example 4

A traditional Chinese medicine granule for treating liver disease intestinal-derived endotoxemia is prepared from the following raw materials:

30 parts of Yin Chen, 15 parts of skullcap, 30 parts of red peony, 12 parts of comfrey, 30 parts of money grass, 15 parts of turmeric, 10 parts of rhubarb.

The preparation method of the traditional Chinese medicine granules described in this example is the same as that in Example 1.

Clinical Trials

1. Diagnostic criteria

All patients were diagnosed in accordance with the western medicine diagnostic criteria for subacute or acute-on-chronic liver failure in the 2012 edition of the liver failure diagnosis and treatment guidelines, and 20%≤PTA≤40%, no upper gastrointestinal bleeding and hepatic encephalopathy stage II or above, and no TCM syndrome differentiation. Those with obvious signs of cold-dampness and yang deficiency (refer to TCM internal medicine jaundice syndrome differentiation and classification), and those with diabetes, endocrine diseases, tumors, rheumatic immune system diseases, serious heart, brain, kidney and other system diseases and mental disorders are excluded. , Those who have recently taken Chinese and Western medicine immune preparations, pregnant and lactating women, and those who are allergic to drugs.

2. Clinical data

The subjects were randomly divided into the experimental group and the control group, with 34 cases in each group. The experimental group included 23 male patients and 8 female patients with an average age of (46.5±8.7) years; the control group included 21 male patients and 8 female patients with an average age of (45.8±6.8) years. There was no significant difference in general data between the two groups (P>0.05), which was comparable.

3. Treatment plan

After admission, both groups of patients were given routine western medicine comprehensive treatment, including general treatment, treatment for etiology and pathogenesis, treatment of complications, and simple plasma exchange (one trip for 3 days, 3-4 times for each patient). The experimental group added the Chinese medicine granules of the present invention on the basis of the above, 2 times a day, one packet each time, 5 g per packet, and blistered. The course of treatment is 30 days.

4. Statistical processing

Statistical analysis was performed using SPSS 19.0 statistical software. Measurement data were expressed as mean±standard deviation (±s). The measurement data conforming to the normal distribution was tested by t test, the categorical and ordered data in the enumeration data was by the rank sum test, and the categorically disordered data was by the χ2 test. P<0.05 was statistically significant.

5. Results

1) Comparison of liver function indexes: after treatment, the levels of TBIL and DBIL in the two groups were decreased compared with those before treatment, and the experimental group was significantly lower than the control group, and the difference was statistically significant (P<0.05). The ALB values were slightly higher than those in the control group, but the difference was not statistically significant (P>0.05). The serum ALT, AST, ALP, and GGT levels of the two groups of patients after treatment were significantly lower than those before treatment, and the experimental group was lower than the control group. , but the difference was not statistically significant (P>0.05). See Table 1.

Table 1 Comparison of liver function indexes before and after treatment between the experimental group and the control group

Note: Compared with before treatment, ☆P<0.05; compared with experimental group, △P<0.05.

2) Comparison of PTA and ET indexes: After treatment, the PTA of both groups increased, and the PTA value of the experimental group was significantly higher than that of the control group, and the difference was statistically significant (P<0.05). See Table 2.

Table 2 Comparison of PTA and ET indexes between the experimental group and the control group before and after treatment

Note: Compared with before treatment, ☆P<0.05; compared with experimental group, △P<0.05.

4) Comparison of clinical efficacy: the total effective rates of the experimental group and the control group were 76.3% and 61.6%, respectively. The rank sum test of the therapeutic effects of the two groups showed that the clinical efficacy difference between the experimental group and the control group was statistically significant (P <0.05), the experimental group was better than the control group. See Table 3.

Table 3 Comparison of clinical efficacy before and after treatment between the experimental group and the control group [case (%)]

Typical cases

1. Li Moumou, male, a factory worker, 39 years old. In July 2016, he was admitted to the hospital with the main complaints of yellow eyes, bloating and fatigue. The patient has a history of hepatitis B for more than 10 years. He started taking entecavir antiviral therapy 3 years ago, and stopped antiviral drugs half a year ago. In the past half month, he felt fatigue, anorexia, and yellowing of the skin and sclera, which gradually worsened. Liver function examination on admission: ALT 298U/L, AST387U/L, ALP 151U/L, GGT 110U/L, TBIL 348.7umol/l, DBIL 234.5umol/l, ET: 0.72EU/L, PTA: 30.5%, HBV- DNA: 3.82×10 ⁵ IU/ML, upper abdominal CT showed: liver cirrhosis, splenomegaly, ascites. In the treatment, measures such as anti-virus, liver protection, anti-inflammation and anti-yellowing, and nutritional support were given, and the traditional Chinese medicine granules prepared in Example 1 were taken orally. 79U/L, AST 86U/L, ALP 133U/L, GGT102U/L, TBIL 121.6umol/l, DBIL 58.8umol/l, ET: 0.22EU/L, PTA: 41.6%, and then continued to give integrative medicine, The patient's condition improved and was discharged from hospital in stable condition.

2. Zhang Mou, male, farmer, 54 years old, went to see a doctor in September 2017 because of yellow eyes and body. The patient has a long history of heavy drinking, with a daily ethanol intake of 50-100 g. He was diagnosed with liver cirrhosis in a foreign hospital two years ago, but the patient has not stopped drinking. Liver function examination after admission: ALT: 225U/L, AST 487U/L, ALP 291U/L, GGT 562U/L, TBIL 278.7umol/l, DBIL 138.5umol/l, ET: 0.69EU/L, PTA: 32.5% , CT of the upper abdomen showed liver cirrhosis. In the treatment, hepatoprotective, jaundice, and nutritional support measures were given. At the same time, traditional Chinese medicine granules were given orally. During the period, the patient's symptoms gradually improved. At the end of the course of treatment, ALT: 87U/L, AST 132U/L, ALP151U/L L, GGT 342U/L, TBIL 89.3umol/l, DBIL 68.5umol/l, ET: 0.29EU/L, PTA: 43.7%, continued drug treatment after discharge, and her condition is stable so far during follow-up.

It should be noted that when a numerical range is involved in the claims of the present invention, it should be understood that the two endpoints of each numerical range and any value between the two endpoints can be selected. In order to prevent repetition, the present invention describes the preferred Example.

Although preferred embodiments of the present invention have been described, additional changes and modifications to these embodiments may occur to those skilled in the art once the basic inventive concepts are known. Therefore, the appended claims are intended to be construed to include the preferred embodiment and all changes and modifications that fall within the scope of the present invention.

It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit and scope of the invention. Thus, provided that these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims (2)

1. a traditional Chinese medicine granule for the treatment of liver disease intestinal-derived endotoxemia, is characterized in that, is prepared from the raw material of following mass points: 15-30 parts of Yin Chen, 10-20 parts of skullcap, 15-30 parts of red peony, 6-12 parts of comfrey, 15-30 parts of money grass, 8-15 parts of turmeric, 5-15 parts of rhubarb. 2. the preparation method of Chinese medicine granule according to claim 1, is characterized in that, comprises the steps: S1, take by weight 15-30 parts of Yin Chen, 10-20 parts of Scutellaria baicalensis, 15-30 parts of red peony, 6-12 parts of comfrey, 15-30 parts of money grass, 8-15 parts of turmeric, 5 parts of rhubarb -15 copies, each API is cleaned and dried; S2, the dried raw materials are superfinely pulverized, passed through a 200-mesh sieve, and the obtained medicinal powder is mixed and stirred to obtain a mixed traditional Chinese medicine composition; S3, the Chinese medicine composition is boiled with water, and the concentrated filtrate obtains the extract; S4. Mix the extract with sucrose and dextrin in a mass ratio of 1:3:1, stir evenly to make soft materials, granulate and dry to obtain finished Chinese medicine granules.