CN104435710A - A traditional Chinese medicine dispersible tablet for soothing the liver and invigorating the spleen and its preparation method - Google Patents

Abstract

The invention discloses a dispersible tablet of traditional Chinese medicine for soothing the liver and invigorating the spleen and a preparation method thereof. The dispersible tablet of the present invention has the effects of clearing heat and detoxifying, soothing the liver and invigorating the spleen, and is used for patients with acute and chronic hepatitis and early liver cirrhosis. It has good solubility and dispersibility, high dissolution rate, and good bioavailability. Rapid distribution, stable quality, good taste, easy to take, can be swallowed, chewed, sucked or dispersed with water, more suitable for the elderly and patients with difficulty in swallowing, has the advantages of good drug stability, convenient packaging, transportation and storage, etc. , and its preparation method is simple and feasible, and is suitable for industrial production.

Description

A traditional Chinese medicine dispersible tablet for soothing the liver and invigorating the spleen and its preparation method

technical field

The invention belongs to the technical field of pharmacy, and in particular relates to a dispersible tablet of traditional Chinese medicine for soothing the liver and invigorating the spleen and a preparation method thereof.

Background technique

Viral hepatitis is an infectious disease mainly caused by liver lesions caused by a variety of hepatitis viruses. It is a common, frequently-occurring infectious disease that seriously endangers people's lives and health. Among them, hepatitis B and C are the most harmful. Clinically, the main manifestations are loss of appetite, nausea, upper abdominal discomfort, pain in the liver area, and fatigue. Some patients may have jaundice, fever and hepatomegaly with liver function damage. Some patients can become chronic, and even develop into liver cirrhosis, and a few can develop into liver cancer.

The treatment of acute and chronic hepatitis with traditional Chinese medicine has its own unique characteristics, which can significantly improve the clinical symptoms and signs of patients. Recent studies have shown that the combination of Chinese and Western medicine in the treatment of acute hepatitis is significantly better than that of Western medicine alone. For acute and chronic viral hepatitis, Inhibiting the effect of virus replication, adjusting immunotherapy is an important direction. Make full use of TCM dialectical treatment to soothe the liver and regulate qi, invigorate the spleen and harmonize the middle, activate blood and detoxify. It has obvious effects in improving tract symptoms and improving the patient's physical signs, so that most patients have achieved good curative effect.

At present, most of the products on the market are made by traditional techniques. Traditional techniques often use various raw medicinal materials to be crushed into fine powder (above 80 mesh), and mixed before taking. However, this traditional technique is used in traditional Chinese medicine pills, powders and solid preparations. The traditional processing technology makes the drug particle size mostly 125-180 μm, which is not conducive to the full absorption of active ingredients, and has the disadvantages of high production cost and general drug utilization.

Contents of the invention

The object of the present invention is to provide a Chinese medicine dispersible tablet for clearing away heat and detoxification, soothing the liver and strengthening the spleen and a preparation method thereof.

In order to achieve the purpose of the present invention, the present invention is achieved through the following technical solutions: a dispersible tablet of Chinese medicine for soothing the liver and invigorating the spleen, characterized in that: it is composed of the following raw materials: a Chinese medicine extract, a filler, an internally added disintegrating agent, It is made by adding disintegrants, flavoring agents, wetting agents and lubricants. The percentages of various raw materials are as follows: 10-50% of traditional Chinese medicine extracts, 10-80% of fillers, and 5-5% of internal disintegrants. 50%, plus 5-15% disintegrating agent, 0.1-10% flavoring agent, 0.1-20% wetting agent, 0.05-20% lubricant; the Chinese medicine extract includes the following raw materials: parts by weight Ratio: Bupleurum 50-70 parts, Polygonum cuspidatum 50-70 parts, Phellodendron 30-50 parts, Schisandra 90-110 parts, Astragalus 50-70 parts, Poria cocos 50-70 parts, Polygonatum 50-70 parts, Banlangen 90-110 parts 50-60 parts of Citrus aurantii, 50-70 parts of Salvia miltiorrhiza, 50-70 parts of gardenia, 30-50 parts of fried Atractylodes macrocephala, and 50-70 parts of gentian.

The optimal weight-to-number ratio of the raw materials in the Chinese medicine extract is: 60 parts of Bupleurum, 60 parts of Polygonum cuspidatum, 40 parts of Cortex Phellodendri, 100 parts of Schisandra chinensis, 60 parts of Astragalus membranaceus, 60 parts of Poria cocos, 60 parts of Polygonatum, 100 parts of Radix Isatidis, Hovenia citrus 40 parts of shell, 60 parts of salvia miltiorrhiza, 60 parts of gardenia, 40 parts of fried Atractylodes macrocephala, and 60 parts of gentian.

10-50 parts of the traditional Chinese medicine extract, 10-80 parts of filler, 5-50 parts of internal disintegrating agent, 5-15 parts of external disintegrating agent, 0.1-10 parts of flavoring agent, 0.1-20 parts of wetting agent parts, lubricant 0.05 to 20 parts.

40 parts of the traditional Chinese medicine extract, 30 parts of filler, 25 parts of internal disintegrating agent, 12 parts of external disintegrating agent, 8 parts of corrective agent, 5 parts of wetting agent and 5 parts of lubricant.

The filler can be one or more of pregelatinized starch, mannitol, microcrystalline cellulose, sucrose, lactose, sodium chloride, calcium sulfate; The disintegrant is low-substituted hydroxypropyl cellulose, sodium starch glycolate, croscarmellose sodium, and crospovidone; the flavoring agent is aspartame, Stevioside, citric acid, sweet orange essence or a mixture of one or more of them; the wetting agent is a mixture of one or two of water and ethanol solution; the lubricant is stearic acid One or more of magnesium, sodium lauryl sulfate, silicon dioxide, and talc powder.

The concrete steps of its preparation method are:

Step 1. Prepare materials: select high-quality Bupleurum bupleurum, Polygonum cuspidatum, Cortex Phellodendron, Schisandra chinensis, Astragalus membranaceus, Poria cocos, Polygonatum, Radix Isatidis, Citrus aurantium, Salvia miltiorrhiza, gardenia, fried Atractylodes macrocephala, and gentian raw materials according to the ratio of parts by weight, wash and remove miscellaneous;

Step 2: Extraction: According to the ratio of parts by weight, decoct the above-mentioned traditional Chinese medicine with water for two times, decoct in 7 times the amount of water for 1.5 hours for the first time, and decoct for 1.5 hours in 7 times the amount of water for the second time, and combine the two decoctions , filter out medicinal residues and impurities, concentrate the filtrate to a relative density of 1.1-1.3 at 90-95°C, then cool to room temperature, add an equal amount of ethanol to precipitate it, extract the supernatant, and put the supernatant at temperature At 60-65°C, concentrate to a clear paste with a relative density of about 1.1-1.3, and finally dry it under reduced pressure at 70°C to obtain the extract;

Step 3. Preparation: According to the ratio of parts by weight, the extract is crushed into fine powder, passed through an 80-mesh sieve, and then added with a filler and an internal disintegrant, mixed evenly, added with a wetting agent, and prepared by fluidized bed granulation technology granules, after the whole granules are prepared, add an additional disintegrant, corrective agent, and lubricant, mix evenly, and compress with a tablet machine to make tablets;

Step 4. Packaging: According to the specifications of the photo agent, it is sorted and packaged to make a finished product.

Among the above-mentioned medicines: Bupleurum reconciles the exterior and interior, soothes the liver, and promotes yang. Treatment of alternating cold and heat, chest fullness and hypochondriac pain, bitter mouth and deafness, headache and dizziness, malaria, prolapse of the anus, irregular menstruation, and prolapse of the uterus. Polygonum cuspidatum dispelling wind, promoting dampness, dispelling blood stasis, promoting menstrual flow. Control rheumatism muscle and bone pain, damp-heat jaundice, stranguria turbid vaginal discharge, women's amenorrhea, postpartum lochia persistent, abdominal mass accumulation, bleeding from hemorrhoids. Injury from falls, burns, malignant sores and ringworm. Anti-arrhythmia and anti-myocardial blood loss, promoting blood circulation and removing blood stasis. Cortex Phellodendri clears away heat. Drying dampness, purging fire, detoxifying. Treatment of hot dysentery, diarrhea, thirst, jaundice, flaccidity, nocturnal emissions, stranguria, hemorrhoids, blood in the stool, leucorrhea, bone steam and heat, red eyes and swelling pain, sores on the mouth and tongue, sores and swelling. Fructus Schisandra restrains the lungs, nourishes the kidneys, produces body fluid, absorbs sweat, and astringent essence. Treatment of asthma and cough due to lung deficiency, dry mouth and thirst, spontaneous sweating, night sweats, fatigue and emaciation, nocturnal nocturnal emission, chronic diarrhea and dysentery. Radix Astragali invigorates qi and strengthens the surface, supports toxins and expels pus, diuresis, and promotes granulation. It is used for qi deficiency and fatigue, chronic diarrhea and prolapse of the anus, spontaneous sweating, edema, prolapse of the genitals, chronic nephritis, proteinuria, diabetes, and sores that do not heal for a long time. Poria wicks dampness and diuresis, benefits the spleen and stomach, calms the mind and calms the nerves. Control dysuria, edema and fullness, phlegm retention and cough, vomiting, diarrhea, spermatorrhea, stranguria, palpitations, and forgetfulness. Polygonatum invigorates the middle and replenishes Qi, moistens the heart and lungs, and strengthens the muscles and bones. Control cold and heat due to deficiency, tuberculosis and hemoptysis, physical weakness after illness, lack of food, weakness of muscles and bones, rheumatism pain, wind leprosy. Banlangen clears away heat, detoxifies, cools blood. Treatment of influenza, meningitis, Japanese encephalitis, pneumonia, erysipelas, hot spots, dizziness, vomiting, swollen throat, mumps, burning eyes, sores, dark purple tongue, sore throat, rotten throat Dansha, big head plague, carbuncle It can prevent and treat Japanese encephalitis, acute and chronic hepatitis, mumps, and osteomyelitis. Fructus Fructus Aurantii dispels qi, promotes phlegm, and eliminates stagnation. Control phlegm stagnation in the chest and diaphragm, chest fullness, hypotension, indigestion, gas, vomiting, heavy diarrhea, prolapse of the anus, and uterine prolapse. Salvia miltiorrhiza promotes blood circulation and removes blood stasis, soothes the nerves and calms the mind, drains pus, and relieves pain. Control angina pectoris, irregular menstruation, dysmenorrhea, amenorrhea, metrorrhagia, lump in the abdomen, accumulation, abdominal pain due to blood stasis, joint pain, palpitation with fear and insomnia, malignant sore and swollen toxin. Fructus Gardenia clears away heat, purifies fire, cools blood. Treatment of febrile disease, restlessness, jaundice, gonorrhea, thirst, red eyes, sore throat, hematemesis, epistaxis, dysentery, hematuria, toxic heat sores, sprains and swelling. Stir-fried Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizoma Atractylodes Rhizome is invigorating the spleen and replenishing qi, eliminating dampness and diuresis, antiperspirant, and preventing miscarriage. For insufficiency of the spleen, lack of food, abdominal distension and diarrhea, dizziness and palpitation due to phlegm and retention, edema, spontaneous sweating, restless fetal movement. Radix Gentiana purifies liver and gallbladder excess fire, and removes damp-heat in the lower burner. Control excessive heat in the liver meridian, convulsions, epilepsy and mania, Japanese encephalitis, headache, red eyes, sore throat, jaundice, dysentery, carbuncle sores, swollen and painful scrotum, and wet itching in the genitals. For damp heat jaundice, pruritus vulvae, vaginal discharge, eczema itching, deafness, hypochondriac pain, bitter mouth, convulsions and convulsions.

Beneficial effects of the present invention: the dispersible tablet of the present invention has the effects of clearing heat and detoxifying, soothing the liver and invigorating the spleen, and is used for patients with acute and chronic hepatitis and early liver cirrhosis. It has good solubility and dispersibility, and high dissolution rate. Good bioavailability, rapid distribution in the body, stable quality, good taste, easy to take, can be swallowed, chewed, sucked or taken after dispersing with water, more suitable for the elderly and patients with difficulty in swallowing, with good drug stability, packaging, It has the advantages of convenient transportation and storage, and its preparation method is simple and easy, which is suitable for industrial production.

The present invention is clinically verified by two groups, wherein one group is the treatment group that eats the present invention, eats the present invention once a day, and 15 days is a course of treatment; Among them, there were 140 males and 63 females, the oldest was 75 years old, and the youngest was 35 years old. It was used once a day, and 15 days was a course of treatment. The clinical manifestations were loss of appetite, nausea, upper abdominal discomfort, liver pain, and fatigue. Table 1 shows Control data after taking a course of treatment:

Table 1 Comparison of two groups of courses of treatment before and after taking (unit: person)

There is a significant difference between the treatment group and the control group, so it can be seen that the clinical application of the present invention has a significant curative effect.

The process characteristics of the present invention: 1. Scientific selection of raw materials, advanced production technology, and convenient storage and use of the product; 2. The medicinal ingredients in the product are easily absorbed by the human body; 3. Wide source of raw materials, short processing line, and easy processing and manufacturing of the product.

Detailed ways:

Example 1

A dispersible tablet of traditional Chinese medicine for soothing the liver and invigorating the spleen, characterized in that it is composed of the following raw materials: it is made of Chinese medicine extract, filler, internally added disintegrating agent, externally added disintegrating agent, corrective agent, wetting agent and lubricant , wherein the percentages of various raw materials are: Chinese medicine extract 10-50%, filler 10-80%, internal disintegrant 5-50%, external disintegrant 5-15%, flavoring agent 0.1- 10%, wetting agent 0.1-20%, lubricant 0.05-20%; the Chinese medicine extract includes the following raw materials: by weight: Bupleurum 50-70 parts, Polygonum cuspidatum 50-70 parts, Cortex Phellodendri 30-50 parts, Schisandra 90-110 parts, Astragalus 50-70 parts, Poria cocos 50-70 parts, Polygonatum 50-70 parts, Radix Radix 90-110 parts, Citrus aurantium 50-60 parts, Salvia miltiorrhiza 50-70 parts, gardenia 50-70 parts, 30-50 parts of fried Atractylodes macrocephala, and 50-70 parts of gentian.

The optimal weight-to-number ratio of the raw materials in the Chinese medicine extract is: 60 parts of Bupleurum, 60 parts of Polygonum cuspidatum, 40 parts of Cortex Phellodendri, 100 parts of Schisandra chinensis, 60 parts of Astragalus membranaceus, 60 parts of Poria cocos, 60 parts of Polygonatum, 100 parts of Radix Isatidis, Hovenia citrus 40 parts of shell, 60 parts of salvia miltiorrhiza, 60 parts of gardenia, 40 parts of fried Atractylodes macrocephala, and 60 parts of gentian.

10-50 parts of the traditional Chinese medicine extract, 10-80 parts of filler, 5-50 parts of internal disintegrating agent, 5-15 parts of external disintegrating agent, 0.1-10 parts of flavoring agent, 0.1-20 parts of wetting agent parts, lubricant 0.05 to 20 parts.

40 parts of the traditional Chinese medicine extract, 30 parts of filler, 25 parts of internal disintegrating agent, 12 parts of external disintegrating agent, 8 parts of corrective agent, 5 parts of wetting agent and 5 parts of lubricant.

The filler can be one or more of pregelatinized starch, mannitol, microcrystalline cellulose, sucrose, lactose, sodium chloride, calcium sulfate; The disintegrant is low-substituted hydroxypropyl cellulose, sodium starch glycolate, croscarmellose sodium, and crospovidone; the flavoring agent is aspartame, Stevioside, citric acid, sweet orange essence or a mixture of one or more of them; the wetting agent is a mixture of one or two of water and ethanol solution; the lubricant is stearic acid One or more of magnesium, sodium lauryl sulfate, silicon dioxide, and talc powder.

The concrete steps of its preparation method are:

Step 1. Prepare materials: select high-quality Bupleurum bupleurum, Polygonum cuspidatum, Cortex Phellodendron, Schisandra chinensis, Astragalus membranaceus, Poria cocos, Polygonatum, Radix Isatidis, Citrus aurantium, Salvia miltiorrhiza, gardenia, fried Atractylodes macrocephala, and gentian raw materials according to the ratio of parts by weight, wash and remove miscellaneous;

Step 2: Extraction: According to the ratio of parts by weight, decoct the above-mentioned traditional Chinese medicine with water for two times, decoct in 7 times the amount of water for 1.5 hours for the first time, and decoct for 1.5 hours in 7 times the amount of water for the second time, and combine the two decoctions , filter out medicinal residues and impurities, concentrate the filtrate to a relative density of 1.1-1.3 at 90-95°C, then cool to room temperature, add an equal amount of ethanol to precipitate it, extract the supernatant, and put the supernatant at temperature At 60-65°C, concentrate to a clear paste with a relative density of about 1.1-1.3, and finally dry it under reduced pressure at 70°C to obtain the extract;

Step 3. Preparation: According to the ratio of parts by weight, the extract is crushed into fine powder, passed through an 80-mesh sieve, and then added with a filler and an internal disintegrant, mixed evenly, added with a wetting agent, and prepared by fluidized bed granulation technology granules, after the whole granules are prepared, add an additional disintegrant, corrective agent, and lubricant, mix evenly, and compress with a tablet machine to make tablets;

Step 4. Packaging: According to the specifications of the photo agent, it is sorted and packaged to make a finished product.

Claims (6)

1. a soothing liver and strengthening spleen dispersible tablets of Chinese medicine, it is characterized in that: be made up of following raw materials according: by Chinese medicine extract, filler, in make with disintegrating agent, additional disintegrating agent, correctives, wetting agent, lubricant, percentage ratio wherein shared by various raw material is, Chinese medicine extract 10 ~ 50%, filler 10 ~ 80%, in disintegrating agent 5 ~ 50%, additional disintegrating agent 5 ~ 15%, correctives 0.1 ~ 10%, wetting agent 0.1 ~ 20%, lubricant 0.05 ~ 20%; Described Chinese medicine extract comprises following raw material: be by ratio of weight and the number of copies: Radix Bupleuri 50-70 part, Rhizoma Polygoni Cuspidati 50-70 part, Cortex Phellodendri 30-50 part, Fructus Schisandrae Chinensis 90-110 part, Radix Astragali 50-70 part, Poria 50-70 part, Rhizoma Polygonati 50-70 part, Radix Isatidis 90-110 part, Fructus Aurantii 50-60 part, Radix Salviae Miltiorrhizae 50-70 part, Fructus Gardeniae 50-70 part, Rhizoma Atractylodis Macrocephalae (parched) 30-50 part, Radix Gentianae 50-70 part.

2. a kind of soothing liver and strengthening spleen dispersible tablets of Chinese medicine according to claim 1, is characterized in that: the optimum weight portion rate of described Chinese medicine extract Raw is: Radix Bupleuri 60 parts, Rhizoma Polygoni Cuspidati 60 parts, Cortex Phellodendri 40 parts, Fructus Schisandrae Chinensis 100 parts, the Radix Astragali 60 parts, 60 parts, Poria, Rhizoma Polygonati 60 parts, Radix Isatidis 100 parts, Fructus Aurantii 40 parts, Radix Salviae Miltiorrhizae 60 parts, Fructus Gardeniae 60 parts, Rhizoma Atractylodis Macrocephalae (parched) 40 parts, Radix Gentianae 60 parts.

3. a kind of soothing liver and strengthening spleen dispersible tablets of Chinese medicine according to claim 1, is characterized in that: described Chinese medicine extract 10 ~ 50 parts, filler 10 ~ 80 parts, in disintegrating agent 5 ~ 50 parts, additional disintegrating agent 5 ~ 15 parts, correctives 0.1 ~ 10 part, wetting agent 0.1 ~ 20 part, lubricant 0.05 ~ 20 part.

4. a kind of soothing liver and strengthening spleen dispersible tablets of Chinese medicine according to claim 1, is characterized in that: described Chinese medicine extract 40 parts, filler 30 parts, in disintegrating agent 25 parts, additional disintegrating agent 12 parts, correctives 8 parts, wetting agent 5 parts, lubricant 5 parts.

5. a kind of soothing liver and strengthening spleen dispersible tablets of Chinese medicine according to claim 1, is characterized in that: described filler can be the mixing of pregelatinized Starch, mannitol, microcrystalline Cellulose, sucrose, lactose, sodium chloride, calcium sulfate wherein one or more; The mixing of low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone wherein one or more with disintegrating agent or additional disintegrating agent in described; Described correctives is aspartame, steviosin, citric acid, orange flavor or the mixing of one or more wherein; Described wetting agent is one or both the mixing in water, alcoholic solution; Described lubricant is the mixing of magnesium stearate, sodium lauryl sulphate, silicon dioxide, Pulvis Talci wherein one or more.

6. the preparation method of a kind of soothing liver and strengthening spleen dispersible tablets of Chinese medicine according to claim 1-5, is characterized in that: the concrete steps of its preparation method are:

Step 1, to get the raw materials ready: by ratio of weight and the number of copies, choose the Radix Bupleuri of high-quality, Rhizoma Polygoni Cuspidati, Cortex Phellodendri, Fructus Schisandrae Chinensis, the Radix Astragali, Poria, Rhizoma Polygonati, Radix Isatidis, Fructus Aurantii, Radix Salviae Miltiorrhizae, Fructus Gardeniae, Rhizoma Atractylodis Macrocephalae (parched), Radix Gentianae raw material, clean and remove impurity;

Step 2: extract: by ratio of weight and the number of copies, by above-mentioned Chinese medicine, decoct with water secondary, 7 times amount soak by water 1.5 hours for the first time, second time 7 times amount soak by water 1.5 hours, merges twice decocting liquid, filtering medicinal residues and impurity, 90 ~ 95 DEG C time, be concentrated into relative density 1.1-1.3 by filtrate, then be chilled to room temperature, the ethanol adding equivalent makes it precipitation, extracts supernatant, by supernatant at temperature 60-65 DEG C, be concentrated into the clear paste that relative density is about 1.1-1.3, finally at 70 DEG C of drying under reduced pressure, obtain extract;

Step 3, preparation: by ratio of weight and the number of copies, extract is ground into fine powder, cross 80 mesh sieves, then add filler, in disintegrating agent mix homogeneously, add wetting agent, adopt fluidized bed granulation technology to granulate, after obtained granulate, add additional disintegrating agent, correctives, mix lubricant evenly, with tabletting machine, make tablet;

Step 4, packaging: according to tablet format, class wrapping, makes finished product.