CN111249396A - Traditional Chinese medicine for treating chronic gastritis and preparation method of micronized particles thereof - Google Patents

Abstract

The invention relates to a traditional Chinese medicine for treating chronic gastritis and a preparation method of micronized granules. It is characterized in that it is composed of 20-30 parts by weight of lizards, 10-20 parts of ebony, 10-20 parts of oysters, 10-20 parts of hawthorn, 10-20 parts of white peony root, 5-15 parts of bark lotus, 5-15 parts of black medicine, 5-15 parts of Panax notoginseng, 10-20 parts of Sichuan neem, 10-20 parts of Corydalis, 10-20 parts of Inula, 10-20 parts of lotus root, 5-15 parts of Baiji, 10-20 parts of skullcap, 10-20 parts of yam, 20-30 parts of licorice. The method micronizes the traditional Chinese medicinal materials, and overcomes the uneven particle size of the traditional Chinese medicinal powder prepared by the ordinary pulverization technology, the inaccurate proportion of the fibrous medicinal materials due to the pulverization problem, and the influence of the temperature increase in the ordinary pulverization process. The bioactive components of the thermally unstable medicinal materials are affected and other shortcomings.

Description

A kind of traditional Chinese medicine for treating chronic gastritis and preparation method of micronized granules

technical field

The invention relates to a traditional Chinese medicine for treating chronic gastritis and a preparation method of micronized granules.

Background technique

Traditional Chinese medicine believes that chronic gastritis can be caused by factors such as improper diet, internal emotional injury, and six external factors. Based on Ye Tianshi's theoretical understanding of "long-term illness enters the collaterals", it is believed that dampness, heat, phlegm, blood stasis and other turbid toxins bind the gastric membrane, block the circulation of qi and blood in the gastrointestinal tract, make the blood and flesh rot, turn the rot into pus, and damage the gastrointestinal tract. mucosa. Therefore, the present invention is combined with the treatment methods of "internal ulcer" and "internal carbuncle", and proposes a method of protecting and repairing the gastric mucosa to cure the sore by protecting the membrane.

The traditional Chinese medicine prescription for treating chronic gastritis is composed of lizard, black plum, oyster, hawthorn, white peony, bark lotus, black medicine, Panax notoginseng, Sichuan neem, Corydalis, inula flower, lotus root, Baiji, Scutellaria baicalensis, Composition with yam and licorice. Lizard in the prescription has the effects of breaking knots and dissipating blood stasis, nourishing blood and promoting blood circulation, clearing heat and detoxifying, which can effectively improve the loss of qi and blood in the stomach, the bitterness of the veins, and promote the repair of gastric mucosa. Pain-relieving, upper can restrain lung qi, lower can astringe the large intestine, enter the stomach and can also promote body fluid and calm ascaris; oyster calms the liver and subdues yang, softens and dissipates stagnation, astringent and astringent; Banzhilian clears heat and detoxifies, promotes blood circulation and removes blood stasis, and assists lizards to dispel Evil; Wuyao Weixin Xingsan, warm in nature and dispelling cold, has the effect of invigorating qi, dispelling cold and relieving pain, and has a two-way regulation effect of excitation and inhibition on gastrointestinal smooth muscle; Panax notoginseng promotes blood and nourishes blood, improves gastric mucosal micro-organisms. Circulation; Chuan Neem promotes Qi, regulates Qi and relieves pain; Corydalis, fried lotus root, Baiji and other medicines promote blood circulation and reduce swelling, enhance swelling and dissipate knots, and promote the repair of gastric mucosa; Scutellaria baicalensis clears heat and detoxifies, and cooperates with lizards to strengthen its detoxification and repair Inula vulgaris has the functions of soothing the liver and expelling heat, and relieving the stomach and lowering the negative effect; Baiji contains colloid and starch and other components, which have the functions of astringing and promoting muscle, reducing swelling and hemostasis, resisting pathogenic microorganisms, regulating immunity, and promoting tissue healing; Chinese yam Contains diosgenin, mucilage, choline, starch, glycoproteins, free amino acids, teratin, vitamin C and amylase, etc. It is nutritious and easy to digest. Licorice can replenish spleen and stomach qi, relieve acute pain and relieve pain; the combination of various medicines can repair damaged gastric mucosa, improve blood circulation on ulcers, enhance its nutrition, and promote healing of ulcers, and is used to effectively treat chronic gastritis.

At present, the dosage form of this traditional Chinese medicine formula for the treatment of chronic gastritis is powder. In the clinical trial, 137 cases were randomly divided into a treatment group of 69 cases and a control group of 68 cases. Lotus root starch was made into a paste with boiled water, taken 2 hours after meals, 3 times a day; the control group was orally taken Weifuchun tablets, 4 tablets each time, 3 times a day, 12 weeks as a course of treatment. After the course of treatment, the clinical efficacy of the two groups of patients was compared, and their safety and adverse reactions were observed. The clinical efficacy is shown in Table 1-3, the total effective rate of the treatment group is 89.86%, and the total effective rate of the control group is 69.12%, and the treatment group can improve chronic gastritis mucosal atrophy, kill Helicobacter pylori (HP), and in the long-term. Good curative effect. No abnormal changes were found in the blood, urine, stool routines, heart, liver and kidney functions of the two groups of patients after treatment, and no adverse reactions were found. Clinical trials have shown that the traditional Chinese medicine formula can effectively treat chronic gastritis and has good safety. However, the powder is prepared by ordinary pulverization technology, the particle size is not uniform, and overheating will occur during the ordinary pulverization process, and some Chinese medicinal materials that are thermally unstable are effective. The ingredients may be affected; at the same time, the medicinal materials rich in fiber components are not easy to pass through the sieve after being crushed by ordinary pulverizers, and those that cannot be sieved after being crushed for many times are thrown away as impurities, resulting in insufficient dosage of medicinal materials rich in fiber components in the prescription. Accurate, affecting the efficacy of the drug. Therefore, it is worth researching and developing traditional Chinese medicine preparation products with uniform particle size, more accurate proportion of medicinal materials and better curative effect.

Table 1 Comparison of clinical efficacy between the two groups

Table 2 Comparison of the improvement of gastric mucosa pathological conditions between the two groups

Table 3 Comparison of the efficacy of anti-HP infection between the two groups

SUMMARY OF THE INVENTION

One of the objects of the present invention is to provide a kind of traditional Chinese medicine for the treatment of chronic gastritis, and the treatment methods of "internal ulcer" and "internal carbuncle" are used for the treatment of chronic gastritis by using the method of protecting and repairing the ulcer and protecting and repairing the gastric mucosa;

The second purpose of the present invention is to provide a preparation method of the above-mentioned traditional Chinese medicine micronized particles, which can increase the stability and moisture resistance of the traditional Chinese medicine, and is beneficial to storage.

A traditional Chinese medicine for treating chronic gastritis, which is special in that it is composed of 20-30 parts by weight of lizard, 10-20 parts of ebony, 10-20 parts of oyster, 10-20 parts of hawthorn, 10-20 parts of white peony root 5-15 parts of Banzhilian, 5-15 parts of black medicine, 5-15 parts of Panax notoginseng, 10-20 parts of Sichuan neem, 10-20 parts of Corydalis, 10-20 parts of Inula flower, 10-20 parts of lotus root 20 parts, 5-15 parts of Baiji, 10-20 parts of skullcap, 10-20 parts of yam, 20-30 parts of licorice.

A preparation method of traditional Chinese medicine micronized granules for the treatment of chronic gastritis, which is special in that it comprises the following steps:

(1) cleaning: get all the Chinese medicinal materials according to the proportioning recorded in claim 1, carry out quick cleaning with purified water, spray 75% alcohol to stand after the water is evaporated to dryness;

(2) Drying: drying the obtained Chinese medicinal materials, controlling the drying temperature to be 50-90°C, and drying to a moisture content of 3%-8%;

(3) Coarse pulverization: pulverize the obtained dried medicinal materials to obtain coarse powder of Chinese medicinal materials;

(4) Micronization: the obtained Chinese medicinal material coarse powder is ultrafinely pulverized to obtain Chinese medicinal material micropowder;

(5) granulation: granulating the obtained Chinese medicinal material micropowder to obtain 12-24 mesh Chinese medicinal micronized granules;

(6) The quantity can be packaged.

In step (4), a low-temperature vibration type ultra-fine pulverizer or an air-flow type ultra-fine pulverizer is specifically used for the micronization, and when the low-temperature vibration type ultra-fine pulverizer is used for pulverization, the pulverization temperature is controlled to be -50 to -20° C., and the pulverization time is 5～20min; when the air flow type ultrafine pulverizer is used for pulverization, the air pressure is controlled to 0.5～1.5MPa, the feed rate is 1～1.5kg/h, the pulverization temperature is -20～-10℃, and the pulverization time is 5～20min.

The granulation in step (5) specifically adopts wet granulation or dry granulation. When wet granulation is adopted, 30% to 90% volume fraction of ethanol is sprayed into the micropowder of the traditional Chinese medicinal material, and the soft material is prepared by stirring uniformly. 24-mesh sieve for granulation, then drying, controlling the drying temperature to be 30-70°C, drying until the moisture content of the decoction pieces is 3%-8%, and passing through a 12-24 mesh sieve for granulation; when dry granulation is used, The Chinese medicinal material micropowder is directly added to the granulator, and the extrusion pressure is controlled to be 10-20 MPa, the extrusion speed is 15-25 r/min, and the feeding speed is 20-30 r/min, so that the particle size is 12-24 meshes. 5. The method for preparing micronized granules of traditional Chinese medicine for the treatment of chronic gastritis as claimed in claim 2, characterized in that: in step (6), the component packaging is specifically that the micronized granules of traditional Chinese medicine are divided into aluminum-plastic film packaging bags, and each The bag contains 3 to 6 g of micronized particles.

The method micronizes the traditional Chinese medicinal materials, and overcomes the uneven particle size of the traditional Chinese medicinal powder prepared by the ordinary pulverization technology, the inaccurate proportion of the fibrous medicinal materials due to the pulverization problem, and the influence of the temperature increase in the ordinary pulverization process. The bioactive components of the thermally unstable medicinal materials are affected and other shortcomings. In the present invention, the micropowder of traditional Chinese medicinal materials is made into granules by granulation technology, which overcomes the disadvantages of poor fluidity and inconvenient packaging of the micronized traditional Chinese medicine due to the extremely fine particle size, and at the same time increases the stability and moisture resistance of the traditional Chinese medicine, which is beneficial to storage. The traditional Chinese medicine micronized granules of the present invention are combined with the treatment methods of "internal ulcer" and "internal carbuncle", adopt the method of protecting the membrane to heal the sore, protecting and repairing the gastric mucosa to cure chronic gastritis, and using the monarch medicine lizard has the function of regenerating and repairing human damaged tissue , Enhance the immune function of the human body, use viscous drugs to make the drugs adhere to the surface of the gastric mucosa and directly act on the lesions, and finally promote the apoptosis of gastric mucosal cells that proliferate and enter the intestines, and help the regeneration and repair of the mucosa. Enlargement is more conducive to the dissolution of traditional Chinese medicine ingredients to exert the curative effect, has the effects of invigorating the spleen, nourishing the stomach, invigorating deficiency and strengthening, good curative effect, high cure rate, and no adverse reactions.

Description of drawings

Fig. 1 is the critical relative humidity curve of Chinese herbal medicine micropowder;

Fig. 2 is the appearance uniformity diagram of the micronized particles of traditional Chinese medicine prepared by the present invention.

Detailed ways

The present invention protects a traditional Chinese medicine micronized granule for treating chronic gastritis and a preparation method thereof. It is prepared from sixteen Chinese herbal decoction pieces of flowers, lotus root, Baiji, skullcap, yam and licorice. In clinical treatment of chronic gastritis, this traditional Chinese medicine formula is used to make a paste with boiling water and take it orally. Control the reflux of intestinal juice and bile, achieve the purpose of ventilating and lowering the air, and the stomach, and repairing the gastric mucosa. Each time one or two courses of traditional Chinese medicine paste are used, and the patients are instructed to flirt, eat less, and live with caution. That is to say, some patients relapse due to improper diet or disorder of seven emotions, etc., and the symptoms are relatively mild, and they can be recovered by continuing to take the traditional Chinese medicine paste. The preparation method of the traditional Chinese medicine micronized granules of the present invention is to pulverize the dried medicinal materials into coarse powder by using a universal pulverizer, use the ultra-fine pulverization technology to micronize the coarse powder, and then use the granulation technology to prepare the micronized granules. The method micronizes the traditional Chinese medicinal materials, and overcomes the uneven particle size of the traditional Chinese medicinal powder prepared by the ordinary pulverization technology, the inaccurate proportion of the fibrous medicinal materials due to the pulverization problem, and the influence of the temperature increase in the ordinary pulverization process. The bioactive components of the thermally unstable medicinal materials are affected and other shortcomings.

In the present invention, the micropowder of traditional Chinese medicinal materials is made into granules by granulation technology, which overcomes the disadvantages of poor fluidity and inconvenient packaging of the micronized traditional Chinese medicine due to the extremely fine particle size, and at the same time increases the stability and moisture resistance of the traditional Chinese medicine, which is beneficial to storage. The micronized granules of the traditional Chinese medicine of the present invention utilize the functions of the monarch drug lizard to enhance the body's immunity and repair damaged tissues, use the viscous drug to make the drug adhere to the surface of the gastric mucosa and directly act on the lesions, and the specific surface area increases after the traditional Chinese medicine is micronized It is more conducive to the dissolution of traditional Chinese medicine ingredients to exert the curative effect, so it has the effects of invigorating the spleen, nourishing the stomach, invigorating deficiency and strengthening, with good curative effect, high cure rate and no adverse reactions.

Aiming at the defects of the above-mentioned traditional Chinese medicine powder and the existing preparation technology, the present invention provides a traditional Chinese medicine micronized granule for treating chronic gastritis and a preparation method thereof. The invention adopts the ultra-fine pulverization technology to micronize the traditional Chinese medicinal materials, which can overcome the disadvantages of uneven particle size and inaccurate proportion of the fibrous medicinal materials prepared by the ordinary pulverization technology, and adopts low-temperature pulverization to solve the problems caused by the temperature increase in the ordinary pulverization process. The problem of active ingredients of heat-labile herbs. However, at the same time, the micro-powder of Chinese medicinal materials has poor fluidity and is inconvenient for packaging due to its extremely fine particle size, and the increase in specific surface area increases the hygroscopicity of the drug accordingly. Sex and mobility.

In order to achieve the above purpose, the technical scheme adopted in the present invention is: a kind of traditional Chinese medicine micronized granules for the treatment of chronic gastritis, wherein each traditional Chinese medicine component is composed of the following parts by weight: 20-30 parts of lizard, 10-20 parts of ebony servings, 10-20 servings of oysters, 10-20 servings of hawthorn, 10-20 servings of white peony root, 5-15 servings of Banzhilian, 5-15 servings of black medicine, 5-15 servings of Panax notoginseng, 10-20 servings of Sichuan neem , 10-20 copies of Corydalis, 10-20 copies of Inula, 10-20 copies of lotus root, 5-15 copies of Baiji, 10-20 copies of skullcap, 10-20 copies of yam, and 20-30 copies of licorice.

A traditional Chinese medicine micronized granule for treating chronic gastritis and a preparation method thereof, the steps are:

(1) Cleaning: Purify lizard, black plum, oyster, hawthorn, white peony, bark lotus, black medicine, Panax notoginseng, Sichuan neem, Corydalis, inula flower, lotus root, Baiji, skullcap, yam and licorice Quickly clean with water, spray 75% alcohol after the water evaporates and let it stand;

(2) Drying: put the Chinese herbal medicine pieces in an electric heating constant temperature drying oven for drying treatment, the drying temperature is 50～90℃, and the water content of the pieces is 3%～8%;

(3) Coarse pulverization: pulverize the dried medicinal materials obtained in step (2) with a universal pulverizer for 5-20 min to obtain coarse powder of Chinese medicinal materials;

(4) Micronization: the coarse powder of Chinese medicinal materials obtained in step (3) is pulverized by ultrafine pulverization technology to obtain micropowder of Chinese medicinal materials;

(5) granulation: using the granulation technology to granulate the Chinese medicinal material micropowder obtained in the step (4) by the granulation technology, to obtain 12-24 mesh Chinese medicine micronized granules.

(6) Quantity packaging: The micronized particles of traditional Chinese medicine are packaged in aluminum-plastic film packaging bags, and each bag contains 3-6g of micronized particles.

As a preferred embodiment of the method for preparing micronized particles of traditional Chinese medicine according to the present invention, in the step (4), the micronization can be prepared by using a low-temperature vibration type ultra-fine pulverizer and an air-flow type ultra-fine pulverizer, wherein the low-temperature vibration type When pulverizing with an ultrafine pulverizer, the pulverization temperature is -50～-20℃, and the pulverization time is 5～20min; when pulverizing by an air flow ultrafine pulverizer, the air pressure is 0.5～1.5MPa, and the feeding speed is 1～1.5kg/h , the pulverization temperature is -20～-10℃, and the pulverization time is 5～20min.

As a preferred embodiment of the method for preparing micronized granules of traditional Chinese medicine according to the present invention, wet granulation and dry granulation can be used in the granulation process in the step (5). 30% to 90% ethanol by volume, and stir evenly to make soft material, granulate with 12 to 24 mesh sieves, and put them in an electric heating constant temperature drying oven for drying treatment. 3%～8%, pass through 12～24 mesh sieves for granulation; during dry granulation, add Chinese medicinal powder directly into the granulator, the extrusion pressure is 10～20MPa, the extrusion speed is 15～25r/min, and the feeding speed is It is 20～30r/min, and the particle size is 12～24 meshes.

In order to better illustrate the purpose, technical solutions and advantages of the present invention, the present invention will be further described below with reference to specific embodiments.

Example 1:

(1) A kind of traditional Chinese medicine micronized granules for the treatment of chronic gastritis, composed of the following Chinese medicinal materials in proportion by weight: 20 parts of lizard, 10 parts of black plum, 10 parts of oyster, 10 parts of hawthorn, 10 parts of white peony root, 10 parts of bark lotus 5 parts, 5 parts of black medicine, 5 parts of Panax notoginseng, 10 parts of Sichuan neem, 10 parts of Corydalis, 10 parts of Inula flower, 10 parts of lotus root, 5 parts of Baiji, 10 parts of skullcap, 10 parts of yam, 20 parts of licorice .

(2) Preparation method:

Weigh the components of lizard, black plum, oyster, hawthorn, white peony, bark lotus, black medicine, Panax notoginseng, Sichuan neem, Corydalis, inula flower, lotus root, Baiji, skullcap, yam and licorice by weight. , use purified water for quick cleaning, spray 75% alcohol after the water evaporates, and leave it to stand. After the alcohol evaporates, put it in an electric heating constant temperature drying box at 50 °C, dry to a water content of 3%, and use a universal pulverizer in the clean room. Machine pulverized for 5 min to obtain coarse powder, and then pulverized with a low-temperature vibrating pulverizer for 5 min at a pulverization temperature of -30° C. to obtain micropowder of Chinese medicinal materials. Add 30% ethanol to make soft material, granulate with a 12-mesh sieve, put it into an electric heating constant temperature drying oven at 50° C. for drying treatment, pass through a 12-mesh sieve for granulation, and obtain micronized granules. Qualified micronized particles

Use aluminum-plastic bags for packaging, control the temperature of the packaging room to be 19 ° C, and the relative humidity to be 40%. The packaging and outer packaging are carried out according to the specifications. Each bag contains 3g of micronized particles.

Table 4 Quality inspection of Chinese herbal medicine micropowder

Table 5 Quality inspection of micronized granules of traditional Chinese medicine

Table 4 shows the quality inspection of the micro-powder of Chinese medicinal materials prepared by the present invention. As a result, the yield of the coarse powder of Chinese medicinal materials is 99.65%, the sieving rate of 65 meshes is 78.71%, and the yield of micro-powders of Chinese medicinal materials is 98.32%, and the yield of 200 meshes is 98.32%. The sieving rate was 95.50%, and the particle size distribution was uniform. However, the angle of repose of the micropowder of Chinese medicinal materials is relatively large. Combined with the results of bulk density and tap density, it can be further considered that its fluidity is poor, which may be caused by the extremely small particle size. The hygroscopicity of Chinese herbal medicine micropowder was investigated by measuring the hygroscopic equilibrium time and critical relative humidity. The results of hygroscopic equilibrium time showed that the moisture-inducing weight gain of Chinese herbal medicine micropowder was less than 15% but not less than 2%, indicating that it had hygroscopicity, and the hygroscopic equilibrium time was 4h. The results of the critical relative humidity are shown in Figure 1. The CRH of the Chinese herbal medicine micropowder is about 57%, so the storage and granulation environment of the Chinese herbal medicine micropowder should be controlled below 57%. Table 5 shows the quality inspection results of the traditional Chinese medicine micronized granules prepared by the present invention. The results show that the granule yield under this preparation process is relatively high; the particle size inspection is carried out according to the provisions of the "Chinese Pharmacopoeia" 2015 edition granules, and the result cannot pass The sum of No. 1 sieve and No. 5 sieve is 0.15%, which is in line with the regulations. From the results of angle of repose, bulk density and tap density, it can be seen that the fluidity of Chinese medicinal powder is obviously improved after being prepared into granules. At the same time, the appearance uniformity of the micronized particles of traditional Chinese medicine was investigated. The results are shown in Figure 2. The micronized particles of traditional Chinese medicine were spread on smooth paper, and it was observed that the color was uniform.

Example 2:

(1) A micronized granule of Chinese medicinal materials for treating chronic gastritis, which is composed of the following Chinese medicinal materials by weight: 25 parts of lizard, 15 parts of black plum, 15 parts of oyster, 15 parts of hawthorn, 15 parts of white peony root, 10 parts of lotus, 10 parts of black medicine, 10 parts of Panax notoginseng, 15 parts of Sichuan neem, 15 parts of Corydalis, 15 parts of Inula flower, 15 parts of lotus root, 10 parts of Baiji, 15 parts of skullcap, 15 parts of yam, 25 parts of licorice share.

(2) Preparation method:

Weigh the components of lizard, black plum, oyster, hawthorn, white peony, bark lotus, black medicine, Panax notoginseng, Sichuan neem, Corydalis, inula flower, lotus root, Baiji, skullcap, yam and licorice by weight. , use purified water for quick cleaning, spray 75% alcohol after the water evaporates, and leave it to stand. After the alcohol evaporates, put it in an electric heating constant temperature drying box at 70 °C, dry it to a water content of 5%, and use it in the clean room. Pulverized by machine for 10 min to obtain coarse powder, and then pulverized with a low-temperature vibrating pulverizer at a pulverization temperature of -20° C. and a pulverization time of 5 min to obtain micropowder of Chinese medicinal materials. Add 60% ethanol to make soft material, granulate with 18-mesh sieve, put it into an electric heating constant temperature drying oven at 70° C. for drying treatment, pass through an 18-mesh sieve for granulation, and obtain micronized granules. The qualified micronized particles are packaged in aluminum-plastic bags, the temperature of the packaging room is controlled to be 25°C, the relative humidity is 50%, and the packaging and outer packaging are carried out according to the specifications. Each bag contains 4g of micronized particles.

Example 3:

(1) A micronized granule of Chinese medicinal materials for treating chronic gastritis, which is composed of the following Chinese medicinal materials by weight: 30 parts of lizard, 20 parts of black plum, 20 parts of oyster, 20 parts of hawthorn, 20 parts of white peony root, 15 parts of lotus, 15 parts of black medicine, 15 parts of Panax notoginseng, 20 parts of Sichuan neem, 20 parts of Corydalis, 20 parts of Inula, 20 parts of lotus root, 15 parts of Baiji, 20 parts of skullcap, 20 parts of yam, 30 parts of licorice share.

(2) Preparation method:

Weigh the components of lizard, black plum, oyster, hawthorn, white peony, bark lotus, black medicine, Panax notoginseng, Sichuan neem, Corydalis, inula flower, lotus root, Baiji, skullcap, yam and licorice by weight. , use purified water for quick cleaning, spray 75% alcohol after the water evaporates, and leave it to stand. After the alcohol evaporates, put it in an electric heating constant temperature drying oven at 90 °C, dry to a water content of 8%, and use a universal pulverizer in the clean room. Pulverized by machine for 20min to obtain coarse powder, and then pulverized with an air flow ultrafine pulverizer. The air pressure is 0.7MPa, the feed rate is 1.2kg/h, and the pulverization time is 15min. is 12MPa, the extrusion speed is 21r/min, the feeding speed is 26r/min, and the particle size is 24 meshes. The qualified micronized particles are packaged in aluminum-plastic bags, and the temperature of the packaging room is controlled to be 28°C and the relative humidity is 55%, and the packaging and outer packaging are carried out according to the specifications. Each bag contains 6g of micronized particles.

Example 4:

(1) Pharmacological test methods

1. Model making of chronic gastritis

150g/L, 55℃ hot saline, 10mL/(kg d), gavage, 3 times/d; 2% salicylic acid solution 10mL/(kg d) gavage, 1 time/d; 20mmol/L deoxygenation Sodium cholate solution was freely drank in combination with abnormal hunger and satiety, that is, 2 days of full food, 1 day of fasting, and continuous modeling for 12 weeks to form a chronic gastritis model. One rat in the group was sacrificed and its stomach was taken. The pathological features of chronic gastritis were confirmed by histopathological examination, indicating that the modeling was successful.

The rats in the normal group were orally gavaged with 0.9% sodium chloride solution 10 mL/kg, twice a day, provided with adequate diet and clean tap water.

2. Animal grouping and administration method

All animals (90 clean-grade male SD rats, 8 weeks old, body weight 200±20g, randomly divided into normal group, model control group, positive control group, and Example 1-3 treatment groups) were obtained from the model after successful modeling. On the 2nd day, the following treatments were respectively given: the rats in the normal group and the model control group continued to be orally administered 10 mL/kg of 0.9% sodium chloride solution twice a day; the rats in the positive control group were administered orally 0.01 g/mL vitamin C Enzyme Suspension 10mL/kg, 2 times/d; Treatment groups in Examples 1-3 were given Susima Erweikang Granule Suspension 10mL/kg, orally, 2 times/d. All rats were continuously given relevant factors for 4 weeks, with adequate diet and drinking water.

3. Observation methods and indicators

At the end of the 16th week of the experiment, the rats were fasted for 24 hours and water for 8 hours, 10% chloral hydrate solution was intraperitoneally anesthetized, blood was taken from the heart, serum was separated, and the serum prostaglandin E ₂ (PGE ₂ ) and nitric oxide synthase of the rats were tested. (NOS) level. The assay method adopts ELISA and nitrate reductase method, and operates strictly according to the kit instructions. 1.5cm away from the cardia and pylorus, the whole stomach was cut off, and the whole stomach was cut open along the side of the greater curvature of the stomach. After flushing with ice saline, the filter paper was blotted and spread out. The gastric tissue of 1cm×0.5cm in the gastric antrum was taken and fixed in 10% medium. Sexual formalin solution for making pathological tissue sections.

(2) Pharmacological test results

Compared with the model control group, the level of PGE ₂ in each treatment group was significantly increased (P<0.01), and the level of NOS was significantly decreased (P<0.01), indicating that each treatment group had curative effect on chronic gastritis; Compared with the positive control group, the difference was significant (P<0.01), indicating that the curative effect of micronized granules of Chinese medicinal materials was better than that of the positive control group.

Table 6 Comparison of serum PGE ₂ and NOS content in each group of rats

Note: Compared with other groups, ^★ P <0.01; compared with positive control group, ^▲ P < 0.01.

Claims (5)

1. the traditional Chinese medicine for treating chronic gastritis is characterized by comprising the following components in parts by weight: 20-30 parts of lizard, 10-20 parts of dark plum fruit, 10-20 parts of oyster, 10-20 parts of hawthorn, 10-20 parts of white peony root, 5-15 parts of barbed skullcap herb, 5-15 parts of combined spicebush root, 5-15 parts of pseudo-ginseng, 10-20 parts of szechwan Chinaberry fruit, 10-20 parts of corydalis tuber, 10-20 parts of inula flower, 10-20 parts of lotus rhizome node, 5-15 parts of bletilla striata, 10-20 parts of scutellaria baicalensis, 10-20 parts of Chinese yam and 20-30 parts of liquorice.

2. A preparation method of traditional Chinese medicine micronized particles for treating chronic gastritis is characterized by comprising the following steps:

(1) cleaning: taking all the traditional Chinese medicinal materials according to the proportion recorded in the claim 1, rapidly cleaning the traditional Chinese medicinal materials by using purified water, spraying 75% alcohol after the water is volatilized, and standing;

(2) and (3) drying: drying the obtained traditional Chinese medicinal materials at 50-90 ℃ until the water content is 3% -8%;

(3) coarse crushing: pulverizing the obtained dried medicinal materials to obtain coarse powder of Chinese medicinal materials;

(4) micronization: carrying out superfine grinding on the obtained Chinese medicinal material coarse powder to obtain Chinese medicinal material micro powder;

(5) and (3) granulating: granulating the obtained Chinese medicinal micro powder to obtain Chinese medicinal micronized particles of 12-24 meshes;

(6) packaging in a weight mode.

3. The preparation method of the micronized Chinese medicine particles for treating chronic gastritis as claimed in claim 2, wherein: in the step (4), micronizing specifically by using a low-temperature vibration type ultrafine pulverizer or an air flow type ultrafine pulverizer, wherein when the low-temperature vibration type ultrafine pulverizer is used for pulverization, the pulverization temperature is controlled to be-50 to-20 ℃, and the pulverization time is controlled to be 5 to 20 min; when the superfine pulverizer is used for pulverizing, the pressure of airflow is controlled to be 0.5-1.5 MPa, the feeding speed is controlled to be 1-1.5 kg/h, the pulverizing temperature is-20 to-10 ℃, and the pulverizing time is 5-20 min.

4. The preparation method of the micronized Chinese medicine particles for treating chronic gastritis as claimed in claim 2, wherein: the granulation in the step (5) specifically adopts wet granulation or dry granulation, wherein when the wet granulation is adopted, 30-90% of ethanol in volume fraction is sprayed into the traditional Chinese medicine micro powder, the mixture is uniformly stirred to prepare a soft material, the soft material is granulated by using a sieve with 12-24 meshes, then the drying treatment is carried out, the drying temperature is controlled to be 30-70 ℃, the drying is carried out until the water content of the decoction pieces is 3-8%, and the granules are sieved by using a sieve with 12-24 meshes to complete the granules; when dry granulation is adopted, the Chinese medicinal micro powder is directly added into a granulator, the extrusion pressure is controlled to be 10-20 MPa, the extrusion speed is 15-25 r/min, and the feeding speed is 20-30 r/min, so that granules with the particle size of 12-24 meshes are prepared.

5. The preparation method of the micronized Chinese medicine particles for treating chronic gastritis as claimed in claim 2, wherein: and (6) packaging the component, namely sub-packaging the traditional Chinese medicine micronized particles by using aluminum plastic film packaging bags, wherein each bag contains 3-6 g of the micronized particles.

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