CN1660159A - Stomach invigorating medicine and preparation method thereof - Google Patents

Abstract

The invention relates to a stomach-invigorating medicine, the active ingredients of which are composed of effective extracts of hawthorn, jujube (denucleated), patchouli, perilla stem and fried malt. Soaking raw materials for extraction in 5-0 times of water for 0.5-2 hours, decocting for three times, each time lasting for 1-2 hours, filtering, combining filtrates, concentrating the filtrates, adding ethanol into the concentrate while stirring until the ethanol content is 50-90%, fully stirring, standing at room temperature for 12-36 hours, carrying out suction filtration, concentrating the filtrates, adding ethanol into the concentrated solution for alcohol precipitation, carrying out alcohol precipitation twice in the way, carrying out content determination on the final concentrated filtrate by an ultraviolet-visible spectrophotometer until the total flavone content of a dry extract is not lower than 35mg in each gram by rutin, wherein the concentrated extract is an active ingredient of the medicine; finally, the obtained active ingredients are mixed with auxiliary materials to prepare various oral preparations, and the content of total flavone in each gram of preparation is not less than 8 percent in terms of rutin.

Description

Stomach invigorating medicine and preparation method thereof

technical field

The invention relates to a stomach-invigorating medicine and a preparation method thereof, belonging to the field of traditional Chinese medicines.

Background technique

The status of existing similar products

The status of existing similar products is shown in Table 1.

Table 1 is similar to the Chinese medicine prescription of curative effect of medicine of the present invention name prescription composition dosage form effect Application range Open Chest Shunqi Pill 8 flavors such as betel nut, morning glory, tangerine peel, woody fragrance, etc. pill Eliminate stagnation Sternal fullness, epigastric pain Stomach and Xiaoshi Tablets Pseudostellariae, tangerine peel, yam, malt, hawthorn tablet Jianweixiaoshi Weak spleen and stomach, indigestion Bohe Maru Hawthorn, Liushenqu, Pinellia, Poria and other 8 flavors pill Digestion food stagnation, indigestion Divine Comedy Tea 17 flavors including Six Divine Comedy, Malt, Hawthorn, Patchouli Granules Jianweixiaoshi Insufficient appetite, abdominal pain Betel nut four Xiaoxiao pills Betel nut, rhubarb, morning glory, pig tooth soap and other 6 flavors pill Digestion and stagnation, qi and diarrhea indigestion Anshen Buxin Wan Danshen, Schisandra, Shichangpu, soothing ointment pill Nourish the mind and calm the nerves Palpitations, insomnia, dizziness and tinnitus Baizi Yangxin Pills Baiziren, Dangshen, Radix Astragalus, Chuanxiong, Angelica and other 13 traditional Chinese medicines honey pill Invigorate Qi, nourish blood, soothe the nerves Deficiency of Qi and cold, palpitations and insomnia

Problems with existing products

The existing products of the same kind are all made by traditional Chinese medicine preparation methods, the preparation technology is backward, the active ingredient content is low, the extractum has strong hygroscopicity, the preparation stability is poor, and the dosage is large each time. The invention utilizes technologies such as water extraction, alcohol precipitation, spray drying and the like to preserve effective components to the greatest extent, and coats the granules, thereby greatly improving the stability of the formulation.

Contents of the invention

The object of the present invention is to provide a medicine for invigorating the stomach, which has better clinical effect and clearer therapeutic effect than the existing similar medicines.

Another object of the present invention is to provide a preparation method of the above-mentioned medicine, which uses modern advanced extraction and refining and spray drying technology, as well as coating technology, to realize the extraction and preservation of active ingredients, and improve the quality and stability of the preparation , reducing the dose of each administration.

Above-mentioned purpose of the present invention is achieved like this:

The active ingredient of the medicine of the present invention is composed of the effective extracts of hawthorn, jujube (pitted), patchouli, perilla stalk, and fried malt, wherein the composition and weight ratio of the raw material used for extraction are: Hawthorn 3～ 20 parts, 5-20 parts of jujube, 1-12 parts of patchouli, 2-15 parts of perilla stalk, 2-20 parts of fried malt. The ratio of raw materials is preferably: 5 parts of hawthorn, 5 parts of jujube (pitted), 5 parts of patchouli, 5 parts of perilla stalk, and 5 parts of fried malt.

The preparation method of medicine of the present invention is as follows:

Soak the raw material drug in 5-10 times the amount of water for 0.5-2 hours, decoct three times for 1-2 hours each time, filter, combine the filtrate, concentrate the filtrate, add ethanol to the concentrate while stirring until the alcohol content 50-90%, stir well, stand at room temperature for 12-36 hours, filter with suction, concentrate the filtrate, then add ethanol to the concentrated solution for alcohol precipitation, so that the total alcohol precipitation is twice, and the last concentrated filtrate is subjected to ultraviolet-visible Spectrophotometer content determination The total flavonoid content of the dry extract shall not be less than 35mg per gram in terms of rutin. The total flavonoid content of rutin shall not be less than 8%.

Various oral preparations can be prepared by adding various common adjuvants of oral preparations to the active ingredient extract of the present invention. Tablets and capsules prepared by the following method have better curative effect. Preparation of tablets: Spray and granulate the active ingredient extract and auxiliary materials microcrystalline cellulose, talcum powder, magnesium stearate, and micropowder silica gel, then compress into tablets, and then coat with coating materials such as HPMC ethanol solution or acrylic resin water dispersion. coated into tablets. Preparation of capsules: the active ingredient extract and auxiliary materials microcrystalline cellulose, talcum powder, magnesium stearate, and micropowder silica gel are sprayed and granulated, and then coated with coating materials such as HPMC ethanol solution or acrylic resin water dispersion, and finally Capsule preparations are made by packing into capsule shells. The weight percent of auxiliary materials used in the preparation is: 20-97% of microcrystalline cellulose, 1-6% of talcum powder, 0.5-2% of magnesium stearate, and 0.5-4% of micropowder silica gel. Preferably: 96% of microcrystalline cellulose, 2% of talc, 1% of magnesium stearate, and 1% of micronized silica gel.

Stomach invigorating medicine provided by the present invention and preparation method thereof have the following advantages:

1. Hawthorn is used in this prescription. The sweet acid can eliminate all dietary stagnation, especially the accumulation of greasy meat. It is the king medicine. The transfer of the spleen and stomach and the transportation and transformation of dampness all depend on the movement of qi. In the case of food accumulation, it is easy to block the qi mechanism, increase dampness and transform heat, and cause disharmony of the spleen and stomach. Dampness and turbidity in the interior, promote clearness and reduce turbidity, help hawthorn to digest food and accumulate, eliminate filth and harmonize the middle. Accompanied by malt to eliminate silt, and jujube to benefit stomach qi and nourish stomach yin. Combined into a prescription, it has the functions of widening the middle and regulating qi, aromatizing turbidity, and strengthening the spleen and stomach.

2. The preparation process adopts the water decoction and alcohol precipitation process, adopts spray drying technology, and coats the granules, which guarantees the preservation of the activity of the active ingredients and improves the stability of the preparation, thereby improving the product quality and overcoming the shortcomings of the existing technology , Obtained stomach invigorating medicine with better curative effect.

Description of drawings

Fig. 1 is a process flow diagram for the preparation of medicine for treating stomach invigorating.

Detailed ways

The present invention is described in detail below by way of examples, and the beneficial effect of described medicine is further set forth. It is necessary to point out that this embodiment is only used to further illustrate the present invention, and cannot be interpreted as limiting the protection scope of the present invention, and those skilled in the art can make some non-essential improvements and adjustments according to the above-mentioned content of the present invention .

Examples 1-11 are preparation examples of the medicament of the present invention.

Example 1

Soak 8 grams of hawthorn, 6 grams of jujube (pitted), 4 grams of patchouli, 2 grams of perilla stalks, and 3 grams of fried malt in 10 times the amount of water for 1 hour, then decoct three times, each time 1 ~2 hours, filter, combine the filtrate, concentrate the filtrate, add 95% ethanol to 80% alcohol content, stir well, let stand at room temperature for 24 hours, filter with suction, concentrate the filtrate, then add 95% ethanol to the concentrated solution for alcohol precipitation , so ethanol precipitation twice, the last filtrate was concentrated. Concentrated extract plus auxiliary materials spray granulation, coated with coating materials such as HPMC ethanol solution or acrylic resin (Eudragit) aqueous dispersion, to make 4 capsules.

Example 2

Soak 10 grams of hawthorn, 5 grams of jujube (pitted), 5 grams of patchouli, 2 grams of perilla stalks, and 3 grams of fried malt in 5 times the amount of water for 2 hours, then decoct three times, each time 1 ~ 2 hours, filter, combine the filtrate, concentrate the filtrate, add ethanol until the alcohol content is 60%, stir fully, let stand at room temperature for 36 hours, filter with suction, concentrate the filtrate, then add ethanol to the concentrated solution for alcohol precipitation, so that the total alcohol Sink twice and concentrate the last filtrate. Concentrated extract plus auxiliary materials (microcrystalline cellulose 1g, talcum powder 0.02g, magnesium stearate 0.01g, micronized silica gel 0.01g) spray granulation, press 4 tablets, use HPMC ethanol solution or Eudragit aqueous dispersion, etc. The coating material can be obtained after coating.

Example 3

Soak 20 grams of hawthorn, 10 grams of jujube (pitted), 10 grams of patchouli, 10 grams of perilla stalks, and 8 grams of fried malt in 10 times the amount of water for 0.5 hours, then decoct three times, each time 1 ~ 2 hours, filter, combine the filtrate, concentrate the filtrate, add ethanol until the alcohol content is 90%, stir fully, let stand at room temperature for 12 hours, filter with suction, concentrate the filtrate, then add ethanol to the concentrated solution for alcohol precipitation, so that the total alcohol Sink twice and concentrate the last filtrate. The concentrated extract is sprayed and granulated, and blank granules made by adding sucrose, lactose, and flavoring agents are added, mixed evenly, and divided into 4 bags to obtain granules.

Example 4

Soak 15 grams of hawthorn, 10 grams of jujube (pitted), 10 grams of patchouli, 8 grams of perilla stalk, and 6 grams of fried malt in 9 times the amount of water for 1.5 hours, then decoct three times, each time 1 ~2 hours, filter, combine the filtrate, concentrate the filtrate, add ethanol until the alcohol content is 70%, stir fully, let stand at room temperature for 18 hours, filter with suction, concentrate the filtrate, then add ethanol to the concentrated solution for alcohol precipitation, so that the total alcohol Sink twice and concentrate the last filtrate. The concentrated extract is sprayed and granulated, and blank granules made by adding sucrose, lactose, and flavoring agents are added, mixed evenly, and divided into 4 bags to obtain granules.

Example 5

Soak 8 grams of hawthorn, 6 grams of jujube (pitted), 4 grams of patchouli, 2 grams of perilla stalks, and 3 grams of fried malt in 10 times the amount of water for 1 hour, then decoct three times, each time 1 ~ 2 hours, filter, combine the filtrate, concentrate the filtrate, add ethanol until the alcohol content is 80%, stir well, let stand at room temperature for 30 hours, filter with suction, concentrate the filtrate, then add ethanol to the concentrated solution for alcohol precipitation, so that the total alcohol Sink twice and concentrate the last filtrate. Concentrated extract and auxiliary materials (microcrystalline cellulose 1g, talc 0.02g, magnesium stearate 0.01g, micropowder silica gel 0.01g) spray granulation, with HPMC ethanol solution or acrylic resin (Eudragit) aqueous dispersion and other coating materials Coated, made into 4 capsules.

Example 6

Soak 4 grams of hawthorn, 10 grams of jujube (pitted), 2 grams of patchouli, 4 grams of perilla stalk, and 5 grams of fried malt, soak in 10 times the amount of water for 1 hour, and decoct three times, 1 hour each time. ~ 2 hours, filter, combine the filtrate, concentrate the filtrate, add 95% ethanol to the alcohol content of 85%, stir fully, let stand at room temperature for 24 hours, filter with suction, concentrate the filtrate, then add ethanol to the concentrated solution for alcohol precipitation, so Alcohol precipitation was carried out twice, and the last filtrate was concentrated. The concentrated extract is spray granulated, coated with coating materials such as HPMC ethanol solution or acrylic resin (Eudragit) aqueous dispersion, and made into 4 capsules.

Example 7

Soak 10 grams of raw hawthorn, 5 grams of jujube (pitted), 1 gram of patchouli, 2 grams of perilla stalk, and 2 grams of fried malt in 10 times the amount of water for 1 hour, then decoct three times, 1 gram each time. ~2 hours, filter, combine the filtrate, concentrate the filtrate, add ethanol until the alcohol content is 65%, stir fully, let it stand at room temperature for 36 hours, filter with suction, concentrate the filtrate, and then add ethanol to the concentrated solution for alcohol precipitation, so that the total alcohol Sink twice and concentrate the last filtrate. Spray granulation of the concentrated extract, add excipients (microcrystalline cellulose 1g, talcum powder 0.02g, magnesium stearate 0.01g, micropowder silica gel 0.01g), compress 4 tablets, use HPMC ethanol solution or Eudragit aqueous dispersion Wait until the coating material is coated.

Example 8

Soak 10 grams of hawthorn, 15 grams of jujube (pitted), 9 grams of patchouli, 15 grams of perilla stalk, and 20 grams of fried malt in 5 times the amount of water for 2 hours, then decoct three times, each time 1 ~ 2 hours, filter, combine the filtrate, concentrate the filtrate, add ethanol until the alcohol content is 70%, stir fully, let stand at room temperature for 36 hours, filter with suction, concentrate the filtrate, and then add ethanol to the concentrated solution for alcohol precipitation, so that the total alcohol Sink twice and concentrate the last filtrate. Concentrated extract plus auxiliary materials (microcrystalline cellulose 1g, talcum powder 0.02g, magnesium stearate 0.01g, micronized silica gel 0.01g) spray granulation, press 4 tablets, use HPMC ethanol solution or Eudragit aqueous dispersion, etc. The coating material can be obtained after coating.

Example 9

Soak 3 grams of hawthorn, 20 grams of jujube (pitted), 12 grams of patchouli, 10 grams of perilla stalk, and 3 grams of fried malt, soak in 10 times the amount of water for 2 hours, and decoct three times, each time 1 ~ 2 hours, filter, combine the filtrate, concentrate the filtrate, add ethanol until the alcohol content is 85%, stir fully, let stand at room temperature for 24 hours, filter with suction, concentrate the filtrate, then add ethanol to the concentrated solution for alcohol precipitation, so that the total alcohol Sink twice and concentrate the last filtrate. Concentrated extract plus auxiliary materials (microcrystalline cellulose 1g, talcum powder 0.02g, magnesium stearate 0.01g, micronized silica gel 0.01g) spray granulation, press 4 tablets, use HPMC ethanol solution or Eudragit aqueous dispersion, etc. The coating material can be obtained after coating.

Example 10

Soak 5 grams of hawthorn, 6 grams of jujube (pitted), 4 grams of patchouli, 5 grams of perilla stalks, and 3 grams of fried malt in 10 times the amount of water for 1 hour, then decoct three times, each time 1 ~2 hours, filter, combine the filtrate, concentrate the filtrate, add 95% ethanol to 80% alcohol content, stir well, let stand at room temperature for 24 hours, filter with suction, concentrate the filtrate, then add 95% ethanol to the concentrated solution for alcohol precipitation , so ethanol precipitation twice, the last filtrate was concentrated. Concentrated extract plus auxiliary materials spray granulation, coated with coating materials such as HPMC ethanol solution or acrylic resin (Eudragit) aqueous dispersion, to make 4 capsules.

Example 11 pilot production results

The pilot test was carried out with 250 times of the compatible raw materials of Example 7, the yield of the extract was about 6-15%, and the total flavonoid content was 17 mg/g. The quality of the finished product is stable, and it is made into 1000 capsules, and the dosage is 2 capsules each time, 2 times a day.

A total of 3 batches were produced and the results are as follows:

                                                      

batch number

(Kg) (Kg) (mg/g)

20020217 100 10.04 17.3

20020218 100 9.98 17.7

20020219 100 10.12 17.8

Embodiment 12, pharmacological action research of medicine of the present invention

1. Materials and methods

1.1 Test sample: the active pharmaceutical ingredient prepared according to the ratio of Example 1 of the present invention.

1.2 Experimental animals: 60 female mice of SPF Kunming species, 10 spares, weighing 18-20 grams, 60 wistar male rats, weighing 140-150 grams, and 10 spares, the animal approval number is Edong Guan Zi No. 19-082 and No. 19-084.

1.3 Animal grouping and dose design: According to the daily intake of human beings 0.03g/kg.bw, respectively expand 10, 20, and 30 times (ie 0.3, 0.6, 0.9g/kg.bw) as the test substance low, medium, and high dose group. A blank control group was also set up, and each dose group prepared the test substance with distilled water to make the corresponding dose orally orally. The tests were carried out after continuous gavage for 20 and 28 days.

1.4 Test methods and observation indicators:

1.4.1 Determination of body weight and food utilization rate: Wistar rats were used to observe the body weight and food utilization rate for 28 days.

1.4.2 Small intestine propulsion test

SPF grade Kunming mice were used and divided into blank control group and low, medium and high dose groups, with 10 mice in each group. The animals in each dose group were given the test substance by gavage for 20 days continuously, and the animals in the blank control group were given the same amount of distilled water at the same time. Before the experiment, the mice in each group of the test substance were fasted for 12 hours, and each dose group was given compound diphenoxylate (about 5mg/kg.bw), and was given by oral gavage at 0.15ml/10g.bw (except the normal control group) After 30 minutes, give the test substance and the carbon powder glue solution 0.2ml/10g.bw (the test substance can be prepared by the carbon powder glue solution) through oral gavage at the same time, and after 25 minutes, each experimental group is in the order of oral gavage (each group Five minutes apart) the animals were killed by cervical dislocation, the mesentery was separated by laparotomy, the intestinal tube from the upper end to the pylorus and the lower end to the ileocecal was cut, the small intestine was gently flattened and straightened, and the progress of the carbon glue from the pyloric sphincter to the small intestine ileocecal was measured length and the total length of the small intestine. Small bowel motility is expressed as small bowel propulsion rate (%):

1.4.3 Determination of digestive enzymes:

SPF grade wistar male rats were used, and the animals were divided into blank control group and low, medium and high dose groups, with 10 rats in each group. Animals in each dose group were given the test substance by gavage continuously for 28 days, and the blank control group was given the same amount of distilled water at the same time. Before the test, the animals in each group were fasted for 24 hours (drinking water freely during the period), and the rats were anesthetized by intraperitoneal injection of 100mg/kg.bw dose of thiopental sodium, and the gastric juice output was collected for 5 hours by pyloric ligation, and the gastric juice output per unit time was measured. , pepsin activity, and calculate the amount of protease excretion; pepsin activity was measured using the Mett’s method, that is, a glass tube with an inner diameter of 1.5mm was used, fresh egg white was injected, placed on a hot water bath to make the protein coagulate, and then taken out, discarded. Protein tubes, stored in the refrigerator, made into 3cm lengths before use, and selected 100ml corked triangular flasks at the same time, adding 0.05mol hydrochloric acid 15ml to 1ml of gastric juice and mixing them in the conical flasks, adding 3cm long protein tubes to each bottle 2 Roots, sealed, take out after 24 hours in the incubator, measure the length (mm) of the transparent part at both ends of the protein tube with a vernier caliper, calculate the average value with the value of the four ends, pepsin activity unit (U)=average value 2 * 16 , and calculate pepsin excretion (U/hr).

1.4.4 Statistical methods: analysis of variance and t-test were used.

2. Results

2.1 Body weight, food intake and food utilization results:

As can be seen from Table 1, the medicine of the present invention has no significant impact on animal body weight and food utilization.

Table 1 The results of body weight, food intake and food utilization rate of male rats (X±S)

Group Dose Number of Animals Initial Weight Final Weight Weight Gain Total Food Utilization Efficiency

(g/kg.bw) (only) (g) (g) (g) (%)

Blank control 0 10 148±2.77 234±5.66 85±6.48 20.7±1.64

Low dose group 0.35 10 149±2.46 235±9.25 86±10.28 22.2±2.73

Medium dose group 0.70 10 150±3.03 242±9.33 93±9.58 24.7±2.78

High dose group 1.10 10 150±2.37 235±9.78 85±10.06 23.5±2.70

2.2 The effect of the test substance on the propulsive movement of the small intestine: see Table 2. As can be seen from Table 2, the small intestine propulsion rate of the mice in the low, middle and high dose groups of the medicine of the present invention is significantly higher than that of the model control group. Compared with the model control group in the low, middle and high doses of the statistical analysis, the difference is very significant. Sex (P<0.01).

Table 2 "medicine of the present invention" on the impact of mouse small intestine mechanical movement (X ± S)

Group Dose Number of Animals Initial Weight Final Weight Small Intestine Total Length Propelling Length Propelling Rate

(g/kg (only) (g) (g) (cm) (cm) (%)

.bw)

normal

Control group 0 10 18.4±1.8 34.1±2.3 45.4±3.6 30.9±6.5 68.2±

14.0 model

Control group 0 10 18.2±0.8 34.4±2.1 41.5±4.4 18.0±3.7 45.2±8.2

Low dose group 0.35 10 18.0±0.9 34.1±2.1 45.2±4.0 17.4±3.0 39.0±9.0

Medium dose group 0.70 10 18.3±1.0 33.9±1.7 41.8±4.9 20.2±4.9 48.7±

12.8

High dose group 1.10 10 18.0±1.2 34.0±1.7 21.2±2.5 47.2±5.7 45.3±

7.0

Compared with the model control group **: P<0.01

2.3 Effects on digestive enzyme activity:

See Table 3. As can be seen from Table 3, each test group of the medicine of the present invention is compared with the control group, and there is no significant difference in the amount of gastric juice discharge in the low, middle and high dose groups (P>0.05). But compared with the matched group, the middle and high dose groups can significantly increase the activity of pepsin, and the difference is significant (P<0.01, P<0.05). Extremely significant (P<0.01).

Table 3 Determination results of pepsin activity in male rats (X±S) group Dose (g/kg.bw) Number of animals (only) Gastric juice volume (ml) Pepsin activity (U) Pepsin output (U/hr) Normal control group, low dose group, middle dose group, high dose group 00.350.701.10 10101010 3.8±1.303.2±1.354.9±1.523.9±1.61 254±115.6316±182.8504±130.2**396±121.3* 207±163.2238±263.6505±239.5**33 3±200.4

Compared with the control group *: P<0.05, **: P<0.01

3. Conclusion:

According to the recommended daily intake of the population 1.8g/60kg.bw, expand 10, 20, and 30 times respectively (ie 03, 0.6, 0.9g/kg.bw) as the low, medium, and high dose groups of the test substance, using SPF grade Kunming mice and Wistar rats were continuously given the test substance for 20 and 28 days, and the results of the digestion promotion test showed that: 1) the test substance could significantly enhance the mechanical movement of the small intestine of the mice, and the small intestine propulsion rate of animals in the three dose groups All significantly increased, and compared with the model control group, the difference was extremely significant (p<0.01). 2) The test substance has no significant effect on animal body weight and food utilization. Compared with the control group, there was no significant difference in gastric juice discharge between the low, middle and high dose groups (P>0.05). The middle and high dose groups can significantly increase the activity of pepsin, and the difference is significant (P<0.01, P<0.05). ). The above experimental results show that: the test substance has a certain function of promoting digestion; the drug has the effect of increasing the secretion of gastric juice; the drug of the invention can mobilize the dysfunctional gastrointestinal activities to achieve the effect of invigorating the spleen and transforming food.

Embodiment 13 clinical curative effect verification

1 Materials and methods

1.1 Sample: the capsule prepared in Example 11; placebo: a mixture of starch and caramel coloring.

1.2 Test objects: Choose 100 children aged 4-6 years old whose body weight is within 1 standard deviation of the normal weight value, accompanied by poor appetite, reduced food intake, partial eclipse and other digestive problems, but without other adverse manifestations.

1.3 Test grouping and consumption: This test adopts double-blind method, and the subjects are randomly divided into two groups, 50 cases in the test group and 50 cases in the control group, with half men and half women in each group. The test group eats the medicine of the present invention, and the control group eats the placebo. According to the consumption amount and the eating method provided by the production unit, 3 times a day, 2 capsules each time, the food trial period is 30 days.

1.4 Statistical analysis method: T test is used.

2 Observation indicators

2.1 General observation indicators

2.1.1 Subjective sensory indicators: diet, sleep and mental state. Parents and attending physicians observed the daily performance of the tested children and described them in terms of good and bad.

2.1.2 Physical examination indicators: height, weight, heart rate, skin, liver, spleen, electrocardiogram and chest X-ray. According to the routine physical examination method, the attending physician will conduct it.

2.1.3 Blood indicators: hemoglobin, red blood cell count, white blood cell count, according to routine clinical testing methods.

2.2 Diet change indicators

2.2.1 Appetite improvement: Appetite improvement is described by the subjects and parents of children, and observed by the attending doctor. It is divided into three categories: good appetite (3 points), moderate (2 points) and poor (1 point).

2.2.2 Improvement of partial eclipse: The improvement of partial eclipse is described by the subjects and parents of children, and observed by the attending doctor. It is divided into three types: no partial eclipse (3 points), moderate partial eclipse (2 points) and partial eclipse (1 point).

2.2.3 Improvement of food intake: Accurately record the total daily food intake (including staple food, non-staple food, beverages and fruits) of the children before and after the test, take three consecutive days of observation as a unit of measurement and measure the staple food intake (three-day mean) for statistical analysis.

3 results

3.1 Changes in general index of eating medicine of the present invention

3.1.1 General situation

Table 1 eats the general situation (X ± S) before the medicine trial of the present invention group Number of cases gender age) Weight (Kg) Hemoglobin (g%) male female male female male female male female test group control group 5050 2525 2525 5.4±0.75.4±0.7 5.3±0.55.3±0.9 18.5±1.618.5±1.2 17.7±1.317.6±1.5 11.9±0.612.0±0.6 11.9±0.511.9±0.7

3.1.2 Changes in subjective feelings and physical examination indicators

The subjects had no adverse reaction after trying the medicine of the present invention and the placebo for 30 days, and their height, weight, heart rate, skin, spleen, lung and electrocardiogram examinations were all normal. And the diet, sleep and mental state of the test subjects have been improved to a certain extent.

3.1.3 Changes in hematological indicators

Table 2 eats the medicine hematology index comparison of the present invention (X ± S) index gender test group control group Before tasting after tasting Before tasting after tasting Red blood cells (10 ¹² /L) White blood cells (10 ⁹ /L) men and women 4.04±0.193.98±0.156.61±1.096.85±1.33 4.10±0.1 34.07±0.236.82±0.686.72±0.73 4.00±0.234.03±0.217.34±1.156.89±1.26 4.00±0.184.01±0.197.62±0.947.13±1.00

The above results showed that the number of red blood cells in the test group tended to increase after the trial feeding, while the number of red blood cells in the control group had no significant change before and after the trial feeding. The white blood cell counts of the test group and the control group were within the normal range before and after feeding.

3.2 Changes in diet of taking medicine of the present invention

Observe the changes in appetite, food intake and partial eclipse of all subjects before and after the test, and the results are shown in Table 3-5.

Table 3 eats medicament appetite improvement of the present invention and compares (scoring, X ± S) group Number of cases Before tasting after tasting test group control group 5050 1.2±0.51.4±0.6 2.3±0.5*1.3±0.7

Compared with before and control group, *P<0.01

Table 4 eats the change situation (X ± S, g/day) of food intake (staple food) of medicine of the present invention gender Trial group control group Number of cases Before tasting after tasting Number of cases Before tasting after tasting men and women 2525 247.1±25.4239.2±30.9 290.4±35.3*281.3±31.5* 2525 241.5±26.9240.6±31.5 242.3±38.7241.1±37.2

Compared with before feeding, *P<0.01

Table 5 eats the variation situation comparison of partial eclipse of medicine of the present invention (scoring, X ± S) group Number of cases Before tasting after tasting test group control group 5050 1.5±0.61.8±0.7 2.2±0.6*1.8±0.8

Compared with before and control group, *P<0.01

From table 3, 4, 5, it is shown that after the experimenter tried food, the appetite and partial eclipse of the test group improved significantly, and there was a highly significant difference (P＜0.01) compared with before the test food and the matched group; the food intake of the test group had Significantly increased, and the difference was highly significant (P<0.01) compared with that before the trial feeding; there was no significant change in the control group.

3.3 Changes in body weight and hemoglobin before and after eating the medicine of the present invention

Table 6 eats body weight change situation (X ± S, Kg) before and after food trial of medicine of the present invention gender test group control group Number of cases Before tasting after tasting Number of cases Before tasting after tasting male 25 18.5±1.6 19.0±1.6* 25 18.5±1.2 18.7±1.2* female 25 17.7±1.3 18.1±1.4* 25 17.6±1.5 17.9±1.5*

Compared with before the test, *P<0.01

Table 7 eats the changing situation of hemoglobin (X ± S, g%) before and after the food trial of the medicine of the present invention gender test group control group Number of cases Before tasting after tasting Number of cases Before tasting after tasting male 25 11.9±0.6 12.1±0.4* 25 12.0±0.6 12.0±0.6 female 25 11.9±0.5 12.0±0.5* 25 11.9±0.6 11.9±0.5

Compared with before the test, *P<0.01

It can be seen from Table 6 that the body weight of the subjects all increased to varying degrees, and the difference in body weight before and after the test group was highly significant (p<0.01), regardless of male or female. It can be seen from Table 7 that the difference in hemoglobin before and after the test group was highly significant (p<0.01); the control group had no significant change in hemoglobin.

4 Conclusion

After the subjects ate the drug capsules continuously for 30 days, the appetite and partial eclipse indicators of the test group were significantly improved, and the difference was highly significant (P<0.01) compared with those before the test and the control group. The comparison difference was highly significant (P<0.01), the weight gain of the test group was obvious, and the difference was highly significant compared with that before the test, and the difference in hemoglobin before and after the test group was highly significant (p<0.01). At the same time, there were no abnormal changes in subjective sensation, physical examination and other related indicators. According to the standard of "human body test method for promoting digestive function", it is judged that the drug capsule has the effect of promoting digestive function.

Claims (9)

1, a kind of medicine that is good for the stomach is characterized in that, it is made by following bulk drugs: 3～20 parts of Fructus Crataegis, 5～20 parts in Fructus Jujubae, 1～12 part of Herba Pogostemonis, 2～15 parts of Caulis Perillaes, 2～20 parts of Fructus Hordei Germinatus (parched)s.

2, medicine according to claim 1 is characterized in that, the consumption of each crude drug is: 5 parts of Fructus Crataegis, 5 parts in Fructus Jujubae, 5 parts of Herba Pogostemonis, 5 parts of Caulis Perillaes, 5 parts of Fructus Hordei Germinatus (parched)s.

3, medicine according to claim 1 is characterized in that, this medicine is an oral formulations.

4, a kind of method for preparing the described medicine of claim 1, it is characterized in that, the above-mentioned raw materials medicine soaked 0.5～2 hour in the water of 5～10 times of amounts after, decoct three times, each 1～2 hour, filter merging filtrate, filtrate concentrates, add ethanol while stirring until containing alcohol amount 50～90% in concentrate, fully stir, room temperature left standstill 12～36 hours, sucking filtration, concentrated filtrate carries out precipitate with ethanol with adding ethanol in the concentrated solution again, and precipitate with ethanol is twice so altogether, last spissated filtrate must not be lower than 35mg in rutin in every gram through ultraviolet-visible spectrophotometer assay dry extract general flavone content, and this concentrated extract is the active ingredient of described medicine; At last the gained active ingredient is made various oral formulations, the general flavone content of every restraint agent must not be lower than 8% in rutin.

5. method according to claim 4 is characterized in that, after described active component extractum drying, the granulation, carries out the preparation of various oral formulations again.

6. method according to claim 5 is characterized in that, described active component extractum adds microcrystalline cellulose excipients, Pulvis Talci, magnesium stearate is behind the micropowder silica gel spray granulation, tabletting forms tablet with coating material coatings such as HPMC alcoholic solution or acrylic resin aqueous dispersions again.

7. method according to claim 5, it is characterized in that, described active component extractum adds microcrystalline cellulose excipients, Pulvis Talci, magnesium stearate, behind the micropowder silica gel spray granulation,, reinstall and make capsule preparations in the capsule shells with coating material coatings such as HPMC alcoholic solution or acrylic resin aqueous dispersions.

8. according to claim 6 or 7 described methods, it is characterized in that described adjuvant percentage by weight is: microcrystalline Cellulose 20-90%, Pulvis Talci 1-6%, magnesium stearate 0.5-2%, micropowder silica gel 0.5-4%.

9. method according to claim 8 is characterized in that, described adjuvant percentage by weight is: microcrystalline Cellulose 96%, Pulvis Talci 2%, magnesium stearate 1%, micropowder silica gel 1%.