CN109172757B - Intestine moistening and bowel relaxing granules - Google Patents

Abstract

The invention discloses a bowel relaxing granule which is prepared from raw materials such as fructus cannabis, sophora flower bud, fructus momordicae, medlar, dried orange peel, chrysanthemum morifolium, lophatherum gracile, hawthorn, resistant dextrin, maltitol, inulin, scented tea extract and the like. The traditional Chinese medicinal materials selected by the invention are tonified, are mild in treatment effect, do not contain anthraquinone substances, do not stimulate intestinal mucosa, prevent colon black lesion, do not generate dependence, and do not relapse after stopping medicine. Therefore, the invention is a reliable and reliable traditional Chinese medicine for relaxing bowel with definite curative effect.

Description

Intestine moistening and bowel relaxing granules

Technical Field

The invention belongs to the field of traditional Chinese medicines, and relates to a bowel relaxing granule.

Background

With the acceleration of life rhythm, the change of eating habits and the influence of social and psychological factors and the like, the incidence rate of constipation in China is higher and higher, and the incidence rate is in a trend of rising year by year. Constipation occurs with all ages, and although the constipation does not directly threaten the lives of people, the constipation has great influence on the lives and the work of people. Constipation is a serious hazard, and not only can aggravate primary diseases, but also can induce cardiovascular and cerebrovascular diseases, resulting in colon cancer, senile dementia, hypomnesis and the like.

The raw materials selected from the components of the laxative traditional Chinese medicine or the health food in the market are mostly rhubarb, aloe, senna leaf, cassia seed and the like. The strong cathartic containing anthraquinone substances has stimulation effect on intestinal mucosa, and can cause pathological change of the intestinal mucosa after a long time, so the strong cathartic is clinically called colon black lesion. Colon dark lesions are currently considered a precancerous lesion that can cause colon cancer. The chronic habitual constipation people can grow dependence after using medicines containing rhubarb, aloe or senna leaves for a long time, and the medicines are used more and more, and finally the medicines are ineffective.

Disclosure of Invention

The invention aims to solve the technical problem of providing the intestine-moistening and bowel-relaxing granules which do not contain anthraquinone substances such as rhubarb, aloe, senna leaf, cassia seed and the like, and have quick response and good curative effect.

In order to solve the technical problems, the invention adopts the following technical scheme:

a bowel relaxing granule is prepared from the following raw materials in parts by weight: 1-18 parts of fructus cannabis, 1-15 parts of sophora flower bud, 1-8 parts of momordica grosvenori, 1-12 parts of medlar, 1-15 parts of dried orange peel, 1-7 parts of chrysanthemum morifolium, 1-17 parts of lophatherum gracile, 1-7 parts of hawthorn, 1-9 parts of resistant dextrin, 1-12 parts of maltitol, 1-12 parts of inulin and 1-12 parts of scented tea extract.

In order to further improve the effect of relaxing bowel, the invention preferably comprises the following raw materials in parts by weight: 15 parts of fructus cannabis, 12 parts of sophora flower bud, 5 parts of momordica grosvenori, 8 parts of medlar, 10 parts of dried orange peel, 5 parts of chrysanthemum morifolium, 9 parts of lophatherum gracile, 3 parts of hawthorn, 3 parts of resistant dextrin, 8 parts of maltitol, 6 parts of inulin and 2 parts of scented tea extract.

The bowel relaxing granule is prepared by the following method:

1) decocting fructus Cannabis, flos Sophorae Immaturus, fructus Siraitiae Grosvenorii, fructus Lycii, pericarpium Citri Tangerinae, flos Chrysanthemi, folium Bambusae and fructus crataegi in water, filtering, and collecting extractive solution;

2) adding complex enzyme into the extractive solution, performing enzymolysis at 35-60 deg.C for 1-5 hr, heating to boil for inactivating enzyme, and concentrating under reduced pressure to obtain fluid extract with relative density of 1.05-1.15;

3) adding ethanol into the fluid extract to make the weight content of ethanol reach 40-70%, stirring, and standing overnight;

4) collecting supernatant after alcohol precipitation, concentrating under reduced pressure to obtain soft extract with relative density of 1.25-1.35; placing resistant dextrin, maltitol, inulin, and scented tea extract in a spray granulator, spray granulating with the soft extract, and drying to obtain granule.

According to the invention, the compound enzyme is added to carry out enzymolysis on the extracting solution, so that macromolecular substances in the traditional Chinese medicine are decomposed into small molecules, the conversion of active ingredients is realized, the absorption and utilization of the medicine are effectively promoted, the curative effect of the medicine is improved, and the granules are quicker to dissolve, clearer and better in taste when taken with water, so that the compliance of patients is improved. The preferred compound enzyme of the invention consists of cellulase, pectinase, amylase and neutral protease, and the dosage of the compound enzyme is 0.8-1.5%, 0.2-0.6% and 0.1-0.5% of the weight of the extracting solution respectively. Preferably, the dosage of the cellulase, the pectinase, the amylase and the neutral protease is 1.2%, 0.5% and 0.3% of the weight of the extracting solution respectively. The optimal enzymolysis parameters are: enzymolysis is carried out for 3h at the temperature of 45 ℃.

In addition, the time, frequency, water addition amount and alcohol precipitation concentration of decoction and extraction also have important influence on the content, curative effect, solubility and the like of active ingredients of the medicine, wherein the aim of alcohol precipitation is to remove impurities such as protein, tannin, polysaccharide, inactivated enzyme and the like in the clear paste. The best decoction extraction of the invention is to add water with 6 times of weight for decoction extraction for 2 times, and each time lasts for 2 hours. The optimal ethanol concentration is 65% during alcohol precipitation.

The invention has the following beneficial effects:

the traditional Chinese medicinal materials selected by the invention are tonified, are mild in treatment effect, do not contain anthraquinone substances, do not stimulate intestinal mucosa, prevent colon black lesion, do not generate dependence, and do not relapse after stopping medicine. Therefore, the invention is a reliable and reliable traditional Chinese medicine for relaxing bowel with definite curative effect.

The invention has strict formula and scientific preparation method. In the formula, fructus cannabis is sweet, neutral and oily, and can treat constipation of deficiency type and constipation of excess type; momordica grosvenori, sweet and moist in nature, cools blood, clears lung and moistens intestine, and both clear excess heat and moisten and nourish both are monarch drugs. Lophatherum gracile is sweet and bland, cold in nature and clear and good at purging and clearing heat; hangzhou white chrysanthemum is bitter and cold in property, can purge and descend, and is good at purging fire and cooling liver; the sophora japonica is a ministerial drug for clearing heat, removing food retention, clearing heat, cooling blood, and assisting monarch drugs in clearing damp-heat accumulation in intestines and stomach; medlar is sweet and neutral, has the effects of nourishing yin and promoting the production of body fluid, increasing fluid and moistening dryness, and is good at nourishing liver, kidney, yin and body fluid to moisten intestinal tracts, and also is a ministerial drug. The tangerine peel is fragrant and has the effects of tonifying spleen and warming middle energizer, promoting gastrointestinal qi stagnation and promoting body fluid to distribute; the hawthorn is used together as adjuvant drugs for promoting appetite and digestion, removing food stagnation and removing food retention, and promoting blood circulation and qi circulation, so as to enhance the effect of relaxing bowel of monarch drugs and ministerial drugs, warm middle-jiao and prevent spleen and stomach from being injured by bitter and cold in excess. The whole formula is compatible, mainly has the effects of clearing and relieving diarrhea and nourishing, and has the effects of purging heat and removing stagnation and relaxing bowel, so the formula is good for treating constipation caused by heat accumulation and body fluid consumption, constipation caused by long-term bed rest, temporary abdominal distension and constipation and habitual constipation of old people.

Meanwhile, the formula contains resistant dextrin and inulin dietary fiber, is not absorbed in small intestine, can directly enter large intestine, can promote growth and reproduction of beneficial flora in intestinal tract, is a bifidobacterium proliferation factor, can regulate intestinal flora, and has the functions of promoting gastrointestinal motility and improving gastrointestinal motility disorder. The dietary fiber can increase the volume of excrement and promote intestinal peristalsis by water swelling, and has good effect of preventing constipation. According to the requirements of color, fragrance and taste, the scented tea extract and the maltitol are added, and the prepared granules are pleasant in fragrance, fresh and natural, clear and bright in soup color and sweet, fresh and cool in taste.

Detailed Description

The present invention will be described in detail with reference to specific examples.

Example 1 Effect of different Chinese medicinal formulations on the defecation function of mice

The Chinese medicine formulations of examples 1-10 are shown in Table 1 below.

TABLE 1 Chinese medicine prescription table (g)

The Chinese herbal medicines of examples 1-10 were taken and ground into fine powder for use as the test sample.

Adult male ICR mice 144, weighing 18-22g, were selected and randomized into 12 groups (examples 1-10, blank, model) of 12 mice each. The groups 1 to 10 are administrated by intragastric administration at the dose of 6.5g/kg, and the blank control group and the model control group are administrated by intragastric administration with distilled water and are continuously administrated by intragastric administration for 15 days.

After 15d, mice in each group were fasted for 24h without water deprivation. Distilled water was given to the blank group, and compound diphenoxylate (10 mg/kg. BW) was given to the model group and 10 test groups by gavage. After the compound diphenoxylate is administered for 0.5h, the mice of the blank control group and the model control group are subjected to intragastric gavage by ink, the test group is administered with the ink containing the tested sample, the animals are all fed in a single cage, and the animals are fed with normal drinking water. Starting from ink filling, recording the time of black excrement discharge of the first grain of each animal, the number and the quality of the black excrement discharge within 6 hours, and observing the characteristics of the excrement. The results are shown in Table 2.

TABLE 2 Effect of the invention on defecating in mice

Group of	First defecation time (min)	Number of stool grains (grains)	Stool weight (g)
				Blank group	143	18.7	0.77
Model set	267	8.6	0.38
				Example 1	221	11.5	0.45
Example 2	194	13.4	0.56
				Example 3	205	12.3	0.51
Example 4	188	14.6	0.59
				Example 5	209	11.7	0.57
Example 6	195	13.1	0.52
				Example 7	176	14.2	0.62
Example 8	215	11.3	0.49
				Example 9	206	12.5	0.58
Example 10	190	13.3	0.60

From the above results, compared with the blank group, the time for the first defecation of the model group is prolonged, the number of the grains and the weight of the excrement are reduced, and the grains and the weight of the excrement are significantly different (P <0.05), which indicates that the constipation mouse model is successfully established. Compared with a model group, the first defecation time can be shortened, and the number and weight of the excrement grains can be increased in examples 1-10, which shows that the traditional Chinese medicine formula disclosed by the invention has the effect of relaxing the bowels, and the difference is very significant in example 7 (P < 0.01).

The experimental result shows that the traditional Chinese medicine can promote the intestinal peristalsis of a constipation model mouse, soften the excrement, shorten the first excrement discharging time, increase the grain number and the quality of the excrement, and thus has the effect of relaxing the bowels. Among them, example 7 has the fastest onset and the best defecation quality.

Example 11

15Kg of fructus cannabis, 12Kg of sophora flower bud, 5Kg of fructus momordicae, 8Kg of medlar, 10Kg of dried orange peel, 5Kg of chrysanthemum morifolium, 9Kg of lophatherum gracile, 3Kg of hawthorn, 3Kg of resistant dextrin, 8Kg of maltitol, 6Kg of inulin and 2Kg of scented tea extract.

1) Decocting fructus Cannabis, flos Sophorae Immaturus, fructus Siraitiae Grosvenorii, fructus Lycii, pericarpium Citri Tangerinae, flos Chrysanthemi, folium Bambusae and fructus crataegi with 6 times of water for 2 times (each time for 2 hr), filtering, and collecting the extractive solution (total 850 Kg);

2) adding complex enzyme composed of 10.2Kg cellulase, 4.25Kg pectinase, 4.25Kg amylase and 2.55Kg neutral protease into the extract, performing enzymolysis at 45 deg.C for 3h, heating and boiling for 15 min to inactivate the enzyme, and concentrating the enzymolysis solution under reduced pressure to obtain fluid extract with relative density of 1.1;

3) adding anhydrous ethanol into the fluid extract to make the weight content of ethanol reach 65%, stirring, and standing overnight;

4) collecting supernatant after alcohol precipitation, concentrating under reduced pressure to obtain soft extract with relative density of 1.32; placing resistant dextrin, maltitol, inulin, and scented tea extract in a spray granulator, spray granulating with the soft extract, and drying to obtain granule.

The content of hesperidin in the granule is 0.16mg/g by high performance liquid chromatography detection.

Example 12

The raw material recipe was the same as in example 11.

1) Decocting fructus Cannabis, flos Sophorae Immaturus, fructus Siraitiae Grosvenorii, fructus Lycii, pericarpium Citri Tangerinae, flos Chrysanthemi, folium Bambusae and fructus crataegi with 12 times of water for 3 hr for 1 time, filtering, and collecting the extractive solution (900 Kg);

2) adding 13.5Kg of cellulase, 2.7Kg of pectinase, 2.7Kg of amylase and 4.5Kg of neutral protease into the extract, carrying out enzymolysis for 1h at 60 ℃, then heating and boiling to inactivate the enzymes, and concentrating the enzymolysis solution under reduced pressure to obtain a fluid extract with a relative density of 1.05;

3) adding anhydrous ethanol into the fluid extract to make the weight content of ethanol reach 40%, stirring, and standing overnight;

4) collecting supernatant after alcohol precipitation, and concentrating under reduced pressure to obtain soft extract with relative density of 1.25; placing resistant dextrin, maltitol, inulin, and scented tea extract in a spray granulator, spray granulating with the soft extract, and drying to obtain granule.

The content of hesperidin in the granule is 0.13mg/g by high performance liquid chromatography detection.

Example 13

The raw material recipe was the same as in example 11.

1) Decocting fructus Cannabis, flos Sophorae Immaturus, fructus Siraitiae Grosvenorii, fructus Lycii, pericarpium Citri Tangerinae, flos Chrysanthemi, folium Bambusae and fructus crataegi with 4 times of water for 3 times (each time for 1 hr), filtering, and collecting the extractive solution (total 800 Kg);

2) adding complex enzyme composed of 8Kg cellulase, 4.8Kg pectinase, 2.4Kg amylase and 1.6Kg neutral protease into the extract, performing enzymolysis at 35 deg.C for 5h, heating to boil for inactivating enzyme, and concentrating the enzymolysis solution under reduced pressure to obtain fluid extract with relative density of 1.15;

3) adding ethanol into the fluid extract to make the weight content of ethanol reach 70%, stirring, and standing overnight;

4) collecting supernatant after alcohol precipitation, and concentrating under reduced pressure to obtain soft extract with relative density of 1.35; placing resistant dextrin, maltitol, inulin, and scented tea extract in a spray granulator, spray granulating with the soft extract, and drying to obtain granule.

The content of hesperidin in the granule is 0.11mg/g by high performance liquid chromatography detection.

Example 14

Adult male ICR mice were selected 48, weighing 18-22g, and randomly divided into 4 groups (examples 11-13 and comparative) of 12 mice each. In each example and comparative example, the medicine is administrated by gastric gavage according to the dose of 6.5g/kg (converted into crude drugs), and gastric gavage is continuously carried out for 15 days. After 15d, mice in each group were fasted for 24h without water deprivation. After 3 test groups are administered with compound diphenoxylate (10 mg/kg. BW) by gavage, the test groups are administered with ink containing tested samples 0.5h later, the first time of defecation of the first grain of each animal and the number and the quality of the defecation of the black grains within 6h are recorded, and the properties of the excrement are observed at the same time. The comparative example is that the traditional Chinese medicinal materials are prepared according to the conventional water decoction extraction process, and the extract is not subjected to enzymolysis treatment. The test results are shown in Table 3.

TABLE 3 influence of the preparation method of Chinese medicine on defecation of mice

Group of	First defecation time (min)	Number of stool grains (grains)	Stool weight (g)
				Example 11	158	16.8	0.71
Example 12	167	15.7	0.67
				Example 13	170	15.1	0.65
Comparative example	173	14.6	0.64

From the above results, it can be seen that the preparation process of the invention can further shorten the defecation time and increase the grain number and weight of the excrement, thereby improving the bowel relaxing effect of the traditional Chinese medicine. The curative effect of the granules prepared by the conventional process is not obviously improved.

Example 15

The health and sub-health population is selected as the subject, the effectiveness and the safety of the invention are observed, and the related research results are reported as follows:

1. the method comprises the following steps: one small bag (2g) each time, two bags (4g) each day, and continuously taken for 7 days.

2. And (3) observing items: (1) the defecation times are as follows: the defecation condition of the test eater is measured 6 days before the test eater takes the test food sample and 7 days after the test eating.

(2) Defecation condition: classifying into I-IV grades according to defecation difficulty degree, and counting integral values before and after the test eating.

Grade I (0 point): defecation is normal;

grade II (1 point): only has the feeling of falling down and discomfort;

grade iii (2 points): the feeling of falling down and discomfort are obvious; or frequent defecation but difficult defecation with less defecation, less abdominal pain or burning sensation in anus, which affects defecation.

Grade iv (3 points): abdominal pain or burning sensation in the anus often occurs.

(3) Stool characteristics: the stool is classified into grades I-III according to the characteristics classification method of Bristol.

Grade I (0 point): like sausage or snake, smooth and soft; like sausage, but its surface has cracks; soft lumps, with sharp edges (easy ejection).

Grade II (1 point): sausage-shaped, but lumpy; loose, lumpy, rough-edged, slushy manure.

Grade III (2 points): separated hard masses like fruit stones (not easily expelled).

3. Determination of results

The defecation times are obviously increased by comparing the test groups before and after the test; the defecation condition and the stool character, and the integral of one index in the two indexes is reduced, so that the tested food can be judged to have the function of relaxing the bowels.

4. Investigation results

In total, 31 people with constipation symptoms are investigated, the age is 32-57 years old, the stool frequency of 31 people is increased, the defecation state of 26 people is improved, the stool character of 23 people is improved, the effective number of people is 26, and the total effective rate is 83%. The patients have no obvious adverse reaction and side effect during the medication period, and have no relapse after the patients stop taking the medicine for 2 weeks.

Claims (1)

1. The bowel relaxing granule is characterized by being prepared from the following raw materials in parts by weight: 15 parts of fructus cannabis, 12 parts of sophora flower bud, 5 parts of momordica grosvenori, 8 parts of medlar, 10 parts of dried orange peel, 5 parts of chrysanthemum morifolium, 9 parts of lophatherum gracile, 3 parts of hawthorn, 3 parts of resistant dextrin, 8 parts of maltitol, 6 parts of inulin and 2 parts of scented tea extract,

the preparation method comprises the following steps:

1) decocting fructus Cannabis, flos Sophorae Immaturus, fructus Siraitiae Grosvenorii, fructus Lycii, pericarpium Citri Tangerinae, flos Chrysanthemi, folium Bambusae and fructus crataegi in water, filtering, and collecting extractive solution; the decoction extraction is carried out by adding 6 times of water by weight and extracting for 2 times, and each time lasts for 2 hours;

2) adding complex enzyme into the extractive solution, performing enzymolysis at 45 deg.C for 3 hr, heating to boil to inactivate enzyme, and concentrating under reduced pressure to obtain fluid extract with relative density of 1.05-1.15; the compound enzyme consists of cellulase, pectinase, amylase and neutral protease, and the dosage of the compound enzyme is 1.2%, 0.5% and 0.3% of the weight of the extracting solution respectively;

3) adding ethanol into the fluid extract to make the weight content of ethanol reach 65%, stirring, and standing overnight;

4) collecting supernatant after alcohol precipitation, concentrating under reduced pressure to obtain soft extract with relative density of 1.25-1.35; placing resistant dextrin, maltitol, inulin, and scented tea extract in a spray granulator, spray granulating with the soft extract, and drying to obtain granule.