CN116870062A - Composition with bowel relaxing function and application thereof - Google Patents

Composition with bowel relaxing function and application thereof Download PDF

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Publication number
CN116870062A
CN116870062A CN202311011202.1A CN202311011202A CN116870062A CN 116870062 A CN116870062 A CN 116870062A CN 202311011202 A CN202311011202 A CN 202311011202A CN 116870062 A CN116870062 A CN 116870062A
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composition
semen
inulin
poria
semen cassiae
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石永平
吉文鑫
董雷玲
陈卉
陈春羽
任艺娇
曹露露
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Jiangsu Normal University
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Jiangsu Normal University
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    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
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Abstract

The invention discloses a composition with intestinal tract relaxing function and application thereof, wherein the composition is prepared from the following components in percentage by weight: 19.33-49.67% of semen pruni, 7.36-65.78% of semen cassiae, 8.31-58.86% of poria cocos and 0.67-3.33% of inulin. Mixing the four materials, decocting with water twice, mixing decoctions, concentrating to relative density of 1.10-1.20 at 65deg.C, adding ethanol, stirring to ethanol content of 60-85% by volume, standing, filtering, concentrating the filtrate under reduced pressure to relative density of 1.20-1.30 at 65deg.C, and recovering ethanol to obtain concentrated solution, adding water and adjuvants, and making into oral liquid, or spray drying the concentrated solution, adding adjuvants, and making into capsule, tablet, or granule. The composition has remarkable effect of improving body function and relieving constipation.

Description

Composition with bowel relaxing function and application thereof
Technical Field
The invention belongs to the field of traditional Chinese medicines and health-care foods, and particularly relates to a composition with an intestinal tract relaxing function and application thereof.
Background
Constipation is a common symptom of the digestive system, and with the influence of factors such as aging of society, acceleration of life rhythm, irregular diet and work and rest, spirit and the like, the number of functional constipation patients in China rapidly rises, wherein the functional constipation is a common clinical disease which is manifested by defecation less than 3 times per week or difficult defecation frequently. The long-term constipation can produce harmful substances such as food residues and the like which can not be discharged in time, can cause symptoms such as abdominal distension, appetite reduction, peculiar smell in mouth and the like, and can also cause hemorrhoids, anal fissure, rectal ulcer and the like. Constipation can significantly increase the incidence of colorectal polyps, but constipation does not significantly increase the incidence of colorectal cancer, but is a risk factor for colorectal cancer, and colorectal polyps are precancerous lesions, constipation has become a non-negligible problem affecting healthy life.
Clinically, constipation is divided into organic and functional constipation. At present, organic constipation is classified into atonic constipation, spastic constipation and rectal constipation. Functional constipation is classified into slow-transit constipation (STC), outlet obstruction type constipation (OOC) and mixed constipation (CSOC) according to pathophysiological mechanisms. Western medicines for treating constipation can be classified into microbial preparations for regulating intestinal tract, laxatives, prokinetic medicines and other four kinds. The microbial preparation for regulating intestinal tracts has small side effect and is often the preferred drug; laxatives can also be divided into solvent type laxatives, lubricants, stimulant laxatives, osmotic laxatives, bulking agents, salt laxatives, etc.; the prokinetic medicine mainly comprises choline, erythromycin and recombinant human neurotrophic factor. The medicines are easy to form dependence after long-term application, and excessive use can interfere with small intestine functions and the like, and have great side effects and are not suitable for long-term administration. On the other hand, the adverse effect of laxatives is rebound effect. In the case of the frequent use of laxatives, the digestive tract and small intestine functions become stagnant and ineffective, which in turn can lead to chronic constipation and even exacerbate the degree of constipation.
The constipation syndrome is divided into the following groups by the Chinese medical science of the universities and colleges: the excessive and deficient secretes are classified into qi, heat and cold secretes, and the deficient secretes are classified into qi deficiency, blood deficiency, yin deficiency and yang deficiency. Constipation is classified into 4 syndromes such as qi-constipation syndrome, heat-constipation syndrome, cold-constipation syndrome and deficiency-constipation syndrome in the guidelines of clinical research of new traditional Chinese medicine. The traditional Chinese medicine considers that constipation is mainly caused by unsmooth movement of viscera, non-descending of turbid qi and abnormal conduction of large intestine. The general principle is also basically used in treatment. In clinical work, the traditional Chinese medicine treatment of senile habitual constipation is mainly overall treatment, and the treatment means are numerous and are mainly individuation treatment. According to the deficiency of qi and blood and yin and yang, the methods of invigorating qi, nourishing blood, nourishing yin, warming yang, regulating qi, and moisturizing intestine are adopted. The traditional Chinese medicine, acupuncture, moxibustion, navel therapy, sticking and other methods can be used together in the treatment means, and the traditional Chinese medicine is not limited by the use of rheum officinale, senna leaf and other strong and aggressive medicines, has too severe purgation effect, is highly stimulated to intestinal tracts, often causes discomfort to patients, cannot be taken for a large amount for a long time, is suitable for the elderly and weak, the weak with long-term illness, the weak with blood deficiency and qi, the weak with spleen and stomach cold, and women in menstrual period, pregnancy period and lactation period. Therefore, the development of safe and effective functional food for improving constipation by using medicinal and edible substances has become an important development trend and direction for improving constipation products.
Disclosure of Invention
The invention aims to provide a composition with intestinal tract relaxing effect and application thereof, wherein the composition consists of traditional Chinese medicines with homology of medicine and food, can reduce adverse reactions of taking, improves safety and has the effect of relaxing the bowel.
In order to achieve the above purpose, the invention provides a composition with intestinal tract relaxing effect, which is prepared from the following components in percentage by weight: 19.33-49.67% of semen pruni, 7.36-65.78% of semen cassiae, 8.31-58.86% of poria cocos and 0.67-3.33% of inulin.
Preferably, the traditional Chinese medicine composition is prepared from the following components in percentage by weight: 19.33% of semen pruni, 25.67% of semen cassiae, 51.67% of poria cocos and 3.33% of inulin.
Preferably, the traditional Chinese medicine composition is prepared from the following components in percentage by weight: 24.58% of semen pruni, 65.78% of semen cassiae, 8.31% of poria cocos and 1.33% of inulin.
The invention also provides application of the composition in preparing traditional Chinese medicine or health food for relaxing bowel.
Preferably, the traditional Chinese medicine is processed and prepared into oral liquid, tablets, capsules or granules by adding medicinal or edible excipient.
Preferably, the excipient is one or more of dextrin, lactose, starch, sucrose, glucose, microcrystalline cellulose, mannose, methyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose and stevioside.
Preferably, the preparation method of the traditional Chinese medicine comprises the following steps: mixing semen Pruni, semen Cassiae, poria and inulin, decocting in water twice, mixing decoctions, concentrating to relative density of 1.10-1.20 at 65deg.C, adding ethanol, stirring to ethanol content of 60-85% by volume, standing, filtering, concentrating the filtrate under reduced pressure to relative density of 1.20-1.30 at 65deg.C, recovering ethanol to obtain concentrated solution, adding water and adjuvants, and making into oral liquid, or spray drying the concentrated solution, adding adjuvants, and making into capsule, tablet, or granule.
Preferably, the health food is a functional drink.
Preferably, the functional beverage is a functional tea.
Further, the preparation process of the functional tea comprises the following steps:
(1) And (3) cleaning: removing sediment and foreign matters in raw materials of semen Pruni, semen Cassiae and Poria;
(2) Cleaning: washing with water for 1-2 times to remove dust attached to the surface of the raw material;
(3) And (3) drying: drying at 80 ℃ by adopting a hot air circulation oven, detecting the moisture content by a rapid moisture detector, and controlling the moisture content of the scape to be below 8%;
(4) And (3) batching: proportioning raw materials of semen Pruni, semen Cassiae, poria and inulin according to a formula ratio;
(5) Crushing: crushing the mixture obtained by the ingredients in the step (4), controlling the mesh within 40 meshes, and uniformly mixing;
(6) And (3) sterilization: sterilizing the environment by combining ozone and ultraviolet lamps;
(7) Bagging, sealing and packaging in an aluminum-plastic bag;
(8) And (3) packaging: and (5) bagging, boxing and boxing the teabags.
The raw materials of the invention are extracted by a scientific method to obtain effective components, and a scientific formula is carried out; on a small intestine propulsion experimental model, the invention optimally screens the traditional Chinese medicine composition with the effect of relaxing bowel, and provides a treatment scheme for clinically preventing or treating constipation of organisms.
Drawings
FIG. 1 is a graph showing the effect of a fifth herbal composition of this example on the ink feed rate of a small intestine feed test;
FIG. 2 is a graph showing the effect of each of the test drugs on VIP concentration in serum of mice tested for intestinal propulsion in the fifth example;
FIG. 3 is the effect of each test drug on colon tissue structure of mice in the small intestine propulsion test in the fifth example;
in the above figures: * P<0.05， ** P<0.01, compared to a normal control group; # P<0.05， ## P<0.01, compared to the model set.
Detailed Description
The present invention will be described in further detail with reference to specific examples.
Comparative example one
A composition with intestinal tract relaxing effect is prepared from the following components in percentage by weight: 33.11% of semen pruni, 7.36% of semen cassiae, 58.86% of poria cocos and 0.67% of inulin.
The preparation method comprises the following steps: weighing semen Pruni 0.99g, semen Cassiae 0.22g, poria 1.76g and inulin 0.02g, decocting with water twice, mixing decoctions, concentrating to relative density of 1.10-1.20 at 65deg.C, adding ethanol, stirring to alcohol content of 60-85% by volume, standing, filtering, concentrating the filtrate under reduced pressure to relative density of 1.20-1.30 at 65deg.C, recovering ethanol to obtain concentrated solution, adding water and adjuvants, and making into oral liquid, or spray drying the concentrated solution, adding adjuvants, and making into capsule.
Comparative example two
A composition with intestinal tract relaxing effect is prepared from the following components in percentage by weight: 49.67% of bunge cherry seed, 33.33% of cassia seed, 16.67% of poria cocos and 0.33% of inulin.
The preparation method comprises the following steps: weighing 1.49g of clean, clean and dried semen Pruni, 1.00g of semen Cassiae, 0.50g of Poria and 0.01g of inulin, pulverizing into coarse powder (below 80 meshes), sterilizing, packaging into heat-sealed filter paper bag, sealing to obtain bagged tea, and soaking 1 bag (3 g) (3 g/bag of shaped product) in 200mL of boiled water.
Example 1
A composition with intestinal tract relaxing effect is prepared from the following components in percentage by weight: 19.33% of semen pruni, 25.67% of semen cassiae, 51.67% of poria cocos and 3.33% of inulin.
The preparation method comprises the following steps: weighing 0.58g of semen Pruni, 0.77g of semen Cassiae, 1.55g of Poria and 0.10g of inulin, decocting with water twice, mixing decoctions, concentrating to relative density of 1.10-1.20 at 65deg.C, adding ethanol, stirring to alcohol content of 60-85% by volume, standing, filtering, concentrating the filtrate under reduced pressure to relative density of 1.20-1.30 at 65deg.C, recovering ethanol to obtain concentrated solution, adding water and adjuvants, and making into oral liquid, or spray drying the concentrated solution, adding adjuvants, and making into capsule.
Example two
A composition with intestinal tract relaxing effect is prepared from the following components in percentage by weight: 24.58% of semen pruni, 65.78% of semen cassiae, 8.31% of poria cocos and 1.33% of inulin.
The preparation method comprises the following steps: weighing 0.74g of semen Pruni, 1.98g of semen Cassiae, 0.25g of Poria and 0.04g of inulin, pulverizing into coarse powder (below 80 mesh), sterilizing, packaging into heat-sealed filter paper bag, sealing to obtain bagged medicinal tea, and soaking 1 bag (3 g) (3 g/bag of shaped product) in 200mL of boiled water.
Embodiment III: formulation screening examples of pharmaceutical compositions
Male Kunming mice, weighing 18-22 g, were fed adaptively for 3 days, were randomly divided into normal group, model group and composition treatment group according to body weight, normal group and model group were filled with normal saline every day, treatment group drug was concentrated after water extraction, and were filled with normal saline according to 0.1mL/10g volume, and continuously filled with stomach for 7 days, normal group and model group were given with equal volume of normal saline. After the last gastric lavage, each group of mice is fasted for 16 hours without water inhibition, the model group and the treatment dose group are subjected to gastric lavage to administer loperamide 4mg/kg BW, and the normal group is subjected to distilled water. After 0.5 hours of loperamide administration, the model and composition treatment groups were separately gavaged with ink (5% active carbon powder, 10% gum arabic) containing the corresponding test samples, except for the normal group.
Immediately after 25 minutes, the animals were sacrificed by cervical vertebra removal, the celiac separation mesentery was opened, the upper end from the pylorus, the lower end to the ileocecum were cut off, the intestinal canal was placed on a tray, the small intestine was gently pulled into a straight line, the length of the intestinal canal was measured as the "total length of the small intestine", and the front edge from the pylorus to the ink was the "push length of the ink". The ink push rate was calculated as follows:
ink advance (%) =ink advance length (cm)/total length of small intestine (cm) ×100%
Formulation one set (example one set): semen Pruni (0.58 g/kg BW/day), semen Cassiae (0.77 g/kg BW/day), poria (1.55 g/kg BW/day), and inulin (0.10 g/kg BW/day);
formulation two (example two) formulation: semen Pruni (0.74 g/kg BW/day), semen Cassiae (1.98 g/kg BW/day), poria (0.25 g/kg BW/day), and inulin (0.04 g/kg BW/day);
formulation three groups (comparative example one formula): semen Pruni (0.99 g/kg BW/day), semen Cassiae (0.22 g/kg BW/day), poria (1.76 g/kg BW/day), and inulin (0.02 g/kg BW/day);
formulation four (comparative example two formulas): semen Pruni (1.49 g/kg BW/day), semen Cassiae (1.00 g/kg BW/day), poria (0.5 g/kg BW/day), and inulin (0.01 g/kg BW/day);
model group: the stomach is irrigated by 0.9% sodium chloride injection;
normal group: the stomach was irrigated with 0.9% sodium chloride injection.
Test results:
as can be seen from table 1, the intestinal propulsive rate of the test animals of the first and second examples was significantly improved compared with the model group, indicating that the intestinal propulsive rate of the test mice was significantly enhanced by the first and second examples, and constipation of the test mice was changed. There was no statistical difference in intestinal progression between the control first and control second groups of test mice.
Regression analysis is carried out on response values of dosage of semen Pruni, semen Cassiae, poria cocos and inulin by adopting DPS software, and a regression equation of the ink pushing rate Y1 of the mice for the small intestine propulsion experiment is obtained as follows:
Y1＝0.734569708-0.08308165191X1+0.7445744413X2*X4
wherein: y1 represents the ink pushing progress of mice in the small intestine pushing experiment, X1 is the dosage of semen Pruni, X2 is the dosage of semen Cassiae, and X4 is the dosage of inulin. In order to test the effectiveness of the regression equation, the equation is analyzed to obtain the correlation coefficient R2= 0.9991 and the significance P= 0.0414, so that the equation can be well fit to the experimental process of the small intestine propulsion experiment. From the regression equation, factor X3 was not included, indicating that Poria has little or no effect on the ink push rate of the mice in the small intestine push experiment. The variables of the equation mainly consist of factors X1 and X2X 4, wherein X1 is inversely related to intestinal propulsion, and the interaction exists between X2 and X4, and the factor which has the greatest influence on the ink propulsion progress of mice in small intestinal propulsion experiments is X2X 4, namely the consumption of semen cassiae and inulin. Therefore, the compatibility of the raw materials is not simple and the superposition effect is not easy.
Table 1 experimental animal intestinal propulsive rate experimental results (n=10)
Embodiment four: tablet preparation obtained from the composition
Taking a proper amount of water extract obtained by the product, sieving with a 80-mesh sieve together with starch, sodium carboxymethyl starch and magnesium stearate, weighing and uniformly mixing; adding 75% ethanol into the mixed powder, stirring to obtain soft material, sieving with 18 mesh sieve, granulating, and drying at 60deg.C; the dried granules are sieved by a 18-mesh sieve, added with magnesium stearate and tableted.
Fifth embodiment: corroborative experiment for relaxing bowel
Male Kunming mice, weighing 18-22 g, were fed adaptively for 3 days, were randomly divided into normal group, model group and composition treatment group according to body weight, normal group and model group were filled with normal saline every day, treatment group drug was concentrated after water extraction, and were filled with normal saline according to 0.1mL/10g volume, and continuously filled with stomach for 7 days, normal group and model group were given with equal volume of normal saline. After the last gastric lavage, each group of mice is fasted for 16 hours without water inhibition, and the model group and the treatment dose group are subjected to gastric lavage to administer 5mg/kg BW of compound diphenoxylate, and the normal group is administered with distilled water. After 0.5 hours of administration of the compound diphenoxylate, the normal, model and composition treatments were each administered with ink (5% active carbon powder, 10% gum arabic) containing the corresponding test sample.
Immediately after 25 minutes, the animals were sacrificed by cervical vertebra removal, the celiac separation mesentery was opened, the upper end from the pylorus, the lower end to the ileocecum were cut off, the intestinal canal was placed on a tray, the small intestine was gently pulled into a straight line, the length of the intestinal canal was measured as the "total length of the small intestine", and the front edge from the pylorus to the ink was the "push length of the ink". The ink push rate was calculated as follows:
ink advance (%) =ink advance length (cm)/total length of small intestine (cm) ×100%
Formulation two low dose group: semen Pruni (0.37 g/kg BW/day), semen Cassiae (0.99 g/kg BW/day), poria (0.12 g/kg BW/day), and inulin (0.02 g/kg BW/day);
dose group in formulation two (example two): semen Pruni (0.74 g/kg BW/day), semen Cassiae (1.98 g/kg BW/day), poria (0.25 g/kg BW/day), and inulin (0.04 g/kg BW/day);
formulation two high dose group: semen Pruni (1.48 g/kg BW/day), semen Cassiae (3.95 g/kg BW/day), poria (0.49 g/kg BW/day), and inulin (0.07 g/kg BW/day);
optimizing a formula group: semen Pruni (0.58 g/kg BW/day), semen Cassiae (1.98 g/kg BW/day), poria (1.35 g/kg BW/day), and inulin (1.5 g/kg BW/day);
model group: the stomach is irrigated by 0.9% sodium chloride injection;
normal control group: the stomach was irrigated with 0.9% sodium chloride injection.
As can be seen from fig. 1, the ink push rate of mice in the model group was significantly reduced compared to that of the normal control group, indicating that the mice had exhibited constipation; compared with the model group, the ink propulsion rate of the mice in the dose group in the formula II is obviously prolonged (p is less than 0.05), which indicates that the formula II has a certain bowel relaxing capability.
VIP activity in serum of mice from the small intestine propulsion experiment was measured using ELISA kit, and the results are shown in fig. 2, in which VIP levels in serum of mice in the model group were significantly reduced (p < 0.01) compared to the normal control group. VIP levels were significantly elevated in serum in mice in the medium and high dose groups of formulation two (p < 0.05) compared to the model group. It follows that the promotion of the second formulation on the intestinal tract may be achieved by modulating the level of gastrointestinal hormone.
As can be seen from fig. 3, the normal control mice have orderly long lines of colon tissue mucosa, and clear structure. Compared with the normal control group, the colon muscle of the mice in the model group is thinned, the goblet cells are reduced, and the submucosa is damaged. Compared with the model group, the composition treatment group mice have thickened colon muscle, increased goblet cells and reduced injury. Therefore, the composition can promote intestinal peristalsis of constipation mice after treatment, repair colon injury and play a role in relaxing bowel.

Claims (10)

1. A composition with intestinal tract relaxing function, which is characterized by comprising the following components in percentage by weight: 19.33-49.67% of semen pruni, 7.36-65.78% of semen cassiae, 8.31-58.86% of poria cocos and 0.67-3.33% of inulin.
2. A composition with bowel movement according to claim 1, characterized in that it is made up of the following components in percentage by weight: the traditional Chinese medicine composition is prepared from the following components in percentage by weight: 19.33% of semen pruni, 25.67% of semen cassiae, 51.67% of poria cocos and 3.33% of inulin.
3. A composition with bowel movement according to claim 1, characterized in that it is made up of the following components in percentage by weight: 24.58% of semen pruni, 65.78% of semen cassiae, 8.31% of poria cocos and 1.33% of inulin.
4. Use of a composition according to claim 1 or 2 or 3 for the preparation of a bowel relaxing traditional Chinese medicine or health food.
5. The use according to claim 4, wherein the Chinese medicine is formulated into oral liquid, tablet, capsule or granule by adding pharmaceutically or edible excipient.
6. The use according to claim 5, wherein the excipient is one or more of dextrin, lactose, starch, sucrose, glucose, microcrystalline cellulose, mannose, methylcellulose, hydroxypropyl cellulose, carboxymethyl cellulose, stevioside.
7. The use according to claim 5 or 6, wherein the preparation method of the traditional Chinese medicine comprises the following steps: mixing semen Pruni, semen Cassiae, poria and inulin, decocting in water twice, mixing decoctions, concentrating to relative density of 1.10-1.20 at 65deg.C, adding ethanol, stirring to ethanol content of 60-85% by volume, standing, filtering, concentrating the filtrate under reduced pressure to relative density of 1.20-1.30 at 65deg.C, recovering ethanol to obtain concentrated solution, adding water and adjuvants, and making into oral liquid, or spray drying the concentrated solution, adding adjuvants, and making into capsule, tablet, or granule.
8. The use according to claim 4, wherein the health food is a functional drink.
9. The use according to claim 8, wherein the functional drink is a functional tea.
10. The use according to claim 9, wherein the process of preparing the functional tea comprises the steps of:
(1) And (3) cleaning: removing sediment and foreign matters in raw materials of semen Pruni, semen Cassiae and Poria;
(2) Cleaning: washing with water for 1-2 times to remove dust attached to the surface of the raw material;
(3) And (3) drying: drying at 80 ℃ by adopting a hot air circulation oven, detecting the moisture content by a rapid moisture detector, and controlling the moisture content of the raw materials to be below 8%;
(4) And (3) batching: proportioning raw materials of semen Pruni, semen Cassiae, poria and inulin according to a formula ratio;
(5) Crushing: crushing the mixture obtained by the ingredients in the step (4), controlling the mesh within 40 meshes, and uniformly mixing;
(6) And (3) sterilization: sterilizing the environment by combining ozone and ultraviolet lamps;
(7) Bagging, sealing and packaging in an aluminum-plastic bag;
(8) And (3) packaging: and (5) bagging, boxing and boxing the teabags.
CN202311011202.1A 2023-08-11 2023-08-11 Composition with bowel relaxing function and application thereof Pending CN116870062A (en)

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CN105878559A (en) * 2016-04-18 2016-08-24 南昌济顺制药有限公司 Medicine composition or health-care food with bowel relaxing and constipation relieving efficacy
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CN105878559A (en) * 2016-04-18 2016-08-24 南昌济顺制药有限公司 Medicine composition or health-care food with bowel relaxing and constipation relieving efficacy
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