CN109700833B - Pharmaceutical composition for treating constipation and preparation method and application thereof - Google Patents
Pharmaceutical composition for treating constipation and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition for treating constipation, which is prepared from the following raw materials in parts by weight: 3-4 parts of plantain seed polysaccharide, 8-10 parts of bee pollen, 2-4 parts of probiotic bacteria agent, 1-2 parts of konjac glucomannan, 1-2 parts of sodium alginate and 1-2 parts of calcium chloride. The konjac glucomannan added in the invention can promote the intestinal tract to wriggle on one hand, and on the other hand, because the konjac glucomannan can only be degraded by enzyme generated by partial thallus in the large intestine, the probiotic bacteria are embedded by compounding the konjac glucomannan and the sodium alginate, the inactivation of the probiotic bacteria in the stomach can be avoided, and the effect of colonizing the intestinal tract by the probiotic bacteria is achieved; in addition, the plantain seed polysaccharide, the bee pollen, the probiotic agent and the konjac glucomannan in the invention are mutually cooperated to play roles in softening feces, promoting gastrointestinal peristalsis and recovering intestinal flora balance, thereby achieving the effect of radically treating constipation.
Description
Technical Field
The invention relates to the technical field of pharmacy, in particular to a pharmaceutical composition for treating constipation and a preparation method and application thereof.
Background
Constipation is a common clinical digestive system disease, is gastrointestinal dysfunction caused by multiple factors, and is mainly manifested as persistent difficult defecation, incomplete defecation or reduced defecation frequency, thus seriously affecting the life quality of patients. Generally, women are more than men, and the elderly are more than young and strong. In recent years, with the pace of life of Chinese people increasing, bad postures such as long-term sitting, bad living habits such as dietary structure change and staying up night, the incidence rate of constipation is on the rise. Long-term constipation can not only cause hemorrhoids, induce cardiovascular and cerebrovascular diseases and increase the risk of intestinal cancer, but also cause dysphoria, depression, anxiety and other unfavorable emotions of patients.
The current common treatment for constipation is oral laxatives or anal lubrication laxatives, although both methods can relieve the symptoms of constipation, neither method can solve the fundamental problem, the laxatives can cause unbalance of intestinal flora after long-term use, some irritant laxatives can even damage intestinal nerves and reduce the sensitivity of intestinal tracts to the stimulation of food residues, once the laxatives are not used, the constipation symptoms are more serious, and the anus lubrication laxatives are used for a long time to reduce the sensitivity of rectal mucosa to respective stimulation, so that the constipation is increased. Therefore, it is very necessary to develop a safe and effective drug capable of fundamentally treating constipation.
The probiotics refer to living microorganisms which can play a role in benefiting health of a host after being ingested, and the probiotics can promote intestinal peristalsis, so that the constipation can be treated. However, because the resistance of the probiotics to low pH value is poor, when the probiotics are taken orally, the probiotics are not resistant to gastric acid, so that the probiotics are easy to inactivate, and the number of viable bacteria is also greatly reduced.
Disclosure of Invention
In order to solve the problems mentioned in the background art, the present invention provides a pharmaceutical composition for treating constipation, which can radically treat constipation, and can protect probiotics from inactivation in the stomach, and a preparation method and application thereof.
A pharmaceutical composition for treating constipation is prepared from the following raw materials in parts by weight: 3-4 parts of plantain seed polysaccharide, 8-10 parts of bee pollen, 2-4 parts of probiotic bacteria agent, 1-2 parts of konjac glucomannan, 1-2 parts of sodium alginate and 1-2 parts of calcium chloride.
Further, the feed additive is prepared from the following raw materials in parts by weight: 3 parts of plantain seed polysaccharide, 9 parts of bee pollen, 2 parts of probiotic agent, 1 part of konjac glucomannan, 1 part of sodium alginate and 2 parts of calcium chloride.
Further, the probiotic agent is prepared by mixing the components in a weight ratio of 0.7-1: 0.7-1.2: 0.5-1 of Lactobacillus bulgaricus, Bifidobacterium and Streptococcus thermophilus.
The invention also discloses a preparation method of the pharmaceutical composition for treating constipation, which comprises the following steps:
(1) adding sodium alginate into deionized water at 20-30 deg.C, and stirring to obtain sodium alginate solution; adding deionized water of 55-65 ℃ into konjac glucomannan, and fully stirring to obtain a konjac glucomannan solution; mixing the obtained konjac glucomannan solution with the sodium alginate solution, heating in water bath at 70-80 deg.C, stirring continuously during heating, stopping heating after stirring for 2-3 hr, and cooling to 30-40 deg.C to obtain composite glue solution;
(2) adding water into probiotic bacteria agent to prepare suspension to obtain probiotic bacteria suspension; adding the composite glue solution into the probiotic suspension, and uniformly mixing;
(3) adding deionized water into calcium chloride, and uniformly stirring to obtain a calcium chloride solution; and (3) dripping the material obtained in the step (2) into a calcium chloride solution, reacting for 50-70 minutes, collecting particles in the calcium chloride solution, drying the obtained particles, and mixing with the plantain seed polysaccharide and the bee pollen and stirring uniformly to obtain the compound.
Further, the concentration of the sodium alginate solution in the step (1) is 0.8-1%.
Further, the concentration of the konjac glucomannan solution in the step (1) is 0.6-0.8%.
Further, the concentration of the calcium chloride solution in the step (3) is 1-2%.
The invention also discloses application of the pharmaceutical composition for treating constipation in preparation of a medicine for treating constipation.
The invention has the beneficial effects that:
the konjac glucomannan added in the invention has a plurality of hydrophilic groups, can be aggregated with water molecules into huge molecules, can increase the water content of excrement after being taken, forms a sticky substance with water, bonds food residues in intestinal tracts, softens food residue aggregates, and promotes intestinal tract movement; on the other hand, because the konjac glucomannan can only be degraded by enzyme generated by partial thalli in the large intestine, the probiotic bacteria are embedded by compounding the konjac glucomannan and the sodium alginate, so that the inactivation of the probiotic bacteria in the stomach can be avoided, and the effect of colonizing the intestinal tract by the probiotic bacteria is achieved; in addition, the added plantain seed polysaccharide, bee pollen, probiotic bacteria agent and konjac glucomannan are mutually cooperated to play roles in softening excrement, promoting gastrointestinal peristalsis and restoring intestinal flora balance, thereby achieving the effect of radically treating constipation.
Detailed Description
The technical solution of the present invention will be described in further detail with reference to specific embodiments.
Example 1
A pharmaceutical composition for treating constipation is prepared from the following raw materials in parts by weight: 3 parts of plantain seed polysaccharide, 8 parts of bee pollen, 2 parts of probiotic agent, 1 part of konjac glucomannan, 1 part of sodium alginate and 1 part of calcium chloride.
Wherein the probiotic agent is prepared from the following components in a weight ratio of 0.7: 0.7: 0.5 of Lactobacillus bulgaricus, Bifidobacterium and Streptococcus thermophilus.
A method for preparing a pharmaceutical composition for treating constipation, comprising the steps of:
(1) adding sodium alginate into deionized water at 20 deg.C, stirring, and making into sodium alginate solution with concentration of 0.8%; adding deionized water of 55 ℃ into konjac glucomannan, fully stirring, and preparing into a konjac glucomannan solution with the concentration of 0.6%; mixing the obtained konjac glucomannan solution with a sodium alginate solution, heating in a water bath at 70 ℃, continuously stirring in the heating process, stopping heating after stirring for 2 hours, and cooling to 30 ℃ to obtain a composite glue solution;
(2) adding water into probiotic bacteria agent to prepare suspension to obtain probiotic bacteria suspension; adding the composite glue solution into the probiotic suspension, and uniformly mixing;
(3) adding deionized water into calcium chloride, and stirring uniformly to prepare a calcium chloride solution with the concentration of 2%; and (3) dripping the material obtained in the step (2) into a calcium chloride solution, reacting for 50 minutes, collecting particles in the calcium chloride solution, drying the obtained particles, and mixing and stirring the dried particles with the plantain seed polysaccharide and the bee pollen uniformly to obtain the compound.
Example 2
A pharmaceutical composition for treating constipation is prepared from the following raw materials in parts by weight: 4 parts of plantain seed polysaccharide, 10 parts of bee pollen, 4 parts of probiotic agent, 2 parts of konjac glucomannan, 2 parts of sodium alginate and 2 parts of calcium chloride.
Wherein the probiotic bacteria agent is prepared from the following components in percentage by weight of 1: 1.2: 1, lactobacillus bulgaricus, bifidobacterium and streptococcus thermophilus.
A method for preparing a pharmaceutical composition for treating constipation, comprising the steps of:
(1) adding sodium alginate into deionized water at 30 ℃, fully stirring, and preparing into a sodium alginate solution with the concentration of 1%; adding 65 ℃ deionized water into konjac glucomannan, fully stirring, and preparing into 0.8% konjac glucomannan solution; mixing the obtained konjac glucomannan solution with a sodium alginate solution, heating in water bath at 80 ℃, continuously stirring in the heating process, stopping heating after stirring for 3 hours, and cooling to 40 ℃ to obtain a composite glue solution;
(2) adding water into probiotic bacteria agent to prepare suspension to obtain probiotic bacteria suspension; adding the composite glue solution into the probiotic suspension, and uniformly mixing;
(3) adding deionized water into calcium chloride, and stirring uniformly to prepare a calcium chloride solution with the concentration of 1%; and (3) dripping the material obtained in the step (2) into a calcium chloride solution, reacting for 70 minutes, collecting particles in the calcium chloride solution, drying the obtained particles, and mixing and stirring the dried particles with the plantain seed polysaccharide and the bee pollen uniformly to obtain the compound.
Example 3
A pharmaceutical composition for treating constipation is prepared from the following raw materials in parts by weight: 3 parts of plantain seed polysaccharide, 9 parts of bee pollen, 2 parts of probiotic agent, 1 part of konjac glucomannan, 1 part of sodium alginate and 2 parts of calcium chloride.
Wherein the probiotic agent is prepared from the following components in a weight ratio of 0.8: 1: 0.8 of Lactobacillus bulgaricus, Bifidobacterium and Streptococcus thermophilus.
A method for preparing a pharmaceutical composition for treating constipation, comprising the steps of:
(1) adding sodium alginate into deionized water at 25 deg.C, stirring, and making into sodium alginate solution with concentration of 0.9%; adding 60 ℃ deionized water into konjac glucomannan, fully stirring, and preparing into 0.7% konjac glucomannan solution; mixing the obtained konjac glucomannan solution with a sodium alginate solution, heating in a water bath at 75 ℃, continuously stirring in the heating process, stopping heating after stirring for 3 hours, and cooling to 35 ℃ to obtain a composite glue solution;
(2) adding water into probiotic bacteria agent to prepare suspension to obtain probiotic bacteria suspension; adding the composite glue solution into the probiotic suspension, and uniformly mixing;
(3) adding deionized water into calcium chloride, and stirring uniformly to prepare a calcium chloride solution with the concentration of 1%; and (3) dripping the material obtained in the step (2) into a calcium chloride solution, reacting for 60 minutes, collecting particles in the calcium chloride solution, drying the obtained particles, and mixing and stirring the dried particles with the plantain seed polysaccharide and the bee pollen uniformly to obtain the compound.
Comparative example 1
The formulation was the same as in example 3.
The preparation method comprises the following steps: (1) adding sodium alginate into deionized water at 25 deg.C, stirring, and making into sodium alginate solution with concentration of 0.9%; adding water into probiotic bacteria agent to prepare suspension to obtain probiotic bacteria suspension; adding the sodium alginate solution into the probiotic suspension, and uniformly mixing;
(2) adding deionized water into calcium chloride, and stirring uniformly to prepare a calcium chloride solution with the concentration of 1%; and (2) dripping the material obtained in the step (1) into a calcium chloride solution, reacting for 60 minutes, collecting particles in the calcium chloride solution, drying the obtained particles, and uniformly mixing the dried particles with the plantain seed polysaccharide, the bee pollen and the konjac glucomannan to obtain the compound.
Clinical trial
1. General data: a total of 180 patients, 86 males and 94 females; the biggest 65 years old and the smallest 18 years old; the longest course is 15 years, and the shortest is half a year. Based on the patient's informed and voluntary, six groups were randomly divided, group a (experimental group 30 cases to which patients were given oral administration of the pharmaceutical composition for constipation prepared in example 3), group B (control group 30 cases to which patients were given oral administration of the pharmaceutical composition prepared in comparative example 1), group C (control group 30 cases to which patients were given oral administration of psyllium polysaccharide), group D (control group 30 cases to which patients were given oral administration of bee pollen), group E (control group 30 cases to which patients were given oral administration of probiotic bacteria), and group F (control group 30 cases to which patients were given oral administration of konjac glucomannan).
2. And (3) inclusion standard: the disease course is at least half a year, and the medicine influencing the gastrointestinal tract power is not taken within a week; diagnosing IBS under-rationale; colonoscopy or colonoscopy eliminates intestinal organic lesions and constipation caused by systemic disease; the last three months satisfy two or more of the following symptoms: (1) at least 25% of the bowel movements feel arduous; (2) at least 25% of the bowel movements are dry, globular or hard; (3) at least 25% of the stools have an inexhaustible sensation; (4) at least 25% of defecation is with anorectal obstruction; (5) the number of bowel movements was less than 3 times per week.
3. The curative effect standard is as follows: (1) the effect is shown: defecation is 1 time per day, the defecation is smooth, the stool is soft, and the symptoms disappear; (2) improvement: the defecation frequency is every other day or 1 time per day, the stool becomes soft, and the symptoms are relieved; (3) and (4) invalidation: before defecation, the symptoms are not relieved.
4. The administration scheme is as follows: the group A, group B, group C, group D, group E and group F are administered for 2 times per day, 7 days is a treatment course, and the treatment courses are continued for 3 times.
5. And (3) evaluating the curative effect:
according to the clinical data, the effective rate of the medicine composition with probiotics embedded by konjac glucomannan and sodium alginate is higher than that of the medicine composition with probiotics embedded only by sodium alginate, and the plantain seed polysaccharide, bee pollen, the probiotic microbial inoculum and the konjac glucomannan have the effect of mutually and synergistically treating constipation.
Although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that changes may be made in the embodiments and/or equivalents thereof without departing from the spirit and scope of the invention. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (7)
1. A pharmaceutical composition for treating constipation is characterized by being prepared from the following raw materials in parts by weight: 3-4 parts of plantain seed polysaccharide, 8-10 parts of bee pollen, 2-4 parts of probiotic agent, 1-2 parts of konjac glucomannan, 1-2 parts of sodium alginate and 1-2 parts of calcium chloride; the method specifically comprises the following steps:
(1) adding sodium alginate into deionized water at 20-30 deg.C, and stirring to obtain sodium alginate solution; adding deionized water of 55-65 ℃ into konjac glucomannan, and fully stirring to obtain a konjac glucomannan solution; mixing the obtained konjac glucomannan solution with the sodium alginate solution, heating in water bath at 70-80 deg.C, stirring continuously during heating, stopping heating after stirring for 2-3 hr, and cooling to 30-40 deg.C to obtain composite glue solution;
(2) adding water into probiotic bacteria agent to prepare suspension to obtain probiotic bacteria suspension; adding the composite glue solution into the probiotic suspension, and uniformly mixing;
(3) adding deionized water into calcium chloride, and uniformly stirring to obtain a calcium chloride solution; and (3) dripping the material obtained in the step (2) into a calcium chloride solution, reacting for 50-70 minutes, collecting particles in the calcium chloride solution, drying the obtained particles, and mixing with the plantain seed polysaccharide and the bee pollen and stirring uniformly to obtain the compound.
2. The pharmaceutical composition for treating constipation according to claim 1, which is prepared from the following raw materials in parts by weight: 3 parts of plantain seed polysaccharide, 9 parts of bee pollen, 2 parts of probiotic agent, 1 part of konjac glucomannan, 1 part of sodium alginate and 2 parts of calcium chloride.
3. The pharmaceutical composition for the treatment of constipation according to claim 1, wherein the probiotic bacterial agent is prepared from the following components in a weight ratio of 0.7-1: 0.7-1.2: 0.5-1 of Lactobacillus bulgaricus, Bifidobacterium and Streptococcus thermophilus.
4. The pharmaceutical composition for treating constipation according to claim 1, wherein the concentration of the sodium alginate solution in step (1) is 0.8-1%.
5. The pharmaceutical composition for treating constipation according to claim 1, wherein the concentration of the konjac glucomannan solution in the step (1) is 0.6-0.8%.
6. The pharmaceutical composition for treating constipation according to claim 1, wherein the concentration of the calcium chloride solution in step (3) is 1-2%.
7. Use of the pharmaceutical composition for treating constipation according to any one of claims 1 to 3 for the preparation of a medicament for treating constipation.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1663573A (en) * | 2004-03-04 | 2005-09-07 | 青岛东海药业有限公司 | A stable and safe microecological formulation, its preparation and usage |
| CN108514121A (en) * | 2018-02-02 | 2018-09-11 | 云南中京国建投资有限公司 | A kind of defaecation, the symphysis unit composition of toxin expelling and its preparation and application |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1663573A (en) * | 2004-03-04 | 2005-09-07 | 青岛东海药业有限公司 | A stable and safe microecological formulation, its preparation and usage |
| CN108514121A (en) * | 2018-02-02 | 2018-09-11 | 云南中京国建投资有限公司 | A kind of defaecation, the symphysis unit composition of toxin expelling and its preparation and application |
Non-Patent Citations (1)
| Title |
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| 益生菌联合膳食纤维改善便秘;丛丽敏 等;《中国微生态学杂志》;20060630;第28卷(第6期);第632-638页 * |
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