CN108030847B - Pharmaceutical composition for treating constipation and application thereof - Google Patents

Pharmaceutical composition for treating constipation and application thereof Download PDF

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CN108030847B
CN108030847B CN201810017713.7A CN201810017713A CN108030847B CN 108030847 B CN108030847 B CN 108030847B CN 201810017713 A CN201810017713 A CN 201810017713A CN 108030847 B CN108030847 B CN 108030847B
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oil
pharmaceutical composition
constipation
treating constipation
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CN108030847A (en
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陈新静
秦凯健
王云云
王振宜
吴炯
金磊
黄信松
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Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of TCM
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736Prunus, e.g. plum, cherry, peach, apricot or almond
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/63Arthropods
    • A61K35/64Insects, e.g. bees, wasps or fleas
    • A61K35/644Beeswax; Propolis; Royal jelly; Honey
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/60Moraceae (Mulberry family), e.g. breadfruit or fig
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/77Sapindaceae (Soapberry family), e.g. lychee or soapberry
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/889Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0031Rectum, anus

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
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Abstract

The invention discloses an external pharmaceutical composition for treating constipation and application thereof, wherein the pharmaceutical composition is prepared from the following raw materials in parts by weight: 20-30 parts of almond oil, 15-25 parts of honey, 20-30 parts of hemp seed oil, 7-13 parts of linseed oil, 7-13 parts of betel nut oil and 7-13 parts of longan pulp juice. The invention has the advantages that: 1. the components and the proportion of the pharmaceutical composition are screened, the medicines are mutually coordinated to exert the maximum curative effect, the pharmaceutical effect is durable, no toxic or side effect exists, and the pharmaceutical composition is worthy of popularization and application. 2. The pharmaceutical composition has good curative effect on constipation, can obviously improve abdominal fullness and constipation symptoms of constipation patients, and has high effective rate. 3. The enema has the advantages of no toxic or side effect, simple preparation method, simple and easy application and the like, is suitable for long-term use, is a safe and effective medicament for treating constipation, and has good application prospect.

Description

Pharmaceutical composition for treating constipation and application thereof
Technical Field
The invention relates to a pharmaceutical composition for treating constipation and application thereof, in particular to an enema for treating constipation.
Background
Constipation means that the frequency of defecation is reduced, and meanwhile, the defecation is difficult and the feces are dry and hard. Constipation can be classified into outlet obstruction type constipation and colon slow transit type constipation. The former is often seen in the elderly, and the stool is discharged due to the relaxation of the pelvic floor muscles. The western medicines for treating constipation are divided into three categories according to the mechanism of relaxing bowels with purgative: the first is irritant laxative, which directly stimulates intestinal wall and strengthens intestinal peristalsis to promote feces excretion, but is not suitable for long-term use because it can cause reduced intestinal irritability. The second category is the dilute purgatives. These cathartics prevent the absorption of water in the intestine and increase the volume of the intestine, and they are difficult to absorb after oral administration, and can form high osmotic pressure in the intestine to increase the water and chyme capacity, and the large volume expands the intestine to mechanically stimulate the intestine, thereby causing the enhancement of intestinal motility and defecation. The third category is lubricity purgatives. The laxative can lubricate intestinal wall, soften stool, and facilitate defecation, wherein liquid paraffin is not absorbed after oral administration or enema, and can obstruct moisture absorption in intestine, so the laxative is an ideal laxative, but can interfere absorption of vitamin A, D, K and calcium and phosphorus after long-term application. Magnesium sulfate, sorbitol and other similar components in the current enema can promote excretion, but long-term use of the enema can lead to the fact that the intestinal wall is less and less sensitive to stimulation, so that dependence is caused, and a vicious circle is formed. And the magnesium sulfate, the sorbitol and other components can ensure that the intestinal wall is seriously dehydrated and the intestinal mucosa is not protected. Pure glycerol has low side effect, but has small effect of lubricating intestinal wall and has different curative effect on constipation.
Chinese patent 201310094416X discloses a compound essential oil for relieving constipation and promoting digestion, which is prepared by uniformly mixing five essential oils of clary sage, nutmeg, fennel, black pepper and sweet almond oil, and has the advantages that: integrates the efficacies of clary sage, nutmeg, fennel, black pepper and sweet almond oil, and coordinates and supplements each other to enhance the curative effect, so that the health care wine has the functions of relieving constipation and helping digestion. Chinese patent 2016100652235 discloses a method for preparing a Chinese medicinal dripping pill for treating constipation, which comprises dissolving polyethylene glycol in water bath as matrix, adding mixture of oleum Cannabis and semen Cassiae oil into the matrix under stirring, and stirring to obtain dripping pill liquid medicine, wherein the matrix is 4-8 times of the total weight of the mixture of oleum Cannabis and semen Cassiae oil; dripping the dripping pill liquid medicine into a cooling oil tube with temperature gradient at 70-80 deg.C and 30-60 drops per minute to obtain dripping pill, centrifuging to remove cooling oil. In the prior art, no report is found about the pharmaceutical composition for treating constipation.
Disclosure of Invention
The first purpose of the present invention is to provide a pharmaceutical composition for external use for treating constipation, which overcomes the disadvantages of the prior art.
A second object of the present invention is to address the deficiencies of the prior art by providing the use of a pharmaceutical composition as described above.
In order to achieve the first purpose, the invention adopts the technical scheme that:
a pharmaceutical composition for external use for treating constipation is prepared from the following raw materials in parts by weight: 20-30 parts of almond oil, 15-25 parts of honey, 20-30 parts of hemp seed oil, 7-13 parts of linseed oil, 7-13 parts of betel nut oil and 7-13 parts of longan pulp juice.
As a preferred embodiment of the invention, the pharmaceutical composition is prepared from the following raw materials in parts by weight: 23-27 parts of almond oil, 18-22 parts of honey, 23-27 parts of hemp seed oil, 9-11 parts of linseed oil, 9-11 parts of betel nut oil and 9-11 parts of longan pulp juice.
As a preferred embodiment of the invention, the pharmaceutical composition is prepared from the following raw materials in parts by weight: 25 parts of almond oil, 20 parts of honey, 25 parts of hemp seed oil, 10 parts of linseed oil, 10 parts of betel nut oil and 10 parts of longan pulp juice.
As a preferred embodiment of the present invention, the honey is nectar, nectar or a mixture of both.
In order to achieve the second object, the invention adopts the technical scheme that:
use of a composition as described in any of the above in the manufacture of a medicament for the treatment of constipation.
As a preferred embodiment of the present invention, the medicament is an enema. The pharmaceutical composition in the weight portion is added into a container and evenly mixed, and then is added into a disposable infusion set for rectal administration after sterilization treatment.
The compendium of materia Medica records: honey is sweet and neutral and has no toxicity, and is mainly used for treating heart and abdomen pathogenic factors, convulsions, epilepsy and spasm, calming the five internal organs and insufficiency, tonifying qi and strengthening the middle warmer, relieving pain and removing toxicity, and removing diseases, and is mixed with hundreds of medicines. Besides the function of moistening intestines and smoothing intestines, many researches report that the honey can promote the healing of wound mucous membranes, and the higher the concentration is, the more effective the honey is; has antibacterial and antiinflammatory effects, and has no risk of drug resistance.
The hemp seed oil can soften stool, slightly excite intestinal canal and increase intestinal canal peristalsis.
The apricot seeds can relieve cough and asthma, moisten lung and relax bowels. Researches find that the bitter almond oil can resist inflammation and ease pain, and can effectively treat pyocutaneous disease and promote wound healing after being externally used.
Hu Ma is indicated in Shen nong Ben Cao Jing for deficiency of the middle energizer, tonifying five internal organs, invigorating qi, growing muscle, replenishing essence and marrow. The linseed oil can effectively relieve the damage, red swelling and even ulceration of perianal skin after being externally used.
The betel nut oil exists in the betel nut seeds, has a wide safety range and has no toxic or side effect. Researches show that the betel nut oil has the functions of resisting inflammation and inhibiting the growth of microorganisms.
Longan pulp, recorded in Shen nong Ben Cao Jing, is sweet in taste, mild in nature and non-toxic. Modern researches have proved that the arillus longan water-soaking agent has the effect of inhibiting dysentery bacillus.
The invention has the advantages that:
1. the pharmaceutical composition for treating constipation is screened, all the medicines are mutually coordinated to exert the maximum curative effect, the drug effect is durable, no toxic or side effect exists, and the pharmaceutical composition is worthy of popularization and application.
2. The pharmaceutical composition has good curative effect on constipation, can obviously improve abdominal fullness and constipation symptoms of constipation patients, and has high effective rate.
3. The enema has the advantages of no toxic or side effect, simple preparation method, simple and easy application and the like, is suitable for long-term use, is a safe and effective medicament for treating constipation, and has good application prospect.
Detailed Description
The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, it should be understood that various changes and modifications can be made by those skilled in the art after reading the disclosure of the present invention, and equivalents fall within the scope of the appended claims.
Example 1 pharmaceutical composition for treating constipation
Taking the following raw material medicines in parts by weight: 25 parts of almond oil, 20 parts of nectar, 25 parts of hemp seed oil, 10 parts of linseed oil, 10 parts of betel nut oil and 10 parts of longan pulp juice.
Example 2 pharmaceutical composition for treating constipation
Taking the following raw material medicines in parts by weight: 20 parts of almond oil, 15 parts of nectar, 20 parts of hemp seed oil, 13 parts of linseed oil, 13 parts of betel nut oil and 13 parts of longan pulp juice.
Example 3 pharmaceutical composition for treating constipation
Taking the following raw material medicines in parts by weight: 30 parts of almond oil, 25 parts of nectar, 30 parts of hemp seed oil, 7 parts of linseed oil, 7 parts of betel nut oil and 7 parts of longan pulp juice.
Example 4 pharmaceutical composition for treating constipation (IV)
Taking the following raw material medicines in parts by weight: 20 parts of almond oil, 15 parts of nectar, 30 parts of hemp seed oil, 13 parts of linseed oil, 7 parts of betel nut oil and 7 parts of longan pulp juice.
Example 5 pharmaceutical composition for treating constipation (V)
Taking the following raw material medicines in parts by weight: 30 parts of almond oil, 25 parts of nectar, 20 parts of hemp seed oil, 7 parts of linseed oil, 13 parts of betel nut oil and 13 parts of longan pulp juice.
Example 6 pharmaceutical composition for treating constipation (VI)
Taking the following raw material medicines in parts by weight: 30 parts of almond oil, 15 parts of nectar, 30 parts of hemp seed oil, 7 parts of linseed oil, 13 parts of betel nut oil and 7 parts of longan pulp juice.
Example 7 pharmaceutical composition for treating constipation (seven)
Taking the following raw material medicines in parts by weight: 20 parts of almond oil, 25 parts of nectar, 20 parts of hemp seed oil, 13 parts of linseed oil, 7 parts of betel nut oil and 13 parts of longan pulp.
Example 8 pharmaceutical composition for treating constipation (eight)
Taking the following raw material medicines in parts by weight: 27 parts of almond oil, 22 parts of nectar, 27 parts of hemp seed oil, 9 parts of linseed oil, 9 parts of betel nut oil and 9 parts of longan pulp juice.
Example 9 pharmaceutical composition for treating constipation (nine)
Taking the following raw material medicines in parts by weight: 23 parts of almond oil, 18 parts of nectar, 23 parts of hemp seed oil, 11 parts of linseed oil, 11 parts of betel nut oil and 11 parts of longan pulp juice.
Example 10 pharmaceutical composition for treating constipation (ten)
Taking the following raw material medicines in parts by weight: 27 parts of almond oil, 22 parts of nectar, 23 parts of hemp seed oil, 9 parts of linseed oil, 11 parts of betel nut oil and 11 parts of longan pulp juice.
Example 11 pharmaceutical composition for treatment of constipation (eleven)
Taking the following raw material medicines in parts by weight: 23 parts of almond oil, 18 parts of nectar, 27 parts of hemp seed oil, 11 parts of linseed oil, 9 parts of betel nut oil and 9 parts of longan pulp juice.
Example 12 pharmaceutical composition for treatment of constipation (twelve)
Taking the following raw material medicines in parts by weight: 23 parts of almond oil, 22 parts of nectar, 23 parts of hemp seed oil, 11 parts of linseed oil, 9 parts of betel nut oil and 11 parts of longan pulp juice.
Example 13 pharmaceutical composition for treating constipation (thirteen)
Taking the following raw material medicines in parts by weight: 27 parts of almond oil, 18 parts of nectar, 27 parts of hemp seed oil, 9 parts of linseed oil, 11 parts of betel nut oil and 9 parts of longan pulp juice.
EXAMPLE 14 clinical trial of the pharmaceutical composition of the present invention for treating constipation
1 data and method
181 patients with constipation between 2013 and 2017 and 8 months, 86 patients with constipation, 95 patients with constipation, 18-70 years of age and 2-10 years of disease course are selected. All patients were randomly divided into four groups, and the sex, age, course of disease and the like of each group were not significantly different and were comparable.
2 diagnostic criteria
The standard is formulated according to the Chinese medicine new drug clinical guideline published by the ministry of health of the people's republic of China as follows: hard stool, difficult defecation, too little stool volume, no defecation or spontaneous defecation for more than 2 times within 7 days under the condition of not applying purgative medicaments, obstruction or blockage of anus and rectum. Colon organic lesions are excluded by barium enema radiography and colonoscopy.
3 methods of treatment
One group of treatments was: 25 parts of almond oil, 20 parts of nectar, 25 parts of hemp seed oil, 10 parts of linseed oil, 10 parts of betel nut oil and 10 parts of longan pulp juice. Mixing, sterilizing, heating to 37-39 deg.C, and administering via disposable infusion apparatus rectally for 1 time/day for 2 treatment courses. During the treatment period, reasonable diet and living habits are required to be established, vegetables, fruits and coarse cereals with more residues are eaten, and smooth and moist foods are selected, so that people can sit less and move more, and defecate regularly.
Two groups of treatments were: 15 parts of almond oil, 10 parts of nectar, 15 parts of hemp seed oil and 15 parts of linseed oil. Mixing, sterilizing, heating to 37-39 deg.C, and administering via disposable infusion apparatus rectally for 1 time/day for 2 treatment courses. During the treatment period, reasonable diet and living habits are required to be established, vegetables, fruits and coarse cereals with more residues are eaten, and smooth and moist foods are selected, so that people can sit less and move more, and defecate regularly.
Three groups were treated: 15 parts of almond oil, 10 parts of nectar, 15 parts of betel nut oil and 15 parts of longan pulp juice are evenly mixed and sterilized, the mixture is heated to 37-39 ℃, and the mixture is rectally administrated through a disposable infusion apparatus, 200ml per time of enema is carried out, 1 time per day and ten days are a treatment course, and 2 treatment courses are continuously used. During the treatment period, reasonable diet and living habits are required to be established, vegetables, fruits and coarse cereals with more residues are eaten, and smooth and moist foods are selected, so that people can sit less and move more, and defecate regularly.
Control group: the fructus Cannabis soft capsule is orally administered 2 capsules each time, 2 times each time, and 3 weeks for continuous use.
4 Observation of therapeutic effects
4.1 Observation index
Before and after treatment, the times and the texture of defecations of the patients are observed through naked eyes and excrement examination, the conditions of lower abdomen distension and the like of the patients are observed, and the times are respectively counted for 1, 3 and 5 according to the light, medium and heavy symptoms.
4.2 Scoring criteria
Stool space: recording for 1 point less than 6 days; recording for 3 points in 6-9 days; when the number of days is more than 9, 5 points are counted.
Stool texture: hard, record 1 point; hard, 3 points are recorded; hard ball, 5 points.
Abdominal distension: slightly, 1 point is recorded; can be tolerated, 3 points are recorded; it is difficult to tolerate it, 5 points.
4.3 therapeutic criteria
The effect is shown: defecating for 1-2 times/1-2 days, and eliminating all symptoms of difficult defecation and combination; the method has the following advantages: the stool frequency is increased compared with that before treatment, the defecation difficulty and the combined symptoms are partially disappeared or obviously improved; and (4) invalidation: the symptoms are not obviously changed after treatment and before treatment.
5 therapeutic results
(1) Clinical efficacy comparison of four groups of patients
The results are shown in table 1, a group of the traditional Chinese medicine composition is treated with 30 cases with 18 cases, and the total effective rate is 100%; the two groups of the traditional Chinese medicine have 14 effective cases, 19 effective cases and 13 ineffective cases, and the total effective rate is 71.7 percent; the three groups of the traditional Chinese medicine have 10 effective cases, 20 effective cases and 12 ineffective cases, and the total effective rate is 71.4%; the control group has 12 cases of obvious effect, 17 cases of effective effect and 16 cases of ineffective effect, and the total effective rate is 64.4 percent. The total effective rate of a group treated is obviously higher than that of a control group, which shows that the pharmaceutical composition of the invention has obvious effect of treating constipation. The total effective rate and the significant efficiency of treating one group are obviously superior to those of treating two groups and three groups, which shows that the pharmaceutical composition has the advantage of obvious effect.
TABLE 1 comparison of clinical efficacy of four groups of patients after treatment
Group of Number of examples Show effect Is effective Invalidation Total effective rate
Control group 45 12 17 16 29(64.4%)
Treatment of a group 48 30 18 0 48(100%)
Two groups of treatment 46 14 19 13 33(71.7%)
Three groups of treatment 42 10 20 12 30(71.4%)
(2) Integral comparison of main symptoms of constipation in four groups of patients
The results are shown in table 2, and the integral of the symptoms of stool separation, stool texture and abdominal fullness after treatment of a group of patients is remarkably reduced compared with that before treatment (P <0.01), which indicates that the pharmaceutical composition of the invention can effectively improve the constipation symptoms of the patients. After treatment, the integral of the symptoms of stool interval, stool texture and abdominal fullness of a group of patients has statistical significance (P is less than 0.05) compared with that of a control group, which shows that the pharmaceutical composition has better improvement effect on constipation symptoms.
TABLE 2 score comparison of chief complaints before and after treatment for four groups of patients
Figure BDA0001542503900000071
Note: p compared to before treatment<0.05,**P<0.01. Comparing with control group#P<0.05,##P<0.05。
The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.

Claims (6)

1. A pharmaceutical composition for external use for treating constipation is characterized by being prepared from the following raw materials in parts by weight: 20-30 parts of almond oil, 15-25 parts of honey, 20-30 parts of hemp seed oil, 7-13 parts of linseed oil, 7-13 parts of betel nut oil and 7-13 parts of longan pulp juice.
2. The pharmaceutical composition for treating constipation according to claim 1, which is prepared from the following raw materials in parts by weight: 23-27 parts of almond oil, 18-22 parts of honey, 23-27 parts of hemp seed oil, 9-11 parts of linseed oil, 9-11 parts of betel nut oil and 9-11 parts of longan pulp juice.
3. The pharmaceutical composition for treating constipation according to claim 1, which is prepared from the following raw materials in parts by weight: 25 parts of almond oil, 20 parts of honey, 25 parts of hemp seed oil, 10 parts of linseed oil, 10 parts of betel nut oil and 10 parts of longan pulp juice.
4. The pharmaceutical composition for treating constipation according to claim 1, wherein the honey is nectar, nectar or a mixture of both.
5. Use of a composition according to any one of claims 1 to 4 for the manufacture of a medicament for the treatment of constipation.
6. The use according to claim 5, wherein the medicament is an enema.
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