A kind of pharmaceutical composition of loosening bowel to relieve constipation
Technical field
The present invention relates to field of medicine preparations, relate to a kind of Chinese medicine preparation specifically with effect of relaxing bowel.
Background technology
Constipation is the global problem in the medical domain, has all dropped into great amount of manpower both at home and abroad and material resources are studied.Because it is very big to human beings'health harm, and has many diseases all relevant with constipation.Therefore, the research of constipation more and more is subjected to people's attention, people also grow with each passing day to the attention degree of constipation.
Constipation is a symptom of multiple disease, shows as: stool amount very little, too hard, discharge too difficulty, or merge some characteristic symptoms, as: firmly the expand sense, defecation of defecation, rectum felt not to the utmost, even needed to help defecation with medicine or other method for a long time.Under the situation of not using cathartic, spontaneous emptying feces is no more than 2 times or does not have a just meaning for a long time in 7 days.
Constipation each age group in natural crowd all has higher sickness rate.Its sickness rate differs because of the different reports of statistical method.The sickness rate of constipation is 2%~28% in the American population, and China Beijing, Tianjin and Xi'an show that to the investigation of crowd more than 60 years old chronic constipation is up to 15%~20%.And 18~70 years old adult in Beijing carried out one at random, layering, classification investigation show that the sickness rate of chronic constipation is 6.07%, the women is more than 4 times of male.
Chinese medicine need always to be emphasized at the cause of disease, to regulate diet, daily life, feelings will from integral body to the treatment of constipation, abides by " protecting stomach-QI, keeping the body fluid " principle, rational use of drug.The traditional Chinese medical science thinks that the etiology and pathogenesis of constipation is that gastrointestinal amasss four aspects such as heat, depression and stagnation of QI, yang blood and qi weakness and YIN-cold stagnate.And by the pathogenesis difference constipation be divided into corresponding four kinds the card marquis promptly: functional constipation, constipation due to disorder of QI, constipation due to insufficiency, constipation due to accumulation of pathogenic cold.Usually the pungent savoury of happiness food, fry in shallow oil stir-frys, alcohol user and easily cause the long-pending heat of gastrointestinal and form functional constipation, promptly amass hot constipation.The characteristics of long-pending hot constipation are to be hard and dry, and hard as sheep stool, difficult defecation can be with diseases such as abdominal distention and pain, halitosis, feverish sensation in the palms and soles; Control to expel the heat-evil purging FU-organs or clearing away heat and moistening the bowels.The purging FU-organs that the expels the heat-evil stomach CHENGQI TANG (Radix Et Rhizoma Rhei, Natrii Sulfas, Radix Glycyrrhizae) etc. of transferring commonly used; Clearing away heat and moistening the bowels is used Maziren Wan (Radix Et Rhizoma Rhei, Fructus Aurantii Immaturus, Cortex Magnoliae Officinalis, Fructus Cannabis, Semen Armeniacae Amarum, the Radix Paeoniae Alba, whitish honey) etc. always.But along with the continuous growth of constipation especially functional constipation sickness rate, the patient is more and more, and existing relieving constipation medicine can't be satisfied the demand.And what have is traditional decoction through proved recipe as transferring the stomach CHENGQI TANG, and patient's medication need boil temporarily, and is extremely inconvenient, and can be when boiling reason such as misoperation cause drug effect to lower even can not reach therapeutic purposes; Maziren Wan is only effective to patients whose symptoms were less severe, and is then inapplicable when the long-pending hot constipation symptom of patient is heavier.
Summary of the invention
Purpose of the present invention just provides a kind of Chinese medicine composition of new loosening bowel to relieve constipation, and this medicine has effects such as heat clearing away, intestine moistening, relieving constipation, intestinal stasis relieving, and long-pending hot constipation is had therapeutical effect preferably.
The technical solution adopted for the present invention to solve the technical problems is: a kind of pharmaceutical composition of loosening bowel to relieve constipation; it by clinically rationally following five groups of crude drug of dosage form: A; Folium Sennae; pockmarks core; Radix Et Rhizoma Rhei; at least a in the Natrii Sulfas etc.; B; Cortex Cinnamomi; Radix Aconiti Lateralis Preparata; Semen Canavaliae; at least a in the Flos Caryophylli etc.; C; Succus Bambusae; Caulis Bambusae In Taenia; Concretio Silicea Bambusae; Fructus Trichosanthis; Calculus Bovis; Borax; Borneolum Syntheticum; Moschus; at least a in the catechu etc.; D; Rhizoma Coptidis; Cortex Phellodendri; Radix Scutellariae; Flos Lonicerae; Flos Chrysanthemi Indici; Herba Andrographis; at least a in the Indigo Naturalis etc., E; Radix Glycyrrhizae; Fructus Canarii and Mentholum.
Wherein the weight proportion of each crude drug is in the pharmaceutical composition of above-mentioned loosening bowel to relieve constipation: A group medicine 50-150 part, B group medicine 1-10 part, C group medicine 5-21 part, D group medicine 20-40 part, Radix Glycyrrhizae 5-15 part, Fructus Canarii 15-25 part, Mentholum 1-10 part in the E group medicine.
According to a preferred version, each crude drug and weight proportion thereof are preferably in the aforementioned pharmaceutical compositions: Radix Et Rhizoma Rhei 50-150 part, Cortex Cinnamomi 0.5-7 part, Flos Caryophylli 0.5-3 part, Borax 2-8 part, Borneolum Syntheticum 1-5 part, catechu 2-8 part, Radix Scutellariae 15-25 part, Indigo Naturalis 5-15 part, Radix Glycyrrhizae 5-15 part, Fructus Canarii 15-25 part, Mentholum 1-10 part.
The further preferred weight proportioning of above-mentioned each crude drug is: Radix Et Rhizoma Rhei 80-120 part, Cortex Cinnamomi 1-5 part, Flos Caryophylli 0.5-1.5 part, Borax 4-6 part, Borneolum Syntheticum 2-4 part, catechu 4-6 part, Radix Scutellariae 18-22 part, Indigo Naturalis 7-10 part, Radix Glycyrrhizae 8-12 part, Fructus Canarii 18-22 part, Mentholum 2-4 part.
The more preferably weight proportion of above-mentioned each crude drug is: 100 parts of Radix Et Rhizoma Rhei, 3 parts of Cortex Cinnamomis, 1 part of Flos Caryophylli, 5 parts of Boraxs, 3 parts of Borneolum Syntheticums, 5 parts in catechu, 20 parts of Radix Scutellariaes, 8.5 parts of Indigo Naturaliss, 10 parts in Radix Glycyrrhizae, 20 parts of Fructus Canariis, 3 parts of Mentholums.
Radix Et Rhizoma Rhei in above-mentioned each crude drug can adopt Radix Et Rhizoma Rhei, Radix Et Rhizoma Rhei, Radix et Rhizoma Rhei (parched to brown), charred Radix Et Rhizoma Rhei, vinegar Radix Et Rhizoma Rhei (parched), Radix et Rhizoma Rhei (parched with wine), wine to boil Radix Et Rhizoma Rhei or Radix et Rhizoma Rhei (processed with wine) etc.
The dosage form preferred oral preparation of aforementioned pharmaceutical compositions.More preferably capsule, tablet, granule, pill, oral liquid etc.
Aforementioned pharmaceutical compositions makes after can handling each crude drug according to the formulation method of routine, can add other an amount of pharmaceutic adjuvant more in case of necessity.
Compared with prior art, the invention has the beneficial effects as follows: from the organic conception of Chinese medicine, the cause of disease at the long-pending hot constipation of gastrointestinal, reuse the purging heat to relax the bowels medicine, be aided with a small amount of heat-clearing and toxic substances removing or dampness medicine, drugs for dispelling internal cold, be equipped with a small amount of removing heat from the lung and dissipating phlegm or awaking drug again, determined curative effect, the patient lighter or heavier to long-pending hot constipation symptom all is suitable for, and can avoid producing bitter cold and cut down untoward reaction such as stomach or secondary constipation.In addition, make preparation after, it is all comparatively convenient to carry and take, and can avoid decocting medicinal herbs because of patient oneself reason such as misoperation and cause drug effect to lower or invalid.
For curative effect and the safety of investigating medicine of the present invention, medicine of the present invention has been carried out animal pharmacodynamics The effects to the inventor and toxicity test is investigated.
1. pharmacodynamic experiment is investigated
1.1 material
40 of Kunming mouses (Sichuan University's Experimental Animal Center provides), male and female dual-purpose, body weight 18g~20g.
Medicine of the present invention: self-control makes (down together) according to embodiment one crude drug proportioning; 3g/ time, 2 times/day.
Diphenoxylate Mixture of hydrochloride with atropine sulfate: Jiaozhuo universal love pharmaceutcal corporation, Ltd product, lot number: 041013; Every hydrochloric diphenoxylate 2.5mg, atropine sulfate 0.025mg, the 1-2 sheet/time, 2-3 time/day.
Fructus Cannabis water-honeyed pill: Huzhou pharmaceutical factory product, lot number: 040923; A 6g, 2 times/day.
1.2 method
Grouping: 40 Kunming mouses divide the normal control group at random, the constipation model group, and medicine group of the present invention and positive controls, each treated animal number average is 10.
Animal model is made and observation item: be lined with filter paper under the sub-cage rearing mice, cage.Get 30 mices of constipation model group, medicine group of the present invention and positive controls, behind the fasting 10h, mice gives Compound Diphenoxylate 0.002g/kg.d every day and irritates the stomach modeling, simultaneously, medicine group of the present invention adds with medicine 1g/kg.d of the present invention irritates stomach, positive controls adds with Fructus Cannabis Bolus 2g/kg.d irritates stomach, and the constipation model group gives the equal-volume normal saline and irritates stomach, continuously 5d.Normal control group (not giving any medicine) gives the equal-volume normal saline and irritates stomach, continuously 5d.Respectively organize the mice argol and count in d1, d3, a d5 days observation.
Statistical procedures numeration data adopts the t check.Experimental result sees Table 1.
Table 1 medicine of the present invention is to the influence (n=10 of constipation model; X ± s)
Group | Dosage (g/kg) | Argol is counted |
d1 | d3 | d5 |
Constipation model group positive controls medicine group of the present invention normal control group | 0 2 1 0 | 6.83±3.76 7.02±2.56. 6.86±2.34 13.17±4.45** | 5.01±3.58 12.37±4.12* 10.10±3.78* 17.67±3.98** | 4.83±4.26 15.89±4.88** 16.42±5.29** 16.50±1.87** |
Annotate: compare * P<0.05 * * P<0.01 with model group
Constipation model group mice gives 24h behind the Compound Diphenoxylate, and argol is counted and compared obvious minimizing (6.83 ± 3.76 vs 13.17 ± 4.45, P<0.05) with the normal control group.Since the 3rd day, medicine group argol of the present invention is counted obviously to be increased, and same time point is compared with the constipation model group all has utmost point significant difference (P<0.05), and along with administration time prolongs, argol is counted to be increased obviously.
Conclusion: the result of study that adopts nonspecific mice constipation model to carry out shows that medicine of the present invention has fairly obvious therapeutical effect to the non-specific constipation of mice.
2. toxicity test is investigated
(1) studies on acute toxicity
Get Kunming mouse and give medicine of the present invention by 20g/kg.d filling stomach, observed continuously 14 days, do not see that animal has abnormal response, zootomy does not find that internal organs have organic disease yet.Therefore think that the maximum tolerated dose of medicine mice gastric infusion every day of the present invention is greater than 20g/kg.
(2) long term toxicity research
According to " Chinese medicine, natural drug long term toxicity investigative technique guideline ", medicine of the present invention carried out 3 months rat long term toxicity test.Dosage reaches 80,45,12 times of clinical dosage respectively.The result shows: each dosage is not all found tangible toxic reaction.Prompting life-time service safety of medicine of the present invention is nontoxic.
The specific embodiment
The present invention is described in further detail below in conjunction with the specific embodiment.
Embodiment one
The present embodiment medicine is made by following materials of weight proportions medicine: 90 parts of Radix Et Rhizoma Rhei, 2 parts of Cortex Cinnamomis, 1 part of Flos Caryophylli, 5 parts of Boraxs, 3 parts of Borneolum Syntheticums, 5 parts in catechu, 22 parts of Radix Scutellariaes, 8 parts of Indigo Naturaliss, 10 parts in Radix Glycyrrhizae, 25 parts of Fructus Canariis, 3 parts of Mentholums.
Embodiment two
The present embodiment medicine is made by following materials of weight proportions medicine: 4 parts of 20 parts of Folium Sennae, 30 parts of Radix Et Rhizoma Rhei, 0.5 part of Cortex Cinnamomi, 0.5 part of Radix Aconiti Lateralis Preparata, 8 parts of Succus Bambusaes, 1 part of Calculus Bovis, 5 parts of Borneolum Syntheticums, 7 parts in catechu, 15 parts of Radix Scutellariaes, 10 parts of Flos Loniceraes, 10 parts of Herba Andrographis, 5 parts of Indigo Naturaliss, 12 parts in Radix Glycyrrhizae, 15 parts of Fructus Canariis and Mentholums.
Embodiment three
The present embodiment medicine is made by following materials of weight proportions medicine: 2 parts of 80 parts of pockmarks core, 30 parts of Radix Et Rhizoma Rhei, 40 parts in Natrii Sulfas, 3 parts of Cortex Cinnamomis, 5 parts of Semen Canavaliaes, 2 parts of Flos Caryophyllis, 2 parts of Concretio silicea Bambusae seu schizostachyi, 1 part of Fructus Trichosanthis, 0.5 part in Moschus, 1.5 parts of Borneolum Syntheticums, 10 parts of Rhizoma Coptidis, 10 parts of Flos Chrysanthemis, 10 parts of Indigo Naturaliss, 5 parts in Radix Glycyrrhizae, 22 parts of Fructus Canariis and Mentholums.
Embodiment four
The present embodiment medicine is made by following materials of weight proportions medicine: 10 parts of 80 parts of pockmarks core, 20 parts in Natrii Sulfas, 3 parts of Semen Canavaliaes, 2.5 parts of Flos Caryophyllis, 3 parts of Caulis Bambusae In Taenia, 5 parts of Boraxs, 4 parts in catechu, 12 parts of Cortex Phellodendris, 8 parts of Radix Scutellariaes, 15 parts in Radix Glycyrrhizae, 18 parts of Fructus Canariis and Mentholums.
Embodiment five
The present embodiment medicine is made by following materials of weight proportions medicine: 1 part of 40 parts of pockmarks core, 80 parts of Radix Et Rhizoma Rhei, 5 parts of Cortex Cinnamomis, 8 parts of Boraxs, 6 parts of Borneolum Syntheticums, 25 parts of Radix Scutellariaes, 8 parts in Radix Glycyrrhizae, 20 parts of Fructus Canariis and Mentholum.
Embodiment six
The present embodiment medicine is made by following materials of weight proportions medicine: 80 parts of Radix Et Rhizoma Rhei, 5 parts of Cortex Cinnamomis, 0.5 part of Flos Caryophylli, 4 parts of Boraxs, 4 parts of Borneolum Syntheticums, 6 parts in catechu, 15 parts of Radix Scutellariaes, 15 parts of Indigo Naturaliss, 15 parts in Radix Glycyrrhizae, 18 parts of Fructus Canariis, 4 parts of Mentholums.
Embodiment seven
The present embodiment medicine is made by following materials of weight proportions medicine: 100 parts of Radix Et Rhizoma Rhei, 3 parts of Cortex Cinnamomis, 1 part of Flos Caryophylli, 5 parts of Boraxs, 3 parts of Borneolum Syntheticums, 5 parts in catechu, 20 parts of Radix Scutellariaes, 8.5 parts of Indigo Naturaliss, 10 parts in Radix Glycyrrhizae, 20 parts of Fructus Canariis, 3 parts of Mentholums.
Embodiment eight
The present embodiment medicine is made by following materials of weight proportions medicine: 120 parts of Radix Et Rhizoma Rhei, 7 parts of Cortex Cinnamomis, 1.5 parts of Flos Caryophyllis, 8 parts of Boraxs, 1 part of Borneolum Syntheticum, 8 parts in catechu, 22 parts of Radix Scutellariaes, 10 parts of Indigo Naturaliss, 12 parts in Radix Glycyrrhizae, 15 parts of Fructus Canariis, 10 parts of Mentholums.
Embodiment nine
The present embodiment medicine is made by following materials of weight proportions medicine: 50 parts of Radix Et Rhizoma Rhei, 1 part of Cortex Cinnamomi, 3 parts of Flos Caryophyllis, 6 parts of Boraxs, 2 parts of Borneolum Syntheticums, 2 parts in catechu, 25 parts of Radix Scutellariaes, 5 parts of Indigo Naturaliss, 8 parts in Radix Glycyrrhizae, 22 parts of Fructus Canariis, 1 part of Mentholum.
Embodiment ten
The present embodiment medicine is made by following materials of weight proportions medicine: 150 parts of Radix Et Rhizoma Rhei, 0.5 part of Cortex Cinnamomi, 0.5 part of Flos Caryophylli, 2 parts of Boraxs, 5 parts of Borneolum Syntheticums, 4 parts in catechu, 18 parts of Radix Scutellariaes, 7 parts of Indigo Naturaliss, 5 parts in Radix Glycyrrhizae, 25 parts of Fructus Canariis, 2 parts of Mentholums.
More than each embodiment medicine make various suitable dosage forms after all can handling each crude drug according to the formulation method of routine, can add other an amount of pharmaceutic adjuvant more in case of necessity.