Summary of the invention
The objective of the invention is to propose a kind of effect of relaxing bowel that has, and raw material is simplified the easy Chinese medicine composition of preparation.
Another object of the present invention is to propose to utilize the Chinese medicine preparation of above-mentioned Chinese medicine composition preparation.
The 3rd purpose of the present invention is to propose the preparation method of above-mentioned Chinese medicine preparation.
Invention thinking of the present invention is: the inventor has proposed the unique preparation at senile constipation, Herba Cistanches sweet-salty in the Chinese medicine composition of the present invention through long term studies, warm in nature, function the kidney warming benefit is smart, warm waist intestine moistening, all medicines share, Synergistic treatment, but both the kidney warming benefit essence was effected a permanent cure, again can loosening bowel to relieve constipation to take stopgap measures, invigorating middle warmer has rushes down, liter is arranged in falling, have the compatibility characteristics of " residence leads among mending, and posts and falls within liter ".And compare with other medicines, the present invention has that composition is few, technology is simple, rapid-action, safe without toxic side effect, characteristics such as be convenient to take, and is the ideal medicament that is used for senile constipation.
The present invention selects Herba Cistanches, Semen Raphani, Semen Cassiae and the Rhizoma Atractylodis Macrocephalae, and four Chinese medicine makes up altogether, makes each medicine produce synergism these drug regimens, thereby can effectively play the effect of loosening bowel to relieve constipation.
The Herba Cistanches of wherein selecting for use: be the chylocaulous of the band scale leaf of orobanchaceae plant cistanche Cistanche deserticola Y.C.Ma..Main product in the Inner Mongol, ground such as Gansu, Xinjiang, Qinghai.Excavate when Seedling is not unearthed or just has been unearthed spring, removes inflorescence.Usefulness is given birth in section, or processed with wine is used.Its property of medicine is sweet, salty, temperature.Return kidney, large intestine channel.Has reinforcing the kidney and supporting YANG, the effect of loosening bowel to relieve constipation.Modern pharmacological research shows: Herba Cistanches can increase the enteral osmotic pressure, reduces the absorption of moisture, makes the stool deliquescing, and it can promote enterokinesia in addition, shortens defecation time.This explanation Herba Cistanches defecating feces excretion is different with other relieving constipation Chinese medicine such as Radix Et Rhizoma Rhei, Folium Sennae etc., is not to rush down down, but loosening bowel to relieve constipation makes stool become wet, deliquescing, is easy to discharge.So Herba Cistanches relieving constipation but wound body not are specially adapted to old people, puerpera and the valetudinarian of constipation, also are applicable to general crowd's constipation certainly.
Semen Raphani: be the mature seed of crucifer Radix Raphani Raphanus sativus L..All there is cultivation all parts of the country.Tap plant during fruit maturation summer, dries, and rubs seed, dries again.Give birth to and use or stir-fry usefulness, the time spent smashs to pieces.Semen Raphani property of medicine suffering, sweet, flat.Return lung, spleen, stomach warp.Having and helping digestion except that expanding the effect of lowering the adverse-rising QI to resolve phlegm.The Compendium of Material Medica record: the Semen Raphani effect has therapeutic method to keep the adverse QI flowing downwards Dingchuan, controls expectorant and helps digestion, and removes and expands sharp defecation; In addition, it contains and enriches oils and fats, and Replenishing QI and nourishing YIN is arranged, the merit of loosening bowel to relieve constipation, and the senile constipation cause of disease is the essence and blood degradation, and body fluid deficiency liquid is weary, and large intestine loses and moistens.The Semen Raphani (parched) circulation of qi promoting is regulated the flow of vital energy, and can make mechanism of qi fluent, just in time cuts the pathogenesis of senile constipation.The modern pharmacology effect shows: antibiotic in addition, eliminate the phlegm, antitussive, relieving asthma, improve urinary function and cholesterol reducing, prevent effects such as arteriosclerosis.
Semen Cassiae: be the dry mature seed of leguminous plant Semen Cassiae Cassia obtusifolia L. or little Semen Cassiae Cassia tora L..All there is cultivation north and south various places, the whole nation, main product in Anhui, ground such as Guangxi, Sichuan, Zhejiang, Guangdong, the mature fruit of gathering autumn is dried, and lays seed, removes impurity.Give birth to and use or fry usefulness.The Semen Cassiae property of medicine is sweet, bitter, salty, is slightly cold.Return liver, large intestine channel.Be used for the puckery pain of conjunctival congestion, it is dizzy to have a headache, constipation." the China's book on Chinese herbal medicine " that State Administration of Traditional Chinese Medicine's tissue is write, it is comparatively extensive to state its application, carries to say: " the liver heat removing kidney tonifying makes eye bright, the diuretic relieving constipation ".Modern pharmacological research shows, Semen Cassiae is except that containing saccharide, protein, fat, also contain steroidal compounds, chrysophanol, emodin etc., also have the trace elements iron, zinc, manganese, copper, nickel of needed by human etc., contained emodin, chrysophanic acid human body is had relieving asthma, function of gallbladder promoting, protect the liver, effects such as blood pressure lowering, defecation.
The Rhizoma Atractylodis Macrocephalae: be feverfew Rhizoma Atractylodis Macrocephalae Atractylodes macrocephala Koidz. rhizome.Main product in Zhejiang, ground such as Hubei, Hunan.Gather winter, dries or dry, and removes fibrous root, cuts sheet, and life usefulness or parching with earth, parched with bran are used.The Rhizoma Atractylodis Macrocephalae property of medicine is sweet, bitter, warm.Return spleen, stomach warp.Has replenishing QI to invigorate the spleen, dampness diuretic, last antiperspirant, antiabortive effect.Modern pharmacological research shows: Rhizoma Atractylodis Macrocephalae decocting liquid has obvious promotion gastric emptying and intestinal propulsion function to mice.
The consumption of each drug component of the present invention also is that the inventor draws through groping in a large number to sum up, and each is organized consumption and all have better curative effect in the following weight parts ratio range.
The concrete technical scheme of the present invention is:
A kind of Chinese medicine composition of loosening bowel to relieve constipation, it is to be made by following raw materials in weight portion medicine:
Herba Cistanches 10-25 weight portion, Semen Raphani 10-20 weight portion, Semen Cassiae 10-20 weight portion, Rhizoma Atractylodis Macrocephalae 10-25 weight portion.
The Chinese medicine composition of above-mentioned a kind of loosening bowel to relieve constipation, preferable weight portion proportioning is:
Herba Cistanches 18-22 weight portion, Semen Raphani 15-18 weight portion, Semen Cassiae 15-18 weight portion, Rhizoma Atractylodis Macrocephalae 18-22 weight portion.
The Chinese medicine composition of above-mentioned a kind of loosening bowel to relieve constipation, best weight portion proportioning is:
Herba Cistanches 20 weight portions, Semen Raphani 15 weight portions, Semen Cassiae 15 weight portions, the Rhizoma Atractylodis Macrocephalae 20 weight portions.
A kind of Chinese medicine preparation of loosening bowel to relieve constipation, it is made up of above-mentioned Chinese medicine composition and pharmaceutics acceptable auxiliary.Can be according to known method in the pharmaceuticals industry, aforementioned pharmaceutical compositions is made various peroral dosage form after by the known method degerming.
According to the route of administration difference, Chinese medicine composition of the present invention is recommended to make oral formulations, as decoction, oral liquid, granule, tablet, sweet mastic, honeydew body or capsule etc.
The most preferred dosage form that the inventor recommends is a capsule, taking convenience, and have the characteristics of sustained-release administration, be more conducive to the absorption metabolism of pharmaceutical composition active component of the present invention.
Other three kinds of medical materials all contain fatty oil component except that Herba Cistanches, therefore the inventor has carried out fatty oil extraction research to other three kinds of medical material powder, and medicinal residues and Herba Cistanches after three kinds of medical material fatty oils are extracted have carried out the research that decocting extracts, to determine optimum extraction process, concrete processing step is as follows:
The preparation method of loosening bowel to relieve constipation Chinese medicine composition active component of the present invention, its concrete steps are as follows:
(1) the weight portion proportioning by claim 1 takes by weighing the Rhizoma Atractylodis Macrocephalae, Semen Cassiae and Semen Raphani, 10 times of alcohol reflux twice, and the time was respectively 1 hour and 2 hours;
(2) reflux extracting liquid of step (1) is added anhydrous sodium sulfate dehydration, standing over night, filter fatty oil, medicinal residues are standby;
(3) medicinal residues with step (2) add Herba Cistanches, and decocting extracts twice, and 1 hour for the first time, 2 hours for the second time, amount of water was 10 times of amounts, extracted twice gained medicinal liquid mixing concentrate drying, and it is standby to do medicated powder;
(4) the fatty oil mixing that obtains of dried medicated powder that step (3) is obtained and step (2) promptly makes the active component of Chinese medicine composition of the present invention.
The inventor has observed the influence of different ethanol concentration to the fatty oil extracted amount, and the concentration of alcohol that finally draws in the described step (1) is preferable at 40%-80% fatty oil extracted amount.Therefore concentration of alcohol is recommended to use the alcoholic solution of 80% concentration to carry out the extraction of fatty oil in 80% left and right sides fatty oil extracted amount the best.
The active component branch that method for preparing is gone out is packed into and is promptly made capsule, the 0.5g/ grain in the soft capsule.
The present invention also can adopt the conventional preparation method of the field of Chinese medicines to be prepared into other peroral dosage forms, as with crude drug grind into powder mix homogeneously, makes powder, uses mixing in water for oral taking.Raw material liquid medicine is carried, and the condensed water decocting liquid is made oral liquid.Also can concentrate and make clear paste, add adjuvant and make sweet mastic (soft extract) etc.
Usage of the present invention and consumption: the present invention is the oral way administration, every day three times, each two seed lac wafers.
Advantage of the present invention and benefit: the present invention write out a prescription the prescription rigorous, merit is specially imitated work, the crude drug wide material sources are with low cost.Because simplifying, prescription makes that drug quality control is simple.The present invention makes soft capsule dosage form according to its effective ingredient characteristics, and quantitatively accurately, after the disintegrate, content can be absorbed by health very soon with the form of liquid state in vivo, the soft capsule smooth surface, and mouthfeel is good, easily swallows.Through the checking of the drug effect of clinical principium, rapid-action, have no side effect especially at person in middle and old age's constipation patient determined curative effect, safe and effective and safe to carry, instant.The present invention reaches more than 90% through clinical experiment checking effective percentage, has good application prospects and market prospect.
The specific embodiment
The used medical material of present embodiment meets 2000 editions one ministerial standards of Pharmacopoeia of People's Republic of China all available from Chinese Medicinal Materials Co.
Pharmaceutical composition technical study of the present invention:
Get Rhizoma Atractylodis Macrocephalae 10g Semen Cassiae 20g Semen Raphani 20g reflux, extract, twice, be respectively 1 hour and 2 hours, the ethanol multiple is 10 times, has observed the influence of different ethanol concentration to the fatty oil extracted amount.The result is as follows:
Concentration of alcohol fat oil mass
40% 16.5ml
60% 21.0ml
80% 31.0ml
Above result has repeated twice, show that it is feasible adopting the ethanol extraction fatty oil, but concentration of alcohol is bigger to the influence of fatty oil extracted amount.Therefore for fatty oil extracts fully, select for use 80% concentration of alcohol to extract fatty oil.
Reflux extracting liquid adds anhydrous sodium sulfate dehydration (the anhydrous sodium sulfate addition is advisable to reach maximum saturation).Standing over night, filter fatty oil, medicinal residues are standby.
Decocting extracts:
Three medicinal residues behind the ethanol extraction fatty oil add Herba Cistanches 10g decocting and extract 2 times, and 1 hour for the first time, 2 hours for the second time, amount of water was 10 times of amounts, extracted twice gained medicinal liquid concentrate drying, and it is standby to do medicated powder.It is as follows to extract the result three times:
Chinese crude drug amount dry extract amount
50g 12.1g
50g 13.2g
50g 11.7g
According to above technical study, we have determined that capsule extraction process of the present invention promptly at first adopts the fatty oil in the 80% alcohol reflux Rhizoma Atractylodis Macrocephalae, Semen Raphani and three kinds of medicines of Semen Cassiae, medicinal residues merge decocting with Herba Cistanches again and extract 2 times, the medicinal liquid concentrate drying, dried medicated powder and fatty oil mixing dress 0.5g/ grain soft capsule get final product, and concrete preparation method is as follows.
The preparation of embodiment 1 medicine capsule of the present invention
Crude drug and consumption:
Herba Cistanches 20g, Semen Raphani 15g, Semen Cassiae 15g, Rhizoma Atractylodis Macrocephalae 20g.
Preparation method:
(1) take by weighing each crude drug by above-mentioned consumption, at first with the Rhizoma Atractylodis Macrocephalae, Semen Cassiae and Semen Raphani, 10 times of alcohol reflux twice were respectively 1 hour and 2 hours.
(2) reflux extracting liquid with step (1) adds anhydrous sodium sulfate dehydration, and standing over night, filtration (80 mesh sieve) get fatty oil, and medicinal residues are standby;
(3) medicinal residues with step (2) add Herba Cistanches, and decocting extracts twice, and 1 hour for the first time, 2 hours for the second time, amount of water was 10 times of amounts, extracted twice gained medicinal liquid mixed atomizing drying, and it is standby to do medicated powder;
(4) the fatty oil mixing that obtains of dried medicated powder that step (3) is obtained and step (2) promptly makes the active component of Chinese medicine composition of the present invention;
(5) the active component branch is packed into promptly make soft capsule, the 0.5g/ grain in the soft capsule.
Embodiment 2 capsule preparations of the present invention
Crude drug and consumption:
Herba Cistanches 10g, Semen Raphani 20g, Semen Cassiae 20g, Rhizoma Atractylodis Macrocephalae 10g.
Preparation method:
(1) take by weighing each crude drug by above-mentioned consumption, at first with the Rhizoma Atractylodis Macrocephalae, Semen Cassiae and Semen Raphani, 10 times of alcohol reflux twice were respectively 1 hour and 2 hours.
(2) reflux extracting liquid with step (1) adds anhydrous sodium sulfate dehydration, and standing over night, filtration (80 mesh sieve) get fatty oil, and medicinal residues are standby;
(3) medicinal residues with step (2) add Herba Cistanches, and decocting extracts twice, and 1 hour for the first time, 2 hours for the second time, amount of water was 10 times of amounts, extracted twice gained medicinal liquid mixed atomizing drying, and it is standby to do medicated powder;
(4) the fatty oil mixing that obtains of dried medicated powder that step (3) is obtained and step (2) promptly makes the active component of Chinese medicine composition of the present invention;
(5) the active component branch is packed into promptly make soft capsule, the 0.5g/ grain in the soft capsule.
Embodiment 3 medicinal granule preparations of the present invention
Preparation method:
By following consumption weighting raw materials, crude drug of the present invention was soaked 20~30 minutes according to a conventional method, add 3 times of water gagings back that is fried boiling and kept fluidized state 10~15 minutes, taking liquid; Add 3 times of water gagings back that is fried boiling again and kept fluidized state 10~15 minutes, taking liquid; Twice medicinal liquid hybrid filtering is concentrated into relative density 1.3~1.34 thick pastes, spray granulation, drying.Packing.
Crude drug and consumption:
Herba Cistanches 25g, Semen Raphani 10g, Semen Cassiae 10g, Rhizoma Atractylodis Macrocephalae 25g.
Clinical experiment of the present invention and interpretation of result:
Case: select the constipation patient of age more than 55 years old; The course of disease is more than 1 year; Constipation with dry stool, the defecation effort; Intestinal fiberscope is got rid of colon, rectum quality sexually transmitted disease (STD) becomes.
The clinical experiment grouping: take the randomized controlled trial method, be divided into two groups, 55 examples are organized in treatment, matched group 50 examples.Treat preceding two groups of comparisons, all pass through statistical analysis, have comparability at aspects such as age, sex, the courses of disease.
Method: the contrast medicine is a MAREN RUANJIAONANG, each 2 times, and each 3.
The treatment group is with this Chinese medicine composition water decoction, every day 3 times, each 1 dose, 1 dose of 200ml.
Efficacy assessment standard: cure: defecation was 1 time in 2 days, and just matter is changeed profit, and unobstructed when separating, short-term does not have recurrence; Effectively: defecation was 1 time in 3 days, and just matter is changeed profit, and it is smooth that defecation is owed; Invalid: symptom does not have improvement.
Result: see Table 1
Table 1 liang group patient curative effect relatively
The Chinese medicine composition of above-mentioned clinical experiment presentation of results kidney loosening bowel to relieve constipation of the present invention is compared the curative effect with good loosening bowel to relieve constipation with matched group, total effective rate reaches 100%.