CN101732474A - Oral preparation with effects of moisturizing intestine and relaxing bowels - Google Patents

Abstract

The invention discloses an oral preparation with the effects of moisturizing the intestine and relaxing bowels and a preparation method thereof. The oral preparation is characterized by being prepared from the traditional Chinese medicine of rehmannia root, especially fresh rehmannia root. The oral preparation has the effects of nourishing yin, reducing fever, moistening dryness and relaxing bowels and is suitable for various kinds of functional constipation. The oral preparation with the effects of moisturizing the intestine and relaxing bowels has good curative effect, high safety and small side effect.

Description

A kind of oral formulations with effect of relaxing bowel

Technical field

The present invention relates to a kind of oral formulations and preparation method thereof, belong to medical technical field with effect of relaxing bowel.

Background technology

Constipation is the most common, thereby the also the easiest disease of ignoring.In daily life, often hear the suggestion of the solution constipation of " having had some cathartic just " and so on.Constipation patient is because of enteral lacks due to the bacillus bifidus mostly, old people especially, and with age, the enteral bacillus bifidus reduces gradually and very easily suffers from constipation.

" ignorance constipation " become the big problem that doctors worry.Because constipation is a phenomenon usually just, in fact, constipation is the undesired and symptom that causes of typical intestinal movement.Its back may be very fearful disease.Some doctor is called constipation in " sources of all kinds of diseases and ailments ".What constipation directly brought is exactly " stool ", and stool is a kind of quite dangerous thing, and it can make multiple toxin, causes a lot of diseases.

In the war in intestinal, if harmful bacterium prevails, intestinal movement will be hindered, the swing of the wriggling of intestinal and enteral fine hair all can weaken, cause a large amount of stool residues to accumulate among the wrinkle Zhe of large intestine, form stool, in the time of maximum, stool in the large intestine can reach 4.5 kilograms, becomes serious burden.New stool is subjected to stopping of stool, is difficult to discharge, and not at all easy having ejected, this moment, intestinal did not absorb moisture, so pull out soft stool through regular meeting; Because stool is half-cream shape or mud shape, we tend to take for is diarrhoea.But with the viewpoint of medical science, this also a kind of at last constipation.

Because of the cause that stool is stagnated, enteral also putresces, and produces harmful substance.These harmful substances by intestinal absorption after, will seriously insulting health.Serious meeting forms the multiple disease that comprises cancer.In fact, constipation sometimes is the remote cause of making us getting killed.

International medical expert's investigation shows: constipation can cause human 90% severe disease, and it is very harmful.Domestic existing relieving constipation series products is many based on irritant laxative, a relieving constipation, and no late result is cured the symptoms, not the disease.Chinese medicine and health product contain the anthraquinone class and rush down composition more, as Radix Et Rhizoma Rhei, Folium Sennae, Aloe, Semen Cassiae, Radix Polygoni Multiflori etc.; Western medicine is with the more usefulness of diphenols preparation.Treat with these products, effective when just beginning medication, in case phenomenon just can appear just secreting again in drug withdrawal.

The present invention aims to provide a kind of oral formulations with effect of relaxing bowel that has the Chinese medicine Radix Rehmanniae to be prepared from, its good effect, and safety, side effect are little, with the no rebound phenomena in back.

Radix Rehmanniae is the dry tuber of scrophulariaceae rehmannia glutinosa plant (Rehmannia glutinosa Libosch), the effect of have clearing away heat and cooling blood, yin nourishing, promoting the production of body fluid.Radix Rehmanniae, former is wild, grows in Xianyang one band the earliest, after reach various places.China's number is economized all production, but its best is " a bosom Radix Rehmanniae ".The Li Shizhen (1518-1593 A.D.) Compendium of Material Medica: " Jiangsu and Zhejiang Provinces territory Huang person is subjected to southern yang-energy, though power is little during the smooth machine of matter; Celebrating mansion product person in bosom reports northern pure the moon, and skin has pimple and power is big ".So people of all times are expensive with " bosom goods ".Discover, contain catalpol, D-mannitol, sucrose, stachyose, cupreol, daucosterol, 1-ethyl-β-D-galactoside etc. in the Radix Rehmanniae.Catalpol is a hypoglycemic composition in the Radix Rehmanniae, and " Radix Rehmanniae " book that China Traditional Chinese Medicine Publishing House publishes is mentioned, and Japanese scholar reports the discharge function that catalpol has the late effect property mitigation.

Stachyose (Stachyose) is a kind of functional oligose of gala saccharide, belongs to cottonseed sugar and belongs to nonreducing sugar.Stachyose is the tetrose that is made of 1 molecule phlorose, 1 molecule β-fructose and 2 molecule α-galactose, and molecular formula is C ₂₄H ₄₂O ₂₁, molecular weight is 666.59, and the water of crystallization threose is the fine crystals that contains 4 molecular waters, and sugariness is 22% of a sucrose, is not is not digested and assimilated at gastrointestinal, therefore, can become the foodstuff of enteral probiotics bifidus bacillus.When bifidus bacillus was preponderated, organic acid such as acetic acid and lactic acid will increase, and stimulated intestinal wall, can obtain the good result of nature relieving constipation.Simultaneously, its maximum characteristic is to have selectivity---it can not become the harmful coliform and the foodstuff of bacillus perfringens.Stachyose helps recovery, the correction alteration of intestinal flora of probiotic bacteria in the gastrointestinal tract, promotes gastrointestinal peristalsis, loosening bowel to relieve constipation.

The major function of stachyose is a large amount of propagation that promote probiotics-bacillus bifidus in the intestinal, remedies because the growth at people's age and wide spectrum and powerful antibiotic extensive use destroy for profitable strain in the human body intestinal canal, and makes its state of having the advantage.The stachyose suction is preserved moisture, softening loose just matter, and full intestinal stimulates the intestinal wall plexus nervorum, and acting on smooth muscle increases enterokinesia, unobstructed intestinal.Stachyose becomes ten thousand multiplications to give birth to bacillus bifidus, produces acetic acid, lactic acid nourishing consume body fluid, remedies the intestinal mucosa myxasthenia, strengthens lubrication.Bacillus bifidus combines with intestinal mucosa and forms the Mycoderma barrier, stops pathogenic bacterium infringement intestinal, repairs damaged intestinal mucosa.The organic acid that produces in the bacillus bifidus metabolic process reduces intestinal pH value and chlorination reduction potential (Eh), suppresses the putrefaction bacteria growth, removes vivotoxin.Stachyose is the most effective in the world bacillus bifidus multiplicaiton factor.Because of more hydroxyl is arranged in the stachyose molecule, in intestinal, can absorb moisture well, and play the function of dietary fiber, and can coordinate mutually with the effect of propagation probiotics, the dual regulation effect is played in constipation and diarrhoea.

YIN nourishing intestine-moisturizing oral liquid in the market is prepared from by Radix Rehmanniae, the suitable and 1g Radix Rehmanniae crude drug of its 1ml oral liquid.Radix Rehmanniae is being processed in the process of Radix Rehmanniae, the content of its catalpol obviously reduces, and patent of the present invention is earlier Radix Rehmanniae to be processed into extract, stores extract then, has so just improved content of effective in the Radix Rehmanniae, thereby has improved curative effect.

Summary of the invention

The invention discloses a kind of oral preparation of Chinese traditional medicinal with effect of relaxing bowel, is to be prepared from by Radix Rehmanniae, has the effect of replenishing YIN and removing heat, moistening dryness for relaxing bowels, is applicable to various functional constipation.The present invention realizes by following steps:

A. get Radix Rehmanniae, clean, be cut into segment, standby.

B. the ethanol (40%～95%) that adds 5～12 times of amounts in Radix Rehmanniae extracts 3 times, and each 1～2 hour, to filter, filtrate merges, and is condensed into thick extractum, and low-temperature reduced-pressure drying or lyophilization get extract.

C. be that carrier mixes mutually with extract and pharmaceutically acceptable optional substrate, be prepared into oral formulations (oral liquid, tablet, capsule, drop pill, soft capsule, dispersible tablet etc.) by special process.

Below by extract of the present invention model is just secreted in the mice dehydration and studied, the present invention is further illustrated.

1. experiment material

A. animal: Kunming mouse, the male and female dual-purpose, body weight 18～22g is available from laboratory animal portion of Medical School of Peking University.

B. reagent:

(1) Radix Rehmanniae extract of the present invention

(2) CONGRONG TONGBIAN KOUFUYE: the sky and water, Gansu pharmaceutical factory, lot number: 040920

(3) india ink: chemical plant in the west, Beijing

2. experimental technique and result

(1) defecation frequency test

With feces color dot algoscopy: the mice of body weight 18～22g is divided into five groups at random: blank group, positive control-CONGRONG TONGBIAN KOUFUYE, the large, medium and small dosage group of Radix Rehmanniae extract of the present invention, gastric infusion after 2 hours places mice (one in every box) in the box, underlay filter paper, be recorded in 1 hour, every animal defecation is counted, and the results are shown in Table 1.

Table 1 Radix Rehmanniae extract is to the influence of mice defecation frequency

Compare with matched group ^*P＜0.05, ^*P＜0.01, ^{* *}P＜0.001

(2) intestinal contents fltting speed test

Get healthy Kunming mouse, be divided into blank group (gavaging equivalent 10% arabic gum), CONGRONG TONGBIAN KOUFUYE group and three dosage groups of Radix Rehmanniae extract (medicine is all with the preparation of 10% arabic gum) at random.With the charcoal end serves as that sign was irritated stomach after 15 minutes, takes off cervical vertebra with sacrifice of animal, the taking-up gastrointestinal of cutting open the belly immediately, it is tiled on the glass plate, measures displacement and the small intestinal total length (from pylorus to ileocecus) of charcoal end head end in intestinal tube, calculate and advance percentage rate, do mathematical statistics, the results are shown in Table 2.

The charcoal end advances percentage rate=charcoal end front end and pylorus apart from ÷ small intestinal total length * 100%

Table 2 Radix Rehmanniae extract influences the intestinal contents fltting speed

Compare with matched group ^*P＜0.05

Following examples explanation the present invention, but do not limit the present invention in any way.

Embodiment 1 oral liquid is produced (1000ml)

Prescription: Radix Rehmanniae 2000g

A. get Radix Rehmanniae, clean, be cut into segment, standby.

B. the ethanol (40%～95%) that adds 5～12 times of amounts in Radix Rehmanniae extracts 3 times, and each 1～2 hour, to filter, filtrate merges, and is condensed into thick extractum, and low-temperature reduced-pressure drying or lyophilization get extract.

C. after an amount of water of adding makes its dissolving in extracting species, add 6% decolorizing with activated carbon again, centrifugal, to filter, filtrate decompression is concentrated into 1000ml, leaves standstill, and is centrifugal, filter, degerming, fill, promptly.

Embodiment 2 tablets are produced (1000)

Prescription: Radix Rehmanniae 2000g

A. get Radix Rehmanniae, clean, be cut into segment, standby.

B. the ethanol (40%～95%) that adds 5～12 times of amounts in Radix Rehmanniae extracts 3 times, and each 1～2 hour, to filter, filtrate merges, and is condensed into thick extractum, and low-temperature reduced-pressure drying or lyophilization get extract.

C. add appropriate amount of auxiliary materials in extract, mixing is made granule, and drying is pressed into 1000, promptly.

Claims (3)

1. the oral formulations with effect of relaxing bowel is characterized in that it is prepared from by Chinese medicine Radix Rehmanniae especially Radix Rehmanniae.

2. oral formulations with effect of relaxing bowel, it is characterized in that it containing catalpol and stachyose etc., can to survey composition be more than 50% of extract.

3. according to claim 1, a kind of oral formulations with effect of relaxing bowel is characterized in that it is realized by following steps:

A. get Radix Rehmanniae, clean, be cut into segment, standby.

B. the ethanol (40%～95%) that adds 5～12 times of amounts in Radix Rehmanniae extracts 3 times, and each 1～2 hour, to filter, filtrate merges, and is condensed into thick extractum, and low-temperature reduced-pressure drying or lyophilization get extract.

C. be that carrier mixes mutually with extract and pharmaceutically acceptable optional substrate, be prepared into oral formulations (oral liquid, tablet, capsule, drop pill, soft capsule, dispersible tablet etc.) by special process.