CN100464765C

CN100464765C - Constipation relieving powder and preparation method thereof

Info

Publication number: CN100464765C
Application number: CNB2006100205280A
Authority: CN
Inventors: 黄亮; 杨帆
Original assignee: Individual
Current assignee: Individual
Priority date: 2006-03-21
Filing date: 2006-03-21
Publication date: 2009-03-04
Anticipated expiration: 2026-03-21
Also published as: CN1864709A

Abstract

The invention discloses a bowel relaxing granule and the preparing process, which is prepared from guava leaves, Chinese angelica root, broomrape, starch gum, stevioside and other auxiliary materials including starch, lactose, mannitol and xylitol through mixing homogenously and granulating.

Description

The preparation method of constipation relieving powder

(1) technical field: the preparation method of constipation relieving powder, belong to the preparation of drug combination method, relating in particular to the vegetable Chinese herbal medicine is the preparation of drug combination method of raw material.

(2) background technology:

Constipation is meant that defecation frequency reduces, every 2-3 days or longer time once, irregularities, excrement matter is stiff, often with the difficult defecation sense, is clinical common a kind of symptom.Along with socioeconomic fast development, people the work quickening of rhythm of life and the raising of quality of life, this disease also becomes one of modern civilization disease.There is 5%-25% population to be subjected to the puzzlement of constipation with regard to the whole world.Epidemiologic data shows, China's incidence rate is about 10%-25%, and shows that first peak of primary disease appears at 30-39 years old, the trend of prompting morbidity has age rejuvenation according to nearest age of onset statistical table.Constipation is very common, especially in modern society, because unreasonable and movable minimizing, the stress of dietary structure are excessive etc., become many people worried symptom, as can not be in time, effective relief of symptoms, often can influence patient's quality of life and work efficiency, also can cause myocardial infarction or cerebrovascular accident old people or serious constipation patient.

Because clinical multiple of constipation, the medicine of a large amount of different these diseases of treatment is arranged on the domestic and international market.The medicine of western medicine constipation is divided three classes according to the mechanism of relieving constipation by purgation: the first kind is irritant laxative such as phenolphthalein tablet, Semen Ricini wet goods.This type of cathartic is the most normal medicine from clothes of constipation patient, if life-time service can cause the side effect that intestinal irritability reduces, so should not use always; Second class is a dilution property cathartic, claims this class cathartic of osmotic laxative that magnesium sulfate, sodium sulfate (Natrii Sulfas) etc. are arranged again; The 3rd class is an emollient laxative, as liquid paraffin, edible wet goods.And during the traditional Chinese medical herbal treatment constipation the principle side of executing medication by determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, treatment must aim at the pathogenesis of disease.As the purging FU-organs that expels the heat-evil accent stomach CHENGQI TANG, the clearing away heat and moistening the bowels Maziren Wan, blood deficiency and constipation side selects pill for smoothing intestines, and jichuan decoction etc. is selected in the yang deficiency constipation, and except that above-mentioned compound recipe, folk prescription, proved recipe also often obtain better effects, rush down leaf, Semen Cassiae, Rhizoma Atractylodis Macrocephalae, Semen Raphani etc. as fence.

The TONGBIAN LING capsule is national basic medical insurance medicine and national essential drugs, it is the compound Chinese medicinal preparation that develops according to Traditional Chinese medical theory and clinical combination, but there is following shortcoming in it: 1, such medicine has only the TONGBIAN LING capsule at present, be unsuitable for clinical different use, can not satisfy the different demand of patient; 2, the capsule dissolution rate is fast inadequately; 3, for the old people, capsule is not easy to swallow; 4, capsule production cost height.

(3) summary of the invention:

Purpose of the present invention is exactly to provide at above deficiency that a kind of absorptions is fast, produce effects is rapid, and the bioavailability height is convenient to take, and production technology is simplified, the preparation method of the constipation relieving powder of production cost reduction.Its technical scheme is as follows:

It is with comprising the medicament that following supplementary material is made: (consumption is a weight portion)

Folium Sennae 2400 Radix Angelicae Sinensis 300 Herba Cistanches 300

Its preparation method is:

Getting 150 parts of Radix Angelicae Sinensis, to be ground into fine powder standby; Remaining Radix Angelicae Sinensis and Folium Sennae, Herba Cistanches are added 6～12 times of water gagings decoctions 1.5 hours, filter; In temperature is 75～85 ℃, and vacuum is under the condition of 0.08～0.1Mpa filtrate to be concentrated into the thick paste that relative density is 1.30～1.40 (60 ℃), adds Chinese Angelica Root, mixing, and 60 ℃～70 ℃ cold drying are pulverized; The adjuvant that adds 1～1.2 times of amount of medicated powder weight after pulverizing, mixing, the ethanol of employing 55%～65% is made granule, promptly.

Compared with prior art the present invention has following beneficial effect:

1, the decoction of water-soluble back of granular preparation and Chinese medicine is similar, and medicine disperses rapidly, so the drug release stripping is fast, produce effects is rapid, and the drug bioavailability height can make medicine arrive disease institute faster; 2, can cover uncomfortable bitterness, be convenient to take; 3, lighttight packaging material can make medicine not be subjected to the influence of dampness and air, light, thereby improve stability of drug; 4, granule is the purification of medicine main component, and volume is little, and in light weight and easily molten, outward appearance is neat and artistic, is beneficial to and carries and take, and transportation, storage are conveniently; 5, granule can be simplified technology, reduces cost; 5, enrich this product dosage form, applied to clinical different use, satisfied the demand of market different crowd.

(4) drawing explanation:

Accompanying drawing is a process chart of the present invention.

(5) specific embodiment:

Take by weighing each supplementary material by following weight:

Folium Sennae 2400g Radix Angelicae Sinensis 300g Herba Cistanches 300g

Dextrin 480g steviosin 20g

Its preparation method is:

Getting Radix Angelicae Sinensis 150g, to be ground into 100 order fine powders standby; Remaining Radix Angelicae Sinensis and Folium Sennae, Herba Cistanches are added 10 times of water gagings decoctions 1.5 hours, filter with 200 order filter clothes; In temperature is 80 ℃, and vacuum is under the condition of 0.08～0.1Mpa filtrate to be concentrated into the thick paste that relative density is 1.30～1.40 (60 ℃), adds Chinese Angelica Root, mixing, and 60 ℃～70 ℃ cold drying are pulverized, and cross 100 mesh sieves; Add dextrin and steviosin, mixing adopts 60% ethanol to make granule, makes 1000g, promptly.

Folium Sennae: this product is the dry lobule of the narrow leaf Senna fruit of leguminous plant Cassia angustifolia Vahl or cassia acutifolia Delile Cassia acuti-folia Delile.

Radix Angelicae Sinensis: this product is the dry root of umbelliferae angelica Angelica sinensis (Oliv.) Diels.

Herba Cistanches: this product is the chylocaulous of the dry zone scale leaf of orobanchaceae plant cistanche Cistanche deserticola Y.C.Ma.

Realize content of the present invention, below some is very important:

1, the decocting for Chinese herbal medicine extraction effect is subjected to the influence of factors such as amount of water, extraction time, extraction time.Because of in the primary standard extraction time, extraction time in the decoction extraction process being investigated, extract when investigating so decoct, selecting extractum recovery rate and two of chrysophanic acid content is evaluation index, chooses amount of water as factor, and the varying level of high spot reviews factor is to decocting the influence of extraction effect.Take all factors into consideration the selection factor level in conjunction with aspects such as production cost, the energy.The optimised process of learning amount of water by test extracted 1.5 hours for adding 10 times of water gagings.

2,,, adopt triple effect concentrating under reduced pressure equipment to concentrate in conjunction with the commercial production condition for preventing that effective ingredient is subjected to heat damage for a long time.Spissated condition is: temperature is 80 ℃, and vacuum is 0.08～0.1Mpa.According to pharmaceutical properties, it is that the thick paste of 1.30-1.40 (60 ℃) gets final product that filtrate is concentrated into relative density.

3, because this product is taken with the form of solution, require to have mouthfeel preferably, thereby must improve mouthfeel by a certain amount of sweeting agent of adding.

Product of the present invention should carry out packing in 300,000 grades of clean areas (18～25 ℃ of temperature, relative humidity is below 60%).

Function cures mainly: the intestinal stasis relieving that purges heat, loosening bowel to relieve constipation.Be used for constipation with heat retention, long-term bed constipation, momentary abdominal distention constipation, senility habitual constipation.Specification: every packed 3g.Usage and dosage: oral, a 2.5g～3g, once-a-day.

We only are made up of three herbal medicines, Folium Sennae consumption maximum in the side, and bitter cold is fallen and is let out, and returns large intestine channel, can rush down intestinal stasis relieving down, can lead excess-heat again clearly, is we's monarch drug, speech its " expel the heat-evil, sharp intestinal internal organs leads to stool " in " decoction pieces is newly joined ".Be aided with the Chinese Angelica blood replonishing loosening bowel to relieve constipation, the Herba Cistanches enrich and benefit essence and blood is moisturized laxation.All medicines share, and play the merit of the intestinal stasis relieving that purges heat, blood enriching and dryness moistening, laxation relieving constipation altogether.

Main pharmacological literature data: contain the anthraquinone derivative in the Folium Sennae, other cathartics that its discharge function and zest contain the anthraquinone class are stronger.Its effective ingredient is mainly Sennoside A, B, after stomach, small intestinal absorb, decomposes in liver, and the capable and excited basin neuroganglion of catabolite menses causes diarrhoea to shrink large intestine.

By the above-mentioned technology of working out, carried out many batches of pilot scale researches, wherein the three batches of pilot plant tests and check result thereof see Table one, table two:

Table one three batch samples trial-production data

Table two sample survey result

Pilot-scale experiment shows that gained preparation technology is reasonable, feasible.

Product constipation relieving powder of the present invention and commercially available Quality Standard of Tongbianling Capsules comparison sheet

Comparative indices	Constipation relieving powder	The defaecation curing capsule
Comparative indices	Constipation relieving powder	The defaecation curing capsule	Specification	Every packed 3g.	Every dress 0.25g.
Usage and dosage	Oral, a 2.5g～3g, one Day once.	Oral, one time 5-6,1 time on the one	Specification	Every packed 3g.	Every dress 0.25g.
Usage and dosage	Oral, a 2.5g～3g, one Day once.	Oral, one time 5-6,1 time on the one	Proterties	This product is granule, and content is The particle of pitchy or brownish black; It is sweet to distinguish the flavor of, little hardship.	This product is capsule, and content is for black The particle of brown or powder; Gas is little, Mildly bitter flavor, salty.
Differentiate	The thin layer of folium sennae, Radix Angelicae Sinensis is differentiated	The folium sennae thin layer is differentiated	Proterties
Differentiate		The folium sennae thin layer is differentiated	Content control	HPLC measures Rhein	No content control

Claims

1, a kind of preparation method of constipation relieving powder, it is standby to it is characterized in that taking by weighing 2400 parts of Folium Sennae, 300 parts of Radix Angelicae Sinensis, 300 parts of Herba Cistanches; Getting 150 parts of Radix Angelicae Sinensis, to be ground into fine powder standby; Remaining Radix Angelicae Sinensis and Folium Sennae, Herba Cistanches are added 6～12 times of water gagings decoctions 1.5 hours, filter; Is 75～85 ℃ with filtrate in temperature, and vacuum is to be concentrated into relative density thick paste of 1.30～1.40 in the time of 60 ℃ under 0.08～0.1Mpa condition, adds Chinese Angelica Root, mixing, and 60 ℃～70 ℃ cold drying are pulverized; One or more adjuvants of the dextrin of 1～1.2 times of amount of adding medicated powder weight, sucrose, steviosin, starch, lactose, mannitol, xylitol, mixing, the ethanol of employing 55%～65% is made granule, promptly.

2, according to the preparation method of the described constipation relieving powder of claim 1, it is characterized in that preparation method is: getting 150 parts of Radix Angelicae Sinensis, to be ground into fine powder standby; Remaining Radix Angelicae Sinensis and Folium Sennae, Herba Cistanches are added 10 times of water gagings decoctions 1.5 hours, filter; In temperature is 80 ℃, and vacuum is under the condition of 0.08～0.1Mpa filtrate to be concentrated into relative density thick paste of 1.30～1.40 in the time of 60 ℃, adds Chinese Angelica Root, mixing, and 60 ℃～70 ℃ cold drying are pulverized; The adjuvant that adds the 1.2 times of amounts of medicated powder weight after pulverizing, mixing, the ethanol of employing 60% is made granule, promptly.