CN105770139A - Traditional Chinese medicine suppository for preventing and treating constipation and preparation method thereof - Google Patents
Traditional Chinese medicine suppository for preventing and treating constipation and preparation method thereof Download PDFInfo
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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- A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The invention discloses a traditional Chinese medicine suppository for preventing and treating constipation, and belongs to the technical field of medicines. The traditional Chinese medicine suppository is prepared from the following traditional Chinese medicinal raw materials in parts by weight: 5-20 parts of radices lithospermi, 15-30 parts of cordate houttuynia, 10-20 parts of humifuse euphorbia herbs, 20-30 parts of herba pteridis multifidae, 3-12 parts of semen litchi and 3-12 parts of Chinese gall. The preparation method comprises the following steps: (1) extracting, namely independently extracting the radices lithospermi by adopting an alkali extraction and acid precipitation mode to prepare precipitate of radices lithospermi, and preparing extracts from cordate houttuynia, humifuse euphorbia herbs, herba pteridis multifidae, semen litchi and Chinese gall by adopting a water extraction mode, and respectively grinding for later use; and (2) preparing, namely mixing the precipitate of radices lithospermi, the extracts and substrate in a ratio of 1:1:4, uniformly grinding, injecting the mixture into a mold, cooling and then taking out. The prepared traditional Chinese medicine suppository is reasonable in prescription and simple and advanced in preparation process, has a remarkable curative effect for preventing and treating constipation, is economical and safe, and has a good clinical application prospect.
Description
Technical field
The present invention relates to Chinese medicine suppository of clinical prevention constipation and preparation method thereof, belong to pharmaceutical technology field.
Background technology
Constipation has higher sickness rate in the world, to old man down to infant on the patient groups of constipation.Constipation can be divided into acute, chronic according to the course of disease；Functional, organic, medicine can be divided into according to patience according to the cause of disease；Functional constipation, constipation of excess type, constipation due to insufficiency, constipation due to pathogenic cold can be divided into according to disease.The Symptoms that constipation patient often has is that feces is dry and hard, defecation time extends, just frequency reduces, feces is discharged smooth just not to the utmost and with abdominal distention, stomachache, tension.Constipation also can cause many complication, such as anal fissure, hemorrhoid, intestinal obstruction, intestinal perforation etc..Research shows, number of patients had obvious ascendant trend in recent years, and its sickness rate is from 0.7%-79% not etc..
Constipation therefrom medical angle is divided into two big seven pattern of syndrome of class, two big classes and constipation of excess type (accumulated heat in gastrointestinal tract, depression and stagnation of QI, YIN-cold are stagnant) and constipation due to insufficiency (deficiency of vital energy, blood deficiency, the deficiency of YIN, yang deficiency).Accumulated heat in gastrointestinal tract type surfeit is pungent, cross and take temperature compensation and make that the intestines and stomach is scorching, body fluid consume；Depression and stagnation of QI type makes large intestine conduction function not normal owing to feelings will is not easypro, sitting is motionless；Type of deficiency of both blood and body fluid prolonged illness, Nian Gao, QI and blood deficiency intestinal conduction function are not normal, drinking-water less, rush down lower impairment of body fluid；Deficiency of spleen and stomach Yang type is due to prolonged illness or catches cold so that spleen kidney damaged intestine transmits unable.Sum it up, the reason one of constipation is that intestinal conduction function is not normal, two is enteral deficiency of body fluid, but causes that the reason of both of these case has again a lot, and the cause of disease is more complicated, it is considered that relevant with the factor such as life style and dietary habit.
The factor of life style is mainly due to along with the development of economic science and technology, and the operating pressure of people is continuously increased, rhythm of life is constantly accelerated, and the convenient quantity of motion minimizing of the vehicles, sitting etc., intestinal peristalsis promoting hypofunction in the course of time will cause the formation of constipation.And the factor of dietary habit to improve, mainly due to the living condition of people, the temperature compensation that brings therewith excessive, cause body fluid consume, intestinal peristalsis promoting to slow down.Therefore, it is chiefly to facilitate intestinal peristalsis promoting, increases enteral body fluid, it is possible to make the symptom of constipation alleviate or alleviate.
The Western medicine one treating constipation at present is main based on cathartic class medicine, if this class drug main stimulates intestinal peristalsis promoting, increases body fluid content；But these medicine toxicity, side effects are big, have dependency, easily recur after drug withdrawal, do not reach ideal treatment curative effect, and current many constipation patients are dissatisfied to the medicine of current existing treatment constipation.
Constipation understanding and pathogenesis are pointed out by motherland's medical science in " General Treatise on the Cause and Symptoms of Diseases constipation time ": " constipation person, is not conformed to by three burnt the five internal organs, and cold and hot gas is uncomfortable, and steam enters stomach partially, and body fluid exhausts dry, and obstruction is also." " Plain Questions lift pain opinion " is mentioned: " steam stays in small intestinal, pain in the intestine, and illness heat is terribly thirsty, then hard dry does not draw, therefore abdominal pain with constipation is obstructed." " Plain Questions faint opinion " is mentioned " and lunar faints, then have one's mind filled with (moon is true) swollen, rear unfavorable." " difficult roll up three or three ten five through justice difficult " proposes " and right large intestine thus can preacher, with its internal organs being lung, lung qi is assigned, therefore can conduct, and is with constipation, have liter act lung qi also." described above constipation lesions position is mainly at large intestine that intestinal conduction function is not normal or enteral body fluid reduces, but it forms the impaired close relation of function with other internal organs such as lung, spleen.For the preventing and treating of constipation, forefathers also have many summaries, mention in "Nei Jing": the preventing and treating that " in fact, dispersing outwards and eliminating inwards ", " its lower person, completely diseharging pathogens through YIN orifices ", " fullness in the epigastrium and abdomen person, eliminating pathogen internally " are constipation provides basic principle." Medical Treasures of the Golden Chamber accumulation of pathogenic wind cold in five ZANG-organs " proposes: " ... floating pulse blending with hesitant pulse, stool is then hard ..., Maziren Wan master it." show that the sub-ball of Fructus Cannabis can prevent and treat the type constipation." endowment give holograph continuous add " proposes: " ..., defecate close puckery, can be taken in small doses at short intervals pig Sanguis caprae seu ovis, or the dirty thick soup of certain herbaceous plants with big flowers dish blood, exhausts and can dredge profit " it is by change diet thus preventing treating constipation.
Chinese medicine treats constipation long-standing, good effect, and side effect is little.But mostly Chinese medicine is decocting at present, and quality, dosage are difficult to control to, and use inconvenience；Other dosage form also have the oral drugs such as pill, tablet, capsule but oral drugs through liver, some can produce first pass effect；Enema is shorter in enteral retention time and is easily caused intestinal perforation etc.；Patch is affixed on skin for a long time, airtight so that patient does not feel well.Therefore be badly in need of a kind of good effect clinically, side effect is little, patient compliance good, Chinese medicine for external application easy to use.
" the anti-Chinese medicine preparation that treats constipation " comes from the late national unconventional and unrestrained right Empirical formula of famous physician in Yangzhou, and to control lung abscess, heat clearing away, invigorate blood circulation, to promote that intestinal peristalsis promoting is for control principle, Radix Arnebiae (Radix Lithospermi), Herba Houttuyniae are monarch drug, and Radix Arnebiae (Radix Lithospermi) is sweet, salty, cold, GUIXIN, Liver Channel.There is removing heat from blood, invigorate blood circulation, clearing away heat and cooling blood effect；Herba Houttuyniae has heat-clearing and toxic substances removing, eliminating carbuncle evacuation of pus effect；Herba Euphorbiae Humifusae, Herba Pteridis Multifidae are ministerial drug: Herba Euphorbiae Humifusae bitter in the mouth, pungent, property are put down, and have heat clearing and blood circulation promoting and control eliminating carbuncle effect, Herba Pteridis Multifidae clearing away heat-damp and promoting diuresis, subduing swelling and detoxicating.Gallic acid is put down, and returns lung, stomach, large intestine channel.Function controls chronic cough of deficiency lung；Semen Litchi hardship sweet, micro-, temperature, return liver, kidney channel, and having promoting QI to circulate and dispersing the agglomeration of the pathogens effect is adjuvant.
Research has proven to this prescription and has good heat clearing away, invigorates blood circulation by experiment, heap soil or fertilizer over and around the roots effect is opened in lung heat clearing, and by clinical research, oneself confirms have the advantage such as good effect, easy to use, non-evident effect.But prescription enema water carries and is unfavorable for Radix Arnebiae (Radix Lithospermi) effective ingredient dissolution, clinically existing existing system, patient oneself can not medication, be so administered inconvenience, should not preserve for a long time again, and during administration, medicinal liquid easily flows out, for a long time with being easily caused bowel dysfunction.
Summary of the invention
An object of the present invention is to provide a kind of easy to use, anti-Chinese medicine suppository treated constipation that therapeutic effect is good.The preparation method that the two of the purpose of the present invention are to provide a kind of anti-Chinese medicine suppository treated constipation.
Technical scheme is as follows:
A kind of anti-Chinese medicine suppository treated constipation, is be prepared from by the raw material of Chinese medicine of following weight: Radix Arnebiae (Radix Lithospermi) 5～20 parts, Herba Houttuyniae 15～30 parts, Herba Euphorbiae Humifusae 10～20 parts, Herba Pteridis Multifidae 20～30 parts, Semen Litchi 3～12 parts, Galla Chinensis 3～12 parts.
Further, the weight proportion of each raw material is: Radix Arnebiae (Radix Lithospermi) 10 parts, Herba Houttuyniae 15 parts, Herba Euphorbiae Humifusae 15 parts, Herba Pteridis Multifidae 20 parts, Semen Litchi 5 parts, Galla Chinensis 9 parts.
The preparation method of a kind of anti-Chinese medicine suppository treated constipation, is characterized in that comprising the following steps:
(1) extract: described Radix Arnebiae (Radix Lithospermi) adopts alkali put forward the heavy mode of acid and individually extracts and obtain Radix Arnebiae (Radix Lithospermi) precipitation, adopt the mode that water carries to obtain extractum described Herba Houttuyniae, Herba Euphorbiae Humifusae, Herba Pteridis Multifidae, Semen Litchi and Galla Chinensis, grind stand-by respectively；(2) prepare: the Radix Arnebiae (Radix Lithospermi) precipitation in step (1), extractum and substrate are mixed according to the ratio of 1:1:4, grinds uniformly, inject in mould, take out after cooling, standby after packaging.
Further, in described step (1), the extraction of described Radix Arnebiae (Radix Lithospermi) precipitation: take Radix Arnebiae (Radix Lithospermi), dividing three secondary chamber warm macerating to carry with the 1%NaOH of 10 times amount, extraction time is 1h, 30min, 30min respectively, collects each extracting solution respectively, pH2～3 are adjusted with dilute hydrochloric acid, placing overnight, sucking filtration obtains Radix Arnebiae (Radix Lithospermi) precipitation, and 40 DEG C of vacuum dryings are stand-by；The extraction of described extractum: take Herba Houttuyniae, Herba Euphorbiae Humifusae, Herba Pteridis Multifidae, Galla Chinensis and Semen Litchi, micro-boils with 10 times of water, 1h extracts twice, united extraction liquid, filters and concentrate and to obtain extractum, and 40 DEG C of vacuum dryings are stand-by.
Further, described substrate is composed as follows: the ratio of semi-synthetic fatty acid glyceride-36 type, tween 80 and Arlacel-20 is 86 4 10 (weight ratios).The mixing in 50～60 DEG C of water-baths of described substrate.
Different from the Empirical formula enema in background technology, the present invention adopts the form of suppository, and suppository can be stored the long period, not needing now-making-now-using clinically, can overcome inconvenience, patient is by after injector self-administration, medicine can be resident in enteric cavity, and the long period maintains drug effect.
The present invention adopts modernization scientific method to develop, reasonable recipe, and preparation technology is simply advanced；Research is it has proven convenient that the present invention has good heat clearing away, invigorates blood circulation, heap soil or fertilizer over and around the roots effect is opened in lung heat clearing by experiment；By clinical research, oneself confirms, the present invention has the advantages such as good effect, easy to use, economic security, non-evident effect, patient compliance are good, and it has good potential applicability in clinical practice.
Accompanying drawing explanation
Fig. 1 is that TCL differentiates shikonin chromatographic band figure: (a) inspects under natural light；B () inspects after spraying 10%KOH-methanol；Wherein, 1-shikonin standard substance, 2-compound recipe Radix Arnebiae (Radix Lithospermi) bolt of the present invention, 3-Radix Arnebiae (Radix Lithospermi) precipitation extract；
The ultraviolet spectrogram of Fig. 2 (a), (b), (c) respectively shikonin standard sample, Radix Arnebiae (Radix Lithospermi) precipitation test sample and compound recipe Radix Arnebiae (Radix Lithospermi) bolt of the present invention；
Fig. 3 is that TCL differentiates Quercetin chromatographic band figure: (a) examines knowledge figure for extractum thin layer under 365nm uviol lamp；B () examines knowledge figure for extractum thin layer by chemiluminescence imaging instrument under 580nm；Wherein, 1-Quercetin standard substance, 2-extractum test sample, 3-compound recipe of the present invention Radix Arnebiae (Radix Lithospermi) bolt test sample；
The ultraviolet spectrogram of Fig. 4 (a), (b), (c) respectively Quercetin element standard sample, extractum test sample and compound recipe Radix Arnebiae (Radix Lithospermi) bolt of the present invention；
Fig. 5 is the feces state collected in 14 days rat 5h of administration；
Fig. 6 is the real figure of rat lower distal colon granule number；
Fig. 7 is rat lower distal colon HE colored graph: 1-blank group, 2-trimebutine group, 3-model group, 1 group of 4-suppository, and 2 groups of 5-suppository, 6-prescription clyster group, 7-Decoction of Four-Drug Juice group, arrow represents mucous layer thickness.
Detailed description of the invention
Below the anti-Chinese medicine suppository treated constipation of the present invention is carried out index components discriminating and assay.
One, solution preparation
Shikonin reference substance solution: precision weighs shikonin reference substance 5.2mg and is placed in 10ml volumetric flask, methanol ultrasonic dissolution, methanol constant volume.
Quercetin reference substance solution: precision weighs Quercetin reference substance 5.3mg and is placed in 10ml volumetric flask, methanol ultrasonic dissolution, methanol constant volume.
Radix Arnebiae (Radix Lithospermi) precipitation need testing solution: quantitatively weighing Radix Arnebiae (Radix Lithospermi) precipitation 30.01mg, ultrasonic 10 minutes of methanol, filter, filtrate is placed in 10ml volumetric flask, methanol constant volume.
Extractum need testing solution: quantitatively weigh immersion cream 30.03mg, ultrasonic 10 minutes of methanol, to filter, filtrate is placed in 10ml volumetric flask, methanol constant volume.
Compound recipe Radix Arnebiae (Radix Lithospermi) bolt need testing solution: take 10 pieces of compound recipe Radix Arnebiae (Radix Lithospermi) bolts, the compound recipe Radix Arnebiae (Radix Lithospermi) bolt of gross weight 3.6893g, add methanol after Wen Rong ultrasonic 10 minutes, filter, filtrate reclaims methanol to 10ml.
Two, index components differentiates
(1) TLC method
Shikonin differentiates: take Radix Arnebiae (Radix Lithospermi) precipitation extract, compound recipe Radix Arnebiae (Radix Lithospermi) bolt need testing solution and each 4 μ l of shikonin reference substance solution respectively, point is on same silica gel G plate (specification: 3 × 10cm) diverse location, with normal hexane acetone chloroform glacial acetic acid=260 641 for developing solvent, launch, take out, dry.In test sample chromatograph, and should showing identical aubergine speckle on standard substance chromatograph relevant position, then spray with 10%KOH-methanol solution, speckle strain is indigo plant.
Quercetin differentiates: takes extractum, compound recipe Radix Arnebiae (Radix Lithospermi) bolt need testing solution and Quercetin reference substance solution 4 μ l, puts in same silica gel G plate (specification: 3 × 10cm), with toluene ethyl acetate formic acid (5 2 1) for developing solvent, launch, take out, dry, observe under natural light；Then spraying with 3% aluminum chloride alcoholic solution, 105 DEG C of heating are clear to spot development, put and inspect under uviol lamp (365nm), should show the fluorescence speckle of same color；Put and examine under chemiluminescence imaging instrument 580nm, answer spottiness to exist with reference substance relevant position.
(2) ultraviolet spectra differentiates
Precision pipettes 1ml shikonin reference substance, Quercetin reference substance solution and Radix Arnebiae extract, extractum, compound recipe Radix Arnebiae (Radix Lithospermi) bolt need testing solution and is placed in 10ml volumetric flask respectively, methanol constant volume.With methanol for blank sample, it is scanned within the scope of 200nm～600nm.
Three, assay
According to Beer-Lambert absorption spectrophotometry philosophy, adopting ultraviolet visible spectrophotometry Plays counter point to shikonin in Radix Arnebiae extract, in extractum, in Quercetin and compound recipe Radix Arnebiae (Radix Lithospermi) bolt, shikonin, Quercetin carry out assay.
Alkannin content measures: by method under 1.3.1 item, Radix Arnebiae extract, compound recipe Radix Arnebiae (Radix Lithospermi) bolt need testing solution and shikonin reference substance solution are prepared.The solution that will prepare again, the accurate 1ml that draws puts in 10ml volumetric flask respectively, and methanol constant volume is to graduation mark.With methanol for blank sample, measure absorbance at 516nm wavelength place and calculate alkannin content.
Quercetin content measures: according to solution preparation method in 1.3.1, extractum, compound recipe Radix Arnebiae (Radix Lithospermi) bolt need testing solution and Quercetin reference substance solution are prepared.The solution that will prepare again, the accurate 1ml that draws puts 10ml in volumetric flask respectively, and methanol constant volume is to graduation mark.With methanol for blank sample, measure absorbance at 372nm wavelength place and calculate quercetin content.
Four, quality examination
By requirement under 2010 editions suppository items of Chinese Pharmacopoeia, from appearance character, weight differential, melt change several aspect such as time limit and dissolution compound recipe Radix Arnebiae (Radix Lithospermi) bolt is carried out quality investigation.
Five, result
5.1 index components qualitative analyses
(1) result is known in shikonin TLC inspection
As seen from Figure 1, compound recipe Radix Arnebiae (Radix Lithospermi) bolt 2, Radix Arnebiae (Radix Lithospermi) precipitation extract 3 and with shikonin standard substance 1 chromatographic band same position on aubergine speckle occurs；After spraying 10%KOH-methanol solution, the color of chromatographic band is become blueness from aubergine.Thus can determine that, compound recipe Radix Arnebiae (Radix Lithospermi) bolt and Radix Arnebiae extract all contain shikonin, the number of the depth mark alkannin content of spot colors.
(2) result is known in the inspection of shikonin ultraviolet spectroscopy
Fig. 2 (a), (b), (c) display: shikonin standard substance, Radix Arnebiae (Radix Lithospermi) precipitation extract, compound recipe Radix Arnebiae (Radix Lithospermi) bolt have at 215nm and 275nm place and absorb more by force；516nm place reference substance solution presents and absorbs more by force, and need testing solution presents relatively weak absorbing；In test sample, beyond shikonin, shikonin is had hypochromic effect at 200～600 wave bands by composition.
(3) result is known in the TLC inspection of Quercetin
Fig. 3 shows: extractum 2 and compound recipe Radix Arnebiae (Radix Lithospermi) bolt 3 test sample have the fluorescence speckle of same color with Quercetin standard substance 1 at same position；Inspect under chemiluminescence imaging 580nm, extractum and compound recipe Radix Arnebiae (Radix Lithospermi) bolt test sample all present more speckle, and compound recipe Radix Arnebiae (Radix Lithospermi) bolt presents more speckle compared with extractum, so, inspecting the chromatography behavior that more can accurately reflect Quercetin sample and standard substance under chemiluminescence imaging instrument 580nm, credibility is higher.
(4) result is known in the inspection of Quercetin ultraviolet spectra
Extractum (Fig. 4 (b)), compound recipe Radix Arnebiae (Radix Lithospermi) bolt (Fig. 4 (c)) and Quercetin reference substance solution (Fig. 4 (a)) have absworption peak at about 255nm, and this place is the Quercetin ultraviolet absorption band produced by benzoyl chromophore；And locating also all to have absworption peak at about 372nm, this place is the Quercetin ultraviolet absorption band produced by cinnamoyl chromophore, thus verifies the existence of Quercetin in extractum and compound recipe Radix Arnebiae (Radix Lithospermi) bolt.
5.2 ultraviolet scene spectrphotometric method for measuring index components content
(1) alkannin content measures (detection wavelength 516nm)
Table 1 alkannin content determination data
Basis:In formula: ASampleFor need testing solution absorbance, AMarkFor reference substance solution absorbance, CMarkFor reference substance solution concentration, 100 is dilution volume, WSampleWeight is weighed for test sample.
(2) assay (detection wavelength 372nm) of Quercetin
Table 2 quercetin content determination data
Table 2 basis is identical with table 1.
5.3 compound recipe Radix Arnebiae (Radix Lithospermi) bolt quality examinations
(1) character
According to suppository preparation method, preparing 1000 pieces of compound recipe Radix Arnebiae (Radix Lithospermi) bolt, it is shaped as bullet-shaped, color atropurpureus, smooth surface, uniform and smooth.
(2) weight differential
Table 3 compound recipe Radix Arnebiae (Radix Lithospermi) bolt weight differential calculates data
As seen from Table 3, compound recipe Radix Arnebiae (Radix Lithospermi) bolt average weight is at below 1g, and according to pharmacopeia suppository average weight at below 1g, limit test of weight variation is ± 10%, and choose 10 weight differentials are all in ± 10% scope, meet the requirements.
(3) melt the change time limit
Table 4 compound recipe Radix Arnebiae (Radix Lithospermi) bolt melts the change time limit
Can be drawn by table 4, compound recipe Radix Arnebiae (Radix Lithospermi) bolt in 19 minutes melted completely, meet the suppository of greasing base and should all melt in 30 minutes or soften or without the requirement of hard-core.
(4) dissolution
Index components dissolution percentage rate in table 5 compound recipe Radix Arnebiae (Radix Lithospermi) bolt
When 45min, in compound recipe Radix Arnebiae (Radix Lithospermi) bolt, the average dissolution percentage rate of shikonin is 82.4% as can be seen from Table 5, and the average dissolution percentage rate of Quercetin is 75%.
For showing that the Chinese medicine suppository of the present invention is to the anti-effect treated constipation, and proves further below by zoopery.
One, laboratory animal and experimental drug
Wistar female rats 49, cleaning grade, body weight (190 ± 10) g, 8 week old, Yangzhou University's comparative medicine center buy.Animal productiong credit number is SCXK (Soviet Union) 2012-0004, and occupancy permit number is: SYXK (Soviet Union) 2012-0029.
Loperamide, lot number: N0115A, Dalian Mei Lun Bioisystech Co., Ltd；Barium sulfate, lot number: KB09140, Aladdin reagent (Shanghai) Co., Ltd.；Decoction of Four-Drug Juice, the quasi-word Z20025044 of traditional Chinese medicines, HuNan HanSen Pharmacy Co., Ltd；Trimebutine Maleate, the quasi-word H20000388 of traditional Chinese medicines, Kaikaiyuansheng Medicine Co., Ltd.；Pentobarbital sodium, lot number: 061206, Beijing chemical reagents corporation；Barium sulfate, lot number: KB09140, Aladdin reagent (Shanghai) Co., Ltd.；Paraformaldehyde, lot number: YY0702B507Y, Sangon Biotech (Shanghai) Co., Ltd.；Dimethylbenzene, lot number: 20111010, Shanghai Su Yi chemical reagent company limited；Haematoxylin, lot number: 10D21C80, doctor's moral bio tech ltd；Eosin W or W S, lot number: 20051037, Shanghai biological engineering company limited；2，4，6-trinitrophenol, lot number: 990404, Taishan, Guangdong chemical plant produces；Neutral gum, lot number: 20100624, traditional Chinese medicines reagent chemical reagent company limited；Paraffin wax, lot number: 20100331, traditional Chinese medicines reagent chemical reagent company limited；Rat NO test kit, article No.: 20150908, biological engineering company limited is built up in Nanjing；Rat Ach test kit, lot number: 201509, Xiang bio tech ltd, upper Haifeng county；Rat MTL test kit, lot number: 201509, Xiang bio tech ltd, upper Haifeng county.
Two, test method
49 rats are randomly divided into 7 groups by the foundation of Constipation Model and medication: after animal normally raises 7d, often group 7.Reference literature (ZhouMY, etal., 2013；LeeHY, etal., 2012) method is transformed carries out model building, with loperamide 6.67mg/kg, model group rats is carried out gavage, and first administration amount doubles, and being administered twice every day is 9:00 and 17:00 respectively.The modeling time is 10 days.After model building success, the marshalling again of each group is divided into blank group (normal saline group) (the 1st group), Western medicine trimebutine matched group (the 2nd group), model group (the 3rd group), compound recipe Radix Arnebiae (Radix Lithospermi) bolt one time 1 (the 4th group), compound recipe Radix Arnebiae (Radix Lithospermi) bolt 2 (the 5th group), a prescription clyster group (the 6th group), the oral matched group (the 7th group) of Chinese medicine Decoction of Four-Drug Juice.In the administration phase except blank group, all the other groups still give loperamide gavage (dosage is constant).Blank group (normal group) gives 200 μ l0.9%NaCl；2nd group of every rat is suspended in the trimebutine in the NaCl of 0.9% to 0.054g/kg, once a day；3rd group by modeling method administration；Each administration group, after giving loperamide 2h, starts to medicine: medicine, to compound recipe Radix Arnebiae (Radix Lithospermi) bolt, is filled in from anal orifice 12cm from anal orifice by the 4th group of every rat with disposable anus catheter, once a day, one time one；5th group of every rat to compound recipe Radix Arnebiae (Radix Lithospermi) bolt, administering mode with the 4th group, one time 2；6th group of every rat gives the compound recipe enema of 6.66g/kg, pours into disposable anus catheter, pours into position with compound recipe Radix Arnebiae (Radix Lithospermi) bolt, once a day；7th group of every rat gives the Decoction of Four-Drug Juice (one day dosage of people is 30ml/70kg) of 2.7ml/kg, once a day.Administration time is at point in the morning 10, and daytime, activities in rats amount was few relative to evening, can extend compound recipe Radix Arnebiae (Radix Lithospermi) bolt at enteral residence time, be administered 2 weeks.
Three, observation index and method
3.1 general states
(1) apparent state observation observes each treated animal active degree, hair color, the mental status twice daily.
(2) body weight 8:00 every morning starts weigh the weight of every animal and record, and calculates and compares body weight variable quantity between blank group and model group and whether have a not statistically significant, the body weight of body weight change amount=one day after-the previous day body weight.
(3) drinking-water, food-intake measure and utilize amount of drinking water, food-intake differential technique to be measured.The every morning same time weighs in the balance and takes the food weight of every treated animal and the weight of water record, and amount of drinking water (food-intake) is exactly deduct remaining weight one day after by the weight that the previous day is initial.
3.2 feces parameters
After every morning 9:00 gastric infusion, the feces collected in 5h is weighed.Then put it in 110 DEG C of baking ovens, overnight, dry, weigh the weight after drying in the balance.Feces water content %=(weight in wet base-dry weight)/weight in wet base × 100%.After weighing morning next day, every cage pad is renewed (note bedding and padding amount can not be too much).
3.3 mouthfuls-anus transmission the time
Terminate to give for second day barium sulfate pasty liquid 2ml/ (before gavage the fasting 12h) of each group of rat 150% at model building.The time is recorded after gavage, the record efflux time when first white feces is discharged, calculate outlet-anus transmission time with this.
3.4 plasma parameters
Taking blood Rat Fast the previous day 12h, can't help water, blood sample collection uses endocanthion blood taking method, every rat 1ml.Collect (during collection, attention cotton swab is by mouth of pipe blood wiped clean) with the 1.5ml centrifuge tube containing heparin, put into after taking in centrifuge, 3000r/min, 15min.Collect serum subpackage, put-80 DEG C standby, in order to measure NO, Ach, MTL content (with on market sell test kit).
3.5 histological observations
After the modeling phase terminates, often group takes a rat execution, and clip lower distal colon 8～10mm from about anal orifice 10mm after taking-up colon, in PBS, concussion removes intestinal contents gently, puts in formaldehyde fixative and fixes more than 24h.Then undertaken tissue embedding, cut into slices, HE dyeing, under just putting binocular biological microscope, carry out structure observation, cellular change in lower distal colon mucous layer thickness and colon.
Four, statistical method
Experimental data all adopts SPSS19.0 statistical software that sample carries out statistical analysis, detects data mean ± standard deviationRepresenting, comparing employing t method of inspection between two groups, more than two comparison uses method of analysis of variance.
Five, result
5.1 general states
(1) apparent state observation situation
Normal rats is comparatively active, and hair color light, fur is smooth, soft；Administration group rat active state is better than model group, but hair color bright degree not as normal group but is better than model group (model group rats dull, fur have slightly hard sense).
(2) body weight change amount, amount of drinking water change, food-intake change
In body weight change amount, compared with model group (the 3rd group), blank group (the 1st group) and administration group (the 2nd, 4,5,6,7 groups) body weight dramatically increase (P < 0.01)；Prescription clyster group (the 6th group) and Decoction of Four-Drug Juice (the 7th group) but organize body weight evolution and increase higher statistically no difference of science of statistics with other groups.
On amount of drinking water, compared with model group, blank group, prescription clyster group and Decoction of Four-Drug Juice group dramatically increase (P < 0.01), trimebutine group (the 2nd group), 1 group of compound recipe Radix Arnebiae (Radix Lithospermi) bolt (the 4th group) and compound recipe Radix Arnebiae (Radix Lithospermi) bolt 2 groups (the 5th group) amount of drinking water statistically significant (P < 0.05)；When statistical analysis, it has been found that trimebutine group and 1 group of suppository also have significant difference (P < 0.05) with prescription clyster group and Decoction of Four-Drug Juice group amount of drinking water.
On the feed in amount, blank group and administration group are significantly more than model group (P < 0.01), and blank group is significantly more than administration group (P < 0.01), food-intake no difference of science of statistics between administration group, as shown in table 6.
Table 6 rat body weight variable quantity, food-intake, amount of drinking water (g,N=6)
Note: in body weight change amount, * represents (the 3rd group), P < 0.01 compared with model group；
In amount of drinking water, * represents compared with model group (the 3rd group), P < 0.01；& represents compared with model group, P < 0.05；# represents compared with prescription clyster group and Decoction of Four-Drug Juice group (the 6th, 7 groups), P < 0.05
In food-intake, # represents compared with model group (the 3rd group), P < 0.01；* represent compared with blank group (the 1st group), P < 0.01
5.2 feces parameters
(1) feces water content situation
Each group of rat feces being carried out apparent observation and water content is measured, first apparent observation finds that in model group 5h, the feces surface of collection is dry and hard, present wad shape；Normal group presents thin soft sausage-like, surface wettability；Administration group is more compared with model group surface mucus gets well and soft compared with model group (such as Fig. 5).And each group of water content is calculated and shows: compared with model group, normal group and administration group feces water content significantly improve (P<0.01), there was no significant difference (P>0.05) (such as table 7) between normal group and administration group and administration group.
Table 7 rat feces water content (%,N=6)
Note: * represents and model group (compared with in the of the 3rd group), P < 0.01
(2) lower distal colon granule number
The lower distal colon granule number of each group of rat is carried out observed and recorded, and model group rats (the 3rd group) lower distal colon granule number is significantly more than blank group (the 1st group) and administration group (the 2nd, 4,5,6,7 groups) as seen from Figure 6；And this result also can draw model group and matched group, administration group significant difference (P < 0.01), significant difference between administration group and blank group from table 8.
Table 8 rat lower distal colon granule number (,N=6)
Note: * represents compared with model group (the 3rd group), P < 0.01
5.3 mouthfuls-anus transmission the time
Mouth-anus transmission the time of each group of rat is recorded and calculating, it has been found that blank group group and administration group time are considerably less than model group (P < 0.01)；And the administration group transmission time is slightly longer than blank group (P < 0.05)；It is trimebutine group (2) < prescription clyster group (6) < 2 groups (5) of compound recipe Radix Arnebiae (Radix Lithospermi) bolt < Decoction of Four-Drug Juice group (7) < 1 group (4) of compound recipe Radix Arnebiae (Radix Lithospermi) bolt, but its no difference of science of statistics (as shown in table 9) between administration group.
Table 9 rat mouth-anus transmission time (min,N=6)
Note: * represents compared with model group (the 3rd group), P < 0.01；# represents compared with blank group (the 1st group), P < 0.05
5.4 plasma parameters
NO, Ach, MTL in the blood plasma of each group of rat are carried out assay.Measurement result finds: first in NO level, the NO content of normal group and administration group is substantially less than model group (P < 0.01)；And prescription clyster group (6) between administration group < Decoction of Four-Drug Juice group (7) < 1 group (4) of compound recipe Radix Arnebiae (Radix Lithospermi) bolt < trimebutine (2) < 2 groups (5) of compound recipe Radix Arnebiae (Radix Lithospermi) bolt, but its zero difference (as shown in table 10) statistically.
In Ach level, blank group, administration group content are higher than model group and have statistical significance (P < 0.05)；Between administration group 2 > 7 > 4 > 5 > 6, but without statistically difference (as shown in table 11).
In MTL level, blank group, administration group content are significantly higher than model group (P < 0.01)；Between administration group 2 > 6 > 5 > 7 > 4, same without statistically difference (as shown in table 12).
NO content in table 10 rat plasma (μm ol/L,N=6)
Note: * represents compared with model group (the 3rd group), P < 0.01
Ach content in table 11 rat plasma (pmol/L,N=6)
Note: * represents (the 3rd group), P < 0.05 compared with model group
MTL content in table 12 rat plasma (ng/L,N=6)
Note: * represents compared with model group (the 3rd group), P < 0.01
5.5 gastrointestinals and all the other internal organs parameter situations
Rat place after death, weighs the heart of each group of every rat, liver, spleen, lung, kidney and gastrointestinal weight.Find the heart, liver, spleen, lung, kidney weight no significant difference.And contain food respectively and the stomach without food is weighed and found that the weight containing normal group in food situation and administration group is significantly lighter than model group (P<0.01, as shown in table 13), and each group of weight no difference of science of statistics (P>0.05, as shown in table 14) without food stomach.
Rat small intestine length is measured, it has been found that blank group connects administration group small intestinal length and is considerably longer than between model group (P<0.01) administration group 2>5>7>4>6, but no significant difference (as shown in Table 15).For the apparent observation of stomach, experiment finds that model group rats coat of the stomach is relatively thin and pleat is smooth；And administration group and blank group gastric wall in rats is comparatively abundant and pleat is more.
Table 13 rat containing food stomach gross weight (g,N=6)
Note: * represents compared with model group (the 3rd group), P < 0.01
Table 14 rat without food stomach weight (g,N=6)
Note: * represents compared with model group (the 3rd group), P < 0.01
Table 15 rat small intestine length (cm,N=6)
Note: * represents compared with model group (the 3rd group), P < 0.01
5.6 histological observations
Rat lower distal colon tissue is carried out HE dyeing: Lignum Sappan uniformly dyeing nucleus (blueness), Yihong dye Cytoplasm (pink colour), observe pit cell and mucous layer difference in thickness.As it is shown in fig. 7, blank group (1) relatively model group (3), acid mucoprotein density is relatively big and mucous layer thickness is significantly thick and model group.Crypt Cells density and the lower distal colon thickness relatively model group of administration group (2,4,5,6,7) are also significantly increased, and between administration group, diversity is little.
Compound recipe Radix Arnebiae (Radix Lithospermi) bolt prescription prepared by the present invention is by the late national unconventional and unrestrained right coloclysis Empirical formula of famous physician in Yangzhou.Compound recipe Radix Arnebiae (Radix Lithospermi) bolt is prepared Chinese medicine and is extracted and use Radix Arnebiae (Radix Lithospermi) alkali instead and carry that acid is heavy individually extracts, and Herba Houttuyniae, Herba Euphorbiae Humifusae, Herba Pteridis Multifidae, Galla Chinensis, Semen Litchi water raise extractum, then by 11 mixing.Substrate selects greasing base semi-synthetic fatty acid glyceride can reach, in the less situation of enteral amount of liquid, to make medicine easily dissolution from substrate；And the addition of a small amount of Arlacel-20 and tween 80 surfactant can to prevent medicine material from disperseing in substrate uneven, reduce suppository fragility, increase toughness plasticity；Substrate prescription ratio is: semi-synthetic fatty acid glyceride tween 80 Arlacel-20 is equal to 86 4 10；The ratio of medicine and substrate is 12.Thus prepare 1000 pieces can in enteral residence time length, facilitate patient's self-administration, treating both the principal and secondary aspects of a disease gives full play to the anti-compound recipe Radix Arnebiae (Radix Lithospermi) bolt treated constipation of drug effect.
And adopt TLC method and UV spectrum that the compound recipe Radix Arnebiae (Radix Lithospermi) bolt extracting medicine and preparation is carried out the qualitative analysis of index components shikonin and Quercetin, in TLC method, test sample and reference substance have same speckle to occur on relevant position；Ultraviolet 200～600nm length scanning, test sample has similar spectrum peak looks to reference substance.According to Bill's-Lang Baite law, adopting ultraviolet visible spectrophotometry Plays counter point that shikonin and Quercetin in Quercetin, compound recipe Radix Arnebiae (Radix Lithospermi) bolt in shikonin, extractum in Radix Arnebiae extract carry out the selected wavelength of assay wherein shikonin be 516nm, Quercetin is 372nm place (shikonin and Quercetin absorb complementary interference under the two wavelength), measurement result respectively 2.55%, 5.26%, 0.01%, 0.02%.
Finally according to requiring under 2010 editions Chinese Pharmacopoeia suppository items to check that the compound recipe Radix Arnebiae (Radix Lithospermi) bolt to preparation carries out quality examination: the atropurpureus compound recipe Radix Arnebiae (Radix Lithospermi) bolt smooth surface of the bullet-shaped of preparation, uniform and smooth, can soften when 37 DEG C until melting, within 20 ± 1 minutes, melt completely, bolt weight (0.36 ± 0.02) g, weight differential ± 0.8%；The dissolution 75% in 45 minutes of index components Quercetin, shikonin dissolution 82.4% in 45 minutes.
The difference of indices notable (P>0.05) is can be seen that between administration group from result, but and the diversity of each index relatively big (P<0.01) between model group.Illustrate that the rat Constipation Model that compound recipe Radix Arnebiae (Radix Lithospermi) bolt is induced for loperamide has certain therapeutical effect.Between various dose compound recipe Radix Arnebiae (Radix Lithospermi) bolt group indices difference notable illustrate on the one hand one time 1 can reach therapeutic effect, be also likely to be on the other hand once fill in 2 medicines also completely dissolution just got rid of external by rat.Compared with model group, compound recipe Radix Arnebiae (Radix Lithospermi) bolt can significantly shorten mouth-anus transmission time, improves gastric emptying ability, increase feces water content (P < 0.01), illustrates that it has loosening bowel to relieve constipation, increases intestinal peristalsis promoting effect.
Anti-constipation this research of mechanism for compound recipe Radix Arnebiae (Radix Lithospermi) bolt carries out Primary Study, and the Constipation Model that this research is set up is that loperamide is induced.Loperamide is to act on the opiate receptor of gastrointestinal wall to stop the release of the irritability enteric nervous mediators such as acetylcholine, in its Constipation Model set up, inhibition enteric nervous mediator NO content compared with normal group substantially increases, irritability gut hormone MTL content compared with normal group significantly reduces simultaneously so that gastrointestinal peristalsis slows down.And in compound recipe Radix Arnebiae (Radix Lithospermi) bolt, Radix Arnebiae (Radix Lithospermi) adopts alkali extraction and acid precipitation to extract in this research, illustrate that medicine contains higher acidity, gastrointestinal motility can be accelerated, and compared with model group, the Ach content of compound recipe Radix Arnebiae (Radix Lithospermi) bolt group has and substantially rises (P < 0.05) and MTL content is also significantly increased (P < 0.01), NO content significantly reduces (P < 0.01).Goblet cell in mucous membrane of colon columnar epithelium can protect mucosa by secreting mucus lubrication enteric cavity, and mucous membrane of colon is protected, and enteral moisture will return to normal level, increases feces water content.And the index components shikonin drafted in prescription and Quercetin have good antioxidation, it is possible to protective epithelium tissue so that epithelial goblet cell is not destroyed.
In a word, compound recipe Radix Arnebiae (Radix Lithospermi) bolt can significantly improve the feces water content of constipation rat, lower distal colon thickness, pit cell density, reduces mouth-anus transmission time, improves intestinal peristalsis promoting speed, reduces NO content, improves Ach, MTL content.And by the apparent observation of the internal organs such as the heart, liver, spleen, lung, kidney and gravimetry be there is no abnormal symptom.Therefore, compound recipe Radix Arnebiae (Radix Lithospermi) bolt has the effect of prevention and treatment constipation and without obvious toxic-side effects.
Below in conjunction with embodiment, the invention will be further described, and following each embodiment is merely to illustrate the present invention but not limitation of the present invention.
Embodiment 1
The preparation method of the anti-Chinese medicine suppository treated constipation comprises the steps:
(1) in every piece of suppository, required substrate and drug quality calculate:
Pure substrate bolt average weight G=0.32g；Substrate forms: semi-synthetic fatty acid glyceride (36 type) tween 80 Arlacel-20 is equal to 86 4 10, and compound recipe Radix Arnebiae (Radix Lithospermi) bolt mesostroma content is 66.67%.
Average bolt weight M=0.36g containing stype.Compound recipe Radix Arnebiae (Radix Lithospermi) bolt drug content is 33.33%, wherein Radix Arnebiae (Radix Lithospermi) precipitation and except Radix Arnebiae (Radix Lithospermi) prescription medicinal material extract gained extractum respectively account for 16.66%.
Every piece of compound recipe Radix Arnebiae (Radix Lithospermi) bolt content of dispersion W=0.12g.
Displacement value:
Thus substrate amount B needed for n piece of compound recipe Radix Arnebiae (Radix Lithospermi) bolt of calculating preparation:
(2) extraction of composition (Radix Arnebiae (Radix Lithospermi) precipitation) in Radix Arnebiae (Radix Lithospermi):
Weighing Radix Arnebiae (Radix Lithospermi) 200g, with the 1%NaOH of 10 times amount, point three secondary chamber warm macerating carry, and extraction time is 1h, 30min, 30min respectively, collects each extracting solution respectively, adjust pH2～3 with dilute hydrochloric acid, place overnight, and sucking filtration must precipitate, 40 DEG C of vacuum dryings, obtain Radix Arnebiae (Radix Lithospermi) precipitation.
(3) the mixed extraction carrying composition in medical material (extractum):
Weigh Herba Houttuyniae: 300g, Herba Euphorbiae Humifusae: 300g, Herba Pteridis Multifidae: 400g, Galla Chinensis: 180g, Semen Litchi: 100g.Micro-boil with 10 times of water, 1h extracts twice, united extraction liquid, filters and concentrate and to obtain immersion cream, and 40 DEG C of vacuum dryings obtain extractum.
(4) if preparing 200 pieces of compound recipe Radix Arnebiae (Radix Lithospermi) bolts:
The substrate quality needed for 200 pieces of suppositorys of preparation can be calculated according to above-mentioned formula:
Then Radix Arnebiae (Radix Lithospermi) precipitation and extractum aequum are respectively 12g.
Then Radix Arnebiae (Radix Lithospermi) precipitation and extractum aequum are respectively 12g.Alkali is carried the heavy Radix Arnebiae (Radix Lithospermi) precipitation 12g obtained of acid with extractum 12g mixed grinding to fine and smooth；By the semi-synthetic fatty acid glyceride (36#) of 41.3g, the tween 80 of 1.9g, 4.8g Arlacel-20, in 50～60 DEG C of water-baths, mixing is as substrate；Finely ground medicine is added in the substrate of mixing；Grind uniformly, inject in mould, take out after cooling, put in wide mouthed bottle standby.
If preparing 500 pieces of compound recipe Radix Arnebiae (Radix Lithospermi) bolts:
The substrate quality needed for 500 pieces of suppositorys of preparation can be calculated according to above-mentioned formula:
Then Radix Arnebiae (Radix Lithospermi) precipitation and extractum aequum are respectively 30g.Alkali is carried the heavy Radix Arnebiae (Radix Lithospermi) precipitation 30g obtained of acid with extractum 30g mixed grinding to fine and smooth；By the semi-synthetic fatty acid glyceride (36#) of 103g, the tween 80 of 5g, 12g Arlacel-20, in 50～60 DEG C of water-baths, mixing is as substrate；Finely ground medicine is added in the substrate of mixing；Grind uniformly, inject in mould, take out after cooling, put in wide mouthed bottle standby.
If preparing 1000 pieces of compound recipe Radix Arnebiae (Radix Lithospermi) bolts:
The substrate quality needed for 1000 pieces of suppositorys of preparation can be calculated according to above-mentioned formula:
Then Radix Arnebiae (Radix Lithospermi) precipitation and extractum aequum are respectively 60g.Alkali is carried the heavy Radix Arnebiae (Radix Lithospermi) precipitation 60g obtained of acid with extractum 60g mixed grinding to fine and smooth；By the semi-synthetic fatty acid glyceride (36#) of 206g, the tween 80 of 10g, 24g Arlacel-20, in 50～60 DEG C of water-baths, mixing is as substrate；Finely ground medicine is added in the substrate of mixing；Grind uniformly, inject in mould, take out after cooling, put in wide mouthed bottle standby.
Embodiment 2
(1) in every piece of suppository, required substrate and drug quality calculate:
Calculate with (1) item in embodiment 1；
(2) extraction of composition (Radix Arnebiae (Radix Lithospermi) precipitation) in Radix Arnebiae (Radix Lithospermi):
Weighing Radix Arnebiae (Radix Lithospermi) 100g, with the 1%NaOH of 10 times amount, point three secondary chamber warm macerating carry, and extraction time is 1h, 30min, 30min respectively, collects each extracting solution respectively, adjust pH2～3 with dilute hydrochloric acid, place overnight, and sucking filtration must precipitate, 40 DEG C of vacuum dryings, obtain Radix Arnebiae (Radix Lithospermi) precipitation.
(3) the mixed extraction carrying composition in medical material (extractum):
Weigh Herba Houttuyniae: 560g, Herba Euphorbiae Humifusae: 200g, Herba Pteridis Multifidae: 400g, Galla Chinensis: 60g, Semen Litchi: 60g.Micro-boil with 10 times of water, 1h extracts twice, united extraction liquid, filters and concentrate and to obtain immersion cream, and 40 DEG C of vacuum dryings obtain extractum.
(4) the different piece number suppository each several part addition of preparation is with (4) item in embodiment 1.
Embodiment 3
(1) in every piece of suppository, required substrate and drug quality calculate:
Calculate with (1) item in embodiment 1；
(2) extraction of composition (Radix Arnebiae (Radix Lithospermi) precipitation) in Radix Arnebiae (Radix Lithospermi):
Weighing Radix Arnebiae (Radix Lithospermi) 250g, with the 1%NaOH of 10 times amount, point three secondary chamber warm macerating carry, and extraction time is 1h, 30min, 30min respectively, collects each extracting solution respectively, adjust pH2～3 with dilute hydrochloric acid, place overnight, and sucking filtration must precipitate, 40 DEG C of vacuum dryings, obtain Radix Arnebiae (Radix Lithospermi) precipitation.
(3) the mixed extraction carrying composition in medical material (extractum):
Weigh Herba Houttuyniae: 375g, Herba Euphorbiae Humifusae: 250g, Herba Pteridis Multifidae: 375g, Galla Chinensis: 150g, Semen Litchi: 150g.Micro-boil with 10 times of water, 1h extracts twice, united extraction liquid, filters and concentrate and to obtain immersion cream, and 40 DEG C of vacuum dryings obtain extractum.
(5) the different piece number suppository each several part addition of preparation is with (4) item in embodiment 1.
Claims (6)
1. the anti-Chinese medicine suppository treated constipation, is characterized in that being prepared from by the raw material of Chinese medicine of following weight: Radix Arnebiae (Radix Lithospermi) 5～20 parts, Herba Houttuyniae 15～30 parts, Herba Euphorbiae Humifusae 10～20 parts, Herba Pteridis Multifidae 20～30 parts, Semen Litchi 3～12 parts, Galla Chinensis 3～12 parts.
2. a kind of anti-Chinese medicine suppository treated constipation as claimed in claim 1, is characterized in that the weight proportion of each raw material is: Radix Arnebiae (Radix Lithospermi) 10 parts, Herba Houttuyniae 15 parts, Herba Euphorbiae Humifusae 15 parts, Herba Pteridis Multifidae 20 parts, Semen Litchi 5 parts, Galla Chinensis 9 parts.
3. a preparation method for the anti-Chinese medicine suppository treated constipation described in claim 1, is characterized in that comprising the following steps:
(1) extract: described Radix Arnebiae (Radix Lithospermi) adopts alkali put forward the heavy mode of acid and individually extracts and obtain Radix Arnebiae (Radix Lithospermi) precipitation, adopt the mode that water carries to obtain extractum described Herba Houttuyniae, Herba Euphorbiae Humifusae, Herba Pteridis Multifidae, Semen Litchi and Galla Chinensis, grind stand-by respectively；
(2) prepare: the Radix Arnebiae (Radix Lithospermi) precipitation in step (1), extractum and substrate are mixed according to the ratio of 1:1:4, grinds uniformly, inject in mould, take out after cooling, standby after packaging.
4. preparation method as claimed in claim 3, is characterized in that in described step (1),
The extraction of described Radix Arnebiae (Radix Lithospermi) precipitation: taking Radix Arnebiae (Radix Lithospermi), divide three secondary chamber warm macerating to carry with the 1%NaOH of 10 times amount, extraction time is 1h, 30min, 30min respectively, collect each extracting solution respectively, adjust pH2～3 with dilute hydrochloric acid, place overnight, sucking filtration obtains Radix Arnebiae (Radix Lithospermi) precipitation, and 40 DEG C of vacuum dryings are stand-by；
The extraction of described extractum: take Herba Houttuyniae, Herba Euphorbiae Humifusae, Herba Pteridis Multifidae, Galla Chinensis and Semen Litchi, micro-boils with 10 times of water, 1h extracts twice, united extraction liquid, filters and concentrate and to obtain extractum, and 40 DEG C of vacuum dryings are stand-by.
5. the preparation method as described in claim 3 or 4, is characterized in that the composed as follows of described substrate: the ratio of semi-synthetic fatty acid glyceride-36 type, tween 80 and Arlacel-20 is 86 4 10 (weight ratios).
6. the preparation method as described in claim 3 or 4, is characterized in that the mixing in 50～60 DEG C of water-baths of described substrate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610205655.1A CN105770139A (en) | 2016-04-05 | 2016-04-05 | Traditional Chinese medicine suppository for preventing and treating constipation and preparation method thereof |
Applications Claiming Priority (1)
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| CN113181292A (en) * | 2021-05-20 | 2021-07-30 | 南京正宽医药科技有限公司 | Traditional Chinese medicine composition for treating constipation |
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| CN101138592A (en) * | 2006-09-08 | 2008-03-12 | 海南优方科技有限公司 | Preparation method for treating internal hemorrhoid and Chinese medicine suppository thereof |
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| CN101138592A (en) * | 2006-09-08 | 2008-03-12 | 海南优方科技有限公司 | Preparation method for treating internal hemorrhoid and Chinese medicine suppository thereof |
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| 冉先德等: "《中华药海 上 第1册 全新修订经典版》", 30 December 1998 * |
| 刘国华等: ""栓剂等直肠给药剂型的进展"", 《中国药学杂志》 * |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113181292A (en) * | 2021-05-20 | 2021-07-30 | 南京正宽医药科技有限公司 | Traditional Chinese medicine composition for treating constipation |
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