CN105853582A - Folium artemisiae argyi containing medicine preparation for treating cholelithiasis and preparation method thereof - Google Patents
Folium artemisiae argyi containing medicine preparation for treating cholelithiasis and preparation method thereof Download PDFInfo
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- CN105853582A CN105853582A CN201610217348.5A CN201610217348A CN105853582A CN 105853582 A CN105853582 A CN 105853582A CN 201610217348 A CN201610217348 A CN 201610217348A CN 105853582 A CN105853582 A CN 105853582A
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- artemisiae argyi
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Abstract
The invention belongs to the technical field of traditional Chinese medicines and relates to a folium artemisiae argyi containing medicine preparation for treating cholelithiasis and a preparation method thereof. The medicine preparation comprises the following preparation raw materials in parts by weight: 25-35 parts of folium artemisiae argyi, 20-33 parts of all-grass of holy thistle, 18-30 parts of lawn pennywort herb, 19-25 parts of spreading hedyotis herb, 18-20 parts of dark plum fruit, 15-18 parts of bittersweet herb, 12-18 parts of parslane herb, 9-15 parts of coptis root, 6-12 parts of paniculate swallowwort root and 6-16 parts of liquorice root. The medicine preparation has the advantages that the medicine preparation is formed by pure natural Chinese herbal medicines, is reasonable in compatibility, makes a distinction between the important and the lesser one, combines nursing with treatment, has good curative effects of clearing away heat and toxic materials, dispelling cold and dampness, dispelling the wind and eliminating dampness, protecting the liver and benefiting the gallbladder and generating sperms and enriching the blood, has the advantages of simple components, low cost, stable effects, good curative effects, quickness in effect taking, short course of treatment, high cure rate, good universality, no side effect and the like, and has a very high clinical promotion value.
Description
Technical field
The invention belongs to technical field of Chinese medicines, be specifically related to the pharmaceutical preparation of a kind for the treatment of cholelithiasis containing Folium Artemisiae Argyi
And preparation method thereof.
Background technology
Cholelithiasis refers to be formed calculus at any position of biliary system (including gallbladder and bile duct), is that clinic is the most normal
One of digestive system disease seen.Cardinal symptom is stomachache (distending pain or angor, severe pain), biliary colic, upper axil
Pain and acute inflammation, and along with nausea and vomiting, fear of cold, heating.If calculus may occur in which after entering common bile duct
Following complication: jaundice, cholangitis and pancreatitis etc..Different according to calculus happening part, be divided into cholelithiasis,
Calculus of intrahepatic duct, choledocholithiasis.In terms of China's National survey at beginning of the eighties result, cholelithiasis occurs
Rate is about 52.8%, and calculus of intrahepatic duct is 36.2%, and choledocholithiasis is 11%.Wherein, calculus of bile duct bag
Include that liver is outer, interior calculus of bile duct or constitutional, Secondary cases calculus of bile duct；Different according to chemical compositions, calculus
Generally include cholesterol calculus, bile pigment calculus or the mixture of the two (mixed type calculus).Cholelithiasis is full generation
One of the disease disease occurred frequently on boundary, according to data, China's cholelithiasis incidence rate is about 7%, with the growth at age,
Sickness rate growth can reach 23%.In recent years, along with the development of economic society, the change of people's dietary structure,
The sickness rate of cholelithiasis is the highest.
The origin cause of formation of cholelithiasis is extremely complex.Any cholesterol that affects changes with bile acid concentration ratio and causes bile
The factor being retarded by silt leads to calculus.Some is the most modifiable factor, such as: age of cumulative year after year,
Women, race, gene and family history etc.；Some is acquired disposition, and part can reverse, such as: pregnant
Be pregnent, fiber fat, low, high calorie dietary structure, long-time fasting, some drugs such as ceftriaxone, blood fat reducing
Medicine, oral contraceptive, fast weight lose (＞ 1.5kg/wk), metabolism syndrome, special disease etc..At me
The cholelithiasis sickness rate of the Northwest of state is of a relatively high, may be relevant with dietary habit.
For Symptomatic cholelithiasis disease patient, if sought medical advice not in time, it may occur however that serious complication,
Reduce quality of life, may threat to life time serious.
The Therapeutic Method of traditional cholelithiasis, based on operation, carries out gallbladder removal, or by choledochofiberscope,
Calculus in gallbladder is directly taken out by the hard mirror of biliary tract, peritoneoscope and other equipment.But operative treatment is expensive, produce effects
Little, relapse rate is higher, sequela easily occurs, such as: Iaotrogenic bile duct injury, postcholecystectomy are comprehensive
Disease, residual stones and recurrence etc..Operation and risk also will increase again, and patient also has the feared state of mind to this, therefore
Surgical operation is not the preferred plan solving cholelithiasis problem.Western medicine cholelithiasis curative effect is not the best enough, often
Cure the symptoms, not the disease, and side effect is relatively big, expensive.
Chinese medical theory basis is followed in Chinese traditional treatment, possesses abundant medication experience, has the spy of dialectical not differential diagnosis of diseases
Point.Traditional Chinese Medicine is more deep for the research of the cholelithiasis pathology cause of disease, it is believed that primary disease is by QI stagnation of the liver and galibladder, damp and hot
Alluvial is caused.
The patent of invention of presently disclosed treatment cholelithiasis has a lot.Chinese patent application 201310662958.2
Disclose a kind of Chinese medicine treating cholelithiasis, the medical material of following weight proportion be prepared from: Radix cotoneastri salicifolii 15 parts,
Gold 12 parts of lion rattan, thorn fossilia dentis mastodi 18 parts, Herba Corydalis tomentellae 8 parts, thin snow Leontopodium leontopodioides (Willd.) Beauv. 12 parts, Herba Glechoma biondiana 14 parts,
Acanthopanan trifoliatus (L.) Merr. 12 parts, Potentilla multifida L. 14 parts, 14 parts of Radix Ilicis Asprellae rattan, Radix Piperis Longi 10 parts, back flower skin ulcer 10 parts, Bi
Clear eggplant 8 parts, shore Flos Calystegiae sepii 16 parts, Tripterygium regelii Spragus et Takeda 12 parts, Costus speciosus 10 parts, mark post spend 16 parts, mountain cured
16 parts of prunus mume (sieb.) sieb.et zucc., 12 parts of big Cornu Caprae seu Ovis wooden dipper, Dryopteris varig (L.) O. Ktze. 12 parts.Although this invention Chinese medicine has certain heat clearing away
Removing toxic substances, cool the blood dissipate blood stasis and the curative effect of warming spleen and stomach for dispelling cold, can be used for treating cholelithiasis disease, but, this invention medicine
Prescription is complicated, and containing multiple rare medicinal herbs, source is few, and cost is high, significantly limit this invention medicine
Use.
In prior art for treating that the most prescription of Chinese medicine of cholelithiasis is complicated, compatibility owe weary rationally.Or mend with big
Medicine, onslaught of suiting the medicine to the illness, although taking effect is exceedingly fast but the most easily recurs；Or delay benefit, but medication effect is slow, takes effect slow,
Treatment time is long, uses inconvenience, based on symptom management progress, relief of symptoms.And oral drugs are deposited mostly
In the untoward reaction such as gastrointestinal reaction, lesions of liver and kidney, bring injury greatly to the body and mind of patient.Therefore, control
The improvement treated on cholelithiasis medicine is the problem needing solution at present badly.
Summary of the invention
Instant invention overcomes the deficiencies in the prior art, it is provided that the medicine system of a kind for the treatment of cholelithiasis containing Folium Artemisiae Argyi
Agent and preparation method thereof.By selecting suitable medical material and regulation compatibility, medical treatment combines, it is possible to heat clearing away effectively
Removing toxic substances, enrich blood by cold damp eliminating, dispeiling pathogenic wind and removing dampness, hepatic cholagogic and spermatogenesis, have with strong points, effective fast,
The advantages such as short treating period, cure rate are high, have no side effect.
For realizing the purpose of the present invention, inventor is according to the test repeatedly of the research of theory of Chinese medical science and clinic and tests
Card, its technical scheme is as follows:
A kind of pharmaceutical preparation of the treatment cholelithiasis containing Folium Artemisiae Argyi, including the raw material of preparing of following parts by weight:
Folium Artemisiae Argyi 25-35 part, Herba Silybi mariani 20-33 part, Herba Hydrocotyles 18-30 part, Serpentis SHECAO 19-25 part, crow
Prunus mume (sieb.) sieb.et zucc. 18-20 part, Herba Solani Lyrati 15-18 part, Herba Portulacae 12-18 part, Rhizoma Coptidis 9-15 part, Radix Cynanchi Paniculati 6-12
Part and Radix Glycyrrhizae 6-16 part.
In the range of these parts by weight, preferably 3 curative effects more significantly formula:
Formula 1: Folium Artemisiae Argyi 25 parts, Herba Silybi mariani 20 parts, Herba Hydrocotyles 18 parts, Serpentis SHECAO 19 parts, Fructus Mume 18
Part, Herba Solani Lyrati 15 parts, Herba Portulacae 12 parts, Rhizoma Coptidis 9 parts, Radix Cynanchi Paniculati 6 parts and 6 parts of Radix Glycyrrhizae.
Formula 2: Folium Artemisiae Argyi 35 parts, Herba Silybi mariani 33 parts, Herba Hydrocotyles 30 parts, Serpentis SHECAO 25 parts, Fructus Mume 20
Part, Herba Solani Lyrati 18 parts, Herba Portulacae 18 parts, Rhizoma Coptidis 15 parts, Radix Cynanchi Paniculati 12 parts and 16 parts of Radix Glycyrrhizae.
Formula 3: Folium Artemisiae Argyi 30 parts, Herba Silybi mariani 27 parts, Herba Hydrocotyles 24 parts, Serpentis SHECAO 22 parts, Fructus Mume 19
Part, Herba Solani Lyrati 17 parts, Herba Portulacae 15 parts, Rhizoma Coptidis 20 parts, Radix Cynanchi Paniculati 9 parts and 11 parts of Radix Glycyrrhizae.
Correspondingly, the present invention also provides for the preparation method of a kind of described pharmaceutical preparation, comprises the following steps:
S1, weigh each taste raw medicinal material, respectively decontamination, clean, dry, after section, be ground into coarse powder；
S2, take Folium Artemisiae Argyi coarse powder, add, according to the 10-15 times amount of coarse powder weight, the ethanol that concentration is 60-75% molten
Liquid, soaks 6-12 hour, and supersound extraction 3 times at a temperature of 40-60 DEG C are each 30-50 minute, ultrasonic
Frequency is 20-30kHz, filters, merging filtrate, retains Folium Artemisiae Argyi medicinal residues, filtrate reduced in volume to 60 DEG C phase
It is the clear paste of 1.10-1.20 to density, prepares Folium Artemisiae Argyi extract；
S3, by Herba Silybi mariani, Herba Hydrocotyles, Herba Solani Lyrati, Herba Portulacae and Radix Glycyrrhizae coarse powder mix, according to coarse powder gross weight
5-10 times amount add volumetric concentration be the ethanol solution of 75-95%, soak 4-8h, reflux, extract, 2-6 time,
2-4h every time, filters and retains filtering residue, merging filtrate, and filtrate cold preservation after alkalization stands 12-24h, filters,
Gained filtrate obtains extractum thing I through concentrating under reduced pressure and microwave drying；
S4, by Folium Artemisiae Argyi filtering residue described in Serpentis SHECAO, Fructus Mume, Rhizoma Coptidis, Radix Cynanchi Paniculati and S2 and the filter described in S3
Slag mixes, and adds purified water according to the 7-9 times amount of coarse powder gross weight, decocts 2-3 time, each 2-4 hour,
Filter, merging filtrate, and be concentrated into the extractum thing II that 55-60 DEG C of relative density is 1.20-1.25；
S5, Folium Artemisiae Argyi extract, extractum thing I and II being sufficiently mixed, centrifugal spray drying prepares medicine of the present invention
Preparation raw material medicine fine powder, wherein, inlet temperature is 120-130 DEG C, and leaving air temp is 65-75 DEG C.
Pharmaceutical preparation of the present invention is arbitrary clinical common dosage forms such as tablet, capsule, pill, granule or powder,
Facilitate patient to carry and take.
The source of Chinese crude drug, nature and flavor used by pharmaceutical preparation of the present invention, return through and drug effect:
Folium Artemisiae Argyi: this product is the dried leaves of feverfew Chinese mugwort；Acrid in the mouth, hardship, warm in nature；Return liver,spleen,kidney warp；Tool
There is dispersing cold for relieving pain, regulate the flow of vital energy along blood, drug effect by cold damp eliminating.
Herba Silybi mariani: this product is Compositae Silybum plant Herba Silybi mariani, is used as medicine with achene；Bitter in the mouth, cool in nature；Have
Heat-clearing and toxic substances removing, hepatic cholagogic, guarantor's brain, the drug effect of anti-X-ray.To acute or chronic hepatitis, liver cirrhosis, fat
Around fat liver, metabolism toxic liver injury, cholelithiasis, cholangitis and hepatic duct, liver, the gallbladder inflammation disease such as scorching all have good
Good curative effect.
Herba Hydrocotyles: this product is samphire Herba Hydrocotyles, with all herbal medicine；Sweet in the mouth, light, micro-pungent, cool in nature；
There is the drug effect of expelling wind and clearing away heat, preventing phlegm from forming and stopping coughing.For icteric infectious hepatitis, cirrhotic ascites, cholelithiasis,
Urinary system infection, urinary system calculus etc..
Serpentis SHECAO: this product is the herb of Rubiaceae plants of Hedyotis Herba Hedyotidis Diffusae；Sweet in the mouth, light, cool in nature；
Return stomach, large intestine, small intestine meridian；There is the drug effect of heat-clearing and toxic substances removing, inducing diuresis to remove edema, promoting blood circulation and stopping pain.
Fructus Mume: this product is the dry almost ripe fruit of rose department plant plum；Sour in the mouth, puckery, property is put down；Return liver, spleen,
Lung, large intestine channel；Have astringe the lung, astringing intestine to stop diarrhea, promote the production of body fluid, the drug effect of relieving colic caused by ascaris.
Herba Solani Lyrati: this product is the herb of plant of Solanaceae Herba Solani Lyrati；Sweet in the mouth, hardship, cold in nature；Return liver, gallbladder, kidney channel；
There is clearing away heat-damp and promoting diuresis, the drug effect of removing toxic substances of dispeling the wind.
Herba Portulacae: this product is the dry aerial parts of portulacaceous plant Herba Portulacae；Sour in the mouth, cold in nature；Return liver,
Large intestine channel；There is the drug effect of heat-clearing and toxic substances removing, cooling blood for hemostasis.
Rhizoma Coptidis: this product is the dry rhizome that ranunculaceae plant is yellow；Bitter in the mouth, cold in nature；GUIXIN, spleen, stomach, liver,
Gallbladder, large intestine channel；There is the drug effect of heat clearing and damp drying, eliminating fire and detoxication.
Radix Cynanchi Paniculati: this product is the dry root and rhizome of trailing plants section Cynanchum plant Radix Cynanchi Paniculati；Acrid in the mouth, warm in nature；
Return liver, stomach warp；There is the drug effect of removing dampness of dispeling the wind, antalgesic-antipruritic.
Radix Glycyrrhizae: this product is glycyrrhizic legume dry root；Sweet in the mouth, property is put down；GUIXIN, lung, spleen, stomach warp；Tool
There are invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, effect of coordinating the actions of various ingredients in a prescription.
The compatibility analysis of pharmaceutical preparation of the present invention:
The prescription of pharmaceutical preparation of the present invention is according to the dialectical cognition to cholelithiasis of the Chinese medicine rationale, it then follows Chinese medicine
Compatibility theory, enhances the usage amount of medical material.This prescription is with Folium Artemisiae Argyi and Herba Silybi mariani as monarch drug, dispersing cold for relieving pain,
Regulate the flow of vital energy along blood, by cold damp eliminating, hepatic cholagogic；With Herba Hydrocotyles, Serpentis SHECAO and Fructus Mume as ministerial drug, expelling wind and clearing away heat,
Inducing diuresis to remove edema, astringing intestine to stop diarrhea of astringing the lung, spermatogenesis are enriched blood；With Herba Solani Lyrati, Herba Portulacae, Rhizoma Coptidis and Radix Cynanchi Paniculati as adjuvant drug, clearly
Thermal detoxification, dispeiling pathogenic wind and removing dampness, eliminating fire and detoxication, cooling blood for hemostasis；With Radix Glycyrrhizae for making medicine, invigorating the spleen and replenishing QI, relieving spasm to stop pain,
The coordinating the actions of various ingredients in a prescription property of medicine.All medicines coordinate mutually and, complement each other, synergism, treatment cholelithiasis is had the most aobvious
The curative effect write.
Compared with prior art, pharmaceutical preparation of the present invention has the advantage that
1, the prescription of pharmaceutical preparation of the present invention is made up of pure natural Chinese herbal medicine completely, compatibility medicine reasonable, all is collaborative,
Medical treatment combine, have good dispersing cold for relieving pain, hepatic cholagogic, regulate the flow of vital energy along blood, heat-clearing and toxic substances removing, dispeiling pathogenic wind and removing dampness,
Effect, evident in efficacy to cholelithiasis；
2, the medical material effective ingredient of pharmaceutical preparation of the present invention uses modern crafts fully to purify, thus improves medicine
The bioavailability of material；Component is simple, is more beneficial for quality control；Efficacy stability；Production technology is simple, ring
Protect and low cost, be suitable for industrialized great production.
3, zoopery and clinical trial all prove that pharmaceutical preparation of the present invention treatment cholelithiasis has good effect, shows
The advantage that effect is fast, short treating period, cure rate are high, have no side effect.
Detailed description of the invention
Below will by specific embodiment, the present invention is described further, but the present invention is not limited only to following
Embodiment.It will be understood by those skilled in the art that for, the present invention is in addition to following example, without departing from the present invention's
The change that under conditions of content, spirit and scope, the present invention carried out, combine or replace, for the skill of this area
It is apparent from for art personnel, is included within the scope of the present invention.
Embodiment 1
The embodiment of the present invention 1 pharmaceutical preparation is made up of the raw material of preparing of following parts by weight:
Folium Artemisiae Argyi 25 parts, Herba Silybi mariani 20 parts, Herba Hydrocotyles 18 parts, Serpentis SHECAO 19 parts, Fructus Mume 18 parts, white
15 parts of rattan of hair, Herba Portulacae 12 parts, Rhizoma Coptidis 9 parts, Radix Cynanchi Paniculati 6 parts and 6 parts of Radix Glycyrrhizae.
Preparation method is as follows:
S1, weigh each taste raw medicinal material, respectively decontamination, clean, dry, after section, be ground into coarse powder；
S2, taking Folium Artemisiae Argyi coarse powder, adding concentration according to 12 times amount of coarse powder weight is the ethanol solution of 70%, leaching
Steeping 6 hours, supersound extraction 3 times at a temperature of 50 DEG C, each 45 minutes, supersonic frequency is 25kHz, mistake
Filter, merging filtrate, retain Folium Artemisiae Argyi medicinal residues, during filtrate reduced in volume to 60 DEG C, relative density is the clear paste of 1.20,
Prepare Folium Artemisiae Argyi extract；
S3, by Herba Silybi mariani, Herba Hydrocotyles, Herba Solani Lyrati, Herba Portulacae and Radix Glycyrrhizae coarse powder mix, according to coarse powder gross weight
8 times amount add volumetric concentrations be the ethanol solution of 85%, soak 5h, reflux, extract, 2 times, each 2h,
Filtering and retain filtering residue, merging filtrate, filtrate cold preservation after alkalization stands 12h, filters, and gained filtrate is through subtracting
Pressure concentrates and microwave drying obtains extractum thing I；
S4, by Folium Artemisiae Argyi filtering residue described in Serpentis SHECAO, Fructus Mume, Rhizoma Coptidis, Radix Cynanchi Paniculati and S2 and the filter described in S3
Slag mixes, and adds purified water according to 8 times amount of coarse powder gross weight, decocts 2 times, each 3 hours, filters,
Merging filtrate, and it is concentrated into the extractum thing II that 60 DEG C of relative densities are 1.20；
S5, Folium Artemisiae Argyi extract, extractum thing I and II being sufficiently mixed, centrifugal spray drying prepares medicine of the present invention
Preparation raw material medicine fine powder, wherein, inlet temperature is 120 DEG C, and leaving air temp is 65 DEG C；
S6, utilize the general technology of preparing of Modern preparations, in pharmaceutical preparation crude drug fine powder, add suitable adjuvant,
Load softgel shell, be prepared as capsule.
Embodiment 2
The embodiment of the present invention 2 pharmaceutical preparation is made up of the raw material of preparing of following parts by weight:
Folium Artemisiae Argyi 35 parts, Herba Silybi mariani 33 parts, Herba Hydrocotyles 30 parts, Serpentis SHECAO 25 parts, Fructus Mume 20 parts, white
18 parts of rattan of hair, Herba Portulacae 18 parts, Rhizoma Coptidis 15 parts, Radix Cynanchi Paniculati 12 parts and 16 parts of Radix Glycyrrhizae.
Preparation method is with embodiment 1.
Embodiment 3
The embodiment of the present invention 3 pharmaceutical preparation is made up of the raw material of preparing of following parts by weight:
Folium Artemisiae Argyi 30 parts, Herba Silybi mariani 27 parts, Herba Hydrocotyles 24 parts, Serpentis SHECAO 22 parts, Fructus Mume 19 parts, white
17 parts of rattan of hair, Herba Portulacae 15 parts, Rhizoma Coptidis 20 parts, Radix Cynanchi Paniculati 9 parts and 11 parts of Radix Glycyrrhizae
Preparation method is with embodiment 1.
The animal toxicity experiment of test example 1 Chinese medicine composition of the present invention
1, Experimental agents
The made capsule of the embodiment of the present invention 3, abolishes capsule shells, adds purified water and is modulated into solution.
2, laboratory animal
Regular grade NIH mice, body weight 20 ± 3g, male and female half and half, female mice is all without pregnant；SD rat, just
Initial body weighs 200 ± 10g, male and female half and half, and female rats is all without pregnant.
3, acute toxicity testing
Take the drug solution that 10 mouse stomaches are prepared to the embodiment of the present invention 3 medicament capsule content,
Under 831.2g crude drug/kg dosage, after administration, mice occurs that light activity reduces, and within about 5 hours, recovers normal,
Continuous Observation 7 days after administration, none dead mouse, and overall health of patients, diet, take the photograph water, urine and body weight increase
Long the most normal.Test result indicate that: the maximum dosage-feeding of the pharmaceutical preparation oral liquid of the mouse stomach present invention is
831.2g crude drug/kg/d (LD50 ＞ 831.2g crude drug/kg).By weighing machine, mouse stomach medicine system of the present invention
The dosis tolerata of agent is 4178.9 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical drug safety.
4.1, long term toxicity test
Select 30 SD rats, give the embodiment of the present invention 3 medicament capsule content preparation drug solution:
High dose group is 33.6g crude drug/kg, middle dosage group is 16.8g crude drug/kg, low dose group is 8.4g crude drug
(, by 20 times of calculating of clinical application amount, clinical application amount is according to " the China people are altogether for per weight dosage for/kg
With state's pharmacopeia " 2010 years versions one).Every day gavage once, continuous 90 days, last be administered latter 24 hours each
Group is lived and is killed 1/2 animal (male and female half and half), and remaining 1/2 animal lives after continuing to observe 2 weeks and kills.See during test
Examine the outward appearance of animal, general behavior, food ration, body weight change；It is administered latter 90 days and drug withdrawal carries out blood in 2 weeks
Liquid (RBC, HB, reticulocyte, PLT, CT, WBC and classification) and blood biochemical (AST, ALT,
ALP, Glu, BUN, Crea, TP, T.BIL, ALB, CHOL), urine biochemistry, organ coefficient, pathologic group
Knit etc. index checking.
4.2, experimental result
Pharmaceutical preparation of the present invention is good at high, medium and low dosage treated animal general state, and outward appearance sign, behavior are lived
Dynamic, food-intake and body weight increase change the most without exception；Three dosage groups and matched group hematological examination, blood life
Chemistry, urine biochemical analysis all between normal range, group without significant difference；Each group main organs histopathology
Inspection shows no obvious abnormalities.These parameters drug withdrawal also had no change after 2 weeks.This test dosage respectively faces
Bed the 180 of dosage, 60,20 times, according to result of the test: pharmaceutical preparation of the present invention is high, medium and low three
Individual dosage (33.6g crude drug/kg, 16.8g crude drug/kg, 8.4g crude drug/kg) is administered rat for continuous 90 days
Having no significant effect, without clear and definite toxicity target organ and sensitive indicator, convalescent period observation also has no that retardance toxicity is anti-
Should, the dose safety of the Chinese medicine preparation clinical practice of the prompting present invention is the highest.
The test example 2 pharmaceutical preparation of the present invention therapeutic effect to Guinea-pig Gallbladder calculus animal model
1, test objective
According to the requirement of " new Chinese medicine pharmaceutical research guide ", lincomycin subcutaneous injection is utilized to induce Cavia porcellus gallbladder
The animal model of capsule calculus, evaluates the pharmaceutical preparation of the present invention curative effect to cholelithiasis.
2, experimental animal and packet
Selecting SPF level healthy guinea pig 60, male and female half and half, body weight 350～450g, by Guangdong Province's laboratory animal
Monitoring is provided.It is divided into 6 groups at random: blank group, calculus matched group, pharmaceutical preparation height agent of the present invention
Dosage group, pharmaceutical preparation low dose group of the present invention, positive drug control group in amount group, pharmaceutical preparation of the present invention.
3, trial drug
Pharmaceutical preparation experimental group of the present invention: the pharmaceutical preparation capsule of the present invention prepared according to embodiment 3, according to
High, medium and low dosage group is administered.
Positive drug control group: Ursodeoxycholic Acid Tablets (traditional Chinese medicines quasi-word H44022804；The easypro limited public affairs of pharmacy of Guangdong ease
Department).
Each group of dosage regimen tested by table 1
| Group | Quantity (only) | Lincomycin (mg/kg/d) | Dosage (g/kg/d) |
| Blank group | 10 | - | Isometric(al) normal saline |
| Calculus matched group | 10 | 60 | Isometric(al) normal saline |
| High doses group of the present invention | 10 | 60 | 2.0 |
| Dosage group in pharmaceutical preparation of the present invention | 10 | 60 | 1.0 |
| Pharmaceutical preparation low dose group of the present invention | 10 | 60 | 0.5 |
| Positive drug control group | 10 | 60 | 0.01 |
4, test modeling and administration
After Cavia porcellus normally feeds observation 1 week, start applying and process factor, use Scott method, except blank right
Outside according to group, remaining 5 groups respectively to Cavia porcellus subcutaneous injection lincomycin 60mg/kg/d, continuous 7d.After injection the 3rd
My god, Cavia porcellus starts loss of appetite occur, the loose tarnish of fur, becomes thin, but without death.6th week starts,
Take the embodiment of the present invention 3 capsule 's content and positive drug comparison medicine grind into powder, give to after molten water Cavia porcellus gavage
Medicine, once a day.The dosage of each group Cavia porcellus is shown in Table 1.
5, sample is drawn materials and analyzes
After 11st week, 6 groups of Cavia porcellus equal fasting 24h can't help water, and every Cavia porcellus first extracts 2mL cardiac blood, then hits
Lethal, cut rapidly chest and abdomen open, block cystic duct by vascular forceps, take off gallbladder, perusal gallbladder profile, Cheng Shi
Situation, and with the whole bile of syringe sucking-off, collect all animal cholelithiasiss, send respectively after drawing materials and test.Wherein, adopt
With pellet technique, make cholelithiasis analysis；Use CL-7200 automatic clinical chemistry analyzer, measure immediately in bile
Total bilirubin, calcium ion and Determination of Bile Acids, make bile studied and hepatic and renal function measures.
6, result of the test
6.1, ordinary circumstance
After testing 11 weeks, the body weight of each group Cavia porcellus has certain change, and it the results are shown in Table shown in 2:
The body weight change of each group of Cavia porcellus tested by table 2
Indicate :+show that body weight increases；-show to lose weight.
Compared with positive controls,*P ＜ 0.05
Calculus, causes Cavia porcellus to become thin, loses weight.Pharmaceutical preparation of the present invention and Ursodeoxycholic Acid Tablets all have
Certain therapeutical effect, it is possible to suppression Cavia porcellus weight loss.But, the dosage high, middle of pharmaceutical preparation of the present invention
Group is substantially better than positive drug control group to the improvement of Mouse Weight, has significant difference (P ＜ 0.05).
6.2, gallbladder wall situation
In addition to blank group, remaining each group all there is thickening of capsule wall of gallbladder in various degree, coarse, gallbladder deformation.
There is gallbladder wall pathological changes, pharmaceutical preparation of the present invention high, medium and low dosage treatment component in 9 Cavia porcelluss of calculus matched group
Not occurring 1,2 and 4, positive drug control group occurs 4.
6.3, stone situation is become in gallbladder
10 Cavia porcelluss of blank group, middle nothing 1 example Cheng Shi.Calculus matched group gallstone formation rate is 90%, the present invention
Pharmaceutical preparation high, medium and low dosage treatment group and positive drug control group calculus rate are respectively as follows: 10%, 20%, 40%
With 40%.According to perusal, gallbladder intracystic stones is single or multiple brown or black calculus, diameter 0.5～
3mm, in irregular shape, quality is soft frangible.Through significant difference analysis, pharmaceutical preparation of the present invention is high,
The therapeutic effect of middle dosage group is substantially better than positive drug, has significant difference (P ＜ 0.05).Low dose group and
The treatment therapeutic equivalence of positive drug.
6.4, bile situation and bile component analysis
The many muddinesses of intracapsular bile of gallbladder of calculus matched group Cavia porcellus, deep yellow, each treatment group and blank treated animal gallbladder
In capsule, bile is much more limpid transparent.Bile measurement result is shown in Table 3.Table 3 shows, after calculus, and Cavia porcellus gallbladder
Total bilirubin (TBIL) and Ca in capsule2+Content rises, and group bile acid (BA) content declines, with blank group phase
Ratio, has significant difference (P ＜ 0.05 or P ＜ 0.01).
Cavia porcellus is after pharmaceutical preparation of the present invention and positive drug are treated, and symptom all has certain alleviation.Medicine of the present invention
After thing preparation dosage group high, middle and positive drug treatment, CTBILAnd Ca2+Content is significantly lower than calculus matched group (P
＜ 0.05 or P ＜ 0.01), bile acid (BA) content is apparently higher than calculus matched group (P ＜ 0.05 or P ＜ 0.01).
C in the improvement gallbladder of high doses group of the present inventionTBILAspect is significantly better than positive controls (P ＜
0.05), Ca is being improved2+The curative effect of content and group bile acid (BA) aspect is suitable with positive drug control group effect.
The bile component analysis of each group of Cavia porcellus tested by table 3
| Group | CTBIL(umol/L) | CBA(umol/L) | Cca2+(mmol/L) |
| Blank group | 20.18±3.16 | 432.52±28.46 | 0.77±0.19 |
| Calculus matched group | 49.47±5.42** | 409.98±31.27* | 2.09±0.28** |
| High doses group of the present invention | 22.01±4.89△△▲ | 452.26±22.18△△ | 0.88±0.35△△ |
| Dosage group in pharmaceutical preparation of the present invention | 29.56±7.22△△ | 447.78±31.08△△ | 1.18±0.21△△ |
| Pharmaceutical preparation low dose group of the present invention | 35.89±6.53△ | 412.42±24.12 | 1.48±0.34△ |
| Positive drug control group | 31.87±5.32△△ | 445.23±30.75△△ | 0.99±0.18△△ |
Note: compared with blank group:*P ＜ 0.05,**P ＜ 0.01；
Compared with calculus matched group:△P ＜ 0.05,△△P ＜ 0.01；
Compared with positive drug control group:▲P ＜ 0.05,▲▲P ＜ 0.01
The test example 3 pharmaceutical preparation of the present invention clinical observation on the therapeutic effect to cholelithiasis clinical patients volunteer
1, basic document
Choose in the March ,-2015 in January, 2013 of the Patients with Cholelithiasis clinic will at Guangdong Province's overseas Chinese's hospital admission
Hope person 120 example, male 82 examples, female 38 example, between age 16-68 year, the mean age is 47 years old, at random
Be divided into treatment group and matched group, often organize each 60 people, two groups at age, sex, coincident with severity degree of condition without significantly
Difference (P ＞ 0.05), has comparability.
2, Therapeutic Method:
Treatment group: the capsule of the oral embodiment of the present invention 3 preparation, containing 1.02g crude drug/grain, 2 times on the 1st,
Each 2；
Matched group: give Ursodeoxycholic Acid Tablets (the quasi-word of traditional Chinese medicines: H44022804, producer: ease easypro pharmacy in Guangdong has
Limit company), each 10mg, every day 2 times, 1 month is 1 course for the treatment of, treats 3 courses for the treatment of the most continuously for 2 groups
Rear observation curative effect.
Points for attention: require that all patients nurse one's health diet 1 week before the treatment, with light food and vegetable protein
It is main, avoids seafood, tobacco and wine, delicious food savoury and pungent.
3, efficacy assessment standard:
Cure: clinical cardinal symptom and sign disappear, and imaging examination calculus disappears；
Effective: clinical cardinal symptom and sign disappearance ＞ 1/2, imaging examination calculus diminishes or reduces ＞ 1/2；
Effective: clinical cardinal symptom and sign alleviate, imaging examination calculus reduces before relatively treating or diminishes；
Invalid: clinical cardinal symptom and sign are improved inconspicuous or unchanged, imaging examination calculus is without changing.
4, therapeutic outcome
According to clinical diagnosis, two groups of patients are administered orally pharmaceutical preparation of the present invention and Ursodeoxycholic Acid Tablets respectively, and it is clinical
Curative effect is shown in Table 4:
4 liang of table group patient comparitive study after treatment in 1 month and 3 months respectively
As can be seen from Table 4,60 example hepatocarcinoma clinical patients of oral pharmaceutical preparation of the present invention, controlled through 1 month
After treatment, the patient of 26.7% reaches the effect cured, and total effective rate reaches 86.7%.Therapeutic effect is substantially better than sun
Property comparison medicine curative effect, illustrate pharmaceutical preparation of the present invention treat cholelithiasis rapid-action.After 3 course of therapy,
Pharmaceutical preparation of the present invention treatment cholelithiasis total effective rate reaches 90.0%, is better than positive controls, medicine system of the present invention
Agent good effect, instant effect, the effect for the treatment of, timely reduction of patient pain and reaching can be reached in the short period of time
Effect to treatment cholelithiasis.
Additionally, with in positive control drug therapeutic process, have 5 example clinical patients symptoms to be eased the most in time,
Aggravation.After using 3 courses for the treatment of of medicine composite for curing of the present invention, final total effective rate can reach 90.0%,
Curative effect of medication is definite, efficacy stability, have positive control drug do not caned and unique advantage.
7 untoward reaction
1) real-time tracing, observe and inquire 120 example volunteer's medications treatment during clinical response, find:
, during taking Ursodeoxycholic Acid Tablets, there is pharyngoxerosis in various degree and oral ulcer in 18 example patients；6
There is pharyngalgia in various degree, dizziness, tinnitus, nose bleeding, uncomfortable in chest and dreaminess in example patient, and this has all had influence on trouble
The orthobiosis of person has a rest and the mental status.Only 1 example patient is during taking pharmaceutical preparation of the present invention, reflection
There is the sense of discomfort of mild nausea and vomiting；
2) check mutually respectively doing a blood before and after 120 example volunteer's medications.Finding, 32 examples (53.3%) are suffered from
Person is after treating through Ursodeoxycholic Acid Tablets, and blood is affected mutually, slight decrease occurs.And take medicine of the present invention
Patient's blood of compositions the most all shows that normally patient's body and mind is joyful, the mental status good, illustrates that the present invention uses
Medicine safety, has good clinical generalization value.
Claims (6)
1. the pharmaceutical preparation of the treatment cholelithiasis containing Folium Artemisiae Argyi, it is characterised in that described pharmaceutical preparation includes
Following parts by weight prepare raw material:
Folium Artemisiae Argyi 25-35 part, Herba Silybi mariani 20-33 part, Herba Hydrocotyles 18-30 part, Serpentis SHECAO 19-25 part, crow
Prunus mume (sieb.) sieb.et zucc. 18-20 part, Herba Solani Lyrati 15-18 part, Herba Portulacae 12-18 part, Rhizoma Coptidis 9-15 part, Radix Cynanchi Paniculati 6-12
Part and Radix Glycyrrhizae 6-16 part.
The pharmaceutical preparation of the treatment cholelithiasis containing Folium Artemisiae Argyi the most according to claim 1, it is characterised in that
Described pharmaceutical preparation includes the raw material of preparing of following parts by weight:
Folium Artemisiae Argyi 25 parts, Herba Silybi mariani 20 parts, Herba Hydrocotyles 18 parts, Serpentis SHECAO 19 parts, Fructus Mume 18 parts, white
15 parts of rattan of hair, Herba Portulacae 12 parts, Rhizoma Coptidis 9 parts, Radix Cynanchi Paniculati 6 parts and 6 parts of Radix Glycyrrhizae.
The pharmaceutical preparation of the treatment cholelithiasis containing Folium Artemisiae Argyi the most according to claim 1, it is characterised in that
Described pharmaceutical preparation includes the raw material of preparing of following parts by weight:
Folium Artemisiae Argyi 35 parts, Herba Silybi mariani 33 parts, Herba Hydrocotyles 30 parts, Serpentis SHECAO 25 parts, Fructus Mume 20 parts, white
18 parts of rattan of hair, Herba Portulacae 18 parts, Rhizoma Coptidis 15 parts, Radix Cynanchi Paniculati 12 parts and 16 parts of Radix Glycyrrhizae.
The pharmaceutical preparation of the treatment cholelithiasis containing Folium Artemisiae Argyi the most according to claim 1, it is characterised in that
Described pharmaceutical preparation includes the raw material of preparing of following parts by weight:
Folium Artemisiae Argyi 30 parts, Herba Silybi mariani 27 parts, Herba Hydrocotyles 24 parts, Serpentis SHECAO 22 parts, Fructus Mume 19 parts, white
17 parts of rattan of hair, Herba Portulacae 15 parts, Rhizoma Coptidis 20 parts, Radix Cynanchi Paniculati 9 parts and 11 parts of Radix Glycyrrhizae.
5., according to the pharmaceutical preparation of the arbitrary described treatment cholelithiasis containing Folium Artemisiae Argyi of claim 1-4, it is special
Levying and be, described pharmaceutical preparation is tablet, capsule, pill, granule or powder.
6. according to the preparation of the arbitrary described pharmaceutical preparation treating cholelithiasis containing Folium Artemisiae Argyi of claim 1-4
Method, it is characterised in that the preparation method of described pharmaceutical preparation comprises the following steps:
S1, weigh each taste raw medicinal material, respectively decontamination, clean, dry, after section, be ground into coarse powder；
S2, take Folium Artemisiae Argyi coarse powder, add, according to the 10-15 times amount of coarse powder weight, the ethanol that concentration is 60-75% molten
Liquid, soaks 6-12 hour, and supersound extraction 3 times at a temperature of 40-60 DEG C are each 30-50 minute, ultrasonic
Frequency is 20-30kHz, filters, merging filtrate, retains Folium Artemisiae Argyi medicinal residues, filtrate reduced in volume to 60 DEG C phase
It is the clear paste of 1.10-1.20 to density, prepares Folium Artemisiae Argyi extract；
S3, by Herba Silybi mariani, Herba Hydrocotyles, Herba Solani Lyrati, Herba Portulacae and Radix Glycyrrhizae coarse powder mix, according to coarse powder gross weight
5-10 times amount add volumetric concentration be the ethanol solution of 75-95%, soak 4-8h, reflux, extract, 2-6 time,
2-4h every time, filters and retains filtering residue, merging filtrate, and filtrate cold preservation after alkalization stands 12-24h, filters,
Gained filtrate obtains extractum thing I through concentrating under reduced pressure and microwave drying；
S4, by Folium Artemisiae Argyi filtering residue described in Serpentis SHECAO, Fructus Mume, Rhizoma Coptidis, Radix Cynanchi Paniculati and S2 and the filter described in S3
Slag mixes, and adds purified water according to the 7-9 times amount of coarse powder gross weight, decocts 2-3 time, each 2-4 hour,
Filter, merging filtrate, and be concentrated into the extractum thing II that 55-60 DEG C of relative density is 1.20-1.25；
S5, Folium Artemisiae Argyi extract, extractum thing I and II being sufficiently mixed, centrifugal spray drying prepares medicine of the present invention
Preparation raw material medicine fine powder, wherein, inlet temperature is 120-130 DEG C, and leaving air temp is 65-75 DEG C.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN117100774A (en) * | 2023-10-25 | 2023-11-24 | 山东中科嘉亿生物工程有限公司 | Application of lactobacillus acidophilus JYLA-16 in preparation of products for treating gall-stone |
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| CN105233181A (en) * | 2015-11-17 | 2016-01-13 | 包莉丽 | Medicine for treating gallstone |
| CN105288344A (en) * | 2015-11-24 | 2016-02-03 | 江崇礼 | Traditional Chinese medicinal composition for treating liver and gall calculi, and application thereof |
| CN105412280A (en) * | 2015-12-31 | 2016-03-23 | 青岛昌安达药业有限公司 | Traditional Chinese medicine preparation for treating hepatic stones and gall-stones |
| CN105456897A (en) * | 2015-12-30 | 2016-04-06 | 暨南大学 | Traditional Chinese medicine composition containing argy wormwood leaf for treating spleen deficiency gasterasthenia type chronic gastritis |
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2016
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105233181A (en) * | 2015-11-17 | 2016-01-13 | 包莉丽 | Medicine for treating gallstone |
| CN105288344A (en) * | 2015-11-24 | 2016-02-03 | 江崇礼 | Traditional Chinese medicinal composition for treating liver and gall calculi, and application thereof |
| CN105456897A (en) * | 2015-12-30 | 2016-04-06 | 暨南大学 | Traditional Chinese medicine composition containing argy wormwood leaf for treating spleen deficiency gasterasthenia type chronic gastritis |
| CN105412280A (en) * | 2015-12-31 | 2016-03-23 | 青岛昌安达药业有限公司 | Traditional Chinese medicine preparation for treating hepatic stones and gall-stones |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN117100774A (en) * | 2023-10-25 | 2023-11-24 | 山东中科嘉亿生物工程有限公司 | Application of lactobacillus acidophilus JYLA-16 in preparation of products for treating gall-stone |
| CN117100774B (en) * | 2023-10-25 | 2024-02-13 | 山东中科嘉亿生物工程有限公司 | Application of lactobacillus acidophilus JYLA-16 in preparation of products for treating gall-stone |
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