CN100581561C - Asiatic moonseed extract, preparations, preparing method and use thereof - Google Patents
Asiatic moonseed extract, preparations, preparing method and use thereof Download PDFInfo
- Publication number
- CN100581561C CN100581561C CN200810088936A CN200810088936A CN100581561C CN 100581561 C CN100581561 C CN 100581561C CN 200810088936 A CN200810088936 A CN 200810088936A CN 200810088936 A CN200810088936 A CN 200810088936A CN 100581561 C CN100581561 C CN 100581561C
- Authority
- CN
- China
- Prior art keywords
- rhizoma menispermi
- preparation
- extract
- treatment
- medicine
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
The invention relates to an Asiatic Moonseed Rhizome extract, a preparation, a preparation method, and the application, in particular to a medicine which is made of raw ingredients extracted using the method. The invention comprises the following steps: the Asiatic Moonseed Rhizome is chopped into sections, to which water is added, the pH value is adjusted to 1 to 3 by using sulphuric acid adjusting immersion fluid, and the temperature is kept from 50 to 60 DEG C; the Asiatic Moonseed Rhizome is steeped for 2 to 12 hours, and the immersion fluid is filtered; then water is added to the herb residue, the pH value is adjusted to 1 to 3 by using the sulphuric acid, and the herb residue is steeped for 2 to 12 hours according to the method; the immersion fluid is filtered; the immersion fluid obtained in the two times is merged, the supernatant fluid is absorbed after stillness, and precipitate is removed; the supernatant fluid is basified by adding with lye until the pH value is 7 to 10, then let stand and filtered; the precipitate is collected, dried, and reserved. The Asiatic method overcomes the disadvantages with the prior art, and provides a stable and efficient total alkali preparation method of the Asiatic Moonseed Rhizome and the preparation method. The Asiatic Moonseed Rhizome extract prepared by adopting the method has the application effect far better than the application effect of the original technologic preparation technology, and new pharmacological functions and purposes are generated as a result.
Description
Technical field
The present invention relates to a kind of Rhizoma Menispermi extract, especially extract the pharmaceutical preparation that raw material is made, the invention still further relates to the preparation method and the purposes of medicine with the method.
Background technology
Rhizoma Menispermi is the dry rhizome of menispermaceous plants Caulis menispermi Menispermum dauricum DC., main product in Hebei, Shandong, Liaoning, Jilin, Heilungkiang, the Inner Mongol etc.Pharmacopeia record Rhizoma Menispermi has heat-clearing and toxic substances removing, and the wind-expelling pain-stopping function is used for laryngopharynx swelling and pain, enteritis and dysentery, rheumatic arthralgia.Main component is that alkaloid comprises Dauricine, phenolic alkaloids of menispermum dauricum, Su Lin alkali etc. in the Rhizoma Menispermi, the modern study Rhizoma Menispermi has effects such as treatment laryngopharynx swelling and pain, tonsillitis, acute pharyngitis, the preparation of making has the Rhizoma Menispermi sheet, Rhizoma Menispermi capsule etc., but traditional Rhizoma Menispermi preparation extraction and preparation technique falls behind, not enough science, the effective ingredient yield is low; Bioavailability is low, absorbs slowly, also is unfavorable for the drug effect performance.Therefore, improving the traditional preparation process technology of Rhizoma Menispermi preparation, further determine to improve its active constituent content by effective ingredient in the medicine, is the necessary process that improves the Rhizoma Menispermi clinical effectiveness, also is the general trend of Chinese medicine development.
Summary of the invention
The objective of the invention is to overcome the deficiency of above-mentioned prior art, the Rhizoma Menispermi total bases extracting method and the resulting Rhizoma Menispermi extract of stability and high efficiency is provided.
Another object of the present invention provides Rhizoma Menispermi preparation and preparation method
A further object of the present invention provides the new pharmacological action and the purposes that are far superior to former prepared The Application of Technology effect and produce therefrom that produces under new technology implementation.
According to the prepared Rhizoma Menispermi preparation of the present invention, extract by Rhizoma Menispermi total bases and to make, by improvement, further clearly go out the effective ingredient in the preparation simultaneously for preparation technology, than the medicine of identical or similar therapeutical effect, its therapeutic effect has had and has significantly improved.Modern pharmacology experiment showed, that said preparation has pharmacological action: 1. heat-clearing and toxic substances removing, 3. eliminating phlegm and stopping cough, relieving sore throat and diminishing swelling 2. arrhythmia resist myocardial ischemia.Rhizoma Menispermi extract is made by following preparation method:
With the Rhizoma Menispermi Hou Jiashui that cuts into chunks, transferring the immersion adjust pH with sulphuric acid is 1～3, and temperature keeps 50～60 ℃, flooded 2-12 hour, and leached immersion, medicinal residues add entry again, with the sulphuric acid adjust pH is 1～3, floods 2-12 hour by last method, leaches immersion, merge twice immersion, supernatant is drawn in static back, discards precipitate, immersion adds alkali liquor alkalizes to pH value and is 7-10, static, filters, the collecting precipitation thing, drying, standby.
Further optimized technical scheme is for getting Rhizoma Menispermi section 600kg, drop in the acidleach jar, add and be preheated to 60 ℃ water, after the medical material submergence, the sulphuric acid 6-7Kg of adding 90%, transferring to pH value is the 2.5-3.5 mixing, keeps 60 ℃ of temperature leachings 3 hours, leaches altogether three times, add for the second time sulphuric acid 4-5Kg, add sulphuric acid 2-3Kg for the third time, pH value, temperature, time all with for the first time, merge immersion, hydro-oxidation sodium or sodium bicarbonate solution, when being neutralized to pH value and being 8.5-9.5, heat leave standstill 3 hours to 70 ℃ after, sucking filtration; Be drying to obtain below 60 ℃.
Extract with above-mentioned gained is that raw material can prepare tablet, capsule, granule, drop pill, soft capsule, dispersible tablet, slow-release tablet, injection, injectable powder.Said preparation also is Film coated tablets or coated tablet.
The preparation of preparation:
A gets the Rhizoma Menispermi total bases extract, adds supplementary product starch, pulverizes or micronizing, makes sticking and preparation granules with ethanol or water, and compress tablet coating is made the Rhizoma Menispermi sheet;
B gets the Rhizoma Menispermi total bases extract, adds supplementary product starch, pulverizes or micronizing, makes bonding agent system granule with ethanol or water, incapsulates and makes the Rhizoma Menispermi capsule;
C gets the Rhizoma Menispermi total bases extract, adds supplementary product starch, pulverizes or micronizing, uses Polyethylene Glycol, and heating and melting splashes into and makes Douricine drop pills in the liquid paraffin;
D gets the Rhizoma Menispermi total bases extract, pulverizes or micronizing, uses Polyethylene Glycol, and heating and melting is made northern bean root soft capsule;
E gets the Rhizoma Menispermi total bases extract, adds the gelatin of 3-5%, at 50-55 ℃, adds the 5-10% acetum and transfers PH 3.5-4.5 to add 30-40 ℃ of water 1-3 doubly, stir evenly, cooling is adding 20%NaOH accent PH8-9 below 10 ℃, add formalin, be washed to formaldehydelessly, promptly get the Rhizoma Menispermi microcapsule;
F gets the Rhizoma Menispermi total bases extract, adds pregelatinized Starch, PVPP pulverizing or micronizing and makes the Rhizoma Menispermi dispersible tablet;
G gets the Rhizoma Menispermi total bases extract, adds in fused waxiness or the materials such as fused fatty acid and esters thereof, makes granule and then tabletting after treatment, promptly gets slow-release tablet;
H gets the Rhizoma Menispermi total bases extract, uses injection NaOH water and additives dosing, filtration, makes injection through embedding, sealing by fusing, sterilization again;
I gets the Rhizoma Menispermi total bases extract, uses the water for injection heating for dissolving, and solution filters, and it is 1～1.2 (heat is surveyed) that filtrate is concentrated into density, degerming, reduces phlegm and internal heat formerly, is divided into some bottles, and lyophilization, gland, sealing promptly get injectable powder.
Wherein said extract can also be made the Film coated tablets coated tablet, gets Rhizoma Menispermi extract and right amount of auxiliary materials mixing, granulates, and drying is pressed into 1000, coating, promptly.Adjuvant in film-making also has starch and/or microcrystalline Cellulose/carboxymethyl starch element to receive/hang down to replace hydroxy methocel/sodium carboxymethyl cellulose.
Prepared Rhizoma Menispermi preparation, be to make, by improvement, further clearly go out the effective ingredient in the preparation simultaneously for preparation technology by the best effective dose of choosing effective ingredient, than the medicine of identical or similar therapeutical effect, its therapeutic effect has had and has significantly improved.Modern pharmacology experiment showed, that said preparation has following pharmacological action: 1. heat-clearing and toxic substances removing, 3. eliminating phlegm and stopping cough, relieving sore throat and diminishing swelling 2. arrhythmia resist myocardial ischemia.
The Rhizoma Menispermi sheet of the present invention's preparation compares with old Rhizoma Menispermi sheet clinical efficacy
Principal indication curative effect statistical table
The Rhizoma Menispermi preparation clinical efficacy that the present invention's preparation is described obviously is better than old Rhizoma Menispermi sheet.
[test example 1] Rhizoma Menispermi preparation for treating acute/chronic pharyngitis clinical observation
The Rhizoma Menispermi preparation is the pharmaceutical preparation of being made by Rhizoma Menispermi extract, has heat-clearing and toxic substances removing, cough-relieving, and the function of eliminating the phlegm is mainly used in the diseases such as pharyngitis for the treatment of laryngopharynx swelling and pain.For carrying out the comparison of new technology and old technology curative effect, we have carried out clinical verification to this medicine, mainly investigate its health giving quality and untoward reaction.Non-at random blind method is adopted in clinical trial, observes 140 examples altogether, and wherein 110 examples are organized in treatment, and matched group 30 examples have obtained satisfied clinical efficacy, and is existing that the clinical test results final report is as follows:
Physical data
This institute has case all to derive from the disease that the meets diagnostic criteria example of diagnosing a disease.
Age: the harmony of two groups of preceding age distribution of treatment relatively
Table 1: age distribution comparison before two groups of treatments (year)
In the treatment group the oldest 65 years old, at minimum 18 years old of age, in the matched group the oldest 65 years old, at minimum 18 years old of age, carry out statistical procedures treatment group and matched group patient there was no significant difference p＞0.05 in age distribution.Illustrate that two groups have comparability in years, see table 1 for details.
The course of disease: the distributing equilibrium of two groups of patient's courses of disease relatively
Table 2: the course of disease distributes relatively (year) before two groups of treatments
As shown in Table 2, the course of disease is the shortest 2 months, the longest 4 years in 110 routine treatment groups, the course of disease is the shortest 2 months in 30 routine matched groups, the longest 4 years, learn processing by statistics and show two groups of there was no significant difference p＞0.05 on the course of disease distributes, illustrate that two groups have comparability on the course of disease.
The state of an illness: the harmony of two groups of state of an illness compares:
Table 3: the state of an illness relatively before two groups of treatments
By table 3 as seen, treatment group and matched group conditions of patients compare on distributing, and the analysis showed that two groups of there was no significant difference p＞0.05 by statistics, have comparability.
The harmony of sex compares:
Table 4: the harmony of two groups of sex distributions relatively
As shown in Table 4, two groups of no significant difference p＞0.05 on sex distributes.
Research method
One, case is selected:
(1) diagnostic criteria: formulate with reference to " the clinical research guideline of new Chinese medicine treatment chronic pharyngitis ".
1. Western medicine diagnose standard
(1) medical history: the acute pharyngitis history of repeated attack is often arranged, or because of the long-term mouth breathing of cacorhinia and tobacco and wine excessive, surrounding air drying, dust and irritant gas pollution etc.
(2) symptom: pharyngeal discomfort, painful or itch, or dry, burning sensation, foreign body sensation etc.; Irritable cough plays firmly expectoration secretions morning, even feel sick; The course of disease is more than 2 months, and reason such as Chang Yin suffers from cold, catches a cold, fatigue, polylogia causes sx.
(3) check: pharyngeal mucosa hyperemia, be kermesinus, or dendroid hyperemia; Retropharyneal folliculosis, or lateral pharyngeal band enlargement; Pharyngeal mucous membrane hypertrophy plumpness, or drying, atrophy, attenuation have secretions to adhere to.
Possess above-mentioned symptom and check finding more than 1 or 1, promptly diagnosable.
2. differential diagnosis in tcm
The expectorant heat syndrome: have sore throat, symptom such as scorching hot, dry, foreign body sensation because of suffer from cold, fatigue, increase the weight of cough, thick sputum, thirst and liking drink after the polylogia.Inspection sees that pharyngeal mucous membrane hyperemia is peony, plumpness, and rear wall lymph follicle and funiculus lateralis enlargement have yellow-white secretions to adhere to, red tongue, greasy fur, rolling pulse.
(2) keep the score standard and state of an illness grade scale of symptom, sign
The standard of keeping the score of Rhizoma Menispermi Film coated tablets treatment chronic pharyngitis
State of an illness classification: slight :-15 moderates :-25 severes :-35
(3) test case standard
1. include the case standard in
Severally be diagnosed as chronic pharyngitis and meet the differential diagnosis in tcm person, can include the test case in.
2. get rid of case standard (comprising inadaptation or rejecting standard)
(1) confirms by oropharynx, nasopharynx, throat, nose, larynx person due to some invisible pathological changes of esophagus, cervical region and whole body on inspection.
(2) gestation or women breast-feeding their children are to this medicine allergy sufferers at under-18s or over-65s the age.
(3) be associated with the serious primary disease of cardiovascular, liver, kidney and hemopoietic system, psychotic.
(4) do not meet the standard of including in, the end is medication in accordance with regulations, can't judge that curative effect or data are not congruent to affect the treatment or safety judgement person.
Two, test method
(1) group technology: be divided into treatment group and matched group according to the random table method.Treatment i10 example and matched group＜30 examples.
(2) Therapeutic Method: adopt non-at random blind method.
(1). treatment group medicine: Rhizoma Menispermi Film coated tablets A sheet, each 2, every day 3 times, oral.Provide by Anshan Pharmaceutical Co., Ltd..
(2). the matched group medicine: Rhizoma Menispermi Film coated tablets B sheet, each 2, every day 3 times, oral.Provide by Anshan Pharmaceutical Co., Ltd.
(3) course of treatment: 15 days is a course of treatment, treats two courses of treatment.
(4) test routine number: 110 examples are organized in treatment, matched group 30 examples.
(5) observation index
1, safety detects:
1. general health check-up project.
2. blood, urine, just routine test,
3. the heart, liver, renal function chemical examination,
2, health giving quality observation
1. symptom: pharyngeal sense of discomfort growth and decline situation of change.
2. pharyngeal sign: apparent variations such as the hyperemia of pharyngeal mucosa, edema, plumpness, drying, atrophy; The enlargement situation of pharyngeal lymphoid tissue (comprising palatine tonsil, retropharyngeal lymph nodes, lateral pharyngeal band etc.) and cervical lymph node.
Three, result of the test
(1), curative effect determinate standard: in " new Chinese medicine clinical guidance principle ", the sick efficacy assessment standard of treatment is formulated this standard, clinical recovery: all symptoms of treatment back, sign all disappear, and integration is 0 minute.
Produce effects: all symptoms of treatment back, the most of disappearance of sign, integration descend 〉=2/2.
Effectively: all symptoms of treatment back, sign partly disappear, and integration descends＞1/2.
Invalid: all symptoms of treatment back, sign do not have obvious improvement or increase the weight of, and integration descends＜1/2.
(2), therapeutic outcome
1, two groups of total effectses relatively
Table 5 liang group total effects relatively
Ridit analyzes: compare between group: u=1.49 p＞0.05
By table 5 as seen, the treatment group obvious effective rate of healing is 61.8%, and total effective rate is 90.9%; The obvious effective rate 46.7% of matched group, total effective rate are 86.7%, the analysis showed that two groups of there was no significant difference p＞0.05 through Ridit.
2, two groups of every tcm symptoms, sign curative effects compare
The table 6 liang every tcm symptom of group, sign curative effect are relatively
Ridit analyzes: between group:
Have sore throat: u=1.13 p＞0.05
Throat is scorching hot: u=0.69 p＞0.05
Dry laryngopharynx: u=1.03 p＞0.05
Foreign body sensation: u=0.55 p＞0.05
Swallow red red: u=0.91 p＞0.05
Pharyngeal mucous membrane plumpness: u=0.66 p＞0.05
Lymph follicle: u=0.80 p＞0.05
Pharyngeal secretion thing: u=0.03 p＞0.05
Cough: u=0.99 p＞0.05
Thick sputum: u=0.25 p＞0.05
Thirsty: u=0.82 p＞0.05
As shown in Table 6.Each symptom, sign all have obviously and alleviate behind two groups of patient treatments, more all there are difference P＜0.01 of highly significant and p＜0.05. to carry out again between two groups relatively before and after the treatment in the group, two groups of there was no significant difference P＞0.05 on to the improvement of all symptoms, sign.
3, two groups of treatment front and back picture of the tongues, pulse conditions change relatively
Picture of the tongue, pulse condition change relatively (N) before and after the table 7 liang group treatment
X 2 analysis: between group:
Picture of the tongue: X2=2.227 p＞0.05
Pulse condition: X2=0.118 p＞0.05
As shown in Table 7, treatment group picture of the tongue has significant difference p＜0.01 in the group before and after treatment, in the group significant difference p＜0.01 is arranged before and after the pulse condition treatment; The matched group picture of the tongue has significant difference p＜0.01 in the group before and after treatment, in the group significant difference p＜0.01 is arranged before and after the pulse condition treatment.Compare there was no significant difference p＞0.05 between the picture of the tongue group; Compare there was no significant difference p＞0.05 between the pulse condition group.
The relation of 4, the treatment group state of an illness and total effects
The relation of the table 8 treatment group state of an illness and total effects
Ridit analyzes: light/middle u=3.05 p＜0.01
In/heavy u=0.04 p＞0.05
Gently/heavy u=1.97 p＜0.05
As shown in Table 8,26 examples that the state of an illness is slight, total effective rate 100%; State of an illness moderate 76 examples, total effective rate are 87.87%; , severe 10 examples, total effective rate is 90.0%.Organize the different state of an illness through Ridit analysis treatment significant difference p＜0.05 is arranged on curative effect.
The relation of 5, the treatment group course of disease and curative effect
The relation of the table 9 treatment group course of disease and curative effect
Ridit analyzes :-0.5 year/-1 year: u=1.71 p＞0.05
-0.5 year/＞1 year: u=0.81 p＜0.05
-1 year/＞1 year: u=0.44 p＞0.05
Know the course of disease-0.5 year 66 examples, total effective rate 100% by table 9; The course of disease-1 year 12 examples, total effective rate is 91.67%; The course of disease＞-1 year 32 examples, total effective rate is 71.88%.Organize the different courses of disease through Ridit analysis treatment significant difference P＜0.05 is arranged on curative effect.
The relation of 6, treatment group age and curative effect
The relation of table 10 treatment group age and curative effect
Ridit analyzes :-30 years old/-45 years old: u=1.06 p＞0.05
-30 years old/-65 years old: u=0.78 p＞0.05
-45 years old/-65 years old: u=0.41 p＞0.05
As shown in Table 10, age-30 year old 16 examples, total effective rate 100%; Age-45 year old 56 examples, total effective rate is 83.92%; Age-65 year old 38 examples, total effective rate is 97.37%.Analyze treatment group all ages and classes there was no significant difference P＞0.05 on curative effect through Ridit.
7, conclusion:
By above-mentioned clinical observation, the Rhizoma Menispermi Film coated tablets is 61.8% to the more obvious effective rate of chronic pharyngitis, and total effective rate is 90.9%; The matched group obvious effective rate of healing is 46.7%, and total effective rate is 86.7%; Between two groups on total effects difference do not have significantly.In a word, the Rhizoma Menispermi sheet all improves significantly before and after treatment to various tcm symptoms that the chronic pharyngitis disease occurred, sign etc., and compare difference with matched group not remarkable.
[test example 2] acute tonsillitis clinical observation of Rhizoma Menispermi preparation for treating
The Rhizoma Menispermi preparation is the pharmaceutical preparation of being made by Rhizoma Menispermi extract, has heat-clearing and toxic substances removing, cough-relieving, and the function of eliminating the phlegm is mainly used in diseases such as treatment laryngopharynx swelling and pain, tonsillitis.Clinical its health giving quality of main investigation and untoward reaction.The randomized, double-blind method is adopted in clinical trial, and my institute observes 60 examples altogether, and wherein 30 examples are organized in treatment, and matched group 30 examples have obtained satisfied clinical efficacy, and is existing that the clinical test results final report is as follows:
Physical data: this institute has case all to derive from the disease that the meets diagnostic criteria example of diagnosing a disease.
Age: the harmony of two groups of preceding age distribution of treatment relatively
Table 11: age distribution comparison before two groups of treatments (year)
In the treatment group the oldest 60 years old, at minimum 18 years old of age, in the matched group the oldest 57 years old, at minimum 18 years old of age, carry out statistical procedures treatment group and matched group patient there was no significant difference p＞0.05 in age distribution.Illustrate that two groups have comparability in years, see table 1 for details.
The course of disease: the distributing equilibrium of two groups of patient's courses of disease relatively
Table 12: course of disease distribution comparison before two groups of treatments (my god)
As shown in Table 12, the course of disease is the shortest 1 day, the longest 3 days in 30 routine treatment groups, and the course of disease is the shortest 1 day in 30 routine matched groups, and is the longest 3 days, learns by statistics to handle to show two groups of there was no significant difference p＞0.05 on the course of disease distributes, and illustrates that two groups have comparability on the course of disease.
The state of an illness: the harmony of two groups of state of an illness relatively
Table 13: the state of an illness relatively before two groups of treatments
By table 13 as seen, treatment group and matched group conditions of patients compare on distributing, and the analysis showed that two groups of there was no significant difference p＞0.05 by statistics, have comparability.
Sex: the harmony of two groups of sex distributions relatively
Table 14: the harmony of two groups of sex distributions relatively
As shown in Table 14, two groups of no significant difference p＞0.05 on sex distributes.
Medicining condition: two groups of antibiotic applicable cases are relatively harmonious
The antibiotic applicable cases is relatively harmonious before the table 15 liang group diagnosis and treatment
As shown in Table 15, two groups of situations for the treatment of preceding antibiotic application do not have significant difference p＞0.05.
Research method
One, case is selected:
(1), diagnostic criteria: formulate with reference to " the clinical research guideline of new Chinese medicine treatment tonsillitis ".
Main clinical manifestation: pharyngeal pain, increase the weight of companion's fever with aversion to cold or hyperpyrexia when swallowing.The pharyngeal tonsils redness.There is yellow pus point on the surface, does not exceed the pharyngeal tonsils scope, easily wipes.
Characteristics of incidence: how relevant with climate change, good sending out in child and table teenager.
Physico-chemical examination: blood leukocytes counting and neutrophilic granulocyte number can increase.
1, Western medicine diagnose standard
(1) medical history: often suffer from cold, tired, tobacco and wine excessively, malnutrition, the low inferior inducement of passive protective physical fitness.
(2) symptom: morbidity is rapid anxious, general malaise, and the shiver with cold heating, fervescence, headache, nape and extremities aching pain, inappetence often has constipation. pharyngeal pain, increase the weight of when swallowing, often accompany in ear pain.
(3) check: patient's face of acute ill, the buccal flushing, halitosis, thick fur is white, the tonsil redness, the crypts mouth has yellow-white pus point, can merge in flakes, and shape such as pseudomembrane are easily wiped, mandibular lymph node enlargement and tenderness. and lab testing blood leukocytes sum can increase.
2, Chinese medical discrimination
The exuberant lung-stomach heat card
Hyperpyrexia, pharyngeal sharp ache is under company and the basal part of the ear and the jaw, dysphagia, halitosis, pharyngeal tonsils redness, surface yellow-white pus point is linked to be pseudomembrane gradually, and very person's isthmus faucium redness has enlargement of lymph nodes under the volume, tenderness is obvious, thirsty polydipsia, and thick Huang brings up phlegm when one coughs, constipation, yellow urine, red tongue, thick, yellow and greasy fur, full and large pulse and counting.
(2) classification of state of an illness weight and symptom, sign scoring system
Hyperpyrexia: 6 minutes: body temperature＞39 ℃, aversion to cold need add clothing;
4 minutes: body temperature＞38 ℃, aversion to cold need not add clothing;
2 minutes: body temperature＞37 ℃, slight chill;
0 minute: body temperature＜37 ℃, not aversion to cold;
Have sore throat: 6 minutes: pain was hard to bear:
4 minutes: constant pain but still can restrain oneself:
2 minutes: the time pain, rise morning obviously;
0 minute: no pain;
Dysphagia: 6 minutes: do not gulp down soup both the pain, gulp down more so; .
4 minutes: gulp down soup still can, in hard food difficulty;
2 minutes: absent deglutition food still can, gulp down then pain;
0 minute: the absent deglutition difficulty:
Pharyngeal tonsils redness: 6 minutes: pharyngeal tonsils is obviously red and swollen:
4 minutes: pharyngeal tonsils was slightly red and swollen;
2 minutes: pharyngeal tonsils hyperemia;
The o branch: pharyngeal tonsils does not have redness;
The red point of pharyngeal tonsils: 6 minutes: the pus point is linked to be lamellar or pus is counted＞and 6;
4 minutes: the pus point was dispersed in several:
2 minutes: pus counts＜and 2;
0 minute; The no pus point;
Yellow urine: 3 minutes: urine is like dark brown;
2 minutes: yellow urine;
1 minute: little Huang of urinating;
0 minute: urine was clear;
Constipation: 3 minutes: it is hard to defecate, the difficult discharge:
2 minutes: big dry stool, discharge effort;
1 minute: dry stool, do not have obviously effort sense but discharge;
0 minute: stool was normal;
Cough: 3 minutes: continue uninterrupted;
2 minutes: cough constantly:
1 minute: idol was coughed;
0 minute: do not have cough;
Expectoration: 3 minutes: abundant expectoration and little Huang;
2 minutes: abundant expectoration was not yellow;
1 minute: white amount of expectoration was few;
0 minute: no expectorant;
Thirsty: 3 minutes: thirsty polydipsia;
2 minutes: time sense was thirsty;
1 minute: idol had thirsty;
0 minute: no thirsty;
Halitosis: 3 minutes: halitosis was difficult to the person of modern times;
1 minute: halitosis was obvious;
1 minute: idol had halitosis;
0 minute: no halitosis:
Red tongue with yellow fur: 3 minutes: red tongue, yellow and greasy fur;
2 minutes: red tongue, yellow and thin fur;
1 minute: red tip of the tongue, white and thin fur:
0 minute: light red tongue, white and thin fur;
Floating and rapid pulse: 3 minutes: floating and rapid pulse;
2 minutes: but number is not floating;
1 minute: but floating several;
Severity extent is divided: slight: integration≤20 minute;
Moderate: integration≤25 minute;
Severe: integration＞25 minute;
(3) test case standard
1, includes the routine standard of sound in;
Meet primary disease diagnostic criteria and differential diagnosis in tcm, the course of disease 3 days with interior person, can receive.Go into case.
2, get rid of case standard (comprising inadaptation or rejecting standard)
(1) age is at under-18s or over-65s, gestation or women breast-feeding their children, allergic constitution or to this medicine allergy sufferers.
(2) adopted the other medicines therapist.
(3) pharyngeal diphtheria, scarlet fever pharyngitis, vincent angina, tuberculosis pharyngeal ulcer, tonsil tumor, infectious monocytosis, granulocyte shortage property angina patient.
(4) be associated with the serious primary disease of cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, psychotic.
(5) do not meet the standard of including in, the end is medication in accordance with regulations, can't judge curative effect, or data is not congruent affects the treatment or safety judgement person.
Two, test method
(1), group technology: this test is divided into treatment group and matched group according to the random table method. treatment group 30 examples and matched group 30 examples.
(2), Therapeutic Method: adopt the randomized, double-blind method, it is similar to northern bean newspaper sheet to develop dosage form, color and taste earlier, but does not have the Rhizoma Menispermi B sheet of pharmacology.
1. treatment group medicine: Rhizoma Menispermi A sheet+antibiotic, each 2, every day 3 times, oral.Anshan Pharmaceutical Co., Ltd. provides.
2. matched group medicine: Rhizoma Menispermi B sheet+antibiotic, each 2, every day 3 times, oral.Anshan Pharmaceutical Co., Ltd. provides.
3. course of treatment: 7 days is a course of treatment, all observes a course of treatment.All cases all select to use penicillin and erythromycin during the treatment, and guarantee kind and dosage zero difference between two groups that antibiotic is used.
(3), observation index
1. safety observation
(1) general health check-up project.
(2) hematuria routine test.
2. health giving quality observation
(1) related symptoms and toposcopy.
(2) numeration of leukocyte and classification.
(3) body temperature.
(4) picture of the tongue, pulse condition.
Three, experimental result
(1) curative effect determinate standard
1, recovery from illness: treat 7 days with interior clinical symptoms and sign disappearance, body temperature, numeration of leukocyte recover normal.Integration was reduced to 0 fen.
2, produce effects: treat 7 days with interior cardinal symptom, the symptom and sign integration descends 〉=2/3.
3, effective: treat 7 days with interior cardinal symptom, the symptom and sign integration descends＞1/3.
4, invalid: as not reach effective standard or deterioration person on the contrary.
(2), therapeutic outcome
1, two groups of total effectses relatively
Table 16 liang group total effects relatively
Ridit analyzes: compare between group: u=2.41 p＜0.05
By table 16 as seen, the treatment group obvious effective rate of healing is 73.33%, and total effective rate is 90.00%; The obvious effective rate 30.00% of matched group, total effective rate are 93.33%, the analysis showed that through Ridit two groups have significant difference p＜0.05.
2, two groups of every tcm symptoms, sign curative effects compare
7 liang of every tcm symptoms of group of table 1, sign curative effect are relatively
Ridit analyzes: between group:
Fever with aversion to cold: u=0.45 p＞0.05
Laryngopharynx swelling and pain: u=1.51 p＞0.05
Dysphagia: u=1.95 p＞0.05
Pharyngeal tonsils redness: u=2.95 p＜0.05
Pharyngeal tonsils pus point: u=0.45 p＞0.05
Halitosis: u=1.45 p＞0.05
Thirsty: u=0.56 p＞0.05
Cough: u=0.14 p＞0.05
Expectoration: u=1.37 p＞0.05
Constipation: u=1.52 p＞0.05
Yellow urine: u=0.80 p＞0.05
Red tongue with yellow fur: u=2.06 p＜0.05
Floating and rapid pulse: u=0.67 p＞0.05
As shown in Table 17, behind two groups of patient treatments, fever with aversion to cold, laryngopharynx swelling and pain, dysphagia, symptom, signs such as pharyngeal tonsils pus point have and obviously alleviate, compare in the group before and after the treatment, significant difference is all arranged, but to improving before and after tongue, arteries and veins, cough, expectoration, the headache treating significantly, matched group improves not remarkable, and difference p＜0.01 and p＜0.05 of highly significant is all arranged before and after other symptom treatment.Carry out between two groups the treatment back more relatively, to pharyngeal tonsils redness and picture of the tongue, two groups have significant difference p＜0.05, to two groups of there was no significant difference P＞0.05 in the improvement of other symptoms, sign.3, two groups of comparisons that body temperature changes
The comparison that body temperature changes before and after the table 18 liang group treatment (X ± S)
Between group: t=0.209 p＞0.05
As shown in Table 18, in the body temperature group significant differences P＜0.01 is arranged relatively before and after two groups of treatments, carry out the not remarkable P of comparing difference＞0.05 between two groups.
4, the comparison of two groups of treatment front and back WBC change detected
The comparison of WBC change detected before and after the table 19 liang group treatment (X ± S)
T check: between group: t=0.457 p＞0.05
As shown in Table 19, the not remarkable P of comparing difference＞0.05 between two groups is carried out in comparing difference highly significant P＜0.01 in the WBC group before and after two groups of treatments.
5, the comparison of two groups of treatment times and curative effect
The comparison of table 20 liang group treatment time and curative effect
Compare between group: 3 days u=2.24 p＜0.05
7 days u=2.41 p＜0.05
As shown in Table 20, effective percentage is apparently higher than matched group after 3 days for treatment group treatment, and treating after 7 days two groups also has significant difference on cure-remarkable-effectiveness rate.
The relation of 6, the treatment group course of disease and total effects
The relation of the table 21 treatment group course of disease and total effects
Ridit analyzes: light/middle u=1.91 p＞0.05
Gently/heavy u=1.51 p＞0.05
In/heavy u=0.17 p＞0.05
As shown in Table 21,10 examples that the state of an illness is slight, total effective rate 90.00%: state of an illness moderate 14 examples, total effective rate are 92.8%; , severe 6 examples, total effective rate is 83.33%.Analyze treatment through Ridit and organize different state of an illness there was no significant difference P＞0.05 on curative effect.
The relation of 7, treatment group sex and curative effect
The relation of table 22 treatment group sex and curative effect
Ridit analyzes: u=0.26 P＞0.05
As shown in Table 22, male's 18 examples, total effective rate 88.89%; Women's 12 examples, total effective rate are 91.67%; Analyze treatment group different sexes there was no significant difference P＞0.05 on curative effect through Ridit.
The relation of 8, treatment group age and curative effect
The relation of table 23 treatment group age and curative effect
Ridit analyzes :-30 years old/-45 years old: u=0.30 p＞0.05
-30 years old/-65 years old: u=1.46 p＞0.05
-45 years old/-65 years old: u=0.95 p＞0.05
As shown in Table 23, age-30 year old 22 examples, total effective rate 95.45%; Age-45 year old 3 examples, total effective rate is 66.67%; Age-65 year old 5 examples, total effective rate is 80.00%.Analyze treatment group all ages and classes there was no significant difference P＞0.05 on curative effect through Ridit.
9, conclusion:
By above-mentioned clinical observation, the Rhizoma Menispermi Film coated tablets is 73.33% to the more obvious effective rate of acute tonsillitis, and total effective rate is 90.00%; The matched group obvious effective rate of healing is 30.00%, and total effective rate is 93.33%.In a word, the Rhizoma Menispermi preparation is being treated on the acute tonsillitis improving laryngopharynx swelling and pain, on symptom, the signs such as cough tangible effect is arranged, compare apparently higher than matched group with matched group (placebo added with antibiotic group), evident difference is especially arranged on cure-remarkable-effectiveness rate, and can alleviate all symptoms, sign of tonsillitis as early as possible and be better than matched group.
Rhizoma Menispermi extract of the present invention is except the application aspect the medicine of preparation treatment acute/chronic pharyngitis, application aspect preparation treatment acute and chronic tonsillitis's medicine, all has significant effect in the application aspect application aspect preparation treatment cough, the bronchitic medicine and the medicine that resists myocardial ischemia in the application aspect the ARR medicine of preparation treatment, in preparation.
The specific embodiment:
Embodiment 1:
Get Rhizoma Menispermi section 600kg, drop in the acidleach jar, adding is preheated to 60 ℃ water, after the medical material submergence, add 90% sulphuric acid 6-7Kg, transferring to pH value is 3 mixings, keep 60 ℃ of temperature leachings 2.5-3.5 hour, leach altogether three times, add sulphuric acid 4-5Kg for the second time, add sulphuric acid 2-3Kg for the third time, pH value, temperature, time all with for the first time, merge immersion, hydro-oxidation sodium or sodium bicarbonate solution solution, when being neutralized to pH value and being 8.5-9.5, heat leave standstill 3 hours to 70 ℃ after, sucking filtration; Be drying to obtain extract below 60 ℃.Get the Rhizoma Menispermi extract that makes, add supplementary product starch, pulverize or micronizing, make sticking and preparation granules with ethanol or water, compress tablet coating is made the Rhizoma Menispermi sheet.
Embodiment 2:
The extracting method of Rhizoma Menispermi is with embodiment 1;
Get Rhizoma Menispermi extract and starch, microcrystalline Cellulose.An amount of mixing is granulated, and drying is pressed into 1000, and coating promptly gets Film coated tablets.
Embodiment 3:
The extracting method of Rhizoma Menispermi is with embodiment 1;
Get the Rhizoma Menispermi total bases extract, add supplementary product starch, pulverize or micronizing, use Polyethylene Glycol, heating and melting splashes into and makes Douricine drop pills in the liquid paraffin
Embodiment 4:
The extracting method of Rhizoma Menispermi is with embodiment 1;
Get the Rhizoma Menispermi total bases extract, pulverize or micronizing, use Polyethylene Glycol, heating and melting is made northern bean root soft capsule;
Embodiment 5:
The extracting method of Rhizoma Menispermi is with embodiment 1;
Get the Rhizoma Menispermi total bases extract, add the gelatin of 3-5%,, add the 5-10% acetum and transfer PH3.5-4.5 to add 30-40 ℃ of water 1-3 doubly at 50-55 ℃, stir evenly, cooling is adding 20%NaOH accent PH8-9 below 10 ℃, add formalin, be washed to formaldehydelessly, promptly get the Rhizoma Menispermi microcapsule.
Embodiment 6:
The extracting method of Rhizoma Menispermi is with embodiment 1;
Get the Rhizoma Menispermi total bases extract, add pregelatinized Starch, PVPP pulverizing or micronizing and make the Rhizoma Menispermi dispersible tablet
Embodiment 7:
The extracting method of Rhizoma Menispermi is with embodiment 1;
Get the Rhizoma Menispermi total bases extract, add in fused waxiness or the materials such as fused fatty acid and esters thereof, make granule and then tabletting after treatment, promptly get slow-release tablet;
Embodiment 8:
The extracting method of Rhizoma Menispermi is with embodiment 1;
Get the Rhizoma Menispermi total bases extract,, make injection through embedding, sealing by fusing, sterilization again with water for injection and additives dosing, filtration.
Embodiment 9:
The extracting method of Rhizoma Menispermi is with embodiment 1;
Get the Rhizoma Menispermi total bases extract, use the water for injection heating for dissolving, solution filters, ultrafiltration, and it is 1.35 (heat is surveyed) that filtrate is concentrated into density, is divided into some bottles, and freezing, dry, gland, sealing promptly get injectable powder.
Claims (11)
1, the extract of a kind of Rhizoma Menispermi, it is characterized in that making: Rhizoma Menispermi is cut into chunks; get Rhizoma Menispermi section 600kg; drop in the acidleach jar, add and be preheated to 50-60 ℃ water, after the medical material submergence; add 90% sulphuric acid 6-7Kg; transferring to pH value is the 1-3 mixing, keeps 50-60 ℃ of temperature leaching 3 hours, leaches altogether three times; add sulphuric acid 4-5Kg for the second time; add sulphuric acid 2-3Kg for the third time, pH value; temperature; the time is all with the first time, merging immersion; hydro-oxidation sodium or sodium bicarbonate solution; when being neutralized to pH value and being 7.5-10 by following method, heat leave standstill 3 hours to 70 ℃ after, sucking filtration; Be drying to obtain below 60 ℃.
2, a kind of pharmaceutical preparation that contains right requirement 1 or 2 described Rhizoma Menispermi extracts is characterized in that said preparation is tablet, capsule, granule, drop pill, soft capsule, dispersible tablet, slow-release tablet, injection or injectable powder.
3, pharmaceutical preparation according to claim 3 is characterized in that said preparation is Film coated tablets or coated tablet.
4, pharmaceutical preparation according to claim 4 is characterized in that described Film coated tablets or coated tablet are made by following method: get Rhizoma Menispermi extract and right amount of auxiliary materials mixing, granulate, drying is pressed into 1000, coating, promptly.
5, pharmaceutical preparation according to claim 5, wherein the adjuvant in film-making also has starch and/or microcrystalline Cellulose/carboxymethyl starch element to receive/hang down to replace hydroxy methocel/sodium carboxymethyl cellulose.
6, Rhizoma Menispermi extract as claimed in claim 1 or 2 is in preparation heat-clearing and toxic substances removing, eliminating phlegm and stopping cough, the application in the relieving sore throat and diminishing swelling medicine.
7, the application of Rhizoma Menispermi extract as claimed in claim 1 or 2 aspect the medicine of preparation treatment acute/chronic pharyngitis.
8, the application of Rhizoma Menispermi extract as claimed in claim 1 or 2 aspect preparation treatment acute and chronic tonsillitis's medicine
9, the application of Rhizoma Menispermi extract as claimed in claim 1 or 2 aspect preparation treatment cough, bronchitic medicine.
10, the application of Rhizoma Menispermi extract as claimed in claim 1 or 2 aspect the ARR medicine of preparation treatment.
11, the application aspect the medicine that resists myocardial ischemia in preparation of Rhizoma Menispermi extract as claimed in claim 1 or 2.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810088936A CN100581561C (en) | 2008-04-08 | 2008-04-08 | Asiatic moonseed extract, preparations, preparing method and use thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810088936A CN100581561C (en) | 2008-04-08 | 2008-04-08 | Asiatic moonseed extract, preparations, preparing method and use thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101249141A CN101249141A (en) | 2008-08-27 |
| CN100581561C true CN100581561C (en) | 2010-01-20 |
Family
ID=39952852
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200810088936A Active CN100581561C (en) | 2008-04-08 | 2008-04-08 | Asiatic moonseed extract, preparations, preparing method and use thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100581561C (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107569450A (en) * | 2017-08-31 | 2018-01-12 | 温美群 | A kind of parenteral solution for treating chill heating and preparation method thereof |
| CN111317754B (en) * | 2018-12-13 | 2022-02-18 | 泰州医药城国科化物生物医药科技有限公司 | Preparation method and application of asiatic moonseed total alkali |
| CN111467390A (en) * | 2020-04-15 | 2020-07-31 | 伊春药业有限公司 | Asiatic moonseed rhizome capsule and preparation method thereof |
-
2008
- 2008-04-08 CN CN200810088936A patent/CN100581561C/en active Active
Non-Patent Citations (1)
| Title |
|---|
| 正交试验法优选北豆根总生物碱的提取工艺. 王栋，刘岩，李红波.哈尔滨商业大学学报(自然科学版)，第21卷第1期. 2005 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101249141A (en) | 2008-08-27 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102670763A (en) | Composition with auxiliary protection effect on chemical liver injury and preparation method of composition | |
| CN105616590A (en) | Composition capable of clearing heat from throat, and preparation method thereof | |
| CN102552769B (en) | Medicine for treating vaginitis and preparation method thereof | |
| CN100382815C (en) | Compound composition for treating arthralgia caused by wind-dampness and preparation thereof | |
| CN101564459A (en) | Application of Chinese medicinal composition in preparing medicament for treating upper respiratory tract infection | |
| CN104189588A (en) | Vitamin C Yinqiao tablets and preparation method thereof | |
| CN100581561C (en) | Asiatic moonseed extract, preparations, preparing method and use thereof | |
| CN101564458B (en) | Application of Chinese medicinal composition in preparing medicament for treating bronchitis | |
| CN101618146A (en) | Complex traditional Chinese medicine preparation for treating upper respiratory tract infection and preparation method thereof | |
| CN102302672B (en) | Honeysuckle flower buccal tablets and preparation method thereof | |
| CN1327875C (en) | Chinese medicine formulation for treating chronic pelvic inflammation and its preparing method | |
| CN1985923B (en) | Medicine composition for preventing and treating throat diseases and its preparing method | |
| CN101850091B (en) | Chinese medicament for treating colorectal polypus and preparation method thereof | |
| CN109820947B (en) | Application of traditional Chinese medicine composition in preparation of medicine for treating upper airway cough syndrome | |
| CN101850084A (en) | Chinese medicinal composition for treating tuberculosis and method for preparing same | |
| CN104524247B (en) | One treats migrainous medical composition and its use | |
| CN105770679A (en) | Chinese herbal mouthwash for treating fungal infection of oral cavity | |
| CN103479978B (en) | A kind of Chinese medicine composition driving ascarid and preparation method thereof | |
| CN104225196A (en) | Traditional Chinese medicine effervescent tablet for treating respiratory diseases and preparation method of traditional Chinese medicine effervescent tablet | |
| CN101695512A (en) | Banlangen buccal tablet and preparation method thereof | |
| CN101485730A (en) | Medicament composition for treating children's exogenous fever and preparation method thereof | |
| CN104436150A (en) | Traditional Chinese medicine composition used for treating rhinitis | |
| CN105169153B (en) | A kind of Chinese medicine composition of removing dampness and destroying parasites and preparation method thereof | |
| JP2020528927A (en) | Chinese herbal medicine composition for treating diseases caused by human papillomavirus, its preparation method and use | |
| CN102335276B (en) | Preparation method and application of tree peony extract and composition of tree peony extract |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |