CN1602941A - Chinese medicinal formulation for treating pelvic inflammation with improved bioavailability and drug effect and preparation process thereof - Google Patents
Chinese medicinal formulation for treating pelvic inflammation with improved bioavailability and drug effect and preparation process thereof Download PDFInfo
- Publication number
- CN1602941A CN1602941A CN 200410058353 CN200410058353A CN1602941A CN 1602941 A CN1602941 A CN 1602941A CN 200410058353 CN200410058353 CN 200410058353 CN 200410058353 A CN200410058353 A CN 200410058353A CN 1602941 A CN1602941 A CN 1602941A
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- gongyanping
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Abstract
A kind of Chinese native medicine palace inflammation even preparation which can enhance the biology exploitability and the drug efficacy and the preparation method.component proportion by weight : 350-550, both sides needle 100-240, the Chinese angelica 100-280, the five fingers peach persimmon 80-140,the wear out stone 100-180, the above component coordinates with the drop pill matrix 80-360to make the drop pill; Or mixs with the dispersion medium 180-220,the helps to hang medicinal preparation 8-16to make the soft capsule; Or mix with the auxiliaries 60-220, breaks up the medicinal preparation 5-40, the lubricant 0.5-5to make the dispersible piece.After the observation, after the patient takes medicine there is no obviously not good respondes; The observation indicated; The palace inflammation even soft capsule, the palace inflammation even disperser piece, the palace inflammation even drop pill (stagnation of flow of vital energy blood stasis sickness) has a better clinical curative effect and with the medicine security to treat the chronic pelvic cavity inflammation, has a remarkable difference treatment effect when compared with the palace inflammation even piece group treatment (the P light rain 0.05), obviously surpass the comparison group in the medicine treatment course, reduces the medicine time.
Description
Technical field
The present invention relates to a kind of Chinese medicine Gongyanping preparation and preparation method that improves bioavailability and drug effect.
Technical background
GONGYANPING forms, treats the Chinese medicine compound of pelvic inflammatory disease with China's Guangdong local speciality medical material prescription.GONGYANPING PIAN has been listed in the 17 of the Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation ".Former dosage form technical characterstic is that five tastes medicinal substances extract adds appropriate amount of auxiliary materials and makes tablet.China Patent No. 03118640.8 has been announced a kind of " the capsular preparation method of GONGYANPING ", and it is that the GONGYANPING extract adds adjuvant and makes hard capsule.Along with the continuous variation and the human adaptive variation for medicine of environment, people have had higher requirement for the bioavailability and the drug effect of Chinese medicine.
Summary of the invention
The object of the invention is to add appropriate amount of auxiliary materials in the prescription medicinal substances extract based on Chinese medicine, and provide a kind of Chinese medicine Gongyanping preparation and preparation method that improves bioavailability and drug effect, the present invention to take following design: the used medical material of Gongyanping preparation of the present invention the component weight proportion:
350～550 parts of Herba Melastomatis dodecandri, 100～240 parts of Radix Zanthoxylis, 100～280 parts of Radix Angelicae Sinensis,
80～140 parts of Herba Fici Simplicissimae, 100～180 parts of Radix Cudraniaes.
Above-mentioned component cooperates the pharmaceutically alleged adjuvant or the substrate of the suitable kind of employing to make drop pill, soft capsule, dispersible tablet respectively.
The extract of said ratio medical material is made drop pill with basic adjuvant drop pill substrate 80～360 at least; Or make soft capsule with basic adjuvant disperse medium 60～300, suspending agent 4～35 at least; Or make dispersible tablet with basic adjuvant filler 120～220, disintegrating agent 5～40, lubricant 0.5～5 at least.
The inventive method contains following steps: at first being extraction process, next is the moulding process of various dosage forms.
Extraction process is:
Get Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Herba Fici Simplicissimae, the common Chinese medicine of the five flavours of Radix Cudraniae in extraction pot by the component weight proportion of above-mentioned used medical material, add 9～11 times of amounts of water, decoct each 1.5～2.5 hours 2～3 times, filter, merging filtrate, being concentrated into relative density is the clear paste of 1.15～1.35 (55 ~ 60 ℃), adds ethanol and reaches 30%～85% to containing the alcohol amount, left standstill 12～36 hours, filter, filtrate recycling ethanol, being concentrated into relative density is the clear paste of 1.10～1.15 (55～60 ℃); Next:
The moulding process of each dosage form:
Make the GONGYANPING drop pill: get above-mentioned clear paste and be concentrated into the thick paste that relative density is 1.35～1.40 (60 ℃), with the drop pill substrate of 45 ℃～65 ℃ of following thermosols, the consumption of substrate is 80～360, mix homogeneously, splash into molding in the coolant, remove coolant, promptly get the GONGYANPING drop pill; Or
Make the GONGYANPING drop pill: above-mentioned clear paste drying, be ground into 80 orders～120 order fine powders, or above-mentioned clear paste spray drying obtains fine powder, with fine powder and 45 ℃～65 ℃ hot melt and dissolved down drop pill substrate, the consumption of substrate is 80～360, and mix homogeneously splashes into molding in the coolant, remove coolant, promptly get the GONGYANPING drop pill; Or
Make the GONGYANPING dispersible tablet: above-mentioned clear paste drying, powder gets dry extract, add recipe quantity filler (120～220) and in 10～65% disintegrating agent (0.5～26 part) mix homogeneously that adds, granulate with the binding agent moistening, dry, granulate adds remaining 90～35% disintegrating agents that add (4.5～14 parts) and lubricant mix homogeneously tablettings such as (0.5～5), promptly gets the GONGYANPING dispersible tablet; Or
Make capsules of Gongyanping for cervicitis: above-mentioned clear paste drying, the powder that gets dry extract is standby.The suspending agent (4～35) of getting above-mentioned share be dissolved in 1/5～4/5 disperse medium (total amount is: 60～300), be preheated to 40～75 ℃ standby; Get in 4/5～1/5 the disperse medium that other adjuvants add above-mentioned share remainder, stir, and be mixed to 37 ℃, add above-mentioned dried cream powder or thick paste, stir, grind homogenizing, make soft capsule with above-mentioned disperse medium.
Herba Melastomatis dodecandri: be the dry herb of Melastomataceae plant Herba Melastomatis dodecandri Melastoma dodecandrum Lour..All can gather the whole year, cleans, and dries.
Radix Zanthoxyli: be the dry root of rutaceae Radix Zanthoxyli Zanthoxylum nitidum (Roxb.) DC..All can excavate the whole year, cleans, and section or section are dried.
Radix Angelicae Sinensis: be the dry root of umbelliferae angelica Angelica sinensis (Oliv.) Diels.
Herba Fici Simplicissimae: be the dry root of moraceae plants Herba Fici Simplicissimae Ficus simplicissima Lour..
Radix Cudraniae: be the dry root of moraceae plants cudrania cochinchinensis Cudrania cochinchinensis (Lour.) Kudo er Masam..
The inventive method contains following steps:
Effect of the present invention: Guangdong LuoFoshan Medicine Co., Ltd treats chronic pelvic inflammatory disease (syndrome of qi stagnation and blood stasis) clinical trial to GONGYANPING and sums up, for objective evaluation GONGYANPING novel form treatment chronic pelvic inflammatory disease clinical efficacy and safety, carried out clinical observation on the therapeutic effect research.Capsules of Gongyanping for cervicitis group 62 examples (women) wherein, 17 examples of fully recovering (27.4%), produce effects 20 examples (32.3%), effective 32 examples (35.5%), invalid 3 examples (4.8%), total effective rate is 95.2%; GONGYANPING dispersible tablet group 63 examples (women), 16 examples of fully recovering (25.4%), produce effects 15 examples (38.1%), effective 21 examples (33.3%), invalid example (3.2%), total effective rate is 96.8%; , GONGYANPING drop pill group 62 examples (women), 16 examples of fully recovering (25.8%), produce effects 22 examples (35.5%), effective 22 examples (35.5%), invalid 2 examples (3.2%), total effective rate is 96.8%; Matched group GONGYANPING PIAN 64 examples (women), 11 examples of fully recovering (17.19%), produce effects 16 examples (25%), effective 32 examples (50.00%), invalid 5 examples (7.81%), total effective rate is 90.62%.Curative effect is checked through Ridit, and there is significant difference P＜0.05, and soft capsule group, dispersible tablet group, drop pill group all are better than matched group.
The tcm syndrome therapeutic evaluation, (call in the following text: the treatment group) (call in the following text: matched group) traditional Chinese medical science curative effect relatively has significant difference, P＜0.05 for the course of treatment and GONGYANPING PIAN for capsules of Gongyanping for cervicitis group, dispersible tablet group, drop pill group etc.The treatment group obviously is better than matched group.Through observing, after taking medicine, treatment group patient do not see obvious adverse reaction; Chronic pelvic inflammatory disease (syndrome of qi stagnation and blood stasis) is had better clinical efficacy and drug safety, on drug treatment, curative effect, obviously be better than matched group, shortened administration time.
1. case is selected
1.1 Western medicine diagnose standard
Related content formulation with reference to " new Chinese medicine clinical research guideline " (try), " obstetrics and gynecology " (national high medical college teaching material the 5th edition), " Chinese obstetrics and gynecology " (People's Health Publisher, 1999 June the 1st edition).
1.1.1 medical history: the acute pelvic inflammatory disease medical history is arranged more.
1.1.2 symptom: low grade fever, tired, lower abdomen weigh down expand pain or lumbosacral region distending pain, leucorrhoea grow in quantity, menoxenia, infertile.
1.1.3 sign: uterine activity is limited or adhesion is fixing with tenderness, attachment area (strand increases thick or lamellar thickens or enclosed mass) tenderness.
1.1.4 lab testing: A, routine blood test: can have total white blood cells or neutrophilic granulocyte slightly to increase;
B, cervical canal secretions plate coating checking: can have unusual or detect pathogen.
1.1.5 ultrasound diagnosis: can visit and fallopian tube increases slightly, hydrops, or the pelvic inflammatory bag is fast.
1.2 tcm syndrome diagnostic criteria
Formulate with reference to " new Chinese medicine clinical research guideline " (trying), " Gynecology of Chinese Medicine " (high medical college teaching material the 4th, 5 editions) related content.
1.2.1 syndrome of qi stagnation and blood stasis
A, primary symptom: inferior belly gas pain or twinge, sore spot is fixed; Waist sacrum distending pain, abdominal pain during menstruation increases the weight of; Leucorrhea amount polychrome is white or yellow.
B, inferior disease: menorrhagia or menostaxis, dark red through color, folder clot, the breast side of body or distending pain of the breast.
C, tongue arteries and veins: dimly red tongue, or see petechia or ecchymosis, stringy pulse or puckery.
1.2.2 symptom scalar quantization standard:
A, primary symptom
A.1 hypogastralgia
There is not no pain.0 minute
End when doing during light pain.2 minutes
Middle pain is frequently shown effect.4 minutes
Heavy pain continues to exist.6 minutes
A.2 waist sacrum distending pain
No waist sacrum anacidity expands uncomfortable.0 minute
Light waist sacrum acid is expanded uncomfortable.2 minutes
Middle part of the side sacrum swelling and pain.4 minutes
Heavy waist sacrum distending pain is subjected to more unbearably.6 minutes
A.3 profuse leukorrhea
Not having does not have showed increased more at ordinary times.0 minute
Gently increase in 1/2 more at ordinary times.2 minutes
In increase 1/2 ~ 1 times more at ordinary times.4 minutes
Heavy increasing more at ordinary times more than 1 times.6 minutes
A.4 leucorrhea with yellow discharge
No leukorrhagia is normal.0 minute
Light leucorrhea with yellow discharge is held concurrently in vain mutually.2 minutes
Middle leucorrhea with yellow discharge.4 minutes
Yellow skin is green under the heave hand.6 minutes
B, inferior disease
B.1 abdominal pain during menstruation increases the weight of
Nothing stomachache nothing when row increases the weight of.0 minute
Have when gently when row, suffering from abdominal pain and increase the weight of.1 minute
In often have through when row stomachache and to increase the weight of.2 minutes
Heavy stomachache when row all increased the weight of at every turn.3 minutes
B.2 breast is coerced distending pain of the breast
Do not have normal.0 minute
Gently through the slight distending pain of preceding appearance.1 minute
In the distending pain discomfort appearred through preceding, menstrual period.2 minutes
Heavily continue to occur, distending pain is obvious.3 minutes
C, tongue arteries and veins
Describe and do not keep the score.
1.3 case is included standard in
1.3.1 meet chronic pelvic inflammatory disease Western medicine diagnose standard.
1.3.2 meet the tcm syndrome diagnostic criteria.
1.3.3 the age was at 18 ~ 50 years old.
1.4 case exclusion standard
1.4.1 do not meet chronic pelvic inflammatory disease Western medicine diagnose standard and tcm syndrome diagnostic criteria.
1.4.2 trimester of pregnancy or prepare gravid woman, women breast-feeding their children in the recent period.
1.4.3 merge to have the inclination, serious disease patients such as liver, kidney and hemopoietic system.
1.4.4 can't the partner, as be associated with nerve, mental disease, or be reluctant the partner.
1.4.5 allergic constitution or to multiple drug allergy person.
1.4.6 once adopted similar Drug therapy in the recent period, as took the medicine of relevant or phase antagonism, and caused curative effect of medication and be difficult to judgement person.
1.5 reject the case standard
1.5.1 after including in, find not meet to include standard person in.
1.5.2 do not use the medicine person after including in.
The case standard 1.6 come off
1.6.1 can't judge curative effect person's (, merge and use the other treatment medicine) not by the scheme medication.
1.6.2 untoward reaction occurs, should count the untoward reaction statistics.
2. physical data
2.1 age distribution: see Table 1.
The age distribution of table 1 case
18 ~ 30 years old 31 ~ 40 years old 41 ~ 50 years old
The total routine number of group
Example number % example number % example number %
Soft capsule group 62 15 24.19 38 61.29 9 14.52
Dispersible tablet group 63 16 25.40 37 58.73 10 15.87
Drop pill group 62 16 25.81 36 58.06 10 16.13
Matched group 64 17 26.56 36 56.25 11 17.19
Treatment group minimal ages 18 years old, maximum 48 years old age, average 33.66 ± 7.52 years old.Matched group minimal ages 21 years old, maximum 49 years old, average 35.29 ± 6.81 years old.Check through t: P＞0.05, relatively there was no significant difference has comparability.
2.2 the course of disease distributes: see Table 2
The table 2 case course of disease (year) distributes
≤ 1 year＞1 year ~≤5 years＞5 years
The total routine number of group
Example number % example number % example number %
Soft capsule group 62 34 54.84 21 33.87 7 11.29
Dispersible tablet group 63 35 55.56 20 31.75 8 12.70
Drop pill group 62 34 54.84 22 35.48 6 9.38
Matched group 64 35 54.69 22 34.38 7 10.94
The treatment group course of disease is the shortest 3 months, and is the longest 9 years, average 2.00 ± 1.23 years.The matched group course of disease is the shortest 4 months, and is the longest 10.5, average 1.89 ± 1.25 years.Check through t: P＞0.05, there was no significant difference.Has comparability.
3. observation index
3.1 general physical examination: body temperature, heart rate, blood pressure, pulse etc.
3.2 safety detects
3.2.1 blood, urine, just routine examination.(treatment before and after look)
3.2.2 the heart, hepatic and renal function inspection.(treatment before and after look)
3.2.3 untoward reaction that may occur and coherent detection index.The time of origin of itemized record untoward reaction, clinical symptoms, persistent period, treatment measures and extinction time.
3.3 health giving quality detects
3.3.1 related symptoms primary symptom, hold concurrently disease and the variation of tongue arteries and veins
Following abdominal distention pain; Waist sacrum distending pain, abdominal pain during menstruation increases the weight of; Leucorrhea amount polychrome is white or yellow; Menorrhagia or menostaxis, dark red through color, folder clot, the breast side of body or distending pain of the breast; Dimly red tongue, or see petechia or ecchymosis, stringy pulse or puckery.
3.3.2 relevant sign
3.3.2.1 ordinary circumstance body temperature, breathing, pulse, and blood pressure.
3.3.2.2 abdominal part sign tenderness, rebound tenderness, muscle tonus and abdominal distention, borborygmus change.
3.3.2.3 the variation of gynecologial examination uterus, fallopian tube ovary, the other connective tissue in palace and pelvic peritoneum inflammatory disease kitchen range.
3.3.3 relevant physico-chemical examination
A. peripheral blood leucocyte sum and neutrophilic granulocyte are counted; B. erythrocyte sedimentation rate; C.B is super to be checked; D cervical canal secretions plate coating checking.
4. observational technique
4.1 the employing random packet, contrast method, capsules of Gongyanping for cervicitis group 62 examples, GONGYANPING is disperseed chip level 63 examples, GONGYANPING drop pill group 62 examples, matched group 64 examples.
4.2 dosage, number of times and the course of treatment
4.2.1 dosage, number of times
The treatment group:
A. capsules of Gongyanping for cervicitis is each 2, every day 3 times, oral.
B. the GONGYANPING dispersible tablet is each 3, every day 3 times, oral.
C. the GONGYANPING drop pill is each 40, every day 3 times, oral.
D. matched group: GONGYANPING PIAN, each 4, every day 3 times, oral.
4.2.2 the course of treatment: 30 days is a course of treatment, judges curative effect after all treating a course of treatment.
4.3 drug combination situation: except that the medicine that scheme is determined, other associated treatment medicine of stopping using.
4.4 the compliance measure of clinical trial: provide the information material of this test to experimenter or family members, the details of relevant clinical trial is described; With and right and possible being benefited.Clinical research person answers the patient and painstaking patient that treats, to obtain patient's trust.
4.5 untoward reaction is observed
4.5.1 main observe the malaise symptoms that occurs together with medication and allergy etc., and blood, urine, just conventional, cardiorenal function check unusual.Untoward reaction to duration of test occurs should be recorded in its kind, degree, time of occurrence, persistent period, treatment measures, pass through etc. on the observation table.
4.5.2 when untoward reaction occurring, observe the doctor and can whether stop clinical trial, the case because of the untoward reaction drug withdrawal is carried out tracing observation, its result of itemized record according to state of an illness decision.
4.5.3 in test as severely adverse event occurs, researcher should adopt suitable protective measure to the experimenter immediately, and report test director immediately, and the latter should report local medicine management department in 24 hours.
4.6 clinical trial record
4.6.1 all case should be observed in strict accordance with clinical protocol, conscientiously fills in the medical history record form.Record faithfully experimenter's medicining condition.
4.6.2 case history and medical history record form must not be changed as protocol, must not change protocol when doing any corrigendum, can only take additional description to give reasons, by the physician's signature who participates in clinical trial and date.
4.6.3 answer the various lab testing data of itemized record in the clinical trial, clinic case should stick on the initial report list on the medical history record.
4.6.4 the experimental data in normal range also should record, must be examined data significantly higher or beyond clinical tolerance interval, does necessary explanation by the doctor who participates in clinical trial.
5. observation of curative effect
5.1 efficacy determination
5.1.1 disease comprehensive therapeutic effect criterion
A. diseases such as recovery from illness treatment back hypogastralgia and waist sacrum distending pain disappear, and gynecologial examination and physico-chemical examination are normal.Syndrome sign integration and minimizing 〉=95%.Drug withdrawal is not recurred in January.
B. diseases such as produce effects treatment back hypogastralgia and waist sacrum distending pain disappear or obviously alleviate, and gynecologial examination and physico-chemical examination obviously improve.Syndrome sign integration and minimizing 〉=70%,＜95%.
C. effectively diseases such as treatment back hypogastralgia and waist sacrum distending pain alleviate, and gynecologial examination and physico-chemical examination make moderate progress.Syndrome sign integration and minimizing 〉=30%,＜70%.
D. disease nothing such as hypogastralgia and waist sacrum distending pain alleviates or has and increases the weight of after the futile treatment, and gynecologial examination and physico-chemical examination do not have before the treatment and improve or increase the weight of.Syndrome sign integration and minimizing＜30%.
5.1.2 therapeutic effect of syndrome criterion
A. the various transference cures in back are treated in recovery from illness, and the syndrome integrated value reduces 〉=95%.
B. each symptom of produce effects treatment back obviously alleviates, and the syndrome integrated value reduces 〉=70%,＜95%.
C. effectively each symptom of treatment back alleviates to some extent, and the syndrome integrated value reduces 〉=30%,＜70%.
D. each symptom does not have to alleviate or have and increases the weight of after the futile treatment, and the syndrome integrated value subtracts＜and 30%.
5.2 safety classification
There is not any untoward reaction, I. safely; Safety indexes is no abnormal.
II. compare safety, mild adverse effects is arranged, do not need to do any processing and can continue medication; Safety indexes is checked no abnormal.
III., safety issue is arranged, moderate untoward reaction is arranged, or the safety indexes inspection there is mile abnormality, can continue medication after dealing with.
IV. end to observe because of serious adverse reaction, or the safety indexes inspection is obviously unusual.
5.3 curative effect of disease is relatively:
Table 3 case curative effect of disease relatively
Recovery from illness produce effects enabledisable
The total routine number of group
Example number % example number % example number % example number %
Soft capsule group 62 17 27.4 20 32.3 22 35.5 3 4.8
Dispersible tablet group 63 16 25.4 24 38.1 21 33.3 2 3.2
Drop pill group 62 16 25.8 22 35.5 22 35.5 2 3.2
Matched group 64 11 17.19 16 25.00 32 50.00 5 7.81
(learn check by statistics, Ridit analyzes: soft capsule treatment group, dispersible tablet treatment group, drop pill treatment group are better than matched group.P＜0.01)
Table 4 case compares the course of treatment
The course of treatment (X ± S)
Group example number
Soft capsule group 62 20.43 ± 2.97
Dispersible tablet group 63 19.27 ± 3.24
Drop pill group 62 18.05 ± 3.16
Matched group 64 24.55 ± 3.95
Advantage of the present invention is:
Drop pill: drop pill is the modern Chinese medicine novel form, belongs to solid dispersion system, and it is big to have specific surface area, and stripping is fast, the characteristics that bioavailability is high.And manufacturing cost is lower.Drops mostly is chemicals and uses, and the development of Chinese medicine dripping pills needs to test the choose reasonable substrate and make flow process by a large amount of.
Soft capsule: the soft capsule introduction also claims the flexible glue pill, and it is not have a kind of preparation that forms in sealings such as the non-water-soluble liquid of dissolution or suspension and the capsule shells with oils or to the gelatin thing, and its shape has circle, ellipse, fish shape is tubular etc.Soft capsule is the tablet that continues, and a kind of novel form that grows up after the injection, its shell are to form with the gelatin compacting, the aqueous medicinal liquid of bag in the softgel shell.Be characterized in slower than injection onset, but than tablet, capsule, granule is rapid-action.More easy to carry than oral liquid.Because the optimization of soft capsule liquid of the present invention prescription, its content can be in human body self emulsifying to a certain degree, increase absorption area, thus the bioavailability height.
Dispersible tablet: be a kind of solidified liquid form of administration, disintegrate fully in 3 minutes at normal temperatures, the effective ingredient stripping is rapid.But solid state is taken, but also liquid condition is taken, and makes things convenient for the patient.The development of dispersible tablets of Chinese medicine need overcome and extract the difficult point that the extractum moisture absorption influences disintegrate, and the present invention is by the screening adjuvant, thereby it is stable to reach end product quality, and disintegrate is characteristics rapidly; Simultaneously also can be on tablet coating, prevent the tablet moisture absorption thereby reach, improve the effect of tablet appearance.
The specific embodiment:
Embodiment 1: medical material component weight proportion: 350 parts of Herba Melastomatis dodecandri, and 100 parts of Radix Zanthoxylis, 100 parts of Radix Angelicae Sinensis,
80 parts of Herba Fici Simplicissimae, 100 parts of Radix Cudraniaes;
Drop pill substrate: 80 parts of polyethylene glycol 6000s;
Step 1: get the preceding five tastes by above-mentioned medical material component weight proportion, add 9 times of amounts of water, decoct each 1.5 hours 2 times, filter, merging filtrate, being concentrated into relative density is 1.20 (55 ℃), adds ethanol and reaches 30% to containing the alcohol amount, left standstill 24 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.10 (55 ℃) clear paste;
Step 2: above-mentioned clear paste is concentrated into the thick paste that relative density is 1.40 (60 ℃), adds above-mentioned drop pill substrate taking polyethylene glycol 6000, and mix homogeneously splashes into molding in the coolant, removes coolant, promptly gets the GONGYANPING drop pill.
Its drop pill substrate or be 80 parts of compositionss such as (6000) 80 parts of Polyethylene Glycol or 80 parts of polyoxyethylene monostearates or 80 parts of sodium stearates or 80 parts of glycerin gelatines or poloxamer and Polyethylene Glycol or stearic acid or glyceryl monostearate or worm be cured.
Coolant in its drop pill is two first class silicone oil.
Embodiment 2: medical material component weight proportion: 140 parts of 170 parts of Radix Angelicae Sinensis of 450 portions of Radix Zanthoxylis of Herba Melastomatis dodecandri
140 parts of 100 parts of Radix Cudraniaes of Herba Fici Simplicissimae;
Drop pill substrate: 360 parts;
Step 1: get the preceding five tastes by above-mentioned medical material component weight proportion, add 10 times of amounts of water, decoct each 2 hours 3 times, filter, merging filtrate, being concentrated into relative density is 1.22 (58 ℃), adds ethanol and reaches 50% to containing the alcohol amount, left standstill 24 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.12 (58 ℃) clear paste;
Step 2: above-mentioned clear paste is concentrated into the thick paste that relative density is 1.38 (60 ℃), and the drop pill substrate that adds 360 parts is Macrogol 4000: polyethylene glycol 6000 (3: 7), mix homogeneously splashes into molding in the coolant, removes coolant, promptly gets the GONGYANPING drop pill.Make 5000 GONGYANPING drop pill.
Coolant in its drop pill is a liquid paraffin.
Embodiment 3: medical material component weight proportion: 550 parts of Herba Melastomatis dodecandri, and 240 parts on two sides, 280 parts of Radix Angelicae Sinensis,
140 parts of Herba Fici Simplicissimae, 180 parts of Radix Cudraniaes;
Drop pill substrate: 135 parts of substrate Macrogol 4000s
30 parts of poloxamers
Step 1: get the preceding five tastes by above-mentioned medical material component weight proportion, add 11 times of amounts of water, decoct each 2.5 hours 3 times, filter, merging filtrate, being concentrated into relative density is 1.25 (60 ℃), adds ethanol and reaches 60% to containing the alcohol amount, left standstill 24 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.15 (60 ℃) clear paste;
Step 2: above-mentioned clear paste is concentrated into the thick paste that relative density is 1.35 (60 ℃), adds 30 parts of 135 parts substrate Macrogol 4000 part and poloxamers, and mix homogeneously splashes into molding in the coolant, removes coolant, promptly gets the GONGYANPING drop pill.
Coolant in its drop pill is one of Oleum Camelliae or vegetable oil or two or more.
Embodiment 4: get the water boiling and extraction thing by the medical material of the foregoing description 1 or embodiment 2 or embodiment 3 used medical material component weight proportions, decocting boils the volatile oil of collection;
The component weight proportion:
Disperse medium: 80 parts in olive oil;
Suspending agent: 35 parts in Cera Flava;
Emulsifying agent: 150 parts of soybean lecithins;
50 parts of co-emulsifier propylene glycol
Antiseptic: 1 part of methyl parahydroxybenzoate
Step 1: the medical material by the foregoing description 1 or embodiment 2 or embodiment 3 used component weight proportions is got the preceding five tastes, adds 9 times of amounts of water, decocts 2 times, each 1.5 hours, collect volatile oil and decoction liquor, decoction liquor filters, merging filtrate, being concentrated into relative density is 1.20 (55 ℃), add ethanol and reach 30%, left standstill 24 hours, filter to containing the alcohol amount, filtrate recycling ethanol, being concentrated into relative density is 1.10 (55 ℃) clear paste; It is standby that moisture is removed in the volatile oil decompression;
Step 2: the clear paste spray drying of above-mentioned steps 1, the powder that gets dry extract is standby.The suspending agent of getting above-mentioned share is dissolved in 40 parts of disperse medium (being preheated to 60 ℃) standby; Get in the emulsifying agent of other adjuvants such as above-mentioned share and the oil phase disperse medium that co-emulsifier adds above-mentioned share remainder, stir, and be mixed to 37 ℃ with above-mentioned oil phase disperse medium, add above-mentioned thick paste (or dried cream powder), stir, grind homogenizing, make 1000 cervicitis soft capsules.
Cera Flava is a suspending agent.
Its emulsifying agent can be soybean lecithin or select for use the nonionic co-emulsifier be liquid egg phospholipid or polyoxyethylene castor oil or Oleum Cocois C8/C10 polyethyleneglycol glyceride or almond oil acid polyethylene glycol glyceride or polyoxyethylene (25) triolein or tween 80 or Polyethylene Glycol-8-glycerol sad/decanoin;
Co-emulsifier can be in its soft capsule: ethanol or propylene glycol or Polyethylene Glycol or propylene carbonate or ethylene glycol monomethyl ether or glycerol furfural or Isosorbide dimethyl ether or its mixture, or the best propylene glycol that uses;
Antiseptic is in its soft capsule: one or more in glycerol or propylene glycol or methyl parahydroxybenzoate or ethylparaben or propyl p-hydroxybenzoate or butyl p-hydroxybenzoate or benzyl p-hydroxybenzoate or the P-hydroxybenzoic acid phenyl ester.
Olive oil is that the oil phase disperse medium also can be:
Used oil phase disperse medium can be olive oil or crude vegetal soybean oil or Oleum Arachidis hypogaeae semen, or the triglyceride oils oleic acid sorbitol ester of long-chain and medium-chain saturation in various degree or olein or propylene glycol or Oleum Cocois C8/C10 monoglyceride or dibasic acid esters or Oleum Cocois C8/C10 propylene glycol ester or Oleum Cocois triglyceride or the acetylizad monoglyceride of purification or olein or glyceryl linoleate or Polyethylene Glycol glyceryl laurate ester or purification Oleum helianthi monoglyceride.
Embodiment 5: medical material component weight proportion: 350 parts of Herba Melastomatis dodecandri, and 100 parts of Radix Zanthoxylis, 100 parts of Radix Angelicae Sinensis,
80 parts of Herba Fici Simplicissimae, 100 parts of Radix Cudraniaes;
Oil phase disperse medium: 300 parts of Oleum Arachidis hypogaeae semen;
Suspending agent: 4 parts in Cera Flava;
Emulsifying agent: 5 parts of tween 80s;
Antiseptic, co-emulsifier: 5 parts of propylene glycol;
Step 1: get the preceding five tastes by above-mentioned medical material component weight proportion, add 10 times of amounts of water, decoct each 2 hours 3 times, filter, merging filtrate, being concentrated into relative density is 1.22 (58 ℃), adds ethanol and reaches 50% to containing the alcohol amount, left standstill 24 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.12 (58 ℃) clear paste;
It is standby that the clear paste of the above-mentioned steps 1 of step 2 is concentrated into relative density 1.35 (30 ℃), gets above-mentioned share suspending agent and be dissolved in 80 parts of oil phase disperse medium (being preheated to 60 ℃) standby; Emulsifier tween-80, the co-emulsifier propylene glycol of getting above-mentioned share add in the remaining oil phase disperse medium, stir, and merge with above-mentioned oil phase disperse medium, be mixed to 37 ℃, add above-mentioned thick paste, stir, grind homogenizing, make 1000 cervicitis soft capsules.
Owing to mix with substrate when clear paste is concentrated into relative density 1.35 (30 ℃), so its capsule liquid can contain the water that accounts for capsule liquid gross weight 1～5%.
Embodiment 6: medical material component weight proportion: 140 parts of 170 parts of Radix Angelicae Sinensis of 450 portions of Radix Zanthoxylis of Herba Melastomatis dodecandri
140 parts of 100 parts of Radix Cudraniaes of Herba Fici Simplicissimae;
Disperse medium: 90 parts of Polyethylene Glycol;
Suspending agent: 14 parts in Cera Flava;
Antiseptic: 25 parts of glycerol;
Step 1: get the preceding five tastes by above-mentioned medical material component weight proportion, add 11 times of amounts of water, decoct each 2.5 hours 3 times, filter, merging filtrate, being concentrated into relative density is 1.25 (60 ℃), adds ethanol and reaches 60% to containing the alcohol amount, left standstill 24 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.15 (60 ℃) clear paste;
Step 2: the clear paste spray drying of above-mentioned steps 1, the powder that gets dry extract is standby.The suspending agent of getting above-mentioned share is dissolved in 100 parts of disperse medium (being preheated to 60 ℃) standby; The antiseptic agent of getting above-mentioned share adds in the oil phase disperse medium of above-mentioned share remainder, stirs, and is mixed to 37 ℃ with above-mentioned disperse medium, adds above-mentioned thick paste (or dried cream powder), stirs, and grinds homogenizing, makes 1000 cervicitis soft capsules.
Embodiment 7: medical material component weight proportion: 350 parts of Herba Melastomatis dodecandri, and 100 parts of Radix Zanthoxylis, 100 parts of Radix Angelicae Sinensis,
80 parts of Herba Fici Simplicissimae, 100 parts of Radix Cudraniaes;
Filler is made up of for 60 parts 60 parts of pregelatinized Starch and lactose;
Disintegrating agent: 5 parts of crospolyvinylpyrrolidone;
Lubricant: 0.5 part of magnesium stearate;
Correctives is 0.5 part of an xylitol;
Step 1: get the preceding five tastes by above-mentioned medical material component weight proportion, add 9 times of amounts of water, decoct each 1.5 hours 2 times, filter, merging filtrate, being concentrated into relative density is 1.20 (55 ℃), adds ethanol and reaches 30% to containing the alcohol amount, left standstill 24 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.10 (55 ℃) clear paste;
Step 2: the clear paste spray drying of above-mentioned steps 1, the powder that gets dry extract is standby.Get dried cream powder, 60 parts of pregelatinized Starch, 60 parts of lactose, reach 4 parts of mix homogeneously of disintegrating agent, granulate drying, granulate with content 95% alcoholic acid alcoholic solution moistening, add stearic 1 part in magnesium and the 0.5 part of tabletting of xylitol calculated of 6 parts of disintegrating agents and lubricant, promptly get the GONGYANPING dispersible tablet.Make 1000 GONGYANPING dispersible tablets.
Crospolyvinylpyrrolidone is a The disintegrating agents of dispersible tablets, removes crospolyvinylpyrrolidone can also be: carboxymethyl starch sodium or low-substituted hydroxypropyl cellulose or cross-linked carboxymethyl cellulose sodium.
The dilute alcohol solution of polyvinylpyrrolidone is the adhesive (or being called wetting agent) in the dispersible tablet.Wetting agent in its dispersible tablet can also be the alcoholic solution or the starch slurry of 80% ethanol～95% alcoholic solution or starch slurry or polyvinylpyrrolidone.
Magnesium stearate lubricant in the above-mentioned dispersible tablet can also be: micropowder silica gel or Pulvis Talci.
Correctives xylitol in the above-mentioned dispersible tablet can also be sweet or mannitol or other medicinal correctives of A Basi.
Embodiment 8: medical material component weight proportion: 170 parts of 450 portions of Radix Zanthoxylis of Herba Melastomatis dodecandri
140 parts of 100 parts of Radix Cudraniaes of 140 parts of Herba Fici Simplicissimae of Radix Angelicae Sinensis;
Filler: 120 parts of 100 parts of pregelatinized Starch and lactose;
Disintegrating agent: 40 parts of cross-linked carboxymethyl cellulose sodium;
Lubricant is 5 parts of magnesium stearate;
Step 1: get the preceding five tastes by above-mentioned medical material component weight proportion, add 10 times of amounts of water, decoct each 2 hours 3 times, filter, merging filtrate, being concentrated into relative density is 1.22 (58 ℃), adds ethanol and reaches 50% to containing the alcohol amount, left standstill 24 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.12 (58 ℃) clear paste;
Step 2: the clear paste spray drying of above-mentioned steps 1, the powder that gets dry extract is standby.Get dried cream powder, 100 parts of pregelatinized Starch, 60 parts of lactose, reach 16 parts of mix homogeneously of disintegrating agent, dilute alcohol solution (5 parts of polyvinylpyrrolidones: moistening granulation 20% ethanol 100ml) with the content polyvinylpyrrolidone, dry, granulate, add stearic 2 parts in magnesium and the 1 part of tabletting of xylitol calculated of 24 parts of disintegrating agents and lubricant, promptly get the GONGYANPING dispersible tablet.Make 1000 GONGYANPING dispersible tablets.Cross-linked carboxymethyl cellulose sodium is a The disintegrating agents of dispersible tablets, removes cross-linked carboxymethyl cellulose sodium can also be: crospolyvinylpyrrolidone, carboxymethyl starch sodium or low-substituted hydroxypropyl cellulose.
The dilute alcohol solution of polyvinylpyrrolidone is the wetting agent in the dispersible tablet.Wetting agent in its dispersible tablet can also be the alcoholic solution of 40% ethanol～95% alcoholic solution or starch slurry or polyvinylpyrrolidone.
Magnesium stearate lubricant in the above-mentioned dispersible tablet can also be: micropowder silica gel or Pulvis Talci.
Correctives xylitol in the above-mentioned dispersible tablet can also be sweet or mannitol or other medicinal correctives of A Basi.
Embodiment 9: get the water boiling and extraction thing by the medical material of the foregoing description 1 or embodiment 2 or embodiment 3 used component weight proportions: Radix Angelicae Sinensis, Radix Zanthoxyli volatile oil clathrate compound 30ml
Filler: 80 parts of 120 parts of pregelatinized Starch and lactose;
Disintegrating agent: 24 parts of crospolyvinylpyrrolidone;
Lubricant: 3 parts of micropowder silica gels;
Correctives is 2 parts of xylitol;
With Radix Angelicae Sinensis, Radix Zanthoxyli with 40～75% alcohol reflux preextraction volatile oil after, cyclodextrin inclusion compound forms volatile oil clathrate compound, medicinal residues are with all the other medical materials 1 water boiling and extraction thing that extracts set by step;
Water intaking decocts extract dried cream powder, Radix Angelicae Sinensis, Radix Zanthoxyli volatile oil clathrate compound, 120 parts of pregelatinized Starch, 80 parts of lactose, reaches 14 parts of mix homogeneously of disintegrating agent, granulate with content 95% alcoholic acid alcoholic solution moistening, dry, granulate, add stearic 3 parts in magnesium and the 2 parts of tablettings of xylitol calculated of 10 parts of disintegrating agents and lubricant, promptly get the GONGYANPING dispersible tablet; Also can select commercially available coating solution for use, make the dispersible tablet of bag film-coat.
Crospolyvinylpyrrolidone is a The disintegrating agents of dispersible tablets, removes crospolyvinylpyrrolidone can also be: carboxymethyl starch sodium or low-substituted hydroxypropyl cellulose or cross-linked carboxymethyl cellulose sodium.
The dilute alcohol solution of polyvinylpyrrolidone is the wetting agent in the dispersible tablet.Wetting agent in its dispersible tablet can also be the alcoholic solution of 40% ethanol～95% alcoholic solution or starch slurry or polyvinylpyrrolidone.
Magnesium stearate lubricant in the above-mentioned dispersible tablet can also be: micropowder silica gel or Pulvis Talci.
Correctives xylitol in the above-mentioned dispersible tablet can also be sweet or mannitol or other medicinal correctives of A Basi.
Embodiment 10: medical material component weight proportion: 550 parts of Herba Melastomatis dodecandri, and 240 parts on two sides, 280 parts of Radix Angelicae Sinensis,
140 parts of Herba Fici Simplicissimae, 180 parts of Radix Cudraniaes,
Filler is 80 parts of 100 parts of pregelatinized Starch and lactose;
Disintegrating agent is 24 parts of crospolyvinylpyrrolidone;
Lubricant is 3 parts of magnesium stearate;
Correctives is 2 parts of xylitol;
Step 1: get the preceding five tastes by above-mentioned medical material component weight proportion, add 11 times of amounts of water, decoct each 2.5 hours 3 times, filter, merging filtrate, being concentrated into relative density is 1.25 (60 ℃), adds ethanol and reaches 60% to containing the alcohol amount, left standstill 24 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.15 (60 ℃) clear paste;
Extract volatile oil in the above-mentioned decoction process, volatile oil is standby with cyclodextrin inclusion compound;
Step 2: the clear paste spray drying of above-mentioned steps 1, the powder that gets dry extract is standby.Get dried cream powder, cyclodextrin of volatile oil clathrate, 100 parts of pregelatinized Starch, 80 parts of lactose, reach 12 parts of mix homogeneously of disintegrating agent, granulate with content 95% alcoholic acid alcoholic solution moistening, dry, granulate, add stearic 3 parts in magnesium and the 2 parts of tablettings of xylitol calculated of 12 parts of disintegrating agents and lubricant, promptly get the GONGYANPING dispersible tablet; Also can select commercially available coating solution for use, make the dispersible tablet of coating.
Embodiment 11: medical material component weight proportion: 550 parts of Herba Melastomatis dodecandri, and 240 parts of Radix Zanthoxylis, 280 parts of Radix Angelicae Sinensis,
140 parts of Herba Fici Simplicissimae, 180 parts of Radix Cudraniaes,
Drop pill substrate: 80 parts of Macrogol 4000s;
Carry volatile oil in advance: get Radix Angelicae Sinensis, Radix Zanthoxyli with 6 times of amount 60% alcohol reflux 1.5 hours, reclaim ethanol, gained alcohol extraction volatile ingredient is standby with cyclodextrin inclusion compound,
Step 1: get the preceding five tastes by above-mentioned medical material component weight proportion, add 11 times of amounts of water, decoct each 2.5 hours 3 times, filter, merging filtrate, being concentrated into relative density is 1.25 (60 ℃), adds ethanol and reaches 60% to containing the alcohol amount, left standstill 24 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.15 (60 ℃) clear paste;
Step 2: above-mentioned clear paste is concentrated into the thick paste that relative density is 1.40 (60 ℃), adds above-mentioned drop pill substrate taking polyethylene glycol 4000, and mix homogeneously splashes into molding in the coolant, removes coolant, promptly gets the GONGYANPING drop pill.
Embodiment 12: in above-mentioned making drop pill, dispersible tablet, each embodiment of soft capsule, increase in its step 1 and collect the volatile oil that is extracted, make drop pill, dispersible tablet, soft capsule together with extracting extract powder or extractum and adjuvant or substrate.
Embodiment 13: in above-mentioned making drop pill, dispersible tablet, each embodiment of soft capsule, before its step 1, can with Radix Angelicae Sinensis, Radix Zanthoxyli with 40～75% alcohol reflux preextraction volatile oil after, cyclodextrin inclusion compound forms volatile oil clathrate compound, medicinal residues 1 extract set by step with all the other medical materials; Volatile oil clathrate compound is made drop pill, dispersible tablet, soft capsule together with extracting extract powder or extractum and adjuvant or substrate.
Embodiment 14: in each embodiment of above-mentioned soft capsule, and before its step 1, can Radix Angelicae Sinensis, Radix Zanthoxyli is standby after with 40～75% alcohol reflux preextraction volatile oil, medicinal residues 1 extract set by step with all the other medical materials; Volatile oil is made soft capsule together with extracting extract powder or extractum and adjuvant or substrate.
Claims (10)
1, a kind of Chinese medicine that improves bioavailability and drug effect, the component weight proportion of used medical material:
Herba Melastomatis dodecandri 350～550, Radix Zanthoxyli 100～240, Radix Angelicae Sinensis 100～280, Herba Fici Simplicissimae 80～140, Radix Cudraniae 100～180,
It is characterized in that: the extract of above-mentioned medical material cooperates the pharmaceutically alleged adjuvant or the substrate of the suitable kind of employing to make drop pill, soft capsule or dispersible tablet.
2, a kind of Chinese medicine Gongyanping preparation preparation method that improves bioavailability and drug effect is characterized in that: the component weight proportion of used medical material:
Herba Melastomatis dodecandri 350～550, Radix Zanthoxyli 100～240, Radix Angelicae Sinensis 100～280, Herba Fici Simplicissimae 80～140, Radix Cudraniae 100～180,
Get Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Angelicae Sinensis, Herba Fici Simplicissimae, Radix Cudraniae Chinese medicine of the five flavours in extraction pot by the component weight proportion of above-mentioned used medical material, add 9～11 times of amounts of water, decoct each 1.5～2.5 hours 2～3 times, filter, merging filtrate, being concentrated into relative density is the clear paste of 1.15～1.35 (55 ~ 60 ℃), adds ethanol and reaches 30%～85% to containing the alcohol amount, left standstill 12～36 hours, filter, filtrate recycling ethanol, being concentrated into relative density is the clear paste of 1.10～1.15 (55～60 ℃); Next:
Make the GONGYANPING drop pill: get above-mentioned clear paste and be concentrated into the thick paste that relative density is 1.35～1.40 (60 ℃), with the drop pill substrate of 45 ℃～65 ℃ of following thermosols, the consumption of substrate is 80～360 parts, mix homogeneously, splash into molding in the coolant, remove coolant, promptly get the GONGYANPING drop pill; Or
Make the GONGYANPING drop pill: above-mentioned clear paste drying, be ground into 80 orders～120 order fine powders, or above-mentioned clear paste spray drying obtains fine powder, with fine powder and 45 ℃～65 ℃ hot melt and dissolved down drop pill substrate, the consumption of substrate is 80～360 parts, and mix homogeneously splashes into molding in the coolant, remove coolant, promptly get the GONGYANPING drop pill; Or
Make the GONGYANPING dispersible tablet: above-mentioned clear paste drying, powder gets dry extract, disintegrating agent (0.5～26 part) mix homogeneously that adds in the filler (120～220 parts) of adding recipe quantity reaches, granulate with the binding agent moistening, drying, granulate adds remaining disintegrating agent that adds (4.5～14 parts) and lubricant mix homogeneously tablettings such as (0.5～5), can pack into Film coated tablets, promptly get the GONGYANPING dispersible tablet; Or
Make capsules of Gongyanping for cervicitis: above-mentioned clear paste drying, the powder that gets dry extract is standby, and the suspending agent (4～35) of getting above-mentioned share is dissolved in 1/5～4/5 disperse medium, and (total amount is: 60～300), be preheated in 40～75 ℃ standby; Get in 4/5～1/5 the disperse medium that other adjuvants add above-mentioned share remainder, stir, and be mixed to 37 ℃, add above-mentioned dried cream powder or thick paste, stir, grind homogenizing, make soft capsule with above-mentioned disperse medium.
3, a kind of Chinese medicine that improves bioavailability and drug effect according to claim 1 is characterized in that: the extract of above-mentioned used medical material is made drop pill with basic adjuvant drop pill substrate 80～360 at least; Or make soft capsule with basic adjuvant disperse medium 60～300, suspending agent 4～35 at least; Or make dispersible tablet with basic adjuvant filler 120～220, disintegrating agent 5～40, lubricant 0.5～5 at least.
4, a kind of Chinese medicine that improves bioavailability and drug effect according to claim 3 is characterized in that: the extract of above-mentioned used medical material with the component weight proportion of the basic adjuvant of the best is:
Drop pill substrate: Macrogol 4000 or polyethylene glycol 6000 or its mixture are 160;
Soft capsule matrix and adjuvant: disperse medium 150; Suspending agent 8～12;
Dispersible tablet adjuvant: filler 160, disintegrating agent 21, lubricant 1～3.
5, according to claim 1 or 3 or 4 described a kind of Chinese medicines that improve bioavailability and drug effect, it is characterized in that: the substrate in its drop pill is Macrogol 4000 or polyethylene glycol 6000 or polyoxyethylene monostearate or sodium stearate or glycerin gelatine or poloxamer or stearic acid or glyceryl monostearate or cured above-mentioned two or more compositions or the independent a kind of composition of worm, and the coolant in its drop pill is two first class silicone oil or liquid paraffin or one of Oleum Camelliae or vegetable oil or the combination of two or more above-mentioned coolant.
6, according to claim 1 or 3 or 4 described a kind of Chinese medicines that improve bioavailability and drug effect, it is characterized in that: the disperse medium of making soft capsule is: oiliness disperse medium or PEG400 or Polyethylene Glycol 500 or Macrogol 600 or isopropyl alcohol or glycerol or propylene glycol and water one or more; Suspending agent can be selected Cera Flava or aluminum monostearate or ethyl cellulose for use.
7, according to claim 1 or 3 or 4 described a kind of Chinese medicines that improve bioavailability and drug effect, it is characterized in that: its The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium or low-substituted hydroxypropyl cellulose or cross-linked carboxymethyl cellulose sodium; Binding agent in its dispersible tablet can be: the alcoholic solution of polyvinylpyrrolidone can also be 40% ethanol～95% alcoholic solution or starch slurry; Magnesium stearate lubricant can also be micropowder silica gel or Pulvis Talci, can add xylitol in its dispersible tablet or A Basi is sweet or mannitol, or other medicinal correctivess.
8, a kind of Chinese medicine Gongyanping preparation preparation method that improves bioavailability and drug effect according to claim 2, it is characterized in that: it is standby to collect the volatile oil that is extracted in its medical material water boiling and extraction, or volatile oil is standby after with cyclodextrin inclusion compound, and volatile oil or volatile oil clathrate compound are made drop pill, dispersible tablet, soft capsule together with water boiling and extraction thing and adjuvant or substrate; Or before its water boiling and extraction, can be with behind Radix Angelicae Sinensis, the Radix Zanthoxyli preextraction volatile oil, or cyclodextrin inclusion compound forms volatile oil clathrate compound, medicinal residues are with all the other medical materials water boiling and extraction still; Volatile oil or volatile oil clathrate compound are made drop pill, dispersible tablet, soft capsule together with water boiling and extraction thing and adjuvant or substrate.
9, according to claim 1 or 3 or 4 described a kind of Chinese medicines that improve bioavailability and drug effect, it is characterized in that: can other adjuvants in its soft capsule liquid process for preparation such as emulsifying agent, co-emulsifier, antiseptic;
1) its emulsifying agent can be soybean lecithin or select for use nonionic emulsifier be liquid egg phospholipid or polyoxyethylene castor oil or Oleum Cocois C8/C10 polyethyleneglycol glyceride or almond oil acid polyethylene glycol glyceride or polyoxyethylene (25) triolein or tween 80 or Polyethylene Glycol-8-glycerol sad/decanoin;
2) co-emulsifier can be in its soft capsule: ethanol or propylene glycol or Polyethylene Glycol or propylene carbonate or ethylene glycol monomethyl ether or glycerol furfural or Isosorbide dimethyl ether or its mixture, or the best propylene glycol that uses;
3) antiseptic is in its soft capsule: one or more in glycerol or propylene glycol or methyl parahydroxybenzoate or ethylparaben or propyl p-hydroxybenzoate or butyl p-hydroxybenzoate or benzyl p-hydroxybenzoate or the P-hydroxybenzoic acid phenyl ester.
10; a kind of Chinese medicine that improves bioavailability and drug effect according to claim 6; it is characterized in that: make the used oil phase disperse medium of soft capsule and can be olive oil or crude vegetal soybean oil or Oleum Arachidis hypogaeae semen, or the triglyceride oils oleic acid sorbitol ester of long-chain and medium-chain saturation in various degree or olein or propylene glycol or Oleum Cocois C8/C10 monoglyceride or dibasic acid esters or Oleum Cocois C8/C10 propylene glycol ester or Oleum Cocois triglyceride or the acetylizad monoglyceride of purification or olein or glyceryl linoleate or Polyethylene Glycol glyceryl laurate ester or purification Oleum helianthi monoglyceride.
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| CNB2004100583533A CN1332649C (en) | 2004-08-12 | 2004-08-12 | Chinese medicinal formulation for treating pelvic inflammation with improved bioavailability and drug effect and preparation process thereof |
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| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: GUANGDONG LUOFUSHAN SINOPHARM Co.,Ltd. Assignor: Ye Yaoliang Contract record no.: 2010440000859 Denomination of invention: Chinese medicinal formulation for treating pelvic inflammation with improved bioavailability and drug effect and preparation process thereof Granted publication date: 20070822 License type: Exclusive License Open date: 20050406 Record date: 20100625 |
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| TR01 | Transfer of patent right | ||
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Effective date of registration: 20190215 Address after: 516133 Bianling Pai Industrial Zone of Guangshan Highway, Changning Town, Boluo County, Huizhou City, Guangdong Province (Luofushan Pharmaceutical City) Patentee after: GUANGDONG LUOFUSHAN SINOPHARM Co.,Ltd. Address before: 516133 Guangdong Luofushan Pharmaceutical Co., Ltd. Changning Town, Boluo County, Guangdong Province Patentee before: Ye Yaoliang |
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| EC01 | Cancellation of recordation of patent licensing contract |
Assignee: GUANGDONG LUOFUSHAN SINOPHARM Co.,Ltd. Assignor: Ye Yaoliang Contract record no.: 2010440000859 Date of cancellation: 20230721 |
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| EC01 | Cancellation of recordation of patent licensing contract | ||
| EE01 | Entry into force of recordation of patent licensing contract |
Application publication date: 20050406 Assignee: Guangzhou Qingyu Intellectual Property Operation Partnership (L.P.) Assignor: GUANGDONG LUOFUSHAN SINOPHARM Co.,Ltd. Contract record no.: X2023980039255 Denomination of invention: A traditional Chinese medicine Gongyanping preparation and preparation method for improving bioavailability and efficacy Granted publication date: 20070822 License type: Common License Record date: 20230811 |
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| EE01 | Entry into force of recordation of patent licensing contract | ||
| CX01 | Expiry of patent term |
Granted publication date: 20070822 |
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