CN106924406A - A kind of pharmaceutical composition of adjuvant drug for treating AIDS and preparation method thereof - Google Patents
A kind of pharmaceutical composition of adjuvant drug for treating AIDS and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of pharmaceutical composition of adjuvant drug for treating AIDS and preparation method thereof.Pharmaceutical composition of the invention contains following compositions：The weight portion of the Radix Astragali 15 45, the weight portion of ganoderma lucidum 10 20, the weight portion of Radix Codonopsis 10 20, the weight portion of cordate houttuynia 8 18, the weight portion of root of Chinese trichosanthes 8 16, the weight portion of the root of large-flowered skullcap 7 17, the weight portion of radix bupleuri 6 18, the weight portion of Radix Glycyrrhizae 5 14.Pharmaceutical composition of the invention has delay fatigue, enhancing nospecific immunity effectiveness, can be used as treating the adjuvant drug of AIDS.
Description
Technical field
The present invention relates to field of medicinal compositions, and in particular to a kind of medicine group for treating the adjuvant drug of AIDS
Compound and preparation method thereof.
Background technology
AIDS is a kind of great infectious disease of harmfulness, is caused by aids infection virus (inhibition of HIV).HIV is one
Plant the virus that can attack human immune system.It is using most important CD4T lymphocytes in human immune system as primary challenge
Target, the considerable damage cell makes human body lose immunologic function.Therefore, human body is easy to infect various diseases, and can occur pernicious
Tumour, case fatality rate is higher.In current existing medicine, shortage can maintain, improve or rebuild the immune system of AIDS patient
Medicine.
The content of the invention
To solve above-mentioned problems of the prior art, the present invention provides a kind of adjuvant drug for treating AIDS
Pharmaceutical composition (below, sometimes referred to as " pharmaceutical composition of the invention "), pharmaceutical composition of the invention have improve it is right
The immunocompetence of HIV, the effect for rebuilding body immune system.
Pharmaceutical composition for treating the adjuvant drug of AIDS of the invention, the pharmaceutical composition contain it is following into
Point：
Pharmaceutical composition as described above, preferably comprises each composition of following weight parts：
Further preferably each composition of following weight parts：
Each composition further preferably containing following weight parts：
Each composition further preferably containing following weight parts：
Pharmaceutical composition as described above, it is characterised in that the pharmaceutical composition is made tablet, capsule, granule, punching
Agent or oral liquid.
The preparation method of the pharmaceutical composition of the adjuvant drug for being used to treat AIDS as described above, it is characterised in that
The Chinese medicine of each composition is made extract dry powder after water extraction or alcohol extracting, pharmaceutically acceptable auxiliary material is added, tablet, glue is made
Wafer, granule, electuary or oral liquid.
Preparation method as described above, it is characterised in that the water extraction is that the Chinese medicine of each composition is measured with 10-35 times
Decocting is boiled 2-4 times, each 1-6 hours；The alcohol extracting be by it is each into Chinese medicine with the 5-15 times of concentration measured be 30~90wt%
Ethanol decoct 2-4 times, it is each 1-6 hours.
Preparation method as described above, it is characterised in that the pharmaceutically acceptable auxiliary material include adhesive, disintegrant,
Glidant, plasticizer and/or diluent.
The preparation method of the pharmaceutical composition of the adjuvant drug for being used to treat AIDS as described above, it is characterised in that
(1) by addition to ganoderma lucidum the Chinese medicine soak 30-120 minutes it is standby；
(2) Chinese medicine will have been soaked described in addition to ganoderma lucidum extract solution, 30-90 DEG C of decompression has been made after water extraction or alcohol extracting
It is concentrated into the medicinal extract that relative density is 1.10-1.58；
(3) ganoderma lucidum is ground into fine powder, the fine powder is that can all pass through No. five sieves and can be by No. six powder of sieve
End is no less than 95%；
(4) the ganoderma lucidum fine powder that step (3) is obtained is added in the medicinal extract of step (2), is added pharmaceutically acceptable auxiliary
Material, is made tablet, capsule, granule, electuary or oral liquid.
Preparation method as described above, it is characterised in that the water extraction is that the Chinese medicine of each composition is measured with 10-35 times
Decocting is boiled 2-4 times, each 1-6 hours；The alcohol extracting be by it is each into Chinese medicine with the 5-15 times of concentration measured be 30~90wt%
Ethanol decoct 2-4 times, it is each 1-6 hours.
Preparation method as described above, it is characterised in that the pharmaceutically acceptable auxiliary material include adhesive, disintegrant,
Glidant, flavouring, plasticizer and/or diluent.
The present invention also provides a kind of method of quality control for treating the pharmaceutical composition of the adjuvant drug of AIDS, its
Using the content of scutelloside in high effective liquid chromatography for measuring sample to be tested.
Method of quality control as described above, the color of the content of scutelloside in high effective liquid chromatography for measuring sample to be tested
Spectral condition is：It is 30 with volume ratio:70 phosphoric acid solution of acetonitrile -0.05% carries out isocratic elution for mobile phase, and Detection wavelength is
280nm。
Method of quality control as described above, it specifically includes following step：
(1) scutelloside reference substance is taken appropriate, it is accurately weighed, plus methyl alcohol is made solution of every 1ml containing 100 μ g, is made the root of large-flowered skullcap
Glycosides reference substance solution；
(2) pharmaceutical composition for taking treatment AIDS adjuvant drug to be measured is appropriate, finely ground, takes about 0.5g, accurately weighed,
In putting the volumetric flask of 100ml, plus methyl alcohol 40ml, weighed weight, ultrasonic extraction 30min, the weight of less loss is supplied with methyl alcohol, filter
Cross, be made need testing solution；
(3) it is another to take the appropriate negative control medicinal material for lacking the root of large-flowered skullcap, it is accurately weighed, in putting the volumetric flask of 100ml, plus methyl alcohol
40ml, weighed weight, ultrasonic extraction 30min supplies the weight of less loss with methyl alcohol, and filtration, the negative control for being made the scarce root of large-flowered skullcap is molten
Liquid；
(4) it is 30 with volume ratio with octadecyl silane as filler:The phosphoric acid solution of 70 acetonitrile -0.05%
It is mobile phase, sets flow velocity as 0.8ml/min, Detection wavelength is 280nm, and column temperature is 28 DEG C, and theoretical cam curve presses scutelloside peak
Meter is not less than 2500；Scutelloside reference substance solution and each 10 μ l of need testing solution are taken, is detected at a wavelength of 280 nm.
Pharmaceutical composition of the invention, is in gold dollar doctor's Li Dong Yuan《Treatise on the spleen and stomach》In on the basis of contained Buzhong Yiqi Tang,
The cause of disease, the interpretation of the cause, onset and process of an illness and clinical syndrome according to AIDS, with reference to modern traditional Chinese medicine achievement in research, according to the prescription of traditional Chinese medical science principle-method-recipe-medicines
Principle, screening is combined.Pharmaceutical composition of the invention Radix Astragali tonifying middle-Jiao and Qi, righting reinforcing, Conair salubrity, based on
Medicine；It is aided with ganoderma lucidum Yijing blood, strong muscles and bones consolidate salubrity.With Radix Codonopsis nourishing Yin and promoting production of body fluid, invigorating qi and benefiting blood；Assistant is with cordate houttuynia heat-clearing
Detoxification, toxic removing evil removing.Close root of Chinese trichosanthes Yin-nourishing and body fluid promoting, purging intense heat toxin expelling.5 root of large-flowered skullcap heat-clearing and damp-drying drugs, removing pattogenic heat from the blood and toxic material from the body.Liver is unclogged and readjusted with radix bupleuri
Gas, evil solution is strongly fragrant thoroughly；Make with Radix Glycyrrhizae invigorating middle warmer and replenishing QI, it is clearing heat and detoxicating, coordinate the property of medicine.The complete all medicines in side are associated with, then gas, blood giving young employees remedial-courses in general knowledge and vocational skills, poison, heat
All solutions, are just so incensed that multiple, and vigour is filled, and the heresy that ends must Eradicates.The Radix Astragali, Radix Codonopsis, ganoderma lucidum have enhancing macrophage phagocytic energy in prescription
Power, positive regulation and Conservative restoration effect are respectively provided with to each system of body；Cordate houttuynia, root of Chinese trichosanthes, the root of large-flowered skullcap, radix bupleuri, Radix Glycyrrhizae have
Preferably antiviral and antibacterial action, and immunocompetence of the body to HIV can be strengthened.The prescription is cured in Lanzhou lung section for many years
Infectious Disease of institute uses, and as the adjuvant drug of AIDS, with heat-clearing eliminating evil, the effect strengthened the body resistance to consolidate the constitution, can suppress the same of HIV
When, rebuild immunity of organism system.Additionally, granule has absorbs fast, it is effective rapid；Dosage is small, in good taste；Production equipment is simple
It is easy to operate；Take, carry, preserving and the characteristics of convenient transportation, Chinese medicine has relative to Western medicine at aspects such as security, economy
Advantage.
Brief description of the drawings
Fig. 1 is reference substance solution high-efficient liquid phase chromatogram.
Fig. 2 is need testing solution high-efficient liquid phase chromatogram.
Fig. 3 is negative control solution high-efficient liquid phase chromatogram.
Specific embodiment
The preferred embodiments of the present invention are illustrated below, it will be appreciated that preferred embodiment described herein is only used
In the description and interpretation present invention, it is not intended to limit the present invention.
First, for treating the preparation and quality control of the pharmaceutical composition of the adjuvant drug of AIDS
Embodiment 1
Weigh each composition of following weight：Radix Astragali 30g, ganoderma lucidum 15g, Radix Codonopsis 15g, cordate houttuynia 12g, root of Chinese trichosanthes 12g, the root of large-flowered skullcap
12g, radix bupleuri 12g, Radix Glycyrrhizae 9g.
By above-mentioned ganoderma lucidum pulverizing medicinal materials, smashing into can all by No. five sieves and can be many by the powder of No. six sieves
In 95% fine powder；The medicinal materials such as remaining Radix Astragali are soaked 1 hour, respectively with 10 times, 8 times, 8 times of water heating and refluxing extractions three
It is secondary, 1 hour for the first time, second 1 hour, third time 0.5 hour, merging filtrate, 60 DEG C are concentrated under reduced pressure into relative density and are
1.20 medicinal extract, it is mixed with ganoderma lucidum fine powder, adds appropriate soluble starch, and granulation is dried, and whole grain is made granule.
Embodiment 2
Weigh each composition of following weight：Radix Astragali 15g, ganoderma lucidum 10g, Radix Codonopsis 10g, cordate houttuynia 8g, root of Chinese trichosanthes 8g, the root of large-flowered skullcap
7g, radix bupleuri 6g, Radix Glycyrrhizae 5g.
By above-mentioned ganoderma lucidum pulverizing medicinal materials, smashing into can all by No. five sieves and can be many by the powder of No. six sieves
In 95% fine powder；The medicinal materials such as remaining Radix Astragali are soaked 1 hour, with 15 times, 10 times, 10 times of water heating and refluxing extractions three times,
1 hour for the first time, second 2 hours, third time 3 hours, merging filtrate, 60 DEG C are concentrated under reduced pressure into the leaching that relative density is 1.38
Cream, it is mixed with ganoderma lucidum fine powder, adds appropriate soluble starch, and granulation is dried, and whole grain is made capsule.
Embodiment 3：
Weigh each composition of following weight：Radix Astragali 45g, ganoderma lucidum 20g, Radix Codonopsis 20g, cordate houttuynia 18g, root of Chinese trichosanthes 16g, the root of large-flowered skullcap
17g, radix bupleuri 18g, Radix Glycyrrhizae 14g.
By above-mentioned ganoderma lucidum pulverizing medicinal materials, smashing into can all by No. five sieves and can be many by the powder of No. six sieves
In 95% fine powder；The medicinal materials such as remaining Radix Astragali are soaked 1 hour, with 3 times, 5 times, 5 times of water heating and refluxing extractions three times, first
Secondary 1 hour, second 1 hour, third time 1 hour, merging filtrate, 60 DEG C are concentrated under reduced pressure into the medicinal extract that relative density is 1.58,
Itself and ganoderma lucidum fine powder are mixed, extract dry powder is dried to obtain, appropriate soluble starch is added, magnesium stearate 0.8g, talcum powder 5g,
It is made tablet.
Embodiment 4：
Weigh each composition of following weight：Radix Astragali 16g, ganoderma lucidum 16g, Radix Codonopsis 16g, cordate houttuynia 13g, root of Chinese trichosanthes 11g, the root of large-flowered skullcap
13g, radix bupleuri 14g, Radix Glycyrrhizae 10g.
Above-mentioned eight tastes traditional Chinese medicine powder is broken into meal, is sieved, mixed, with 5 times of ethanol (concentration 70wt%) of amount, decoct 2
It is secondary, 1 hour every time, merge decoction liquor, filtration, filtrate concentrate drying obtains extract dry powder.Sucrose 30g, essence 20g are added, plus
Water is made 1000mL and adjusts pH value to 7, shakes up, and stands 12 hours, and filtering is filling, and sterilizing is made oral liquid.
Embodiment 5：
Weigh each composition of following weight：Radix Astragali 20g, ganoderma lucidum 15g, Radix Codonopsis 20g, cordate houttuynia 15g, root of Chinese trichosanthes 9g, the root of large-flowered skullcap
9g, radix bupleuri 10g, Radix Glycyrrhizae 9g.
Above-mentioned eight tastes traditional Chinese medicine powder is broken into meal, sieve, mix, with 15 times amount water, decoct 3 times, 3 hours every time,
Merge extract solution, filtration, filtrate is concentrated into right amount, is dried to obtain extract dry powder.Extract dry powder is dissolved in purified water, plus simple syrup
To 1000ml, syrup is made.
Embodiment 6：To the adjuvant drug pharmaceutical composition for treating AIDS prepared in above-described embodiment 1-5
Quality control is carried out, the detecting step is as follows：
(1) scutelloside reference substance is taken appropriate, it is accurately weighed, plus methyl alcohol is made solution of every 1ml containing 100 μ g, is made the root of large-flowered skullcap
Glycosides reference substance solution.
(2) medicine for taking the adjuvant drug for the treatment of AIDS to be measured is appropriate, finely ground, takes about 0.5g, accurately weighed, puts
In the volumetric flask of 100ml, plus methyl alcohol 40ml, weighed weight, ultrasonic extraction 30min, the weight of less loss is supplied with methyl alcohol, filter,
It is made need testing solution；
(3) it is another to take the appropriate negative control medicinal material for lacking the root of large-flowered skullcap, it is accurately weighed, in putting the volumetric flask of 100ml, plus methyl alcohol
40ml, weighed weight, ultrasonic extraction 30min supplies the weight of less loss with methyl alcohol, and filtration, the negative control for being made the scarce root of large-flowered skullcap is molten
Liquid；
(4) it is 30 with volume ratio with octadecyl silane as filler:The phosphoric acid solution of 70 acetonitrile -0.05%
It is mobile phase, sets flow velocity as 0.8ml/min, Detection wavelength is 280nm, and column temperature is 28 DEG C, and theoretical cam curve presses scutelloside peak
Meter is not less than 2500；Scutelloside reference substance solution and each 10 μ l of need testing solution are taken, is detected at a wavelength of 280 nm.
Fig. 1-Fig. 3 is specifically referred to, wherein, Fig. 1 is reference substance solution high-efficient liquid phase chromatogram.Fig. 2 is that test sample (is implemented
Pharmaceutical composition obtained in example 1) solution high-efficient liquid phase chromatogram.Fig. 3 is negative control solution high-efficient liquid phase chromatogram.
Result shows, negative control with scutelloside reference substance retention time same position on occur without chromatographic peak, show
Other medicinal materials on measurement result without influence, while prepared in above-described embodiment 1-5 for treat AIDS auxiliary use
Between the scope of the assay result of scutelloside is 5.31-5.82mg/g in medicine pharmaceutical composition, the pharmaceutical composition has
Quality controllability.
During said determination, comprise the following steps for system suitability experiment：
(1) investigation of linear relationship
Take scutelloside reference substance appropriate, it is accurately weighed, plus methyl alcohol is made solution of every 1ml containing 1.06mg, shakes up, as storage
Standby liquid.Precision draws above-mentioned stock solution 0.2ml, 0.6ml, 1.0ml, 1.2ml, 1.4ml, 1.6ml, 2.0ml to 10ml capacity
In bottle, with the phosphoric acid water of acetonitrile -0.05% (30:70) scale is diluted to, miillpore filter filtration takes subsequent filtrate, and the μ L of each sample introduction 10 are surveyed
Determine peak area, with reference substance peak area as ordinate (Y), concentration carries out linear regression for abscissa (X), obtains regression equation y=
9E+07x -29273 (r=0.9996), the range of linearity is 0.212~2.12 μ g.
(2) precision test is accurate draws the same μ l of reference substance solution 10, and continuous sample introduction 6 times determines the peak face of chromatographic peak
Product, the RSD of scutelloside is 0.31%, is as a result shown, precision is good.
(3) stability test is accurate draws the same μ l of reference substance solution 10, respectively at 0,2,4,6,12 hours sample introductions, determines
The peak area of chromatographic peak, it is 0.82% to obtain the RSD values of scutelloside peak area, as a result shows good in 0~12 hour internal stability.
(4) replica test takes the same lot number adjuvant drug pharmaceutical composition for treating AIDS to be measured in right amount, finely ground, takes
5 parts of samples of about 0.5g, it is accurately weighed respectively, sample treatment is carried out according to sample preparation methods, sample introduction is determined respectively, obtains Huang
The RSD of a kind of reed mentioned in ancient books glycosides is 1.45%, as a result shows that the method reappearance is preferable.
(5) recovery test take known content same lot number it is to be measured treatment AIDS adjuvant drug pharmaceutical composition fit
Amount, it is finely ground, about 0.25g is taken, it is accurately weighed, a certain amount of scutelloside reference substance is added, determine in accordance with the law, according to chromatographic peak peak area
Value, calculates the rate of recovery, and it is 1.19% to obtain RSD, is shown in Table 5.Result shows that this law rate of recovery is good.
The rate of recovery result of table 5
(6) measure of sample
The adjuvant drug pharmaceutical composition of Example 1-3 treatment AIDS to be measured is appropriate, finely ground, respectively takes about 0.5g, essence
It is close weighed, in putting the volumetric flask of 100ml, plus methyl alcohol 40ml, weighed weight, ultrasonic extraction 30min, the weight of less loss is supplied with methyl alcohol
Amount, filtration is made need testing solution, and precision draws the μ L sample introductions of subsequent filtrate 10, and the content of scutelloside is determined by above-mentioned chromatographic condition,
The results are shown in Table 6.
The sample size measurement result (n=3) of table 6
2nd, effect experiment
Strengthen immunity drug effect is designed
(1) experimental study of pharmaceutical composition resisted motion fatigue effect of the present invention
1 experimental animal
Healthy adult Kunming mouse 48,18~22g of body weight, male and female are not limited.
2 methods and result
2.1 experimental techniques
2.1.1 animal packet
48 mouse are randomly divided into three groups, experimental group, positive controls, blank control group, every group 16.Experimental group is filled
Stomach pharmaceutical composition 3.93g/ (kgd) of the present invention, (Beijing rhodiola root technological development of positive controls gavage Rhodiola root oral liquid
Co., Ltd) 1ml/d, blank control group gavage distilled water 10ml/ (kgd).Every group of successive administration 28 days.
2.1.2 to the influence of mice burden swimming time：After last gavage 0.5h, by the mouse tail root load after packet
The lead of 5% body weight, (depth of water 30cm, temperature (25 ± 1.0) DEG C, record mouse enters water swimming to be put into swimming pool went swimming by group
Do not refloated to sinking under water the required time.
2.1.3 to the influence of mouse normobaric hypoxia ability：According to above-mentioned packet requirement, three groups of mouse, last are equally chosen
After gavage 0.5h, mouse is placed in the port grinding bottle added with the 250ml of 5% soda lime, bottleneck is applied with vaseline and sealed, records mouse
Since bottle inlet to the dead time experienced.
2.1.4 to the influence of mouse HB contents：Packet is required more than, chooses three groups of mouse, after last gavage 0.5h,
Eyeball of mouse blood sampling is won, every mouse HB content is determined using Automatic Blood Cell Analyzer (stepping auspicious BC-5000, Guangdong).
2.1.5 to the influence of mouse Serum lactic acid content after motion：Three groups of mouse are chosen, after last gavage 0.5h, blood sampling (
At intraocular corner of the eyes veniplex) 20 μ l, determine Serum lactic acid content using blood lactase acid analyzer (YSI1500SPORT, the U.S.).Then exist
In the case of not bearing a heavy burden, swimming pool went swimming [water temperature (30 ± 1.0) DEG C] is put into, is taken out after 10min, blood sampling immediately determines blood lactase acid
Content, blood sampling determines Serum lactic acid content again after rest 20min.Before contrasting the motion of three groups of experiment mices, immediate postexercise and fortune
The change of Serum lactic acid content in vivo after dynamic end 20min.
2.1.6 to the influence of mouse blood BUN：Three groups of mouse are chosen, after last gavage 0.5h, swimming pool went swimming [water is put into
Warm (30 ± 1.0) DEG C], taken out after 90min, eyeball of mouse blood sampling is won immediately, serum is centrifuged, determine BUN contents.
2.2 statistical analysis
All data mean ± standard deviationRepresent, mean compares and checked with t between group.United using SPSS16.0
Meter software carries out data processing.One-way analysis of variance is carried out, is checked with LSD when variance has homogeneous, heterogeneity of variance is used
Dunnett, s T3 inspections are compared between carrying out each group.P<0.05 expression difference has conspicuousness.
2.3 results
2.3.1 to the influence of mice burden swimming time and normobaric hypoxia endurance：Through small after this pharmaceutical composition gavage
Compared with blank control group, walking weight load extends 118.9% (P to mouse<0.01) it is, positive right with gavage Rhodiola root oral liquid
(P is more also obviously prolonged according to group<0.01)；The anoxia tolerance of experimental mice is also significantly increased 40.2% (P<0.01),
But with positive controls comparing difference without conspicuousness (P>0.05, n=16) (it is shown in Table 1).
The pharmaceutical composition of the present invention of table 1 to mice burden swimming time and normobaric hypoxia endurance influence (min,)
Note：Compare with positive controls, * P<0.05, * * P<0.01；
Compare with blank control group, #P<0.05, ##P<0.01
2.3.2 to the influence of blood BUN after mouse HB contents and motion：Result shows, after taking this medicine 28 days, mouse HB
Content raises 34% (P<0.01), with positive controls comparing difference without conspicuousness (P>0.05, n=16) this medicine, is taken small
Serum BUN contents decline 25% (P after mouse motion<0.01), reduce by 12% (P compared with positive controls<0.01, n=16) (see
Table 2).
Influence of the medicine of the present invention of table 2 to mouse HB and BUN
Note：Compare with positive controls, * P<0.05, * * P<0.01；
Compare with blank control group, #P<0.05, ##P<0.01
2.3.3 to the influence of mouse blood lactase acid value：Test result indicate that, the different equal nothing of blood lactase acid value difference before each group mouse movement
Statistical significance (P>0.05).After swimming at once, each group mouse blood lactase acid value has and substantially increases (P<0.05)；With blank
Group compares, and experimental group and positive controls have notable difference (P<0.01), that is, take Rhodiola root oral liquid and take the medicine
Mouse blood lactase acid value elevated levels be significantly lower than blank control group, and no significant difference (P between positive group and experimental group<
0.05).After rest 20 minutes, each group blood lactase acid value has substantially reduces (P<0.05)；Experimental group and positive controls blood lactase acid
Value is below blank control group (P<0.01), and between experimental group and positive controls there is also difference (P<0.01, n=16)
(being shown in Table 3).
The pharmaceutical composition of the present invention of table 3 to mouse Lactate influence (mmol/L,)
Note：Compare with positive group, * P<0.05, * * P<0.01
Test result indicate that：This medicine can be obviously prolonged mice burden swimming run duration, illustrate that it has stronger
The effect of delay fatigue, can effectively improve exercise tolerance；Tolerance of the body to anaerobic environment can effectively be strengthened；Can
Significantly improve HB contents；The content of BUN after moving can be reduced, its reduction amplitude becomes apparent from compared with rhodiola root；Can significantly reduce small
The accumulation of blood lactase acid in vivo after mouse motion.This shows that anaerobic glycolysis is suppressed, and cell has coefficient of oxygen utilization to be improved, so that
Enhance aerobic metabolism and the energy supply of body；After rest 20min, blood lactase acid value greatly reduces, and fatigue is relieved.
(2) pharmaceutical composition enhancing body of the present invention strengthens the experimental study of non-specific immune function
Endoxan (cyclophosphamide, CTX) as a kind of cellulotoxic chemotherapeutics, while falling within alkylating agent
Para-immunity inhibitor, its effect mainly destroys the structure of DNA, so as to block its duplication, causes cell death.And in immune poison
In Neo-Confucianism, endoxan is the common drug for preparing immunosuppression model.
1 material
Reagent, apparatus and medicine
Endoxan (Sigma companies), by 60mg/kg body weight (weekly dose), is prepared, daily orally administration with distilled water；
Electron portable balance (model：JM5102, Yuyao City discipline inscription is weighed calibration equipment Co., Ltd, precision 0.1g)；Syringe
(specification：1ml)；Injection needle；Gavage syringe needle；Psychrometer；Brown reagent bottle；Positive controls：Positive control drug:Shark liver
Alcohol, is left intact, and only uses forage feed；Tested group：Medicine group of the present invention.
1.2 experimental animals
Balb/C mouse 72, female, 6~8 week old, 18~22g of body weight.
2 methods and result
2.1 pairs of function of increasing leukocyte of endoxan model mice
Mouse 36 is taken, 3 groups are randomly divided into, the daily gavage distilled water 10ml/kgd of blank control group, remaining group is daily
Gavage 60mg/kg endoxan, the cycle is 30 days.Experimental group gavage pharmaceutical composition 1.0g/ (kgd) of the present invention, it is positive right
According to group gavage batyl alcohol 10ml/kg.d, every group of successive administration 28 days.After last dose 1 hour, mouse orbit takes blood and surveys leucocyte
Number.Result shows：Endoxan can make mouse blood leukocytes number be decreased obviously (P<0.01), medicine of the present invention can resist ring phosphinylidyne
The effect that amine induced mice leucocyte declines, is shown in Table 4.
The influence that the pharmaceutical composition of the present invention of table 4 is reduced to caused by cyclophosphamide murine interleukin
Note：Compare with positive controls, * P<0.05, * * P<0.01
Compare with blank control group, △ P<0.05, △ △ P<0.01
2.2 pairs of influences of endoxan model mice immune organ
Mouse 36 is taken, 3 groups are randomly divided into, experimental technique is ibid.In after last dose 1 hour, solution take mouse thymus,
Spleen, weighs and calculates organ index.Result shows：Endoxan can cause mouse thymus, spleen atrophy, organ organ index
Significantly mitigate, and pharmaceutical composition of the present invention plays the role of confrontation endoxan and suppresses immune organ, to non-specific epidemic disease function
There is certain promotion, be shown in Table 5.
The pharmaceutical composition of the present invention of table 5 is to the thymus gland of caused by cyclophosphamide mouse, the influence of spleen weight mitigation
Note：Compare with positive controls, * P<0.05, * * P<0.01
Compare with blank control group, △ P<0.05, △ △ P<0.01 .
Claims (10)
1. a kind of pharmaceutical composition for treating the adjuvant drug of AIDS, it is characterised in that under the pharmaceutical composition contains
State composition：
Radix Astragali 15-45 weight Ganoderma Lucidum 10-20 weight portions
Radix Codonopsis 10-20 weight portion cordate houttuynia 8-18 weight portions
Root of Chinese trichosanthes 8-16 weight portion root of large-flowered skullcap 7-17 weight portions
Radix bupleuri 6-18 weight portion Radix Glycyrrhizae 5-14 weight portions.
2. pharmaceutical composition as claimed in claim 1, it is characterised in that the pharmaceutical composition is made tablet, capsule, particle
Agent, electuary or oral liquid.
3. the preparation method of the pharmaceutical composition of the adjuvant drug for treating AIDS as described in claim 1-2, it is special
Levy and be, the Chinese medicine of each composition is made extract dry powder after water extraction or alcohol extracting, add pharmaceutically acceptable auxiliary material, be made
Tablet, capsule, granule, electuary or oral liquid.
4. preparation method as claimed in claim 3, it is characterised in that the water extraction is by the Chinese medicine 10-35 of each composition
The decocting of amount again is boiled 2-4 times, each 1-6 hours；The alcohol extracting be by it is each into Chinese medicine with the 5-15 times of concentration measured be 30~
The ethanol of 90wt% is decocted 2-4 times, each 1-6 hours.
5. preparation method as claimed in claim 3, it is characterised in that the pharmaceutically acceptable auxiliary material includes adhesive, collapses
Solution agent, glidant, plasticizer and/or diluent.
6. the preparation method of the pharmaceutical composition of the adjuvant drug for treating AIDS as described in claim 1-2, it is special
Levy and be,
（1）By in addition to ganoderma lucidum the Chinese medicine soak 30-120 minutes it is standby；
（2）Chinese medicine will be soaked described in addition to ganoderma lucidum extract solution has been made after water extraction or alcohol extracting, 30-90 DEG C has been concentrated under reduced pressure
It is the medicinal extract of 1.10-1.58 to relative density；
（3）Ganoderma lucidum is ground into fine powder, the fine powder is that can all pass through No. five sieves and can be by No. six powder of sieve not
Less than 95%；
（4）By step（3）The ganoderma lucidum fine powder for obtaining is added to step（2）Medicinal extract in, add pharmaceutically acceptable auxiliary material, make
Piece agent, capsule, granule, electuary or oral liquid.
7. preparation method as claimed in claim 6, it is characterised in that the water extraction is by the Chinese medicine 10-35 of each composition
The decocting of amount again is boiled 2-4 times, each 1-6 hours；The alcohol extracting be by it is each into Chinese medicine with the 5-15 times of concentration measured be 30~
The ethanol of 90wt% is decocted 2-4 times, each 1-6 hours.
8. preparation method as claimed in claim 6, it is characterised in that the pharmaceutically acceptable auxiliary material includes adhesive, collapses
Solution agent, glidant, flavouring, plasticizer and/or diluent.
9. a kind of quality control of the pharmaceutical composition of the adjuvant drug for being used to treat AIDS as claimed in claim 1 or 2
Method, it is characterised in that using the content of scutelloside in high effective liquid chromatography for measuring sample to be tested；Chromatographic condition is：With
Volume ratio is 30:70 phosphoric acid solution of acetonitrile -0.05% carries out isocratic elution for mobile phase, and Detection wavelength is 280nm.
10. method of quality control as claimed in claim 9, it is characterised in that specifically include following step：
（1）Take scutelloside reference substance appropriate, it is accurately weighed, plus methyl alcohol is made solution of every 1ml containing 100 μ g, is made scutelloside pair
According to product solution；
（2）The pharmaceutical composition for taking treatment AIDS adjuvant drug to be measured is appropriate, finely ground, takes about 0.5g, accurately weighed, puts
In the volumetric flask of 100ml, plus methyl alcohol 40ml, weighed weight, ultrasonic extraction 30min, the weight of less loss is supplied with methyl alcohol, filter,
It is made need testing solution；
（3）It is another to take the appropriate negative control medicinal material for lacking the root of large-flowered skullcap, it is accurately weighed, in putting the volumetric flask of 100ml, plus methyl alcohol 40ml,
Weighed weight, ultrasonic extraction 30min supplies the weight of less loss with methyl alcohol, filtration, is made the negative control solution of the scarce root of large-flowered skullcap；
（4）It is 30 with volume ratio with octadecyl silane as filler:The phosphoric acid solution of 70 acetonitrile -0.05% is flowing
Phase, sets flow velocity as 0.8ml/min, and Detection wavelength is 280nm, and column temperature is 28 DEG C, and theoretical cam curve is not low based on scutelloside peak
In 2500；Scutelloside reference substance solution and each 10 μ l of need testing solution are taken, is detected at a wavelength of 280 nm.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107569564A (en) * | 2017-09-14 | 2018-01-12 | 桂林医学院 | A kind of AIDS adjuvant therapy medicaments and preparation method thereof |
| CN107582631A (en) * | 2017-09-30 | 2018-01-16 | 贾忠 | A kind of Chinese medicine compound prescription of auxiliary treatment AIDS and preparation method thereof |
| CN107894466A (en) * | 2017-10-16 | 2018-04-10 | 贾忠 | The assay method and the antitoxin quality of the pharmaceutical preparations control method of golden mulberry stilbene of a kind of golden antitoxin preparation HPLC fingerprint pattern of mulberry stilbene |
| CN108969700A (en) * | 2018-09-29 | 2018-12-11 | 杭州中非生物科技有限公司 | The Chinese medicine composition of strengthen immunity |
| CN110898181A (en) * | 2019-12-18 | 2020-03-24 | 天津冠勤医药科技有限公司 | anti-AIDS medicine and its preparing method |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101264148A (en) * | 2006-06-16 | 2008-09-17 | 贵州益佰制药股份有限公司 | Quality control method of yinzhihuang preparation |
-
2017
- 2017-03-30 CN CN201710203961.6A patent/CN106924406B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101264148A (en) * | 2006-06-16 | 2008-09-17 | 贵州益佰制药股份有限公司 | Quality control method of yinzhihuang preparation |
Non-Patent Citations (1)
| Title |
|---|
| 王建云等: "中医药治疗艾滋病临床疗效观察", 《医学信息》 * |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107569564A (en) * | 2017-09-14 | 2018-01-12 | 桂林医学院 | A kind of AIDS adjuvant therapy medicaments and preparation method thereof |
| CN107582631A (en) * | 2017-09-30 | 2018-01-16 | 贾忠 | A kind of Chinese medicine compound prescription of auxiliary treatment AIDS and preparation method thereof |
| CN107894466A (en) * | 2017-10-16 | 2018-04-10 | 贾忠 | The assay method and the antitoxin quality of the pharmaceutical preparations control method of golden mulberry stilbene of a kind of golden antitoxin preparation HPLC fingerprint pattern of mulberry stilbene |
| CN108969700A (en) * | 2018-09-29 | 2018-12-11 | 杭州中非生物科技有限公司 | The Chinese medicine composition of strengthen immunity |
| CN108969700B (en) * | 2018-09-29 | 2021-07-30 | 杭州中非生物科技有限公司 | Traditional Chinese medicine composition for enhancing immunity |
| CN110898181A (en) * | 2019-12-18 | 2020-03-24 | 天津冠勤医药科技有限公司 | anti-AIDS medicine and its preparing method |
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