CN106924406B - A pharmaceutical composition for adjuvant treatment of AIDS and its preparation method - Google Patents

A pharmaceutical composition for adjuvant treatment of AIDS and its preparation method Download PDF

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CN106924406B
CN106924406B CN201710203961.6A CN201710203961A CN106924406B CN 106924406 B CN106924406 B CN 106924406B CN 201710203961 A CN201710203961 A CN 201710203961A CN 106924406 B CN106924406 B CN 106924406B
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pharmaceutical composition
chinese medicinal
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aids
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贾忠
董大海
吴晶
刘鸿雁
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贾忠
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481Astragalus (milkvetch)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06Fungi, e.g. yeasts
    • A61K36/07Basidiomycota, e.g. Cryptococcus
    • A61K36/074Ganoderma
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/233Bupleurum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/34Campanulaceae (Bellflower family)
    • A61K36/344Codonopsis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/42Cucurbitaceae (Cucumber family)
    • A61K36/428Trichosanthes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/539Scutellaria (skullcap)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/78Saururaceae (Lizard's-tail family)
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/88Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/88Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/884Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample organic compounds

Abstract

The invention discloses a pharmaceutical composition for adjuvant treatment of AIDS and a preparation method thereof. The pharmaceutical composition of the invention comprises the following components: 15-45 parts of astragalus, 10-20 parts of lucid ganoderma, 10-20 parts of codonopsis pilosula, 8-18 parts of houttuynia cordata, 8-16 parts of trichosanthes root, 7-17 parts of scutellaria baicalensis, 6-18 parts of radix bupleuri and 5-14 parts of liquorice. The pharmaceutical composition has the effects of delaying fatigue and enhancing nonspecific immunity, and can be used as an auxiliary medicine for treating AIDS.

Description

A pharmaceutical composition for adjuvant treatment of AIDS and its preparation method
Technical Field
The invention relates to the field of pharmaceutical compositions, in particular to a pharmaceutical composition for adjuvant treatment of AIDS and a preparation method thereof.
Background
AIDS is a very harmful infectious disease caused by infection with the HIV virus. HIV is a virus that attacks the human immune system. It takes the most important CD4T lymphocyte in human immune system as the main target of attack, largely destroys the cell, and makes human body lose immune function. Therefore, the human body is easy to be infected with various diseases, malignant tumors can occur, and the fatality rate is high. The existing medicines at present lack medicines which can maintain, improve or rebuild the immune system of AIDS patients.
Disclosure of Invention
In order to solve the above problems in the prior art, the present invention provides a pharmaceutical composition for adjuvant therapy for treating aids (hereinafter, sometimes referred to as "the pharmaceutical composition of the present invention"), which has the effects of enhancing the immunity against HIV and reconstructing the immune system of the body.
The invention relates to a pharmaceutical composition for adjuvant treatment of AIDS, which comprises the following components:
the pharmaceutical composition preferably comprises the following components in parts by weight:
further preferably contains the following components in parts by weight:
also preferably contains the following components in parts by weight:
also preferably contains the following components in parts by weight:
the pharmaceutical composition is characterized by being prepared into tablets, capsules, granules or oral liquid preparations.
The preparation method of the pharmaceutical composition for adjuvant therapy of AIDS is characterized in that the traditional Chinese medicinal materials of all the components are extracted by water or alcohol to prepare extract dry powder, and then pharmaceutically acceptable auxiliary materials are added to prepare tablets, capsules, granules or oral liquid preparations.
The preparation method is characterized in that the water extraction is to decoct the traditional Chinese medicinal materials of each component with 10-35 times of water for 2-4 times, and each time lasts for 1-6 hours; the alcohol extraction is to decoct each Chinese medicinal material with 5-15 times of 30-90 wt% ethanol for 2-4 times, and each time lasts for 1-6 hours.
The preparation method is characterized in that the pharmaceutically acceptable auxiliary materials comprise a binder, a disintegrant, a glidant, a plasticizer and/or a diluent.
The preparation method of the pharmaceutical composition for adjuvant therapy of AIDS is characterized in that,
(1) soaking the Chinese medicinal materials except for Ganoderma for 30-120 min;
(2) extracting the soaked Chinese medicinal materials except Ganoderma with water or ethanol to obtain extractive solution, and concentrating under reduced pressure at 30-90 deg.C to obtain extract with relative density of 1.10-1.58;
(3) crushing the lucid ganoderma into fine powder, wherein the fine powder is not less than 95% of powder which can pass through a fifth sieve and can pass through a sixth sieve;
(4) adding the ganoderma lucidum fine powder obtained in the step (3) into the extract obtained in the step (2), adding pharmaceutically acceptable auxiliary materials, and preparing tablets, capsules, granules, electuary or oral liquid preparations.
The preparation method is characterized in that the water extraction is to decoct the traditional Chinese medicinal materials of each component with 10-35 times of water for 2-4 times, and each time lasts for 1-6 hours; the alcohol extraction is to decoct each Chinese medicinal material with 5-15 times of 30-90 wt% ethanol for 2-4 times, and each time lasts for 1-6 hours.
The preparation method is characterized in that the pharmaceutically acceptable auxiliary materials comprise a binder, a disintegrant, a glidant, a flavoring agent, a plasticizer and/or a diluent.
The invention also provides a quality control method of the pharmaceutical composition for adjuvant drug use for treating AIDS, which adopts high performance liquid chromatography to determine the content of baicalin in a sample to be tested.
In the quality control method, the chromatographic conditions for determining the content of the baicalin in the sample to be tested by the high performance liquid chromatography are as follows: taking acetonitrile-0.05% phosphoric acid solution with a volume ratio of 30:70 as a mobile phase for isocratic elution, wherein the detection wavelength is 280 nm.
The quality control method specifically comprises the following steps:
(1) taking appropriate amount of baicalin reference substance, precisely weighing, adding methanol to obtain solution containing 100 μ g of baicalin per 1ml, and making into baicalin reference substance solution;
(2) taking a proper amount of the pharmaceutical composition to be tested for the aids adjuvant drug, grinding, precisely weighing about 0.5g, placing in a 100ml volumetric flask, adding 40ml of methanol, weighing, ultrasonically extracting for 30min, supplementing the lost weight with methanol, filtering, and making into a test solution;
(3) precisely weighing appropriate amount of negative control material lacking Scutellariae radix, placing in 100ml volumetric flask, adding 40ml of methanol, weighing, ultrasonically extracting for 30min, supplementing the weight loss with methanol, and filtering to obtain negative control solution lacking Scutellariae radix;
(4) octadecyl bonded silica gel is used as a filling agent, acetonitrile-0.05 percent phosphoric acid solution with the volume ratio of 30:70 is used as a mobile phase, the set flow rate is 0.8ml/min, the detection wavelength is 280nm, the column temperature is 28 ℃, and the theoretical plate number is not less than 2500 according to the baicalin peak; taking 10 μ l each of baicalin control solution and sample solution, and detecting at 280nm wavelength.
The medicinal composition is prepared by screening and combining the middle-jiao tonifying and qi-benefiting decoction carried by the Jinyuan medical Li Dongyuan 'the theory of spleen and stomach' according to the causes, pathogenesis and clinical symptoms of AIDS and the formula principle of the traditional Chinese medical science and methods and the research results of modern traditional Chinese medicines. The medicinal composition uses the astragalus root as a main medicament, and has the effects of tonifying middle-jiao and Qi, strengthening body resistance and banking up root; the lucid ganoderma is used for supplementing essence and enriching blood, strengthening muscles and bones, and strengthening the body. Radix Codonopsis is added to nourish yin and promote the production of body fluid, and invigorate qi and nourish blood; the houttuynia cordata thunb can clear heat and remove toxicity, and eliminate toxicity and eliminate evil. And the snakegourd root is used for nourishing yin, promoting the production of body fluid, purging fire and expelling toxin. Wu Huang Qin clears heat and dries dampness, cools blood and detoxifies. The bupleurum root is matched for regulating liver qi, expelling pathogenic factors and resolving stagnation; the liquorice is used for tonifying qi and strengthening the middle-jiao, clearing away heat and toxic material and coordinating the property of the medicine. The medicines of the whole formula are compatible, so that qi and blood are supplemented, toxicity and heat are relieved, healthy qi is recovered, original qi is full, and moxa evil must be eliminated. In the formula, the astragalus, the codonopsis pilosula and the lucid ganoderma have the effects of enhancing the phagocytic capacity of macrophages and positively regulating, protecting and repairing all systems of an organism; the heartleaf houttuynia herb, the Mongolian snakegourd root, the baical skullcap root, the Chinese thorowax root and the liquoric root have better antiviral and antibacterial effects and can enhance the immunity of organisms to HIV. The composition is used in Lung Hospital infectious department in Lanzhou for many years, is used as an auxiliary medicine for AIDS, has the effects of clearing heat, eliminating pathogenic factors, strengthening body resistance and consolidating constitution, and can be used for reconstructing an organism immune system while inhibiting HIV. In addition, the granules have the advantages of quick absorption and quick effect; the dosage is small, and the taste is good; the production equipment is simple and easy to operate; the traditional Chinese medicine has the characteristics of convenience in taking, carrying, storage and transportation, and has advantages in the aspects of safety, economy and the like compared with western medicines.
Drawings
FIG. 1 is a high performance liquid chromatogram of a control solution.
FIG. 2 is a high performance liquid chromatogram of a test solution.
FIG. 3 is a high performance liquid chromatogram of a negative control solution.
Detailed Description
The following description of the preferred embodiments of the present invention is provided for the purpose of illustration and description, and is in no way intended to limit the invention.
Preparation and quality control of pharmaceutical composition for adjuvant treatment of AIDS
Example 1
The following ingredients were weighed: 30g of astragalus, 15g of lucid ganoderma, 15g of codonopsis pilosula, 12g of houttuynia cordata, 12g of trichosanthes root, 12g of scutellaria baicalensis, 12g of radix bupleuri and 9g of liquorice.
Pulverizing the above Ganoderma materials into fine powder which can pass through a fifth sieve and no less than 95% of the powder which can pass through a sixth sieve; soaking the rest materials such as radix astragali in water for 1 hr, reflux-extracting with 10 times, 8 times and 8 times of water for three times, 1 hr for the first time, 1 hr for the second time and 0.5 hr for the third time, mixing filtrates, concentrating under reduced pressure at 60 deg.C to obtain extract with relative density of 1.20, mixing with Ganoderma fine powder, adding appropriate amount of soluble starch, granulating, drying, grading, and making into granule.
Example 2
The following ingredients were weighed: 15g of astragalus, 10g of lucid ganoderma, 10g of codonopsis pilosula, 8g of houttuynia cordata, 8g of trichosanthes root, 7g of scutellaria baicalensis, 6g of radix bupleuri and 5g of liquorice.
Pulverizing the above Ganoderma materials into fine powder which can pass through a fifth sieve and no less than 95% of the powder which can pass through a sixth sieve; soaking the rest materials such as radix astragali in water for 1 hr, reflux-extracting with 15 times, 10 times and 10 times of water for three times, 1 hr for the first time, 2 hr for the second time and 3 hr for the third time, mixing filtrates, concentrating under reduced pressure at 60 deg.C to obtain extract with relative density of 1.38, mixing with Ganoderma fine powder, adding appropriate amount of soluble starch, granulating, drying, grading, and making into capsule.
Example 3:
the following ingredients were weighed: 45g of astragalus, 20g of lucid ganoderma, 20g of codonopsis pilosula, 18g of houttuynia cordata, 16g of trichosanthes root, 17g of scutellaria baicalensis, 18g of radix bupleuri and 14g of liquorice.
Pulverizing the above Ganoderma materials into fine powder which can pass through a fifth sieve and no less than 95% of the powder which can pass through a sixth sieve; soaking the rest materials such as radix astragali in water for 1 hr, reflux-extracting with 3 times, 5 times and 5 times of water for three times, 1 hr for the first time, 1 hr for the second time and 1 hr for the third time, mixing filtrates, concentrating under reduced pressure at 60 deg.C to obtain extract with relative density of 1.58, mixing with Ganoderma fine powder, drying to obtain dry extract powder, adding appropriate amount of soluble starch, 0.8g magnesium stearate and 5g pulvis Talci, and making into tablet.
Example 4:
the following ingredients were weighed: 16g of astragalus, 16g of lucid ganoderma, 16g of codonopsis pilosula, 13g of houttuynia cordata, 11g of trichosanthes root, 13g of scutellaria baicalensis, 14g of radix bupleuri and 10g of liquorice.
Pulverizing the above eight Chinese medicinal materials into coarse powder, sieving, mixing, decocting with 5 times of ethanol (concentration 70 wt%) for 2 times, each time for 1 hr, mixing decoctions, filtering, concentrating the filtrate, and drying to obtain dry extract powder. Adding sucrose 30g and essence 20g, adding water to 1000mL, adjusting pH to 7, shaking, standing for 12 hr, filtering, bottling, sterilizing, and making into oral liquid.
Example 5:
the following ingredients were weighed: 20g of astragalus, 15g of lucid ganoderma, 20g of codonopsis pilosula, 15g of houttuynia cordata, 9g of trichosanthes root, 9g of scutellaria baicalensis, 10g of radix bupleuri and 9g of liquorice.
Pulverizing the above eight Chinese medicinal materials into coarse powder, sieving, mixing, decocting with 15 times of water for 3 times, each for 3 hr, mixing extractive solutions, filtering, concentrating the filtrate to appropriate amount, and drying to obtain dry extract powder. Dissolving the dry extract powder in purified water, adding simple syrup to 1000ml, and making into syrup.
Example 6: the quality control of the pharmaceutical composition for adjuvant treatment of aids prepared in the above examples 1-5 was carried out by the following detection steps:
(1) taking appropriate amount of baicalin control, precisely weighing, adding methanol to obtain solution containing 100 μ g of baicalin per 1ml, and making into baicalin control solution.
(2) Taking a proper amount of medicine of an auxiliary medicine for treating AIDS to be detected, grinding, precisely weighing about 0.5g, placing in a volumetric flask of 100ml, adding 40ml of methanol, weighing, ultrasonically extracting for 30min, supplementing the lost weight with methanol, filtering, and making into a test solution;
(3) precisely weighing appropriate amount of negative control material lacking Scutellariae radix, placing in 100ml volumetric flask, adding 40ml of methanol, weighing, ultrasonically extracting for 30min, supplementing the weight loss with methanol, and filtering to obtain negative control solution lacking Scutellariae radix;
(4) octadecyl bonded silica gel is used as a filling agent, acetonitrile-0.05 percent phosphoric acid solution with the volume ratio of 30:70 is used as a mobile phase, the set flow rate is 0.8ml/min, the detection wavelength is 280nm, the column temperature is 28 ℃, and the theoretical plate number is not less than 2500 according to the baicalin peak; taking 10 μ l each of baicalin control solution and sample solution, and detecting at 280nm wavelength.
Specifically, refer to fig. 1-3, wherein fig. 1 is a high performance liquid chromatogram of a control solution. FIG. 2 is a high performance liquid chromatogram of a solution of a test substance (the pharmaceutical composition prepared in example 1). FIG. 3 is a high performance liquid chromatogram of a negative control solution.
The result shows that no chromatographic peak appears on the negative control at the same position of the retention time of the baicalin control, which indicates that other medicinal materials have no influence on the determination result, and the range of the determination result of the baicalin content in the auxiliary medicinal composition for treating AIDS, which is prepared in the above examples 1-5, is between 5.31 mg/g and 5.82mg/g, and the medicinal composition has quality controllability.
In the above measurement process, the test for the applicability of the system comprises the following steps:
(1) investigation of Linear relationships
Taking appropriate amount of baicalin as reference substance, precisely weighing, adding methanol to obtain solution containing 1.06mg per 1ml, and shaking to obtain stock solution. Precisely sucking the stock solution into a volumetric flask with the volume of 0.2ml, 0.6ml, 1.0ml, 1.2ml, 1.4ml, 1.6ml and 2.0ml to 10ml, diluting the flask with acetonitrile-0.05% phosphoric acid water (30:70) to a scale, filtering the flask with a microfiltration membrane, taking subsequent filtrates, feeding 10 mu L of each sample, measuring the peak area, and performing linear regression by taking the peak area of a reference substance as an ordinate (Y) and the concentration as an abscissa (X) to obtain a regression equation Y of 9E + 07X-29273 (r is 0.9996) with the linear range of 0.212 to 2.12 mu g.
(2) The precision test precisely absorbs 10 mul of the same reference substance solution, samples are continuously injected for 6 times, the peak area of a chromatographic peak is measured, the RSD of the baicalin is 0.31 percent, and the result shows that the precision is good.
(3) The stability test precisely absorbs 10 mul of the same reference substance solution, samples are respectively injected in 0 hour, 2 hours, 4 hours, 6 hours and 12 hours, the peak area of a chromatographic peak is measured, the RSD value of the baicalin peak area is 0.82%, and the result shows that the stability is good in 0-12 hours.
(4) The repeatability test takes a proper amount of the auxiliary medicine composition to be tested for treating AIDS of the same batch number, grinds the same, takes 5 parts of samples of about 0.5g, precisely weighs the samples respectively, processes the samples according to the sample preparation method, and performs sample injection measurement respectively to obtain the RSD of the baicalin of 1.45 percent, and the result shows that the method has better repeatability.
(5) Recovery test A proper amount of the pharmaceutical composition for adjuvant treatment of AIDS is collected from the same batch to be tested, and ground, about 0.25g is precisely weighed, and a certain amount of baicalin reference substance is added, and the recovery is calculated according to the peak area value of chromatographic peak, and the RSD is 1.19%, as shown in Table 5. The results show that the method has good recovery rate.
TABLE 5 recovery results
(6) Determination of samples
Taking a proper amount of the auxiliary medicine composition to be tested for treating AIDS in the embodiments 1-3, grinding, precisely weighing about 0.5g of each medicine composition, placing the medicine composition into a volumetric flask of 100ml, adding 40ml of methanol, weighing, ultrasonically extracting for 30min, complementing the lost weight with methanol, filtering to prepare a test solution, precisely sucking 10 mu L of subsequent filtrate for sample injection, and determining the content of baicalin according to the chromatographic conditions, wherein the results are shown in Table 6.
Table 6 results of content measurement of sample (n ═ 3)
Second, drug effect experiment
Design of medicine effect for enhancing immunity
(I) Experimental study on anti-exercise-induced fatigue effect of pharmaceutical composition of the invention
1 laboratory animal
48 healthy adult Kunming mice with the weight of 18-22 g and unlimited sexes.
2 methods and results
2.1 Experimental methods
2.1.1 animal groups
The 48 mice were randomly divided into three groups, an experimental group, a positive control group, a blank control group, 16 mice per group. The experimental group is perfused with 3.93 g/(kg. d) of the pharmaceutical composition, the positive control group is perfused with 1ml/d of perfused rhodiola rosea oral liquid (Beijing rhodiola rosea technical development Co., Ltd.), and the blank control group is perfused with 10 ml/(kg. d) of distilled water. Each group was administered for 28 consecutive days.
2.1.2 Effect on weight bearing swimming time of mice: after the last intragastric administration for 0.5h, the grouped lead blocks loaded with 5% of body weight at the tail roots of the mice are put into a swimming pool according to the groups for swimming (the water depth is 30cm, the temperature is 25 +/-1.0) DEG C, and the time required for the mice to swim in water until the mice sink to the water bottom and do not float any more is recorded.
2.1.3 Effect on the normotensive hypoxia Capacity of mice: according to the grouping requirements, three groups of mice are selected, after the mice are subjected to the last intragastric gavage for 0.5h, the mice are placed in 250ml ground bottles added with 5% soda lime, the bottle openings are sealed by vaseline, and the time from bottle feeding to death of the mice is recorded.
2.1.4 Effect on mouse HB content: selecting three groups of mice according to the grouping requirements, extracting eyeballs of the mice after the last gastric lavage for 0.5h, collecting blood, and measuring the HB content of each mouse by using a full-automatic hematology analyzer (Meyer BC-5000, Guangdong).
2.1.5 Effect on post-exercise blood lactate content in mice: three groups of mice are selected, blood is collected (at the canthus vein plexus in the eye) for 20 mu l after the last gastric lavage for 0.5h, and the blood lactic acid content is determined by applying a blood lactic acid analyzer (YSI1500SPORT, USA). Then putting into swimming pool to swim without load [ water temperature (30 + -1.0) deg.C ], taking out after 10min, immediately taking blood to measure blood lactic acid content, taking blood again after resting for 20min to measure blood lactic acid content. The change of blood lactic acid content in vivo before, immediately after and 20min after exercise was compared among three groups of experimental mice.
2.1.6 Effect on blood BUN in mice: selecting three groups of mice, performing last gastric lavage for 0.5h, placing in a swimming pool for swimming (water temperature (30 +/-1.0) DEG C), taking out after 90min, immediately picking up eyeballs of the mice to take blood, centrifuging serum, and measuring the BUN content.
2.2 statistical analysis
All data are mean. + -. standard deviationMean comparisons between groups were tested by t-test. Data processing was performed using SPSS16.0 statistical software. One-way anova was performed, with homogeneity of variance tested by LSD and variance tested by Dunnett, s T3 for comparisons between groups. P<0.05 indicates that the difference is significant.
2.3 results
2.3.1 effects on mouse weight bearing swimming time and normal pressure anoxia endurance: compared with a blank control group, the mouse after gastric lavage by the pharmaceutical composition has the advantages that the loaded swimming time is prolonged by 118.9 percent (P is less than 0.01), and the loaded swimming time is obviously prolonged (P is less than 0.01) compared with a positive control group of the gavage rhodiola rosea oral liquid; the hypoxia endurance of the experimental group mice is also improved by 40.2 percent (P <0.01), but the difference is not significant compared with the positive control group (P >0.05, n ═ 16) (see table 1).
Table 1 the effect of the pharmaceutical composition of the present invention on the time of weight bearing swimming and the hypoxia endurance at normal pressure in mice (min,)
note: p <0.05, P <0.01, compared to positive control group;
compared with blank control group, # P <0.05, # P <0.01
2.3.2 Effect on mouse HB content and post-exercise blood BUN: the results show that the HB content of the mice is increased by 34 percent (P <0.01) after the administration of the drug for 28 days, the difference is not significant compared with the positive control group (P >0.05, n is 16), the serum BUN content of the mice is reduced by 25 percent (P <0.01) after the exercise of the mice taking the drug and is reduced by 12 percent (P <0.01, n is 16) compared with the positive control group (see Table 2).
TABLE 2 Effect of the drugs of the invention on HB and BUN in mice
Note: p <0.05, P <0.01, compared to positive control group;
compared with blank control group, # P <0.05, # P <0.01
2.3.3 Effect on mouse blood lactic acid number: the experimental results show that the difference of the blood lactic acid values of the mice in each group before movement has no statistical significance (P is more than 0.05). Immediately after swimming, the blood lactic acid value of each group of mice is obviously increased (P is less than 0.05); compared with the blank control group, the experimental group and the positive control group have obvious difference (P <0.01), namely the high blood lactic acid value rise of mice taking the rhodiola rosea oral liquid and the medicine is obviously lower than that of the blank control group, and the positive group and the experimental group have no obvious difference (P < 0.05). After 20 minutes of rest, the blood lactic acid value of each group is obviously reduced (P is less than 0.05); the blood lactic acid values of the experimental group and the positive control group are lower than that of the blank control group (P <0.01), and the difference between the experimental group and the positive control group is also existed (P <0.01, n ═ 16) (see Table 3).
Table 3 effect of the pharmaceutical composition of the invention on the lactic acid value of mice (mmol/L,)
note: p <0.05, P <0.01, compared to positive group
The experimental results show that: the medicine can obviously prolong the weight-bearing swimming exercise time of mice, which shows that the medicine has stronger function of delaying fatigue and can effectively improve exercise endurance; can effectively enhance the tolerance of the organism to the anoxic environment; the HB content can be obviously improved; the BUN content after exercise can be reduced, and the reduction range is more obvious than that of the rhodiola rosea; can obviously reduce the accumulation of blood lactic acid in the body of the mouse after the movement. This indicates that anaerobic glycolysis is inhibited and the aerobic utilization of the cells is increased, thereby enhancing the aerobic metabolism and energy supply of the body; after 20min of rest, the blood lactic acid value is greatly reduced, and the fatigue is obviously relieved.
(II) Experimental study on enhancing non-specific immune function of body by using pharmaceutical composition of the invention
Cyclophosphamide (CTX) is used as a cytotoxic chemotherapy drug and also belongs to an alkylating immunosuppressant, and mainly acts to destroy the structure of DNA, thereby blocking the replication of DNA and leading to cell death. In immunotoxicology, cyclophosphamide is a commonly used drug for preparing immunosuppressive models.
1 Material
Reagent, apparatus and medicament
Cyclophosphamide (Sigma) formulated in distilled water at 60mg/kg body weight (weekly dose) and administered orally daily; an electronic portable balance (model: JM5102, Jiming weighing and verifying equipment Co., Ltd. Yuyao City, precision 0.1 g); a syringe (specification: 1 ml); an injection needle; a stomach irrigation needle; a dry and wet thermometer; a brown reagent bottle; positive control group: the positive control drug is batyl alcohol, and is fed by only feed without any treatment; test group: the invention also relates to a medicine group.
1.2 Experimental animals
72 Balb/C mice, female, 6-8 weeks old and 18-22 g in weight.
2 methods and results
2.1 leukocyte-elevating Effect on cyclophosphamide model mice
36 mice are taken and randomly divided into 3 groups, the blank control group is intragastrically filled with distilled water 10ml/kg d every day, the other groups are intragastrically filled with 60mg/kg cyclophosphamide every day, and the period is 30 days. The experimental group is perfused with 1.0 g/(kg. d) of the pharmaceutical composition of the invention, the positive control group is perfused with 10ml/kg. d of batyl alcohol, and each group is continuously administrated for 28 days. After 1 hour from the last administration, the mice were bled from the orbital wells to determine the number of leukocytes. The results show that: cyclophosphamide can obviously reduce the number of white blood cells of mice (P <0.01), and the medicine can resist the effect of the mice white blood cells reduction caused by cyclophosphamide, and is shown in table 4.
TABLE 4 Effect of the pharmaceutical compositions of the present invention on cyclophosphamide-induced leukopenia in mice
Note: p <0.05, P <0.01, compared to positive control group
Compared with blank control group, delta P is less than 0.05, and delta P is less than 0.01
2.2 Effect on immune organs of cyclophosphamide model mice
36 mice were selected and randomly divided into 3 groups, and the experimental method was the same as above. After 1 hour of the last administration, the thymus and spleen of the mice were dissected, weighed and the organ index was calculated. The results show that: cyclophosphamide can cause the atrophy of thymus and spleen of mice, and organ index is obviously reduced, while the pharmaceutical composition of the invention has the function of resisting cyclophosphamide to inhibit immune organs and has certain promotion effect on nonspecific epidemic function, which is shown in table 5.
TABLE 5 Effect of the pharmaceutical compositions of the present invention on weight loss of thymus and spleen in mice caused by cyclophosphamide
Note: p <0.05, P <0.01, compared to positive control group
Compared with the blank control group, the delta P is less than 0.05, and the delta P is less than 0.01.

Claims (8)

1. A pharmaceutical composition for adjuvant treatment of AIDS is characterized in that the pharmaceutical composition is prepared from the following components:
15-45 parts of astragalus membranaceus and 10-20 parts of ganoderma lucidum
10-20 parts of radix codonopsis pilosulae, 8-18 parts of cordate houttuynia
8-16 parts of trichosanthes root, 7-17 parts of scutellaria baicalensis
6-18 parts of bupleurum root and 5-14 parts of licorice.
2. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is formulated as a tablet, capsule, granule or oral liquid.
3. The preparation method of the pharmaceutical composition for adjuvant therapy of AIDS as claimed in claim 1 or 2, wherein the Chinese medicinal materials of each component are extracted with water or alcohol to obtain dry extract powder, and then pharmaceutically acceptable adjuvants are added to make into tablet, capsule, granule or oral liquid preparation.
4. The preparation method according to claim 3, wherein the water extraction is to decoct the Chinese medicinal materials of each component with 10-35 times of water for 2-4 times, each time for 1-6 hours; the alcohol extraction is to decoct each Chinese medicinal material with 5-15 times of 30-90 wt% ethanol for 2-4 times, and each time lasts for 1-6 hours.
5. The process according to claim 3, wherein the pharmaceutically acceptable excipients comprise binders, disintegrants, glidants, plasticizers and/or diluents.
6. The method for preparing the pharmaceutical composition for adjuvant therapy of AIDS according to claim 1 or 2,
(1) soaking the Chinese medicinal materials except for Ganoderma for 30-120 min;
(2) extracting the soaked Chinese medicinal materials except Ganoderma with water or ethanol to obtain extractive solution, and concentrating under reduced pressure at 30-90 deg.C to obtain extract with relative density of 1.10-1.58;
(3) crushing the lucid ganoderma into fine powder, wherein the fine powder is not less than 95% of powder which can pass through a fifth sieve and can pass through a sixth sieve;
(4) adding the ganoderma lucidum fine powder obtained in the step (3) into the extract obtained in the step (2), adding pharmaceutically acceptable auxiliary materials, and preparing tablets, capsules, granules or oral liquid preparations.
7. The preparation method of claim 6, wherein the water extraction is to decoct the Chinese medicinal materials of each component with 10-35 times of water for 2-4 times, each time for 1-6 hours; the alcohol extraction is to decoct each Chinese medicinal material with 5-15 times of 30-90 wt% ethanol for 2-4 times, and each time lasts for 1-6 hours.
8. The method of claim 6, wherein the pharmaceutically acceptable excipients comprise binders, disintegrants, glidants, flavoring agents, plasticizers and/or diluents.
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