CN105748989B - Antibacterial and antiviral composition and preparation method thereof - Google Patents
Antibacterial and antiviral composition and preparation method thereof Download PDFInfo
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- CN105748989B CN105748989B CN201610145117.8A CN201610145117A CN105748989B CN 105748989 B CN105748989 B CN 105748989B CN 201610145117 A CN201610145117 A CN 201610145117A CN 105748989 B CN105748989 B CN 105748989B
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/19—Acanthaceae (Acanthus family)
- A61K36/195—Strobilanthes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/315—Isatis, e.g. Dyer's woad
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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Abstract
The invention belongs to the technical field of Chinese patent medicines, and particularly relates to an antibacterial and antiviral composition and a preparation method thereof. The invention mainly solves the problems of easy relapse of symptoms, relapse of illness, poor curative effect and the like after the current antibacterial and antiviral medicaments are taken out of medicine. An antibacterial and antiviral composition takes the following medicines in parts by weight as raw material medicines: 1-10 parts of indigo naturalis, 10-30 parts of rheum officinale, 15-30 parts of radix tinosporae, 1-10 parts of gypsum, 1-10 parts of fritillaria, 10-20 parts of concretio silicea bambusae and 6-20 parts of borneol. The antibacterial and antiviral composition has the functions of inward permeation, protein solidification and denaturation, stronger pathogenic microorganism killing function, can be used for treating bacterial and viral infection diseases, is convenient and easy to administer, has quick response and short treatment course, can well control and improve the disease condition, can relieve neuralgia and reduce pigmentation, and has clinical application significance.
Description
Technical Field
The invention belongs to the technical field of Chinese patent medicines, and particularly relates to an antibacterial and antiviral composition and a preparation method thereof.
Background
Staphylococcus aureus, Streptococcus, Pseudomonas aeruginosa can cause skin and soft tissue infections, Escherichia coli, Klebsiella pneumoniae, Bacillus influenzae, etc. can cause pneumonia, meningitis, septicemia, etc., and Staphylococcus aureus, α hemolytic and non-hemolytic Streptococcus, enterococcus, Alcaligenes, Pseudomonas aeruginosa, etc. can cause infective endocarditis.
Viral diseases are diseases caused by viral infections. Common diseases include influenza, chicken pox, herpes, etc.; serious diseases include smallpox, AIDS, avian influenza, etc. When the virus invades the body, it has strong affinity to nerve tissue and skin tissue, and the skin-friendly person forms wart, and the nerve-friendly person can cause herpes, etc. Condyloma is a sexually transmitted disease caused by infection with Human Papillomavirus (HPV). Herpes simplex is caused by Herpes Simplex Virus (HSV), frequently invades the junction of skin and mucous membrane, and rash is limited clustered small blisters, which are clinically characterized by long-term latent and repeated relapse of the virus. Herpes zoster is a varicella-zoster virus latent in sensory ganglia and causes skin infection through reactivation, which most often affects the elderly, and is easy to cause postherpetic neuralgia for the elderly and weak patients, and has sequela lasting for years.
Disclosure of Invention
The invention mainly aims at the defects that the current antibacterial and antiviral medicine has easy relapse of symptoms, relapse of disease conditions, poor curative effect and the like after stopping taking the medicine, and provides the antibacterial and antiviral composition which has definite curative effect, comprehensive conditioning, good curative effect, low price and no toxic or side effect.
An antibacterial and antiviral composition takes the following medicines in parts by weight as raw material medicines:
1-10 parts of indigo naturalis, 10-30 parts of rheum officinale, 15-30 parts of radix tinosporae, 1-10 parts of gypsum, 1-10 parts of fritillaria, 10-20 parts of concretio silicea bambusae and 6-20 parts of borneol.
The composition of the invention follows the formula principle of 'monarch, minister, assistant and guide' in traditional Chinese medicine. In the formula, the natural indigo and the rhubarb are monarch drugs, and the two drugs are cold in nature, clear heat and purge fire, cool blood and remove toxicity; gypsum Fibrosum, Bulbus Fritillariae Cirrhosae, clear away heat and toxic materials, dissipate stagnation, relieve carbuncle, relieve pain, it is ministerial medicine; radix tinosporae, concretio silicea bambusae and borneol are all adjuvant drugs for clearing heat, removing toxicity and relieving pain. The medicines are combined to clear away heat and toxic materials, cool blood and relieve pain, eliminate stagnation and cure carbuncle, astringe and promote granulation, and are used for treating infection caused by bacteria and viruses.
The invention also provides a preparation method of the composition.
The composition of the invention is any pharmaceutical dosage form.
The preparation method of the antibacterial and antiviral composition comprises the following steps: the preparation method comprises the following steps of taking single raw material medicines or randomly combined and mixed raw material medicines, adding an extraction solvent, obtaining an extract by adopting a decoction method, an ultrasonic extraction method, a percolation method, a reflux method, an immersion method, a microwave extraction method or a supercritical fluid extraction method, mixing the extract of the single raw material medicines or the extracts of the randomly combined and mixed raw material medicines, or mixing the singly or randomly combined and mixed raw material medicines with the extract of the singly or randomly combined and mixed raw material medicines, and adding a solvent and a pharmaceutically acceptable additive into the mixture according to a conventional method to prepare the traditional Chinese medicine.
The extraction solvent is as follows: water, methanol, ethanol, acetone, ethyl acetate, diethyl ether, chloroform, n-butanol, dichloromethane, dimethyl sulfoxide, tert-butyl methyl ether, petroleum ether, hydrochloric acid, sodium hydroxide and a mixture of any two or more of the above solvents in any proportion.
The solvent is water, alcohols or oil; the pharmaceutically acceptable additive is Chinese medicinal clarifying agent, percutaneous absorption promoter, solubilizer, antibacterial antiseptic, suspending agent, flocculant, deflocculant, antioxidant, pH regulator, isotonic regulator, plasticizer, suppository matrix, ointment matrix, cream matrix, plaster matrix, patch material or gel matrix.
The preparation method of the antibacterial and antiviral composition comprises the following steps: taking one or a mixture of any combination of indigo naturalis, rheum officinale, radix tinosporae, gypsum, fritillaria, tabasheer and borneol, adding 1-40 times of water, decocting for 1-8 times according to a conventional method for 0.3-6 hours each time, combining concentrated decoction, and filtering to obtain the traditional Chinese medicine composition.
The preparation method of the antibacterial and antiviral composition comprises the following steps: taking one or a mixture of any combination of indigo naturalis, rheum officinale, radix tinosporae, gypsum, fritillaria, concretio silicea bambusae and borneol, adding an extraction solvent with the volume of 1-40 times of that of the mixture, carrying out ultrasonic treatment at normal temperature or under heating for 0.3-6 hours, filtering, and collecting filtrate.
The percolation method in the preparation method of the antibacterial and antiviral composition comprises the following steps: soaking one or a mixture of any combination of indigo naturalis, rheum officinale, radix tinosporae, gypsum, fritillaria, tabasheer and borneol in 5-95% ethanol for 6-72 hours, flowing out percolate at the flow rate of 0.3-10 mL/min kg, collecting 85% of primary percolate, storing in another container, concentrating at low temperature, and mixing with the primary percolate to prepare the traditional Chinese medicine composition.
The reflux method in the preparation method of the antibacterial and antiviral composition comprises the following steps: taking one or a mixture of any combination of indigo naturalis, rheum officinale, radix tinosporae, gypsum, fritillaria, concretio silicea bambusae and borneol, adding a solvent with the volume of 1-40 times, performing reflux extraction for 1-8 times, performing reflux extraction for 1-144 hours each time, filtering, combining filtrates, and recovering ethanol to obtain the traditional Chinese medicine.
The preparation method of the antibacterial and antiviral composition comprises the following steps: one or any combination of indigo naturalis, rheum officinale, radix tinosporae, gypsum, fritillaria, tabasheer and borneol is taken, the mixture is added with an extraction solvent and soaked for 0.1-168 hours at normal temperature or under heating, the soaking is repeated for 1-5 times, and the soaking solution is combined and concentrated to prepare the traditional Chinese medicine composition.
The solvent is selected from one or more of the following: the water, the ethanol, the propylene glycol and the glycerol are added, wherein the adding amount of the water is 0-95% of the volume ratio of the mass of the composition to the volume of the water; the amount of ethanol applied is 0-90% by mass of the composition to the volume ratio of ethanol, the amount of glycerin applied is 0-50% by mass of the composition to the volume ratio of glycerin, and the amount of propylene glycol applied is 0-60% by mass of the composition to the volume ratio of propylene glycol.
The Chinese medicinal clarifying agent is one or more of gelatin, agar, ZTC clarifying agent and egg white; the percutaneous absorption enhancer is one or more of surfactant, organic solvent, azone and its homologues and terpenes; the solubilizer is one or more of polysorbate 80 and sodium dodecyl sulfate; the bacteriostatic preservative is one or more of benzoic acid, sodium benzoate, potassium sorbate, ethyl p-hydroxybenzoate and borax; the suspending agent is one or more of acacia, tragacanth and glycerol; the flocculating agent and the deflocculating agent are one or more of aluminum trichloride, citric acid and sodium citrate; the antioxidant is one or more of sodium bisulfite, sodium metabisulfite, sodium sulfite, tartaric acid and disodium ethylene diamine tetraacetate; the pH regulator is one or more of triethanolamine, sodium hydroxide and sodium bicarbonate; the isotonic regulator is sodium chloride; the plasticizer is glycerol triacetate; the suppository matrix is one or more of semisynthetic fatty acid, cacao butter, semisynthetic fatty glyceride, and gelatin; the ointment matrix or cream matrix is one or more of vaseline, glyceryl monostearate and stearic acid; the patch material is acrylic acid pressure-sensitive adhesive and polyester film; the gel matrix is one or more of carbomer and cellulose.
The composition can be prepared into a mixture of raw material medicaments or a mixture of single or any combination of mixed raw materials and single or any combination of mixed raw material extracts for use.
The application of the antibacterial and antiviral composition comprises the following components: can be used for inhibiting diseases caused by bacterial and viral infections, such as Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Streptococcus, herpes zoster virus, herpes simplex virus, and human papilloma virus.
The antibacterial and antiviral composition has the functions of inward permeation, protein solidification and denaturation, stronger pathogenic microorganism killing function, can be used for treating bacterial and viral infection diseases, is convenient and easy to administer, has quick response and short treatment course, can well control and improve the disease condition, can relieve neuralgia and reduce pigmentation, and has clinical application significance.
To further demonstrate the therapeutic effect of the present invention, the present invention was clinically validated as follows:
sampling a patient:
63 patients with herpes zoster were selected and divided into two groups according to the random number table method: observation group 32, of which, male 17, aged 37-80 years, mean age 58 years, female 15, aged 48-90 years, mean age 61 years; control group 31, of which 16 men were aged 39-75 years, the mean age was 54 years, 15 women were aged 46-78 years, and the mean age was 58 years. Through statistical treatment difference, the two groups of patients have no significance (P <0.05) in terms of gender and age distribution and are comparable.
Diagnostic criteria:
according to the diagnosis standard of herpes zoster in the clinical diagnosis and treatment guide-skin disease and venereal disease brochure (compiled by the Chinese medical society) and the clinical technical operation specification-skin disease and venereal disease brochure (compiled by the Chinese medical society, published by the civil military medical society), ① pathological skin is clustered and blister and is distributed in a zonal manner along peripheral nerves on one side, and ② has obvious neuralgia and local lymphadenectasis.
The treatment method comprises the following steps:
the composition is applied to affected part for treatment by patients in observation group, and is administered 5 times daily, preferably 5 times or more for each time. Acyclovir was administered orally to control patients at 200mg each time 5 times daily. No other drugs were used in either group.
The curative effect standard is as follows:
the observation indexes include the herpes regressions and the pain relief time, the symptoms, signs and adverse reactions of the 1d, the 2d, the 3d, the 5d, the 7d, the 10d and the 14d are recorded by a grading method, and the total curative effect is evaluated at the 14 d.
The therapeutic index is (total before therapeutic effect-total after therapeutic effect)/total before therapeutic effect + 100%.
The standard is established according to trial 2002 of clinical research guidelines for new Chinese medicines:
and (3) healing: the curative effect index is 100 percent, the rash is completely eliminated, the neuralgia is relieved, and only the pigmentation spots are remained.
The effect is shown: the curative effect index is more than or equal to 70 percent, most of the rash is completely eliminated, and the local neuralgia is obviously relieved.
The method has the following advantages: the curative effect index is 30-69%, part of rash is removed, and pain is relieved.
And (4) invalidation: the therapeutic index is less than 30% or aggravated, and the neuralgia is not reduced.
The treatment results are as follows:
the observation group and the control group have obvious curative effect on treating the herpes diseases, 32 observation groups have 28 cases of recovery, 4 cases of obvious effect have 87.5 percent of recovery rate, and the total effective rate is 100 percent; in the control group, 16 cases are cured, 8 cases are obviously effective, 5 cases are effective, 2 cases are ineffective, the cure rate is 51.6%, and the total effective rate is 93.5%.
TABLE 114 d evaluation of therapeutic efficacy
Compared with the control group for treating the herpes diseases, the treatment course of the observation group is shorter. Observation group: the mean analgesic time was 1 day, the mean scabbing time was 3 days, and the mean scabbing time was 6 days. Control group: the pain-relieving time of herpes is 5 days averagely, the scab-forming time is 9 days averagely, and the scab-removing time is 11 days averagely.
TABLE 214 d evaluation of therapeutic efficacy
Overall clinical observations suggest that: the composition has good clinical curative effect on treating herpes diseases, the curative effect of the composition is better than that of a control group, and the composition has short treatment course and quick response.
Detailed Description
EXAMPLE 1 suspension spray preparation of a composition of the invention
The composition is prepared from the following raw material medicines:
40g of indigo naturalis, 90g of rheum officinale, 50g of gypsum, 120g of radix tinosporae, 35g of fritillaria, 70g of concretio silicea bambusae, 30g of borneol, 10g of borax, 80g of glycerin, 8030 g of polysorbate, 50g of Arabic gum and 0.15g of aluminum trichloride.
The preparation method of the composition of the invention comprises the following steps:
1. extraction of
Taking more than six medicines of indigo naturalis, rhubarb, gypsum, radix tinosporae, tabasheer and fritillaria, adding 8 times of water, decocting for 2 times, decocting for 2.5 hours each time, combining concentrated decoction, and filtering to obtain the traditional Chinese medicine.
2. Preparation of
① dissolving borax with 50% glycerol-water solution;
② dissolving Borneolum Syntheticum in ethanol, slowly adding into polysorbate 80, and stirring;
③ adding ethanol into the concentrated solution after recovering ethanol, adding ① and ② liquid, adding acacia and aluminum trichloride, grinding, adding water to 1000mL, stirring, and bottling.
The using method comprises the following steps: the composition is applied 5 times a day, and is applied by spraying for more than 5 times, preferably for multiple times (the medicinal liquid sprayed on the skin surface must be dried and then sprayed for the next time).
EXAMPLE 2 suspension spray preparation of a composition of the invention
The composition of the invention is prepared from the following components:
20g of indigo naturalis, 105g of rheum officinale, 35g of gypsum, 135g of radix tinosporae, 40g of fritillaria, 55g of concretio silicea bambusae, 45g of borneol, 12g of borax, 150g of glycerin, 8020 g of polysorbate, 50g of azone, 8g of tragacanth, 0.1g of citric acid and 0.1g of sodium citrate.
The preparation method of the composition of the invention comprises the following steps:
1. extraction of
Mixing indigo naturalis and radix et rhizoma Rhei, Gypsum Fibrosum and radix tinosporae, concretio silicea Bambusae seu Schizostachyi and Bulbus Fritillariae Cirrhosae, adding 7 times of water, decocting for 2 times, each for 1.5 hr, mixing decoctions, concentrating, and filtering.
2. Preparation of
① dissolving borax with 50% glycerol-water solution;
② dissolving Borneolum Syntheticum in ethanol, slowly adding into polysorbate 80, and stirring;
③ adding ethanol, adding ①, ② and azone, adding tragacanth, citric acid and sodium citrate, grinding, adding water to 1000mL, stirring, and packaging.
The using method comprises the following steps: the composition is applied 5 times a day, and is applied by spraying for more than 5 times, preferably for multiple times (the medicinal liquid sprayed on the skin surface must be dried and then sprayed for the next time).
EXAMPLE 3 solution spray preparation of the composition of the invention
The composition of the invention is prepared from the following components:
45g of indigo naturalis, 100g of rheum officinale, 20g of gypsum, 110g of radix tinosporae, 45g of fritillaria, 60g of concretio silicea bambusae, 30g of borneol, 15g of sodium benzoate, 150g of glycerol, 100g of propylene glycol and 8015 g of polysorbate
The preparation method of the composition of the invention comprises the following steps:
1. adding water 9 times the amount of indigo naturalis, radix et rhizoma Rhei, Gypsum Fibrosum, radix tinosporae, concretio silicea Bambusae seu Schizostachyi and Bulbus Fritillariae Cirrhosae respectively, decocting for 2 times, each time for 1.5 hr, mixing decoctions, concentrating, and filtering.
2. Preparation of
① adding 50% egg white solution into the concentrated solution, stirring, boiling, and filtering;
② dissolving Borneolum Syntheticum in ethanol, slowly adding into polysorbate 80, and stirring;
③ adding propylene glycol, sodium benzoate, glycerol and appropriate amount of ethanol into ① clear solution, adding ② liquid, adding water to 1000mL, stirring, and bottling.
The using method comprises the following steps: the composition is applied 5 times a day, and is applied by spraying for more than 5 times, preferably for multiple times (the medicinal liquid sprayed on the skin surface must be dried and then sprayed for the next time).
EXAMPLE 4 solution spray preparation of the composition of the invention
The composition of the invention is prepared from the following components:
50g of indigo naturalis, 125g of rheum officinale, 5g of gypsum, 75g of radix tinosporae, 35g of fritillaria, 100g of concretio silicea bambusae, 35g of borneol, 5g of borax, 70g of glycerol, 120g of propylene glycol, 8040 g of polysorbate and 40g of azone.
The preparation method of the composition of the invention comprises the following steps:
1. extraction of
Soaking indigo naturalis, radix et rhizoma Rhei, Gypsum Fibrosum, radix tinosporae, concretio silicea Bambusae seu Schizostachyi and Bulbus Fritillariae Cirrhosae in 65% ethanol for 48 hr, flowing out percolate at flow rate of 2 mL/min.kg, collecting 85% primary percolate, storing in a container, concentrating at low temperature, and mixing with the primary percolate.
2. Preparation of
① mixing agar and gelatin at a ratio of 1:2 to obtain 3% water solution, adding into the extractive solution, stirring for 3min, standing for 20min, and filtering to obtain clear solution.
② dissolving borax with 50% glycerol-water solution;
③ dissolving Borneolum Syntheticum in ethanol, slowly adding into polysorbate 80, and stirring;
④ adding appropriate amount of ethanol and propylene glycol into the clarified solution, adding ②, ③ solution and azone, adding water to 1000mL, stirring, and bottling.
The using method comprises the following steps: the composition is applied 5 times a day, and is applied by spraying for more than 5 times, preferably for multiple times (the medicinal liquid sprayed on the skin surface must be dried and then sprayed for the next time).
EXAMPLE 5 gel preparation of the composition of the invention
The composition of the invention is prepared from the following components:
36g of natural indigo, 68g of rhubarb, 24g of gypsum, 150g of tinospora root, 50g of fritillaria, 120g of concretio silicea bambusae, 24g of borneol, 0.4g of ethyl p-hydroxybenzoate, 80g of glycerin, 8025 g of polysorbate, 20g of carbomer, 0.1g of sodium metabisulfite and 0.1g of disodium ethylenediamine tetraacetate.
The preparation method of the composition of the invention comprises the following steps:
1. extraction of
Taking six medicines of indigo naturalis, rhubarb, gypsum, radix tinosporae, tabasheer and fritillaria, adding 75% ethanol with the volume 10 times that of the traditional Chinese medicine, heating and ultrasonically treating for 5 hours, and filtering; collecting the filtrate, and concentrating to obtain the final product.
2. Preparation of
Wetting carbomer with water, gradually adding water to swell, stirring at high speed to mix uniformly, adding appropriate amount of triethanolamine solution dropwise into carbomer to adjust pH to 5.0, adding the above fluid extract, ethyl p-hydroxybenzoate, Borneolum Syntheticum, polysorbate 80, sodium metabisulfite, disodium edetate and glycerol, stirring uniformly, making into gel 1000g, and bottling.
The using method comprises the following steps: the treatment is carried out once a day.
EXAMPLE 6 gel preparation of the composition of the invention
The composition of the invention is prepared from the following components:
50g of indigo naturalis, 125g of rheum officinale, 40g of gypsum, 130g of tinospora root, 36g of fritillaria, 80g of concretio silicea bambusae, 30g of borneol, 25g of borax, 250g of glycerin, 8060 g of polysorbate, 10g of carbomer, 50g of hydroxypropyl methylcellulose, 30g of azone, 0.1g of tartaric acid, 0.1g of sodium bisulfite and 9g of sodium chloride.
The preparation method of the composition of the invention comprises the following steps:
1. extraction of
Soaking indigo naturalis, radix et rhizoma Rhei, Gypsum Fibrosum, radix tinosporae, concretio silicea Bambusae seu Schizostachyi and Bulbus Fritillariae Cirrhosae in 10 times volume of 30% ethanol for 3 hr, reflux extracting for 3 times, each for 2 hr, and filtering; mixing filtrates, and recovering ethanol.
2. Preparation of
Wetting carbomer and hydroxypropyl methylcellulose with water, gradually adding water to swell, stirring at high speed to mix uniformly, adding appropriate amount of sodium bicarbonate solution dropwise into the matrix to adjust pH to 5.0, adding the above fluid extract, borax, Borneolum Syntheticum, polysorbate 80, azone, tartaric acid, sodium bisulfite, glycerol, and sodium chloride, stirring uniformly, making into gel 1000g, and bottling.
The using method comprises the following steps: the treatment is carried out once a day.
EXAMPLE 7 gel preparation of the composition of the invention
The composition of the invention is prepared from the following components:
130g of indigo naturalis, 180g of rheum officinale, 120g of gypsum, 300g of tinospora cordifolia, 60g of fritillaria, 170g of concretio silicea bambusae, 95g of borneol, 2g of potassium sorbate, 100g of glycerin, 8025 g of polysorbate, 5g of sodium carboxymethylcellulose, 0.1g of sodium sulfite, 0.1g of disodium edetate and 9g of sodium chloride.
The preparation method of the composition of the invention comprises the following steps:
1. extraction of
Soaking indigo naturalis, radix et rhizoma Rhei, Gypsum Fibrosum, radix tinosporae, concretio silicea Bambusae seu Schizostachyi and Bulbus Fritillariae Cirrhosae in water at room temperature for 2 days, and repeating for 3 times; mixing the soaking solutions, and concentrating.
2. Preparation of
① diluting KBZ-ZTC clarifying agent A, B to 5% water solution, adding 2% solution A into the Chinese medicinal concentrated solution, stirring, holding at 50 deg.C for 45min, adding equal amount of solution B under stirring, standing, clarifying supernatant, and filtering.
② boiling water, adding sodium carboxymethylcellulose under high speed stirring, stopping heating, condensing to get gel, adding 0.1mol/L sodium hydroxide solution to adjust pH to 5.0, adding prescription amount of fluid extract, potassium sorbate, Borneolum Syntheticum, polysorbate 80, sodium sulfite, disodium edetate, glycerol, and sodium chloride, stirring, making into gel 1000g, and bottling.
The using method comprises the following steps: the treatment is carried out once a day.
EXAMPLE 8 Patch preparation of a composition of the invention
The composition of the invention is prepared from the following components:
120g of indigo naturalis, 180g of rheum officinale, 130g of gypsum, 280g of tinospora root, 60g of fritillaria, 170g of concretio silicea bambusae, 90g of borneol, 2g of potassium sorbate, 150g of glycerin, 8025 g of polysorbate, 25g of azone, 3g of water-soluble chitosan and 4g of methyl cellulose.
The preparation method of the composition of the invention comprises the following steps:
1. extraction of
Soaking indigo naturalis, radix et rhizoma Rhei, Gypsum Fibrosum, radix tinosporae, concretio silicea Bambusae seu Schizostachyi and Bulbus Fritillariae Cirrhosae in 50% ethanol at room temperature for 3 days, and repeating for 3 times; mixing the soaking solutions, and concentrating.
2. Preparation of
① heating appropriate amount of water, adding methyl cellulose, mixing, adding chitosan under stirring, swelling, adding 0.1mol/L sodium hydroxide solution, adjusting pH to 4.0, adding fluid extract, potassium sorbate, Borneolum Syntheticum, polysorbate 80, glycerol, and azone, stirring, and making into gel 1000 g;
② coating the gel on a polyester film, coating an acrylic pressure sensitive adhesive layer around the gel, making into patch, covering the backing layer, sealing under heat and pressure, and punching.
The using method comprises the following steps: for external use, the affected part is cleaned and replaced once every 1-2 days.
EXAMPLE 9 suppository preparation of the compositions of the invention
The composition of the invention is prepared from the following components:
45g of indigo naturalis, 70g of rheum officinale, 30g of gypsum, 90g of radix tinosporae, 35g of fritillaria, 70g of concretio silicea bambusae, 40g of borneol, 10g of benzoic acid, 1600g of cocoa butter and 400g of semisynthetic fatty acid.
The preparation method of the composition of the invention comprises the following steps:
1. extraction of
① heating radix et rhizoma Rhei with 10 times volume of methanol under reflux for 1h, cooling, shaking, filtering, placing in a flask, volatilizing solvent, adding 8% hydrochloric acid solution 20mL, ultrasonic treating for 5min, adding chloroform, extracting for 3 times, mixing chloroform solutions, and recovering solvent under reduced pressure to obtain concentrated solution;
② soaking indigo naturalis, Gypsum Fibrosum, radix tinosporae, concretio silicea Bambusae seu Schizostachyi and Bulbus Fritillariae Cirrhosae in 10 times of 30% ethanol for 3 hr, reflux extracting for 3 times, each for 2 hr, filtering, mixing filtrates, and recovering ethanol to obtain concentrated solution.
③ the concentrated solutions ① and ② are combined for use.
2. Preparation of
① grinding Borneolum Syntheticum into fine powder;
② heating cocoa butter and semisynthetic fatty acid to melt, adding the concentrated solution, benzoic acid and Borneolum Syntheticum, mixing, pouring into suppository mold, cooling, demolding, and packaging.
The using method comprises the following steps: administered to vagina one granule at a time and once a day.
EXAMPLE 10 suppository preparation of the compositions of the invention
The composition of the invention is prepared from the following components:
35g of indigo naturalis, 90g of rheum officinale, 10g of gypsum, 80g of radix tinosporae, 35g of fritillaria, 75g of concretio silicea bambusae, 30g of borneol, 10g of borax, 105g of glycerol, 30g of gelatin and 800g of semisynthetic fatty glyceride.
The preparation method of the composition of the invention comprises the following steps:
1. extraction of
① adding concentrated hydrochloric acid 1 times the amount of indigo naturalis, stirring until no foam is generated, diluting with boiling water, filtering, washing the insoluble substance with water to neutrality, drying, extracting the dried substance with ethanol 1 times the amount of ethanol under reflux for 5 times (1 hr each time), mixing the ethanol extractive solutions, standing, filtering, extracting the insoluble substance with ethyl acetate 1 times the amount of ethanol under reflux for 6 times (1 hr each time), mixing the extractive solutions, and recovering ethyl acetate to obtain concentrated solution;
② defatting the ethanol-recovered extract with petroleum ether, dissolving in 1% NaOH solution, washing with water to neutral, extracting with ethyl acetate, and recovering ethyl acetate to obtain concentrated solution;
③ soaking radix Et rhizoma Rhei, Gypsum Fibrosum, radix tinosporae, concretio silicea Bambusae seu Schizostachyi and Bulbus Fritillariae Cirrhosae in 15 times of 40% ethanol overnight, reflux extracting for 3 times (2 hr each time), filtering, mixing filtrates, and recovering ethanol to obtain concentrated solution;
④ and mixing the concentrated solutions ①, ② and ③.
2. Preparation of
① grinding Borneolum Syntheticum into fine powder;
② dissolving gelatin in water, heating in water bath, adding glycerol, stirring, steaming to remove excessive water, and adding semisynthetic fatty glyceride to obtain suppository matrix.
③ mixing the concentrated solution, borax and Borneolum Syntheticum, adding into suppository matrix under stirring, mixing, pouring into suppository mold, cooling, demolding, and packaging.
The using method comprises the following steps: administered to vagina one granule at a time and once a day.
EXAMPLE 11 cream preparation of a composition of the invention
The composition of the invention is prepared from the following components:
50g of indigo naturalis, 90g of rheum officinale, 20g of gypsum, 75g of radix tinosporae, 35g of fritillaria, 70g of concretio silicea bambusae, 50g of borneol, 5g of ethyl p-hydroxybenzoate, 20g of sodium dodecyl sulfate, 200g of glycerin monostearate, 350g of vaseline, 200g of stearic acid, 350g of glycerol and 8020 g of polysorbate.
The preparation method of the composition of the invention comprises the following steps:
1. extraction of
① reflux-extracting radix tinosporae powder with diethyl ether for 2 days, filtering, recovering diethyl ether, standing, crystallizing, filtering to obtain white crystal, and dissolving the white crystal in 5mL of dimethyl sulfoxide to obtain liquid.
② soaking indigo naturalis, radix Et rhizoma Rhei, Gypsum Fibrosum, concretio silicea Bambusae seu Schizostachyi and Bulbus Fritillariae Cirrhosae in 75% ethanol for 48h, collecting 85% primary percolate, storing in a container, concentrating at low temperature, mixing with the primary percolate, and concentrating to obtain the final product ①.
2. Preparation of
① dissolving Borneolum Syntheticum in ethanol;
② dissolving oil phase adjuvants such as vaseline, glyceryl monostearate, stearic acid, sodium laurylsulfate, and ethyl p-hydroxybenzoate in oil bath;
③ dissolving water-phase adjuvants including glycerol, concentrated solution, water, and polysorbate 80 in water bath, and mixing;
④ slowly adding the oil phase into the water phase, stirring to emulsify, cooling to below 50 deg.C, adding Borneolum Syntheticum ethanol solution dropwise, stirring to emulsify, and packaging.
The using method comprises the following steps: the ointment is applied to the affected part for cleaning 2-4 times a day.
EXAMPLE 12 film coating preparation of a composition of the invention
The composition of the invention is prepared from the following components:
40g of indigo naturalis, 60g of rheum officinale, 15g of gypsum, 75g of radix tinosporae, 40g of fritillaria, 75g of concretio silicea bambusae, 45g of borneol, 5g of borax, 80g of glycerin, 8020 g of polysorbate, 100g of polyvinyl alcohol, 80g of glycerol triacetate and 2g of sodium metabisulfite.
The preparation method of the composition of the invention comprises the following steps:
1. extraction of
① decocting Gypsum Fibrosum and concretio silicea Bambusae seu Schizostachyi with 8 times of water for 2 times, each for 1.5 hr, and mixing filtrates;
② soaking indigo naturalis, radix Et rhizoma Rhei, radix tinosporae, and Bulbus Fritillariae Uninbracteatae in 65% ethanol for 24h, collecting 85% primary percolate, mixing with the primary percolate, mixing with ① solution, and concentrating.
2. Preparation of
① dissolving Borneolum Syntheticum in ethanol, adding polysorbate 80, and mixing;
② dissolving borax in 50% glycerol-water solution;
③ dissolving polyvinyl alcohol in 50% ethanol-water solution, adding the above concentrated solution, Borneolum Syntheticum ethanol solution, and Borax glycerol-water solution, stirring, adding sodium pyrosulfite and glycerol triacetate, adding water to 1000mL, stirring, and packaging.
The using method comprises the following steps: the ointment is applied to the affected part for cleaning 2-4 times a day.
Claims (8)
1. An antiviral composition is characterized in that the following medicines in parts by weight are taken as raw material medicines:
1-10 parts of indigo naturalis, 10-30 parts of rheum officinale, 15-30 parts of radix tinosporae, 1-10 parts of gypsum, 1-10 parts of fritillaria, 10-20 parts of concretio silicea bambusae and 6-20 parts of borneol;
the use of the composition for the manufacture of a medicament for inhibiting a disease caused by herpes zoster virus infection.
2. The antiviral composition according to claim 1, wherein said composition is in any one of pharmaceutical dosage forms.
3. The method for preparing an antiviral composition according to claim 1, wherein the antiviral composition is prepared by adding an extraction solvent to a single crude drug or a mixture of any two of the crude drugs, obtaining an extract by a decoction method, an ultrasonic extraction method, a percolation method, a reflux method, an immersion method, a microwave extraction method or a supercritical fluid extraction method, mixing the extract of the single crude drug or the extract of the mixture of any two of the crude drugs, or mixing the mixture of the single crude drug or the mixture of any two of the crude drugs with the extract of the single crude drug or the mixture of any two of the crude drugs, and adding a solvent and a pharmaceutically acceptable additive to the mixture according to a conventional method.
4. The method for preparing an antiviral composition according to claim 3, wherein the extraction solvent is: water, methanol, ethanol, acetone, ethyl acetate, diethyl ether, chloroform, n-butanol, dichloromethane, dimethyl sulfoxide, tert-butyl methyl ether, petroleum ether, hydrochloric acid or sodium hydroxide and a mixture of any two or more of the above solvents in any proportion.
5. The method for preparing an antiviral composition according to claim 3, wherein the decocting comprises: taking one or a mixture of any combination of indigo naturalis, rheum officinale, radix tinosporae, gypsum, fritillaria, tabasheer and borneol, adding 1-40 times of water, decocting for 1-8 times according to a conventional method, decocting for 0.3-6 hours each time, combining concentrated decoction, and filtering to obtain the traditional Chinese medicine composition;
the ultrasonic extraction method comprises the following steps: taking one or a mixture of any combination of indigo naturalis, rheum officinale, radix tinosporae, gypsum, fritillaria, tabasheer and borneol, adding an extraction solvent with the volume of 1-40 times of that of the mixture, carrying out ultrasonic treatment at normal temperature or under heating for 0.3-6 hours, filtering, and collecting filtrate to prepare the traditional Chinese medicine composition;
the percolation method comprises the following steps: soaking one or a mixture of any combination of indigo naturalis, rheum officinale, radix tinosporae, gypsum, fritillaria, tabasheer and borneol in 5-95% ethanol for 6-72 hours, enabling percolate to flow out at the flow rate of 0.3-10 mL/min-kg, collecting 85% of primary percolate, storing in another container, concentrating at low temperature, and mixing with the primary percolate to prepare the traditional Chinese medicine composition;
the reflux method comprises the following steps: taking one or a mixture of any combination of indigo naturalis, rheum officinale, radix tinosporae, gypsum, fritillaria, tabasheer and borneol, adding a solvent with the volume of 1-40 times, performing reflux extraction for 1-8 times, performing reflux extraction for 1-144 hours each time, filtering, combining filtrates, and recovering ethanol to obtain the extract;
the impregnation method comprises the following steps: one or any combination of indigo naturalis, rheum officinale, radix tinosporae, gypsum, fritillaria, tabasheer and borneol is taken, the mixture is added with an extraction solvent and soaked for 0.1-168 hours at normal temperature or under heating, the soaking is repeated for 1-5 times, and the soaking solution is combined and concentrated to prepare the traditional Chinese medicine composition.
6. The method for preparing an antiviral composition according to claim 3, wherein the vehicle is one or more of the following: the water, the ethanol, the propylene glycol and the glycerol are added, wherein the adding amount of the water is 0-95% of the volume ratio of the mass of the composition to the volume of the water;
the amount of ethanol applied is 0-90% by mass of the composition to the volume ratio of ethanol, the amount of glycerin applied is 0-50% by mass of the composition to the volume ratio of glycerin, and the amount of propylene glycol applied is 0-60% by mass of the composition to the volume ratio of propylene glycol.
7. The method for preparing an antiviral composition according to claim 3, wherein the pharmaceutically acceptable additive is a Chinese medicinal clarifying agent, a percutaneous absorption enhancer, a solubilizing agent, a bacteriostatic preservative, a suspending agent, a flocculating agent, a deflocculating agent, an antioxidant, a pH adjusting agent, an isotonicity adjusting agent, a plasticizer, a suppository base, an ointment base, a cream base, a plaster base, a patch material or a gel base.
8. The method for preparing an antiviral composition according to claim 7, wherein the Chinese medicinal clarifying agent is one or more of gelatin, agar, ZTC clarifying agent and egg white;
the percutaneous absorption enhancer is one or more of surfactant, organic solvent, azone and its homologues and terpenes;
the solubilizer is one or more of polysorbate 80 and lauryl sodium sulfate;
the bacteriostatic preservative is one or more of benzoic acid, sodium benzoate, potassium sorbate, ethyl p-hydroxybenzoate and borax;
the suspending agent is one or more of acacia, tragacanth and glycerol;
the flocculating agent and the deflocculating agent are one or more of aluminum trichloride, citric acid and sodium citrate; the antioxidant is one or more of sodium bisulfite, sodium metabisulfite, sodium sulfite, tartaric acid and disodium ethylene diamine tetraacetate;
the pH regulator is one or more of triethanolamine, sodium hydroxide and sodium bicarbonate;
the isotonic regulator is sodium chloride; the plasticizer is glycerol triacetate;
the suppository matrix is one or more of semisynthetic fatty acid, cacao butter, semisynthetic fatty glyceride, and gelatin;
the ointment matrix or cream matrix is one or more of vaseline, glyceryl monostearate and stearic acid;
the patch material is acrylic acid pressure-sensitive adhesive and polyester film;
the gel matrix is one or more of carbomer and cellulose.
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Denomination of invention: A composite with antibacterial and antiviral properties and its preparation method Effective date of registration: 20230721 Granted publication date: 20200310 Pledgee: Bank of China Limited Taiyuan Pingyang sub branch Pledgor: Shanxi Langjian Pharmaceutical Co.,Ltd. Registration number: Y2023140000042 |
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