CN112999177A - Chinese herbal medicine bacteriostatic effervescent tablet containing ligusticum wallichii extract and preparation method thereof - Google Patents
Chinese herbal medicine bacteriostatic effervescent tablet containing ligusticum wallichii extract and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
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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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- A—HUMAN NECESSITIES
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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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/236—Ligusticum (licorice-root)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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)
- A61K36/58—Meliaceae (Chinaberry or Mahogany family), e.g. Azadirachta (neem)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/74—Rubiaceae (Madder family)
- A61K36/744—Gardenia
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
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- A61K2236/30—Extraction of the material
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The invention discloses a Chinese herbal medicine bacteriostatic effervescent tablet containing ligusticum wallichii extract and a preparation method thereof, wherein the effervescent tablet mainly comprises active ingredients and auxiliary materials; the active ingredients comprise 15-30 parts by mass of ligusticum wallichii, 10-20 parts by mass of gardenia, 5-15 parts by mass of szechwan chinaberry fruit and 5-15 parts by mass of myrobalan; the auxiliary materials comprise an acid source, an alkali source, a lubricant, lactose and tea polyphenol. The effervescent tablet disclosed by the invention has a good inhibition effect on common bacteria types which are easily contacted with skin in daily exposure. The hand cleaning and sterilizing liquid is convenient to carry and easy to store, and can be used for soaking and cleaning skin exposed parts such as hands and the like at any time by soaking the liquid in water, so that the cleaning and sterilizing effects are achieved. Many seasonal influenza viruses are transmitted by the way of hands and mouths, and the effervescent tablet can achieve the purpose of reducing the transmission of epidemic diseases.
Description
Technical Field
The invention belongs to a Chinese medicinal extract preparation, and particularly relates to a Chinese medicinal herb bacteriostatic effervescent tablet containing a ligusticum wallichii extract and a preparation method thereof.
Background
The bacteriostatic effervescent tablet needs to be dissolved in water and then externally used, and has certain bacteriostatic activity. Compared with other bacteriostatic agents, the effervescent tablets are convenient to use and easy to store, so that the effervescent tablets are popular. However, the bacteriostatic effect of the bacteriostatic effervescent tablets on the market is limited, and needs to be further improved.
Disclosure of Invention
The invention aims to provide a Chinese herbal medicine bacteriostatic effervescent tablet containing ligusticum wallichii extract and a preparation method thereof, and the Chinese herbal medicine bacteriostatic effervescent tablet has good inhibitory effect on common bacteria which are easily contacted with skin in daily exposure, and can achieve the purpose of reducing epidemic disease transmission.
The Chinese herbal medicine bacteriostatic effervescent tablet containing the ligusticum wallichii extract mainly comprises active ingredients and auxiliary materials;
the active ingredients comprise 20 parts by mass of ligusticum wallichii, 15 parts by mass of gardenia, 10 parts by mass of szechwan chinaberry fruit and 10 parts by mass of myrobalan;
the auxiliary materials comprise an acid source, an alkali source, a lubricant, a diluent and a flavoring agent.
Further, tartaric acid and/or citric acid is used as the acid source.
Further, sodium bicarbonate is used as the alkali source.
Further, polyethylene glycol is used as the lubricant.
Further, lactose is used as a diluent.
Furthermore, the flavoring agent is tea polyphenol.
The invention provides a preparation method of Chinese herbal medicine bacteriostatic effervescent tablets containing ligusticum wallichii extract, which comprises the following steps:
(1) extracting the extractum:
weighing rhizoma Ligustici Chuanxiong, fructus Gardeniae, fructus Toosendan, and fructus Chebulae according to the dosage of claim 1, pulverizing into powder, soaking in ethanol overnight, ultrasonic extracting, filtering, and concentrating under reduced pressure to obtain extract;
(2) grinding the auxiliary materials respectively;
(3) and (3) granulating acid granules and alkali granules:
taking two equal parts of the extract, respectively placing the extract in two mortars, wherein the two mortars are used for preparing acid granules and alkali granules respectively; adding a diluent and a flavoring agent into the two mortars and grinding; taking another mortar, putting the lubricant into the mortar, adding absolute ethyl alcohol, grinding, adding an alkali source for wrapping, and then adding into the mortar for preparing alkali particles for mixing; adding absolute ethanol into the two mortars, mixing, granulating through a 16-mesh sieve, and drying;
(4) tabletting:
and mixing the acid source and the lubricant, adding the mixture into a mortar of acid granules, continuously grinding, uniformly mixing the acid granules and the alkali granules, and tabletting to obtain the target product.
Further, in the step (2), the auxiliary materials are ground in the environment with the temperature of 15-25 ℃ and the humidity of 10-30 percent, and are sieved by a 100-mesh sieve.
Further, in the step (3), drying is carried out in an oven at 50 ℃ for 1.5 h.
Further, in the step (3), the mass ratio of the diluent and the flavoring agent added into the two mortar containing the acid granules and the alkali granules to the extract in the mortar is 45-55: 4-7: 3; the mass ratio of the reducing source added in the mortar of the alkali particles to the extract in the mortar is 30-35: 3, the mass ratio of the acid source added into the mortar of the acid granules to the extract in the mortar is 30-35: 3.
the invention has the following characteristics and beneficial effects:
the effervescent tablet comprises four traditional Chinese medicines of ligusticum wallichii, gardenia, szechwan chinaberry fruit and myrobalam. Chuan Xiong is the dried rhizome of Ligusticum wallichii (Ligusticum chuanxiong Hort) which is a plant of Ligusticum of Umbelliferae (Umbelliferae), and it is recorded in Shen nong Ben Cao Jing (Shennong Ben Cao Jing), the top-grade product, and is mainly produced in Sichuan. It is warm in nature and pungent in flavor, and has a long medicinal history in China. Modern researches find that the extract of the ligusticum wallichii has a certain bacteriostatic action.
Gardenia is a common traditional Chinese medicine for clearing heat and removing toxicity, and the active ingredients of gardenia are researched and reported more at present. Has antibacterial, antiviral, antipyretic, analgesic and antiinflammatory effects, and can be used for treating upper respiratory infection clinically. Research shows that the gardenia extract has obvious in-vitro anti-influenza A virus (H1N1) effect.
The toosendan fruit contains various chemical components such as triterpene, lignan, flavone, steroid, organic acid and the like, and has wide pharmacological effects of resisting tumor, oxidation, bacteria, inflammation and pain, viruses and insects, and the like. In vitro experimental studies find that the water extract of fructus Toosendan has inhibitory effect on Trichosporon violaceum, Microsporum ozoensis, Candida albicans, and Staphylococcus aureus.
The myrobalan is a traditional Mongolian medicine, has various pharmacological actions such as antibiosis, antivirus, antioxidation, cardiotonic, anti-tumor and the like, is used for astringing intestines and astringing lung, reducing pathogenic fire and relieving sore throat, and is widely applied in clinical traditional Chinese medicine. In-vitro antibacterial experiments show that the myrobalan aqueous extract has obvious inhibition effect on acinetobacter baumannii, escherichia coli, klebsiella pneumoniae and staphylococcus aureus, and the inhibition rate is higher than that of the myrobalan ethanol extract and the ethyl acetate extract.
The four traditional Chinese medicines with in vitro antibacterial activity are combined to achieve the synergistic effect and remarkably promote the antibacterial effect. The effervescent tablet disclosed by the invention has a good inhibition effect on common bacteria types which are easily contacted with skin in daily exposure. The hand cleaning and sterilizing liquid is convenient to carry and easy to store, and can be used for soaking and cleaning skin exposed parts such as hands and the like at any time by soaking the liquid in water, so that the cleaning and sterilizing effects are achieved. Many seasonal influenza viruses are transmitted by the way of hands and mouths, and the effervescent tablet can achieve the purpose of reducing the transmission of epidemic diseases.
Detailed Description
The present invention will be further described with reference to the following examples. The following examples are preferred embodiments of the present invention and are not intended to limit the scope of the present invention in any way. The reagents, methods and apparatus used in the examples are conventional in the art, unless otherwise indicated. Unless otherwise indicated, reagents and materials used in the following examples are commercially available.
Examples
The effervescent tablet of this example was prepared as follows:
(1) extracting the extractum:
mixing 15-30 parts by mass of ligusticum wallichii, 10-20 parts by mass of gardenia, 5-15 parts by mass of szechwan chinaberry fruit and 5-15 parts by mass of myrobalan, pulverizing, soaking overnight in ethanol with the mass concentration of 70%, performing ultrasonic extraction for 60min, filtering, and performing reduced pressure concentration to obtain an extract. In this example, one part has a mass of 50g to 150 g.
(2) Sieving auxiliary materials:
the auxiliary materials comprise an acid source, an alkali source, a lubricant, a diluent and a flavoring agent, wherein in the embodiment, the acid source adopts tartaric acid, the alkali source adopts sodium bicarbonate, the diluent adopts lactose, the lubricant adopts PEG6000, and the flavoring agent adopts tea polyphenol. All the auxiliary materials are ground in the environment with the temperature of 15-25 ℃ and the humidity of 10-30 percent until the auxiliary materials pass through a 100-mesh sieve.
The main innovation of the effervescent tablet is the combination of active ingredients, and the dosage of the auxiliary materials is the conventional dosage for preparing the effervescent tablet.
(3) And (3) granulating:
two equal portions of the extract, in this example 3g of the extract, were taken and placed in two mortar, one for the preparation of alkaline pellets and one for the preparation of acid pellets. Adding lactose 50g and tea polyphenols 6.5g into mortar for preparing alkali granule, and grinding. 56g of lactose and 6.5g of tea polyphenol are also added into a mortar for preparing acid granules, and the mixture is uniformly ground.
Another mortar is taken, 5g of PEG6000 is put into the mortar, 5mL of absolute ethyl alcohol is added, and 33g of NaHCO is added after grinding3Wrapping, mixing, adding into mortar for preparing alkali granule, and mixing. For the convenience of subsequent tabletting, anhydrous ethanol used as a binder was added into the mortar of the acid granules and the alkali granules, respectively, mixed well, and then sieved through a 16-mesh sieve to size, and dried in an oven at 50 ℃ for 1.5 hours.
The lubricant PEG6000 and the absolute ethyl alcohol are used as granulation binders, and the dosage of the lubricant PEG6000 and the absolute ethyl alcohol is the conventional dosage in the preparation process of the effervescent tablets.
(4) Tabletting:
and (3) uniformly mixing 33g of tartaric acid and 4g of PEG6000, adding the mixture into a mortar of acid granules, continuously uniformly mixing, uniformly mixing the acid granules and the alkali granules, and tabletting to obtain the effervescent tablet.
Example 2
This example is used to determine the bacteriostatic and antibacterial synergy effects of the effervescent tablets obtained in example 1.
(1) Strain activation:
under the aseptic condition, transferring the preserved strains of escherichia coli, staphylococcus aureus and bacillus subtilis by using a freshly prepared bacterial solid slant culture medium, and culturing at 37 ℃ for 24 hours for later use; culturing the strain with fungus solid slant culture medium and Penicillium and Aspergillus niger at 28 deg.C for 72 hr.
(2) Preparation of bacterial suspension:
adding sterile water into the activated test bacteria slant test tube, pouring into 50mL sterile physiological saline with glass beads, wrapping, and shaking in a shaking table at 37 deg.C for 30 min. Using blood cell counting method, making sterile water into product with thallus content of 106And (3) storing the bacterial suspension in a refrigerator at 4 ℃ in the presence of CFU/mL.
(3) Preparing a test solution of the bacteriostatic effervescent tablet:
taking the effervescent tablet prepared in the example 1, grinding, sieving with a 200-mesh sieve, weighing 10g, adding 50mL of 75% ethanol, soaking for 60min, and performing ultrasonic extraction for 2 times, each time for 30 min; filtering, adding 50mL of 75% ethanol into the filter residue, ultrasonic extracting for 1 time, and filtering. Mixing the filtrates, concentrating to 1g/mL to obtain antibacterial effervescent tablet test solution, and storing in a refrigerator at 4 deg.C.
(4) Preparing a test solution of a single medicinal material:
taking a proper amount of dried medicinal materials of the ligusticum wallichii, the gardenia, the szechwan chinaberry fruit and the myrobalan respectively, crushing, sieving by a 200-mesh sieve, weighing 10g of the medicinal materials respectively, preparing a test solution by the method in the step (3), concentrating the test solution to 1g/mL in the same way, and storing the test solution in a refrigerator at 4 ℃ for later use.
(5) And (3) measuring the antibacterial action by a filter paper diffusion method:
0.2mL of each of the 5 test bacterium suspensions is inoculated on the surface of the culture medium, and the culture medium is uniformly coated to prepare a bacterium-containing plate. And (3) beating the filter paper into a filter paper sheet with the diameter of 5mm by using a puncher, and soaking the filter paper in sterile water, 75% ethanol and bacteriostatic effervescent tablet test solutions for 2h respectively after sterilization. Sterile water soaked filter paper was used as a blank, 75% ethanol soaked filter paper was used as a control, and the filter papers were equally spaced and parallel 3 times. Culturing bacteria at 30 deg.C for 24 hr, culturing fungi at 28 deg.C for 72 hr, measuring the diameter of zone by cross method, averaging, and calculating the zone increase rate. The increase rate of the inhibition zone is (diameter of the inhibition zone of the test solution-diameter of the control inhibition zone)/diameter of the control inhibition zone multiplied by 100%. The data of the increase rate of the measured inhibition zone are shown in table 1, and p is less than 0.01 and less than 0.05 compared with the test solution of the effervescent tablets in table 1. As can be seen from table 1, the bacteriostatic effect of the bacteriostatic effervescent tablet of the invention on the test bacteria is as follows: staphylococcus aureus, escherichia coli, bacillus subtilis, penicillium and aspergillus niger. The effervescent tablets have better inhibition effects on escherichia coli, bacillus subtilis, staphylococcus aureus and penicillium than single medicinal materials, and the synergistic effect is achieved after compatibility.
TABLE 1 zone of inhibition increase data
(6) Determination of Minimum Inhibitory Concentration (MIC):
4 sterilized test tubes were aseptically diluted two-fold with 0.5g/mL of test solution to 0.25, 0.125, and 0.0625g/mL, respectively. And (3) measuring the minimum inhibitory concentration of each test bacterium by adopting a filter paper diffusion method, taking the mass concentration of the sample solution with just appeared inhibitory zone around the filter paper as the minimum inhibitory concentration (MI C), measuring each dose in parallel for three times, and taking the maximum value. The data of the measured minimum inhibitory concentration are shown in table 2. In the table, "+" indicates a significant bacteriostatic effect, "+" indicates a weak bacteriostatic effect, and "-" indicates no bacteriostatic effect. As can be seen from the table 2, the bacteriostatic effervescent tablet provided by the invention has different degrees of inhibitory action on escherichia coli, bacillus subtilis, staphylococcus aureus and penicillium.
Table 1 minimum inhibitory concentration data
Those skilled in the art will appreciate that, in the embodiments of the methods of the present invention, the sequence numbers of the steps are not used to limit the sequence of the steps, and it is within the scope of the present invention for those skilled in the art to change the sequence of the steps without inventive work. The examples described herein are intended to aid the reader in understanding the practice of the invention and it is to be understood that the scope of the invention is not limited to such specific statements and examples. Those skilled in the art can make various other specific changes and combinations based on the teachings of the present invention without departing from the spirit of the invention, and these changes and combinations are within the scope of the invention.
Claims (10)
1. The Chinese herbal medicine bacteriostatic effervescent tablet containing the ligusticum wallichii extract is characterized in that:
mainly comprises active ingredients and auxiliary materials; the active ingredients comprise 15-30 parts by mass of ligusticum wallichii, 10-20 parts by mass of gardenia, 5-15 parts by mass of szechwan chinaberry fruit and 5-15 parts by mass of myrobalan; the auxiliary materials comprise an acid source, an alkali source, a lubricant, a diluent and a flavoring agent.
2. The Chinese herbal medicine bacteriostatic effervescent tablet containing ligusticum wallichii extract as claimed in claim 1, which is characterized in that:
the acid source adopts tartaric acid and/or citric acid.
3. The Chinese herbal medicine bacteriostatic effervescent tablet containing ligusticum wallichii extract as claimed in claim 1, which is characterized in that:
the alkali source adopts sodium bicarbonate.
4. The Chinese herbal medicine bacteriostatic effervescent tablet containing ligusticum wallichii extract as claimed in claim 1, which is characterized in that:
the lubricant adopts polyethylene glycol.
5. The Chinese herbal medicine bacteriostatic effervescent tablet containing ligusticum wallichii extract as claimed in claim 1, which is characterized in that:
the diluent is lactose.
6. The Chinese herbal medicine bacteriostatic effervescent tablet containing ligusticum wallichii extract as claimed in claim 1, which is characterized in that:
the flavoring agent is tea polyphenol.
7. The preparation method of the Chinese herbal medicine bacteriostatic effervescent tablet containing the ligusticum wallichii extract as claimed in claim 1, which is characterized by comprising the following steps:
(1) extracting the extractum:
weighing rhizoma Ligustici Chuanxiong, fructus Gardeniae, fructus Toosendan, and fructus Chebulae according to the dosage of claim 1, pulverizing into powder, soaking in ethanol overnight, ultrasonic extracting, filtering, and concentrating under reduced pressure to obtain extract;
(2) grinding the auxiliary materials respectively;
(3) and (3) granulating acid granules and alkali granules:
taking two equal parts of the extract, respectively placing the extract in two mortars, wherein the two mortars are used for preparing acid granules and alkali granules respectively; adding a diluent and a flavoring agent into the two mortars and grinding; taking another mortar, putting the lubricant into the mortar, adding absolute ethyl alcohol, grinding, adding an alkali source for wrapping, and then adding into the mortar for preparing alkali particles for mixing; adding absolute ethanol into the two mortars, mixing, granulating through a 16-mesh sieve, and drying;
(4) tabletting:
and mixing the acid source and the lubricant, adding the mixture into a mortar of acid granules, continuously grinding, uniformly mixing the acid granules and the alkali granules, and tabletting to obtain the target product.
8. The preparation method of the Chinese herbal medicine bacteriostatic effervescent tablet containing the ligusticum wallichii extract as claimed in claim 7, which is characterized in that:
in the step (2), the auxiliary materials are ground in the environment with the temperature of 15-25 ℃ and the humidity of 10-30 percent, and are sieved by a 100-mesh sieve.
9. The preparation method of the Chinese herbal medicine bacteriostatic effervescent tablet containing the ligusticum wallichii extract as claimed in claim 7, which is characterized in that:
in the step (3), drying is carried out in an oven at 50 ℃ for 1.5 h.
10. The preparation method of the Chinese herbal medicine bacteriostatic effervescent tablet containing the ligusticum wallichii extract as claimed in claim 7, which is characterized in that:
in the step (3), the mass ratio of the diluent, the flavoring agent and the extractum in the mortar added into the two mortars of the acid granules and the alkali granules is 45-55: 4-7: 3; the mass ratio of the reducing source added in the mortar of the alkali particles to the extract in the mortar is 30-35: 3, the mass ratio of the acid source added into the mortar of the acid granules to the extract in the mortar is 30-35: 3.
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