CN113559147A - A pharmaceutical composition for treating gynecological inflammation, and its preparation method - Google Patents
A pharmaceutical composition for treating gynecological inflammation, and its preparation method Download PDFInfo
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- CN113559147A CN113559147A CN202110955123.0A CN202110955123A CN113559147A CN 113559147 A CN113559147 A CN 113559147A CN 202110955123 A CN202110955123 A CN 202110955123A CN 113559147 A CN113559147 A CN 113559147A
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- gynecological inflammation
- pharmaceutical composition
- olive oil
- treating gynecological
- organic solvent
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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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/04—Antipruritics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation 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
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
Abstract
The invention discloses a composition for treating gynecological inflammation, which consists of a herba elsholtziae extract and olive oil, wherein the herba elsholtziae extract accounts for 0.5-20% of the weight of the olive oil. The applicant finds for the first time that the components such as flavone in the elsholtzia chinensis have good curative effect on gynecological inflammation, can play a better antibacterial synergistic effect with volatile oil, and the components such as flavone and alkaloid can play a multi-target treatment role in resisting inflammation, relieving itching, enhancing immunity, promoting mucous membrane and tissue repair and the like, thereby being more beneficial to promoting the recovery of gynecological inflammation. Therefore, the applicant finally enriches the components by screening the extraction solvent and the method, and the pharmacodynamic experiment shows that the invention can better play the role of treating gynecological inflammation.
Description
Technical Field
The invention belongs to the field of pharmacy, and relates to a pharmaceutical composition for treating gynecological inflammation and a preparation method thereof.
Background
Gynecological inflammation is a disease with pruritus, causalgia, abnormal fluid and the like as main clinical manifestations, the etiology is usually caused by exogenous microbial infection or vaginal flora balance imbalance, the morbidity of the disease is high, and the daily life and physical and psychological health of women are seriously affected. At present, gynecological inflammation is mainly treated by using antibiotics, but as is known, the antibiotics can not be used for a long time because of easy drug resistance, and the secondary infection is caused because the flora balance is further aggravated by overuse of the antibiotics.
In contrast, natural plant medicines have the advantages of small toxic and side effects, environmental protection and the like, and are increasingly researched and applied in the medical field. Herba Moslae (Mosla chinensis Maxim.) is a plant of genus Boehmeria of family Labiatae, and is widely distributed in China. The Chinese medicine is prepared with whole herb of herba Moslae and can be used for treating common cold, diarrhea, traumatic injury, blood stasis and pain, edema, eczema, pruritus, etc. and its tender stem and leaf may be used as vegetable or oil material.
The content of volatile oil in the herba lysimachiae medicinal material is as high as about 2%, the modern medicine mainly focuses on the volatile oil part, various components are identified from the herba lysimachiae volatile oil at present, wherein active ingredients of traditional Chinese medicines such as thymol, carvacrol, cymene and the like are not lacked, the herba lysimachiae volatile oil is obtained by using high critical carbon dioxide extraction such as gesbice (2005) and the like, and the functions of resisting bacteria, resisting viruses, regulating immune function, promoting gastrointestinal smooth muscle movement and the like are verified, however, the herba lysimachiae is also rarely used for treating gynecological inflammation at present.
Disclosure of Invention
The invention aims to provide a medicament for treating gynecological inflammation, which takes elsholtzia extract as a main active ingredient, enriches the contents of thymol and general flavone active substances by selecting a proper extraction solvent and an extraction method, and discovers that the curative effect of the medicament taking the extract as the main active ingredient on the gynecological inflammation is higher than that of the medicament taking volatile oil as the main active ingredient through pharmacodynamic experiment verification.
The above purpose is realized by the following technical scheme:
a pharmaceutical composition for treating gynecological inflammation comprises herba Moslae extract and olive oil, wherein the herba Moslae extract accounts for 0.5-20% of the weight of the olive oil.
Preferably, the elsholtzia extract accounts for 5-15% of the weight of the olive oil.
Preferably, the elsholtzia extract is a product obtained by extracting a medicinal material of elsholtzia with an organic solvent.
Further preferably, the organic solvent is ethyl acetate.
Preferably, the extraction is percolation extraction.
Further preferably, the specific method of percolation extraction is: pulverizing herba Moslae chinensis into powder of above 40 meshes, filling into a percolation tank, adding organic solvent, soaking overnight, opening a liquid outlet valve to regulate the liquid outlet speed to 5-20ml per 1Kg of medicinal material per minute, supplementing organic solvent to above medicinal material, stopping when the percolate is colorless and clear, collecting percolate, concentrating under reduced pressure, and lyophilizing.
A preparation method of a medicine for treating gynecological inflammation comprises the following steps:
1) pulverizing herba Moslae chinensis into powder of above 40 meshes, filling into a percolation tank, adding organic solvent, soaking overnight, opening a liquid outlet valve to regulate the liquid outlet speed to 5-20ml per 1Kg of medicinal material per minute, supplementing organic solvent to above medicinal material, stopping when the percolate is colorless and clear, collecting percolate, concentrating under reduced pressure, and lyophilizing;
2) adding the freeze-dried powder obtained in the step 1) into olive oil, wherein the freeze-dried powder accounts for 0.5-20% of the weight of the olive oil, and carrying out high-speed shearing and canning to obtain the olive oil.
The invention has the beneficial effects that:
(1) the applicant finds for the first time that the components such as flavone and the like in the herba elsholtziae have good curative effects on gynecological inflammation, can play a better antibacterial synergistic effect together with the volatile oil, and can play a multi-target treatment role in resisting inflammation, relieving itching, enhancing immunity, promoting mucous membrane and tissue repair and the like, so that the recovery of the gynecological inflammation is facilitated.
(2) The invention is derived from natural plants, and has the advantages of less side effect, small drug resistance and the like. The olive oil used as a drug carrier has the advantages of good biocompatibility and stability, small irritation to skin and human bodies, safety, reliability and the like.
Detailed Description
The present invention will be described in detail below with reference to specific examples.
Example 1 comparison of extraction solvents
Taking 100g of elsholtzia, crushing into 100-mesh powder, performing ultrasonic extraction on the powder for 3 hours at room temperature by using water, 90% ethanol, n-butanol, ethyl acetate, chloroform and petroleum ether respectively, filtering, performing rotary evaporation on the filtrate until the filtrate is dry, weighing, and detecting the content of thymol and flavone in the dry extract. Wherein, the content of thymol is determined by HPLC method, the substance to be detected is detected after being extracted by methanol ultrasound, C18 chromatographic column; mobile phase: methanol-1% acetic acid water (55:45), detection wavelength 254 nm; the flavone content is determined by ultraviolet spectrophotometry, the wavelength is 510nm, and rutin is used as a reference. The results are shown in Table 1.
TABLE 1 Effect of different extraction solvents on thymol and Total Flavonoids content
| Extraction solvent | Thymol content (%) | Total flavone content (%) |
| Water (W) | 0.21 | 5.19 |
| 90% ethanol | 0.67 | 11.85 |
| N-butanol | 0.82 | 19.53 |
| Ethyl acetate | 1.21 | 17.22 |
| Chloroform | 1.34 | 4.97 |
| Petroleum ether | 1.55 | 3.68 |
From the above results, it can be seen that the total flavone content in the product is higher when n-butanol or ethyl acetate is used as the extraction solvent, and ethyl acetate is finally selected as the extraction solvent in consideration of the fact that the thymol content in the ethyl acetate extract is significantly higher than that of n-butanol.
EXAMPLE 2 pharmaceutical preparation
1) Pulverizing herba Moslae (containing 0.54% thymol and 5.5% total flavonoids) into 60 mesh powder (all the medicinal materials can pass through 60 mesh sieve), filling 1Kg of powder into a percolation tank, adding ethyl acetate, soaking overnight, opening a liquid outlet valve to adjust the liquid outlet speed to 8ml per minute, supplementing ethyl acetate to keep the liquid level above the medicinal materials, continuously percolating until the percolate is colorless and clear, collecting percolate, concentrating under reduced pressure, lyophilizing to obtain lyophilized powder 146.1g, with a yield of 14.6%, detecting that the lyophilized powder contains 1.78% thymol and 24.19% total flavonoids, and the component extraction transfer rates are 48.1% and 64.2%, respectively;
2) adding the freeze-dried powder obtained in the step 1) into olive oil to enable the freeze-dried powder to account for 8% of the weight of the olive oil, and canning after high-speed shearing.
Example 3 efficacy test
(1) Molding die
Staphylococcus aureus and Pseudomonas aeruginosa were prepared in 108CFU/mL of bacterial solution, and then adding 1: mixing at a ratio of 1. Taking 40 Wistar female white rats with the weight of 150-. After infection, the vaginal lesion condition of the rat is observed, a large amount of white secretion of the pudendum of the rat is visible on the 5 th day, and the rat is accompanied with red swelling, and staphylococcus aureus and pseudomonas aeruginosa are detected to be positive by a secretion objective lens, which indicates that the animal model for bacterial vaginal inflammation is successfully prepared.
(2) Administration of drugs
Randomly dividing 40 white rats into a model group, a control 1 group, a control 2 group and a test drug group, wherein 10 mice in each group are respectively treated as follows:
control 1 group: mixing herba Moslae volatile oil with oleum Olivarum 8 wt%, and injecting into vagina of model animal 0.1ml/100 g;
control 2 group: pulverizing herba Moslae into 200 mesh fine powder, mixing with small amount of glycerol, and injecting into vagina of model animal at dosage of 0.1g/100 g;
test drug groups: injecting the medicine prepared in example 2 into vagina of model animal at dosage of 0.1ml/100 g;
model group: an equal amount of saline was injected.
Injecting the mixture once in the morning and at the evening every day for 7 days continuously, observing the histopathological changes of the vagina on the 8 th day, simultaneously taking the vaginal secretion for culturing, and observing the condition that the strains turn negative.
(3) Determination of therapeutic effect
And (3) healing: the secretion and red swelling disappear, the vaginal lesion is obviously improved, and the bacteria colony grows in the culture.
The method has the following advantages: the secretion and redness were significantly reduced and only a small number of infectious bacteria were present in the culture.
And (4) invalidation: a large amount of purulent secretion of the pudendum is accompanied by red swelling, and a large amount of infectious bacteria are found in the culture.
(4) Results of the experiment
The results of the experiments are shown in table 2 below.
TABLE 2 curative effects on the animals of each group
| n | Recovery method | Is effective | Invalidation | Total effective rate (%) | |
| Model set | 10 | 0 | 0 | 10 | 0 |
| Control 1 group | 10 | 2 | 4 | 4 | 60 |
| Control 2 group | 10 | 2 | 3 | 5 | 50 |
| Test drug groups | 10 | 4 | 4 | 2 | 80Δ﹡﹡ |
As compared with the control 1 group,ΔP<0.05; compared with the control group 2, the control group,﹡P<0.05，﹡﹡P<0.01。
from the results, the medicine prepared by the invention has obvious antibacterial activity and can promote vaginal infection to quickly turn to the negative. Meanwhile, the medicine contains active substances in the elsholtzia volatile oil, and also contains a large amount of active ingredients such as flavone and alkaloids, and the ingredients can not only play a synergistic antibacterial role of various substances together with the volatile oil, but also play a multi-target treatment role in resisting inflammation, relieving itching, enhancing immunity and promoting mucous membrane and tissue repair, so that the curative effect of the medicine is obviously superior to that of a control group 1 (P <0.05), and is extremely obviously superior to that of a control group 2 (P < 0.01).
Claims (9)
1. A pharmaceutical composition for treating gynecological inflammation is characterized by comprising herba Moslae extract and olive oil, wherein the herba Moslae extract accounts for 0.5-20% of the weight of the olive oil.
2. The pharmaceutical composition for treating gynecological inflammation according to claim 1, characterized in that: the herba elsholtziae extract accounts for 5-15% of the weight of the olive oil.
3. The pharmaceutical composition for treating gynecological inflammation according to claim 1, characterized in that: the herba Moslae extract is obtained by extracting herba Moslae with organic solvent.
4. The pharmaceutical composition for treating gynecological inflammation according to claim 3, characterized in that: the organic solvent is ethyl acetate.
5. The pharmaceutical composition for treating gynecological inflammation according to claim 3, characterized in that: the extraction is percolation extraction.
6. The pharmaceutical composition for treating gynecological inflammation according to claim 5, wherein the specific method of percolation extraction is: pulverizing herba Moslae chinensis into powder of above 40 meshes, filling into a percolation tank, adding organic solvent, soaking overnight, opening a liquid outlet valve to regulate the liquid outlet speed to 5-20ml per 1Kg of medicinal material per minute, supplementing organic solvent to above medicinal material, stopping when the percolate is colorless and clear, collecting percolate, concentrating under reduced pressure, and lyophilizing.
7. A preparation method of a pharmaceutical composition for treating gynecological inflammation is characterized by comprising the following steps:
1) pulverizing herba Moslae chinensis into powder of above 40 meshes, filling into a percolation tank, adding organic solvent, soaking overnight, opening a liquid outlet valve to regulate the liquid outlet speed to 5-20ml per 1Kg of medicinal material per minute, supplementing organic solvent to above medicinal material, stopping when the percolate is colorless and clear, collecting percolate, concentrating under reduced pressure, and lyophilizing;
2) adding the freeze-dried powder obtained in the step 1) into olive oil, wherein the freeze-dried powder accounts for 0.5-20% of the weight of the olive oil, shearing at a high speed to obtain emulsion, and canning to obtain the olive oil.
8. The use of the pharmaceutical composition according to any one of claims 1 to 6 for the preparation of a medicament for the treatment of gynecological inflammation, which comprises not only the active ingredients of the elsholtzia volatile oil, but also flavone and alkaloid active ingredients, which not only exert the synergistic bacteriostatic action of a plurality of substances together with the active ingredients of the volatile oil, but also exert the multi-target therapeutic effects of anti-inflammation, relieving itching, enhancing immunity, and promoting mucosal and tissue repair, thereby better treating gynecological inflammation.
9. Use according to claim 8, characterized in that: the gynecological inflammation is vaginitis, especially bacterial vaginitis.
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Application publication date: 20211029 |