CN110772556B - Preparation method of compound lithospermum oil aerosol - Google Patents

Preparation method of compound lithospermum oil aerosol Download PDF

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CN110772556B
CN110772556B CN201911220947.2A CN201911220947A CN110772556B CN 110772556 B CN110772556 B CN 110772556B CN 201911220947 A CN201911220947 A CN 201911220947A CN 110772556 B CN110772556 B CN 110772556B
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lithospermum
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曾庆恢
向阳
李丽娟
黄志军
吴木琴
任平远
高凯
吴金刚
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Jianmin Pharmaceutical Groups Corp ltd
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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)
    • A61K36/30—Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
    • A—HUMAN NECESSITIES
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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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    • 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
    • A—HUMAN NECESSITIES
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    • A61K9/00—Medicinal preparations characterised by special physical form
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    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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    • 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
    • A61K2236/35—Extraction with lipophilic solvents, e.g. Hexane or petrol ether

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Abstract

The invention discloses a preparation method of compound lithospermum oil aerosol, which comprises the steps of adding 10-40% of dimethyl silicone oil into edible oil by weight to serve as extraction oil, adding lithospermum, honeysuckle stem and angelica dahurica into the extraction oil for frying, filtering the oil liquid after frying, adding borneol after the oil liquid is placed to room temperature, stirring to dissolve, uniformly mixing, finally subpackaging in a pressure-resistant container, installing a valve system and sealing, filling a propellant into the pressure-resistant container, and obtaining the compound lithospermum oil aerosol after the air tightness inspection is qualified. The invention improves the content of the L-alkannin in the compound lithospermum oil aerosol and the curative effect of treating burns and scalds, and reduces the production cost of the compound lithospermum oil aerosol.

Description

Preparation method of compound lithospermum oil aerosol
Technical Field
The invention belongs to the field of pharmacy, and relates to a preparation method of a compound lithospermum oil aerosol.
Background
The compound lithospermum oil aerosol is a traditional Chinese medicine prepared from four traditional Chinese medicinal materials of lithospermum, honeysuckle stem, angelica dahurica and borneol, has the functions of clearing heat and cooling blood, and detoxifying and relieving pain, and is mainly used for treating burns and scalds clinically. The existing compound oil aerosol of lithospermum is prepared by frying lithospermum, honeysuckle stem and angelica dahurica in sesame oil, adding borneol into the oil, subpackaging and filling propellant.
The method mainly has the following defects: (1) the extraction efficiency of active ingredients of traditional Chinese medicines by the sesame oil is low, the quality of oil products is uneven, and the curative effect cannot be guaranteed; (2) the edible oil has expensive price, short resource and high production cost. Therefore, the preparation method of the product is urgently needed to be improved, so that the product can be better applied to clinic.
Disclosure of Invention
The invention aims to provide a preparation method of a compound lithospermum oil aerosol, aiming at improving the content and curative effect of medicinal components and reducing the production cost.
A preparation method of a compound lithospermum oil aerosol comprises the following steps: adding 10-40% of dimethyl silicone oil by weight into edible oil to serve as extraction oil, adding lithospermum, honeysuckle stem and angelica dahurica into the extraction oil for frying, wherein the frying time is 20-60 minutes, the frying temperature is 120-180 ℃, the weight of the extraction oil is 6-10 times of the weight of the medicinal materials, filtering the oil liquid after the frying is finished, adding borneol after the oil liquid is placed to room temperature, stirring to dissolve, uniformly mixing, finally subpackaging in a pressure-resistant container, sealing after a valve system is installed, filling a propellant into the pressure-resistant container, and obtaining the product after the air tightness inspection is qualified.
Preferably, the weight ratio of the lithospermum to the honeysuckle stem to the angelica dahurica to the borneol is 1-5: 1-5: 1-5: 0.5-3, and the optimal ratio is 2: 2: 2: 1.
preferably, the edible oil is olive oil.
Preferably, the dimethicone is added in an amount of 30% by weight of the olive oil.
Preferably, the frying time is 40 minutes.
Preferably, the frying temperature is 150 ℃.
Preferably, the weight of the extracted oil is 8 times of the weight of the medicinal materials.
Preferably, the frying is carried out under a vacuum condition of 0.02 to 0.06 MPa.
Further preferably, the frying vacuum degree is 0.06 MPa.
The invention has the beneficial effects that:
(1) the invention improves the content of the L-alkannin in the compound lithospermum oil aerosol.
(2) The invention improves the curative effect of the compound lithospermum oil aerosol on treating burns and scalds.
(3) The invention reduces the production cost of the compound lithospermum oil aerosol.
(4) The quality of the raw materials is more stable, and the resource source is easily ensured.
Detailed Description
The present invention will be described in detail below with reference to examples.
Example 1 selection of edible oil types
The common edible oil mainly comprises sesame oil, peanut oil, corn oil, soybean oil, rapeseed oil, olive oil and the like, 6 parts of experimental samples are weighed, each part contains 90g of medicinal materials (30 g of lithospermum, honeysuckle stem and angelica dahurica) and 720g of edible oil, the mixture is heated to 140 ℃ for 30min, 200-mesh sieves are used for filtering to obtain oil solutions, the content of the laevorotatory alkannin in different oil solutions is respectively determined according to an ultraviolet spectrophotometry, and the specific detection method is as follows:
preparation of a reference solution: the levorotatory alkannin reference substance is added with ethyl acetate to prepare a solution containing 30 mug per 1 ml.
Preparation of a test solution: precisely measuring 5ml of oil solution, adding 4% sodium hydroxide solution, shaking for 8 times (15 ml each time), mixing alkali solutions, adjusting pH to 1-2 with concentrated hydrochloric acid, standing for 30min, shaking for 6 times with diethyl ether (20 ml each time), mixing diethyl ether solutions, volatilizing, dissolving the residue with ethyl acetate, transferring to a 25ml measuring flask, adding ethyl acetate to dilute to scale, and shaking.
The determination method comprises the following steps: measuring absorbance of the reference solution and the sample solution at 516nm with ethyl acetate as blank according to ultraviolet spectrophotometry (appendix V A of first part of Chinese pharmacopoeia 2015), and calculating the content.
The results are shown in Table 1.
TABLE 1 Effect of frying different edible oils on L-alkannin content
Serial number Kind of edible oil L-alkannin (mu g/ml)
1 Peanut oil 130.25
2 Corn oil 115.08
3 Soybean oil 147.53
4 Sesame oil 153.87
5 Rapeseed oil 162.11
6 Olive oil 185.64
From the above experiments, it can be seen that the olive oil extracted L-alkannin was the highest in content.
Considering that the natural edible oil is expensive, high in cost and uneven in quality, the synthetic silicone oil with lower price and more stable quality is used for replacing part of the edible oil, so that the dimethyl silicone oil is added into the olive oil according to different proportions, and the test is carried out according to the method, wherein each part contains 90g of medicinal materials and 720g of mixed oil, and the mixture is heated to 140 ℃ for 30 min. The results are shown in Table 2.
TABLE 2 influence of Silicone oils of different addition amounts on the content of Chinese medicinal materials
Serial number Amount of Silicone oil added (%) L-alkannin (mu g/ml)
1 0 185.64
2 10 187.42
3 20 174.50
4 30 177.39
5 40 155.63
6 50 131.71
From the tests, it can be seen that the addition of silicone oil has a certain adverse effect on the extraction effect, the content of the L-alkannin is reduced, but the content of the L-alkannin is reduced less obviously within 30 percent of the addition amount, and considering that the price of the silicone oil is only 1/3 to 1/10 of olive oil, the quality is more stable, and the source can be ensured, so that 30 percent of dimethyl silicone oil is added into the olive oil by weight to extract the traditional Chinese medicinal materials.
Example 2 selection of frying Process parameters
In order to select the optimal extraction conditions, 4 factors of frying temperature, time, oil adding amount and vacuum degree are selected as investigation factors, the content of the L-alkannin is used as an evaluation index, and a 4-factor 3 horizontal orthogonal experiment is designed. Weighing 90g of traditional Chinese medicinal materials in each part, weighing 9 parts in total, adding 30% of dimethyl silicone oil into olive oil by weight as extraction oil, extracting in a vacuum frying machine, performing tests according to parameters designed by a factor level table, and detecting the content of laevorotatory alkannin in the extraction oil, wherein the factor level table is shown in table 3, and orthogonal test results are shown in table 4.
TABLE 3 orthogonal experiment factor horizon
A (temperature:. degree. C.) B (time: min) C (oil filling amount: multiple) D (vacuum degree: MPa)
1 120 20 6 0.02
2 150 40 8 0.04
3 180 60 10 0.06
TABLE 4L 9 (3)4) Results of orthogonal experiments
Figure BDA0002300824390000041
Figure BDA0002300824390000051
TABLE 5 analysis of variance in orthogonal experiments
Sources of variance Sum of squared deviations Degree of freedom F ratio Critical value of F Significance of
A 219.228 2 4.192 19
B 80.415 2 1.538 19
C (error) 52.292 2 1.000 19
D 1117.001 2 21.361 19 ＊
According to the orthogonal result, A2B3C2D3 should be selected, no significant difference is considered in consideration of B factor, results of B2 and B3 are not greatly different, and finally, B2 is selected better from the viewpoint of reducing man-hour.
According to the orthogonal test result, the A2B2C2D3 is finally selected, and the extraction method of the Chinese medicinal materials is determined as follows: mixing 550g of olive oil with 165g of dimethyl silicone oil, adding 90g of medicinal materials into the mixed oil, frying in vacuum for 40 minutes at 150 ℃ under the vacuum degree of 0.06MPa, and filtering to obtain filtrate.
Example 3 verification of frying Process
Taking 550g of olive oil, adding 165g of simethicone, mixing, adding 90g of medicinal materials (30 g of each of lithospermum, honeysuckle stem and angelica dahurica) into the mixed oil, frying in vacuum for 40 minutes at the frying temperature of 150 ℃ and the frying vacuum degree of 0.06MPa, filtering after frying, taking filtrate, and detecting the content of the L-alkannin in the extracted oil.
Taking 550g of olive oil, adding 165g of dimethyl silicone oil, mixing, adding 90g of medicinal materials (30 g of each of lithospermum, honeysuckle stem and angelica dahurica) into the mixed oil, frying for 40 minutes at normal pressure at the frying temperature of 150 ℃, filtering after frying, taking filtrate, and detecting the content of the levorotatory alkannin in the extracted oil.
TABLE 6 comparison of vacuum and atmospheric frying results
Figure BDA0002300824390000052
Figure BDA0002300824390000061
From the above results, it can be seen that the content of vacuum frying was increased by 10% compared to atmospheric frying.
Example 4 therapeutic Effect of Lithospermum erythrorhizon oil on Scald model mice
Preparation of test drugs: to the extracted oil obtained in the vacuum frying in example 3, 15g of borneol was added, stirred to be melted, and mixed to prepare a test drug.
Preparation of positive control: mixing radix Arnebiae (30 g each), caulis Lonicerae and radix Angelicae Dahuricae (720 g each), adding oleum Sesami, frying in a pan, filtering to obtain oil, cooling to room temperature, adding Borneolum Syntheticum (15 g), stirring to dissolve, and mixing to obtain control medicine.
Taking 40 SPF Balb/C mice with the weight of 18-22 g, randomly dividing the mice into 4 groups of 10 mice. The back hair of each group of mice was shaved, depilated with sodium sulfide, anesthetized by intraperitoneal injection of 4% sodium pentobarbital, a beaker with a diameter of 3cm was placed in the depilated area of the back, boiled water at 100 ℃ was poured in, and after 10s, the beaker was removed and the timer was started. After 30min, rats in each group were dosed at the scalded site:
treatment groups: 0.2ml of test medicine is smeared on the scald part.
Positive control group: 0.2ml of contrast medicine is smeared on the scald part.
Blank control group: 0.2ml of olive oil added with 30% of simethicone is smeared on the scald part.
Model group: 0.2ml of normal saline is smeared on the scald part.
After administration, the mixture is bound and fixed by medical sterile gauze, raised in cages, freely eaten and drunk, and changed with medicines 1 time every day for 14 days continuously. The scald area of the mice on day 1, 3, 7 and 14 was measured, and the healing rate (initial scald area-scald area at each time point)/initial scald area × 100% was calculated, and the results are shown in table 7.
Table 7 effect of arnebia oil on wound healing in scalded mice (n ═ 10)
Figure BDA0002300824390000062
Figure BDA0002300824390000071
Note: in comparison to the set of models,＊P＜0.05；＊＊P＜0.01。
from the results, the blank control group coated with the olive oil and the dimethicone also has a certain promotion effect on wound healing of the scalded mice, but the effect is not obvious (P is more than 0.05), the compound lithospermum oil can obviously promote wound healing, and the effect of the compound lithospermum oil prepared by the invention is slightly superior to that of the compound lithospermum oil prepared by the conventional method.
EXAMPLE 5 preparation of Aerosol
The test drug prepared in example 4 was put in a pressure-resistant container, a valve system was installed, and then the container was sealed, and tetrafluoroethane was poured into the pressure-resistant container to 1000ml, and the test drug was obtained after the air-tightness test was passed.

Claims (7)

1. The preparation method of the compound lithospermum oil aerosol is characterized by comprising the following steps: adding 10-40% of dimethyl silicone oil by weight into olive oil to serve as extraction oil, adding lithospermum, honeysuckle stem and angelica dahurica into the extraction oil for frying, wherein the frying time is 20-60 minutes, the frying temperature is 120-180 ℃, the weight of the extraction oil is 6-10 times of the weight of medicinal materials, filtering the oil liquid after frying is finished, adding borneol after the oil liquid is placed to room temperature, stirring to dissolve, uniformly mixing, finally subpackaging in a pressure-resistant container, sealing after a valve system is installed, filling a propellant into the pressure-resistant container, and obtaining the lithospermum, the honeysuckle stem, the angelica dahurica and the borneol after the airtight inspection is qualified, wherein the weight ratio of the lithospermum to the honeysuckle stem to the angelica dahurica to the borneol is 1-5: 1-5: 1-5: 0.5-3.
2. The preparation method of the compound lithospermum oil aerosol as claimed in claim 1, which is characterized in that: the addition amount of the dimethyl silicone oil is 30 percent of the weight of the olive oil.
3. The preparation method of the compound lithospermum oil aerosol as claimed in claim 1, which is characterized in that: the frying time was 40 minutes.
4. The preparation method of the compound lithospermum oil aerosol as claimed in claim 1, which is characterized in that: the frying temperature is 150 ℃.
5. The preparation method of the compound lithospermum oil aerosol as claimed in claim 1, which is characterized in that: the weight of the extracted oil is 8 times of the weight of the medicinal materials.
6. The process for preparing the compound arnebia oil aerosol as claimed in any of claims 1 to 5, which comprises the following steps: the frying is carried out under the vacuum condition of 0.02-0.06 MPa.
7. The method for preparing the compound lithospermum oil aerosol as claimed in claim 6, which is characterized in that: the frying vacuum degree is 0.06 MPa.
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