CN113318232B - Preparation method of oleum Viticis negundo preparation - Google Patents
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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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)
- A61K36/85—Verbenaceae (Verbena family)
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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- A61P11/06—Antiasthmatics
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- A61P11/10—Expectorants
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/14—Antitussive agents
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Abstract
The invention provides a preparation method of a vitex oil preparation, which relates to the field of pharmacy and comprises the following steps: heating medicinal matrix to melt, adding oleum Viticis negundo, mixing, and cooling; wherein the medicinal matrix comprises polyethylene glycol, poloxamer, beta-cyclodextrin, arachidonic acid oil, sodium dodecyl sulfate, tween-80 and beta-hydroxy-beta-methylbutyrate calcium. The finally prepared vitex oil preparation is not easy to mildew and age, can be quickly dissolved and can well meet the requirements of medicinal composition and clinical treatment.
Description
Technical Field
The invention relates to the field of pharmacy, in particular to a preparation method of a vitex oil preparation.
Background
The oleum Viticis negundo is volatile oil extracted from herba Viticis negundo of Verbenaceae, is light yellow or orange yellow clear liquid, has expectorant, antitussive, and antiasthmatic effects, and has good therapeutic effect on chronic tracheitis. At present, researchers take the vitex oil as a main drug and successively research preparations in dosage forms of capsules, dripping pills and the like. However, the problems of adhesion, mildew, delayed disintegration, poor preparation efficacy and the like in the production and storage processes of the conventional vitex oil preparation in each dosage form generally exist, and although the stability and the shelf life of the preparation are improved by additionally adding auxiliary materials such as a plasticizer, a colorant, a preservative and the like, the problems of complicated preparation steps and high cost also exist.
In order to solve the problems, Chinese patent CN101579449A discloses a method for preparing a vitex oil dripping pill, which comprises the steps of uniformly mixing vitex oil and a medicinal substrate, dripping the mixture into condensate through a dripping pill device, taking out and drying, wherein the medicinal substrate is polyethylene glycol and the like, the weight ratio of the vitex oil to the medicinal substrate is 1: 1-9, the temperature of a dripping head of a dripping pill machine is kept between 60 and 110 ℃, the temperature of the condensate is kept between-5 and 50 ℃, and the inner diameter of a dripping pipe opening is 2 to 5 mm. The dripping pill can be film coated or sugar coated after drying. Colorant, plasticizer and preservative are not needed to be added, so that the auxiliary material cost is saved; the production period is shortened; the requirements on the temperature and the humidity of the production environment are low; the product quality is good; the product has good stability. Chinese patent CN101773578A discloses a vitex oil nanoemulsion and a preparation method thereof, and the invention applies nanotechnology to the prescription and process design of a vitex oil emulsion, wherein, vitex oil, medium-chain fatty acid triglyceride, soybean phospholipid, ethanol and the like are uniformly mixed to be used as an oil phase, poloxamer and water and the like are uniformly mixed to be used as a water phase, the oil phase is added into the water phase to be mixed and emulsified at the temperature of 40-60 ℃, and the mixture is treated by a two-step high-pressure homogenizer to obtain the vitex oil nanoemulsion with milky appearance and the average grain diameter of less than 100 nm. The finally prepared vitex oil nanoemulsion has the advantages of excellent quality, reliable quality stability, good biocompatibility and good effects of eliminating phlegm, relieving cough and relieving asthma. The two inventions simplify the process to a certain extent and ensure the stability and the quality of the product, but the addition of the partial auxiliary materials can weaken the efficacy of the vitex oil due to the reduction of the content of the vitex oil, so that a large amount of patent drugs need to be taken in the treatment process of eliminating phlegm, relieving cough and asthma or chronic bronchitis, and the experience of patients is reduced. Meanwhile, the stability of the vitex oil nanoemulsion in the latter patent is difficult to guarantee, and meanwhile, the emulsion is difficult to store and is easy to be invaded by bacterial and fungi, so that the problem of mildew is caused.
Aiming at the problems of adhesion, mildew, delayed disintegration, poor preparation efficacy, complex preparation process, high production cost and the like in the production and storage processes of the preparation method of the vitex oil in the prior art, a preparation method of the vitex oil preparation is urgently needed to be found, so that the problems can be effectively solved.
Disclosure of Invention
The invention provides a preparation method of a vitex oil preparation aiming at the problems in the prior art, and the preparation method optimizes the preparation process and medicinal substrates of the vitex oil, so that the finally prepared vitex oil preparation is not easy to mildew and age, can be quickly dissolved and can well meet the requirements of medicinal composition and clinical treatment.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
the invention provides a preparation method of a vitex oil preparation, which comprises the following steps:
heating medicinal matrix to melt, adding oleum Viticis negundo, mixing, and cooling;
the medicinal matrix comprises polyethylene glycol, poloxamer, beta-cyclodextrin, arachidonic acid oil, sodium dodecyl sulfate, tween-80 and calcium beta-hydroxy-beta-methylbutyrate.
Further, the medicinal matrix comprises the following components in parts by weight: 10-15 parts of polyethylene glycol, 5-8 parts of poloxamer, 2-5 parts of beta-cyclodextrin, 1-2.5 parts of arachidonic acid grease, 0.5-1.5 parts of sodium dodecyl sulfate, 0.5-0.8 part of tween-80 and 1-2 parts of beta-hydroxy-beta-methylbutyrate calcium.
Preferably, the medicinal matrix comprises the following components in parts by weight: 12 parts of polyethylene glycol, 6 parts of poloxamer, 3 parts of beta-cyclodextrin, 2 parts of arachidonic acid grease, 1 part of sodium dodecyl sulfate, 0.6 part of tween-80 and 1.5 parts of beta-hydroxy-beta-methylbutyrate calcium.
Further, the weight ratio of the polyethylene glycol to the poloxamer to the arachidonic acid oil is 10-15:5-8: 1-2.5. Preferably 6:3: 1.
Further, the weight ratio of the arachidonic acid oil and the beta-hydroxy-beta-methylbutyrate calcium is 1-2.5: 1-2. Preferably 2: 1.5.
Further, the step-by-step addition of the vitex oil means that the vitex oil is added for the first time, and the vitex oil is added for the second time after heating.
Further, the weight ratio of the first addition of the vitex oil to the second addition of the vitex oil is 2-3: 1.
Further, the heating temperature is 50-60 ℃, and the heating time is kept for 10-15 min.
Further, the weight ratio of the total weight of the vitex oil to the pharmaceutical base is 1:2-8, preferably 1: 5.
The invention also provides a vitex oil preparation prepared by the preparation method.
Further, the preparation is a pill, an emulsion or a capsule. For example, different dosage forms are prepared and obtained according to actual requirements, for example, the vitex oil preparation is added into a dripping device of a dripping pill machine, a dripping head is dripped into condensate, a temperature control system of the dripping pill machine is adjusted, the dripping head temperature of the dripping pill machine is kept between 60 and 110 ℃, the gradient temperature of the condensate is kept between-5 and 50 ℃, and the inner diameter of a dripping pipe opening is 2 to 5 mm; (3) wiping pills: taking out the pill, and removing surface condensate to obtain dripping pill. The dripping pill can be made into coated dripping pill by coating sugar or film. In addition, oleum Viticis negundo preparation can be added into capsule according to conventional method to make into capsule.
The technical effects obtained by the invention are as follows:
the final preparation is prepared by optimizing the components and content of the medicinal substrate and matching with the vitex oil, and the vitex oil preparation does not need to add coloring agents, plasticizers and preservatives, so that the auxiliary material cost is saved, and the safety problem caused by using additives in medicines is reduced. The stability of the product can be remarkably improved by compounding the polyethylene glycol, the poloxamer and the arachidonic acid oil in a certain proportion; in addition, the arachidonic acid oil and the beta-hydroxy-beta-methylbutyrate calcium are matched and cooperated, so that the absorption of the vitex oil preparation in the body can be promoted and strengthened to a certain extent, and the efficacy of the vitex oil preparation is enhanced. The finally prepared vitex oil preparation is not easy to mildew and age, can be quickly dissolved and can well meet the requirements of medicinal composition and clinical treatment.
Detailed Description
It should be noted that the vitex oil used in the present invention is purchased from Jiangxi kang pharmaceutical industry Co., Ltd, lot number is 20180103, and other raw materials are all common commercial products, so the source thereof is not particularly limited.
Example 1
A preparation method of a vitex oil preparation is characterized by comprising the following steps: the method comprises the following steps:
heating medicinal matrix to melt, adding oleum Viticis negundo, cooling, heating to 50 deg.C, holding for 10min, adding oleum Viticis negundo, mixing, and cooling;
wherein the medicinal matrix comprises the following components in parts by weight: 10 parts of polyethylene glycol, 5 parts of poloxamer, 2 parts of beta-cyclodextrin, 1 part of arachidonic acid grease, 0.5 part of sodium dodecyl sulfate, 0.5 part of tween-80 and 1 part of beta-hydroxy-beta-methylbutyrate calcium. The weight ratio of the first oleum Viticis negundo to the second oleum Viticis negundo is 2:1, and the weight ratio of oleum Viticis negundo to the medicinal matrix is 1: 2.
Example 2
A preparation method of a vitex oil preparation is characterized by comprising the following steps: the method comprises the following steps:
heating medicinal matrix to melt, adding oleum Viticis negundo, cooling, heating to 60 deg.C, holding for 10min, adding oleum Viticis negundo, mixing, and cooling;
wherein the medicinal matrix comprises the following components in parts by weight: 15 parts of polyethylene glycol, 8 parts of poloxamer, 5 parts of beta-cyclodextrin, 2.5 parts of arachidonic acid grease, 1.5 parts of sodium dodecyl sulfate, 0.8 part of tween-80 and 2 parts of beta-hydroxy-beta-methylbutyrate calcium. The weight ratio of the first addition of oleum Viticis negundo to the second addition of oleum Viticis negundo is 3:1, and the weight ratio of oleum Viticis negundo to the medicinal matrix is 1: 8.
Example 3
A preparation method of a vitex oil preparation is characterized by comprising the following steps: the method comprises the following steps:
heating medicinal matrix to melt, adding oleum Viticis negundo, cooling, heating to 55 deg.C, holding for 12min, adding oleum Viticis negundo, mixing, and cooling;
wherein the medicinal matrix comprises the following components in parts by weight: 12 parts of polyethylene glycol, 6 parts of poloxamer, 3 parts of beta-cyclodextrin, 2 parts of arachidonic acid grease, 1 part of sodium dodecyl sulfate, 0.6 part of tween-80 and 1.5 parts of beta-hydroxy-beta-methylbutyrate calcium. The weight ratio of the first oleum Viticis negundo to the second oleum Viticis negundo is 2.5:1, and the weight ratio of oleum Viticis negundo to the medicinal matrix is 1: 5.
Comparative example 1
The difference from the example 1 is that the medicinal matrix comprises the following components in parts by weight: 8 parts of polyethylene glycol, 10 parts of poloxamer, 1 part of beta-cyclodextrin, 3 parts of arachidonic acid grease, 0.3 part of sodium dodecyl sulfate, 1 part of tween-80 and 0.5 part of beta-hydroxy-beta-methylbutyrate calcium.
Comparative example 2
The only difference from example 1 is that the weight ratio of polyethylene glycol, poloxamer and arachidonic acid oil is 6:1:1 (the total weight of the three is the same as example 1).
Comparative example 3
The only difference from example 1 is that the weight ratio of arachidonic acid oil and calcium beta-hydroxy-beta-methylbutyrate is 3:0.8 (the total weight of both is identical to example 1).
Comparative example 4
The only difference from example 1 is that the vitex oil was added directly to the molten pharmaceutical base without adding the vitex oil in portions to give a vitex oil preparation.
The oleum Viticis negundo preparation in each granulation is prepared into dripping pills, and the preparation method comprises the following steps: adding oleum Viticis negundo preparation into dripping device of dripping pill machine, dripping into condensate via dripper, adjusting temperature control system of dripping pill machine, maintaining dripper temperature of dripping pill machine at 75 + -2 deg.C, gradient temperature of condensate at 0 + -5 deg.C, and inner diameter of dripping tube at 3 mm; (3) wiping pills: taking out the pill, and removing surface condensate to obtain dripping pill. The dripping pill can be made into coated dripping pill by coating sugar or film.
First, the stability test of the oil preparation of Vitex negundo of the invention
The stability of the vitex oil preparation in each example of the invention is examined, the test temperature condition is 40 ℃ +/-2 ℃ and the humidity condition is 75% +/-5%, the refractive index, the dissolution time and the appearance of the vitex oil preparation at the initial stage of the test (namely 0 month) after 1 month and 6 months are examined, the detection method of each item is carried out according to 'Chinese pharmacopoeia' of 2020 edition, and the results are counted in table 1.
TABLE 1
As can be seen from Table 1, the disintegration delay and the blocking phenomenon of the oleum Viticis negundo preparation of each example of the present invention are greatly improved, the related preparation still has excellent volatile oil content and dissolution time after 6 months of storage in accelerated test, and the whole appearance of the product is round, without blocking and without mildew.
Second, blood test of the Vitex oil preparation of the present invention
Test animals: SD rats 70 were randomly divided into 7 groups of 10 rats each.
The test method comprises the following steps: the formulations of the examples were administered to each group of rats, dissolved in distilled water and administered by gavage so that the administration amount was 250mg/kg, and the concentration of vitex oil in the plasma of rats was measured and counted at 60min, 120min and 360min, respectively, to obtain table 2.
TABLE 2
As is clear from table 2, the vitex oil preparation of the present invention has excellent dissolution rate, and the content of vitex oil in rat plasma can be increased in a short period of time after administration, and thus, the vitex oil of the present invention can be rapidly and effectively absorbed by living things, thereby exhibiting the effect.
Finally, it should be noted that the above-mentioned contents are only used for illustrating the technical solutions of the present invention, and not for limiting the protection scope of the present invention, and that the simple modifications or equivalent substitutions of the technical solutions of the present invention by those of ordinary skill in the art can be made without departing from the spirit and scope of the technical solutions of the present invention.
Claims (6)
1. A preparation method of a vitex oil preparation is characterized by comprising the following steps: the method comprises the following steps:
heating medicinal matrix to melt, adding oleum Viticis negundo, mixing, and cooling;
the medicinal matrix comprises the following components in parts by weight: 10-15 parts of polyethylene glycol, 5-8 parts of poloxamer, 2-5 parts of beta-cyclodextrin, 1-2.5 parts of arachidonic acid grease, 0.5-1.5 parts of sodium dodecyl sulfate, 0.5-0.8 part of tween-80 and 1-2 parts of beta-hydroxy-beta-methylbutyrate calcium;
the adding of the vitex oil in several times specifically means adding the vitex oil for the first time, cooling, heating again and adding the vitex oil for the second time.
2. The method of claim 1, wherein: the weight ratio of the first addition of the vitex oil to the second addition of the vitex oil is 2-3: 1.
3. The method of claim 1, wherein: the heating temperature is 50-60 deg.C, and the temperature is maintained for 10-15 min.
4. The method of claim 1, wherein: the weight ratio of the total weight of the vitex oil to the medicinal substrate is 1: 2-8.
5. The Vitex oil preparation prepared by the method of any one of claims 1 to 4.
6. The vitex oil formulation of claim 5, wherein: the preparation is pill, emulsion or capsule.
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