CN112933160A

CN112933160A - Viola yedoensis makino-based ointment as well as preparation method and application thereof

Info

Publication number: CN112933160A
Application number: CN202110155154.8A
Authority: CN
Inventors: 侯璐璐; 霍巍; 李云; 候小滨
Original assignee: JIANGXI XIER KANGTAI PHARMACEUTICAL CO Ltd
Current assignee: JIANGXI XIER KANGTAI PHARMACEUTICAL CO Ltd
Priority date: 2021-02-04
Filing date: 2021-02-04
Publication date: 2021-06-11

Abstract

The invention relates to the field of medicines, and particularly discloses an ointment based on Chinese violet and a preparation method and application thereof, wherein the ointment based on Chinese violet is characterized in that medicine permeability is improved or improved by adopting an ointment matrix, the raw materials of the ointment matrix at least comprise any one of sesame oil, beeswax and lanolin, and the prepared ointment based on Chinese violet is not easy to dry and knot when being applied to an affected part, so that the curative effect of the medicine is improved; the preparation method of the ointment based on the Chinese violet provided by the invention has the characteristics of simplicity and feasibility, the prepared finished product has good antibacterial and pus discharging effects, the problem of low drug permeability due to the fact that most of the existing Chinese violet ointment adopts sesame oil as a matrix is solved, and the ointment has a wide market prospect.

Description

Viola yedoensis makino-based ointment as well as preparation method and application thereof

Technical Field

The invention relates to the field of medicines, in particular to an ointment based on Chinese violet, a preparation method and an application thereof.

Background

Viola yedoensis makino, also called viola yedoensis makino, belongs to perennial herbaceous plants, and in the prior art, an ointment of viola yedoensis makino prepared by taking viola yedoensis makino as a raw material belongs to dermatology medicines, has good antibacterial and pus discharge effects, can be used for suppurative inflammation, frostbite, cellulitis and the like, and can be applied to the affected parts which are already broken and not broken; also has obvious curative effect on cervicitis.

At present, most of the traditional viola yedoensis makino ointment adopts sesame oil as a substrate, and can be used for treating all furuncle and mastitis. However, the above technical solutions have the following disadvantages in practical applications: the viola yedoensis makino ointment in the prior art is mostly prepared from concentrated viola yedoensis makino ointment and sesame oil as a matrix, and has the problems of low drug permeability, easy drying and caking when being applied to an affected part, unsatisfactory percutaneous permeability and influence on the curative effect of the drug.

Disclosure of Invention

The invention aims to provide an ointment based on Chinese violet, and aims to solve the problem that most of the existing Chinese violet ointments proposed in the background art adopt sesame oil as a matrix and have low drug permeability.

In order to achieve the purpose, the invention provides the following technical scheme:

an ointment based on herba Violae, specifically herba Violae ointment, is prepared by taking herba Violae concentrated ointment as raw material, adding ointment matrix, and mixing; wherein the herba Violae concentrated paste is prepared by decocting herba Violae (dried whole plant) with water, evaporating, and concentrating to obtain paste; the ointment matrix is prepared from at least one of oleum Sesami, Cera flava, and lanolin.

As a further scheme of the invention: the paste yield of evaporation and concentration is about 20-23wt%, and the paste yield is obtained by multiplying the weight ratio of the total dry paste to the medicinal material by 100%.

As a still further scheme of the invention: 0.05-0.15wt% of ethylparaben is added into the herba Violae concentrated paste as a preservative.

Preferably, the addition amount of the ethylparaben is 0.1wt% of the weight of the concentrated extract of the Chinese violet.

As a still further scheme of the invention: in the ointment based on the Chinese violet, the mass ratio of the Chinese violet concentrated ointment to the ointment matrix is 80-90: 10-20.

As a still further scheme of the invention: the ointment matrix comprises sesame oil and beeswax as raw materials, and the mass ratio of the concentrated ointment of Chinese violet herb to the beeswax is 80-90:8-12: 4-6.

Preferably, the mass ratio of the concentrated extract of the Chinese violet, the sesame oil and the beeswax is 85:10: 5.

As a still further scheme of the invention: the ointment matrix comprises the following raw materials in parts by weight: 30-40 parts of glyceryl monostearate, 130 parts of stearic acid 110-containing material, 50-70 parts of liquid paraffin, 90-110 parts of white vaseline, 40-60 parts of lanolin, 3-5 parts of triethanolamine, 0.8-1.2 parts of ethylparaben and 650 parts of water 600-containing material.

As a still further scheme of the invention: the water may be any one selected from purified water, distilled water, and soft water, and is not limited thereto and may be selected as needed.

Preferably, the water is purified water.

As a still further scheme of the invention: the preparation method of the ointment base comprises the following steps: weighing ethylparaben according to a certain proportion, adding into boiling water, stirring to dissolve completely, adding glyceryl monostearate, stearic acid, liquid paraffin, white vaseline, lanolin and triethanolamine, heating in water bath to 75-85 deg.C (preferably 80 deg.C), stirring to obtain white fine paste, stopping heating, and stirring to condense to obtain the ointment matrix.

Further preferably, the raw materials of the ointment based on the Chinese violet comprise: 850g of concentrated extract of Chinese violet and 150g of ointment base; wherein the ointment base comprises the following raw materials: 35 parts of glycerin monostearate, 120 parts of stearic acid, 60 parts of liquid paraffin, 100 parts of white vaseline, 50 parts of lanolin, 4 parts of triethanolamine, 1 part of ethylparaben and 630 parts of purified water.

Another object of an embodiment of the present invention is to provide a method for preparing an ointment based on viola yedoensis, which includes the following steps:

weighing the concentrated extract of the Chinese violet according to the prescription amount, mixing the concentrated extract with an ointment matrix, and uniformly stirring to obtain the ointment based on the Chinese violet.

Another object of the embodiments of the present invention is to provide an ointment based on viola yedoensis makino prepared by the above method for preparing an ointment based on viola yedoensis makino.

Another object of the embodiments of the present invention is to provide an application of the ointment based on viola yedoensis in preparing a medicament for antibacterial and/or pus discharge.

Compared with the prior art, the invention has the beneficial effects that:

the ointment based on the Chinese violet prepared by the invention can improve or improve the drug permeability by adopting the ointment matrix, the raw materials of the ointment matrix at least comprise any one of sesame oil, beeswax and lanolin, and the prepared ointment based on the Chinese violet is not easy to dry and knot when being applied to an affected part, so that the drug curative effect is improved; the preparation method of the ointment based on the Chinese violet provided by the invention has the characteristics of simplicity and feasibility, the prepared finished product has good antibacterial and pus discharging effects, the problem of low drug permeability due to the fact that most of the existing Chinese violet ointment adopts sesame oil as a matrix is solved, and the ointment has a wide market prospect.

Drawings

Fig. 1 is a process flow chart of a preparation method of an ointment based on viola yedoensis makino according to an embodiment of the present invention.

FIG. 2 is a process flow chart of the preparation method of the ointment based on Viola yedoensis Makino according to another embodiment of the present invention.

FIG. 3 is a process flow chart of the preparation method of the concentrated Viola yedoensis Makino paste according to another embodiment of the present invention.

FIG. 4 is a process flow diagram of a method for preparing an ointment base according to another embodiment of the present invention.

Detailed Description

The present invention will be described in further detail with reference to the following detailed description of the preferred embodiments in conjunction with the accompanying drawings. The following examples will assist those skilled in the art in further understanding the invention, but are not intended to limit the invention in any way. It should be noted that variations and modifications can be made by persons skilled in the art without departing from the spirit of the invention. All falling within the scope of the present invention.

Example 1

A preparation process of a herba violae concentrated paste is shown in figure 3, and specifically comprises the following steps:

taking 5kg of dried whole herb of the Chinese violet, washing off attached mud and sand with water, chopping, adding ten times of water, boiling and decocting for 30 minutes (first time of decoction), separating decoction liquid, adding five times of water into dregs of a decoction, decocting (second time of decoction), combining the decoction liquid with the first time of decoction, standing and settling, taking supernate, evaporating and concentrating to be thick, and adding 0.1wt% of ethylparaben as a preservative to obtain the Chinese violet concentrated paste. The paste yield is about 20-23%. The ointment based on herba violae was prepared using the concentrated paste of herba violae of this example as a raw material in the following examples.

Example 2

In the prior art, the preparation method of the traditional viola yedoensis ointment specifically comprises the following steps:

1) 15g of sesame oil with the prescription dosage is decocted for 30 minutes and is placed to be cold to be used as ointment base.

2) Taking 85g of the herba violae concentrated paste according to the prescription amount, mixing the herba violae concentrated paste with the ointment base cooled in the step 1), and uniformly stirring to obtain 100g of herba violae ointment.

Example 3

An ointment based on herba Violae, the specific formula is shown in Table 1, and the preparation method comprises the following steps:

1) mixing the prescription amount of sesame oil and the beeswax, decocting for 30 minutes, and standing to cool.

2) Mixing the formula amount of the herba violae concentrated paste with the ointment matrix cooled in the step 1), and uniformly stirring to obtain the herba violae ointment.

TABLE 1 ointment formulation table based on Viola yedoensis Makino

Viola yedoensis makino concentrated paste	85g
		Sesame oil	10g
Beeswax (Cera flava)	5g
		Total of	100g

Example 4

The ointment based on the Chinese violet has the specific formula shown in tables 2 and 3, the preparation method of the ointment refers to fig. 1-4, and the ointment specifically comprises the following steps:

1) adding the ethylparaben in the prescription amount into boiled purified water, and stirring until the ethylparaben is completely dissolved.

2) Taking the formula amount of glyceryl monostearate, stearic acid, liquid paraffin, white vaseline, lanolin and triethanolamine, heating in water bath to 80 deg.C, continuously stirring in the same direction until the mixture is white fine paste, stopping heating, and continuously stirring for condensation to obtain ointment matrix, specifically O/W type ointment matrix.

3) Mixing the concentrated herba violae paste with the ointment base obtained in the step 2), and stirring uniformly to obtain the herba violae ointment.

TABLE 2O/W TYPE OINTMENT BASE FORMULATION TABLE

Glyceryl monostearate	35g
		Stearic acid	120g
Liquid paraffin	60g
		White vaseline	100g
Lanolin	50g
		Triethanolamine	4g
Hydroxyphenyl Ethyl ester	1g
		Purified water	630g
Total of	1000g

TABLE 3 ointment formulation table based on Viola yedoensis Makino

Viola yedoensis makino concentrated paste	850g
		Ointment base	150g
Total of	1000g

Example 5

An ointment based on herba Violae is prepared by taking herba Violae concentrated paste as raw material, adding ointment matrix, and mixing. Wherein the ointment matrix is sesame oil and beeswax, and the mass ratio of the sesame oil to the beeswax is 8: 4.

In this example, the method for preparing the ointment based on viola yedoensis makino (see fig. 1 to 4) is as follows:

1) taking 5kg of dried whole herb of the Chinese violet, washing off attached mud and sand with water, chopping, adding ten times of water, boiling and decocting for 30 minutes (first time of decoction), separating decoction liquid, adding five times of water into dregs of a decoction, decocting (second time of decoction), combining the decoction liquid with the first time of decoction, standing and settling, taking supernate, evaporating and concentrating to be thick, and adding 0.1wt% of ethylparaben as a preservative to obtain the Chinese violet concentrated paste. The cream yield was about 20%.

2) Weighing the concentrated herba violae paste and the ointment matrix according to the mass ratio of 80:10, mixing, and uniformly stirring to obtain the ointment based on the herba violae.

Example 6

An ointment based on herba Violae is prepared by taking herba Violae concentrated paste as raw material, adding ointment matrix, and mixing. Wherein the ointment matrix is sesame oil and beeswax, and the mass ratio of the sesame oil to the beeswax is 12: 6.

1) taking 5kg of dried whole herb of the Chinese violet, washing off attached mud and sand with water, chopping, adding ten times of water, boiling and decocting for 30 minutes (first time of decoction), separating decoction liquid, adding five times of water into dregs of a decoction, decocting (second time of decoction), combining the decoction liquid with the first time of decoction, standing and settling, taking supernate, evaporating and concentrating to be thick, and adding 0.1wt% of ethylparaben as a preservative to obtain the Chinese violet concentrated paste. The cream yield was about 23%.

2) Weighing the concentrated herba violae paste and the ointment matrix according to the mass ratio of 90:20, mixing, and uniformly stirring to obtain the ointment based on the herba violae.

Example 7

An ointment based on herba Violae is prepared by taking herba Violae concentrated paste as raw material, adding ointment matrix, and mixing. Wherein the ointment base is lanolin.

1) taking 5kg of dried whole herb of the Chinese violet, washing off attached mud and sand with water, chopping, adding ten times of water, boiling and decocting for 30 minutes (first time of decoction), separating decoction liquid, adding five times of water into dregs of a decoction, decocting (second time of decoction), combining the decoction liquid with the first time of decoction, standing and settling, taking supernate, evaporating and concentrating to be thick, and adding 0.1wt% of ethylparaben as a preservative to obtain the Chinese violet concentrated paste. The cream yield was about 22%.

2) Weighing the concentrated herba violae paste and the ointment matrix according to the mass ratio of 90:10, mixing, and uniformly stirring to obtain the ointment based on the herba violae.

Example 8

An ointment based on herba Violae is prepared by taking herba Violae concentrated paste as raw material, adding ointment matrix, and mixing. Wherein the ointment base comprises the following raw materials: 30g of glycerin monostearate, 110g of stearic acid, 50g of liquid paraffin, 90g of white vaseline, 40g of lanolin, 3g of triethanolamine, 0.8g of ethylparaben and 600g of purified water. The preparation method of the ointment base comprises the following steps: weighing the ethylparaben, adding the ethylparaben into boiling water, stirring until the ethylparaben is completely dissolved, adding glyceryl monostearate, stearic acid, liquid paraffin, white vaseline, lanolin and triethanolamine, heating in a water bath to 80 ℃, stirring until the mixture is white and fine paste, stopping heating, and continuously stirring until the mixture is condensed to obtain the ointment matrix.

Example 9

An ointment based on herba Violae is prepared by taking herba Violae concentrated paste as raw material, adding ointment matrix, and mixing. Wherein the ointment base comprises the following raw materials: 40g of glycerin monostearate, 130g of stearic acid, 70g of liquid paraffin, 110g of white vaseline, 60g of lanolin, 5g of triethanolamine, 1.2g of ethylparaben and 650g of purified water. The preparation method of the ointment base comprises the following steps: weighing the ethylparaben, adding the ethylparaben into boiling water, stirring until the ethylparaben is completely dissolved, adding glyceryl monostearate, stearic acid, liquid paraffin, white vaseline, lanolin and triethanolamine, heating in a water bath to 75 ℃, stirring until the mixture is white and fine paste, stopping heating, and continuously stirring until the mixture is condensed to obtain the ointment matrix.

Example 10

An ointment based on herba Violae is prepared by taking herba Violae concentrated paste as raw material, adding ointment matrix, and mixing. Wherein the ointment base comprises the following raw materials: 35g of glycerin monostearate, 120g of stearic acid, 60g of liquid paraffin, 100g of white vaseline, 50g of lanolin, 4g of triethanolamine, 1g of ethylparaben and 625g of purified water. The preparation method of the ointment base comprises the following steps: weighing the ethylparaben, adding into boiling water, stirring to dissolve completely, adding glyceryl monostearate, stearic acid, liquid paraffin, white vaseline, lanoline and triethanolamine, heating in water bath to 85 deg.C, stirring to obtain white fine paste, stopping heating, and stirring to condense to obtain ointment matrix.

2) Weighing the concentrated herba violae paste and the ointment matrix according to the mass ratio of 85:15, mixing, and uniformly stirring to obtain the ointment based on the herba violae.

Example 11

The same as example 5 except that the paste yield was about 21wt% as compared with example 5.

Example 12

The same as example 5 except that the paste yield was about 22wt% as compared with example 5.

Example 13

The same as example 5 except that the paste yield was about 23wt% as compared with example 5.

Example 14

The same procedure as in example 5 was repeated, except that 0.05wt% of ethylparaben was added as a preservative to the concentrated extract of Viola yedoensis Makino as in example 5.

Example 15

The same procedure as in example 5 was repeated, except that 0.12wt% of ethylparaben was added as a preservative to the concentrated extract of Viola yedoensis Makino as in example 5.

Example 16

The same procedure as in example 5 was repeated, except that 0.15wt% of ethylparaben was added as a preservative to the concentrated extract of Viola yedoensis Makino as in example 5.

Example 17

The in vitro transdermal permeability research experiment is carried out on the viola philippica ointment with different prescriptions in the above examples, and the specific steps are as follows:

1) treatment of the skin: taking male rats with the weight of 150-200g, electrically shearing hairs on abdominal skin immediately after dislocation and sacrifice, peeling off the skin at the hair-removed part, removing subcutaneous tissues, washing the skin with physiological saline, soaking the skin in the physiological saline for about 30min, taking out the skin, and sucking the skin with filter paper for later use.

2) Skin penetration test: the treated rat skin was placed between the two halves of a modified Franz diffusion cell and secured with clips. The stratum corneum faces the half pool for administration, and the dermis faces the half pool for receiving. 10mL of physiological saline is added into a receiving pool, 0.1g of the ointment (namely the ointment of the Chinese violet) based on the Chinese violet in the embodiments 2, 3 and 4 is respectively and uniformly smeared on the skin of the horny layer, small stirring bars are respectively added into two half pools, water with the temperature of 32 ℃ is filled in an interlayer, magnetic stirring is carried out at 200RPM, and sampling is carried out in the receiving pool for 12 h. Taking out the receiving solution, filtering with microporous membrane, discarding the primary filtrate, and determining the content of aesculetin.

3) Detecting the content of aesculetin:

chromatographic conditions and system applicability conditions: octadecylsilane chemically bonded silica is used as a filling agent; acetonitrile-0.1% phosphoric acid solution (10: 90) is used as a mobile phase; the detection wavelength is 344nm, and the theoretical plate number is not less than 5000 calculated according to the aesculetin peak.

Preparation of control solutions: taking appropriate amount of aesculetin reference substance, precisely weighing, and adding methanol to obtain solution containing 0.1mg per 1mL to obtain reference substance solution.

Preparation of a test solution: and (3) taking the filtrate of the skin permeation experiment receiving pool, precisely measuring 5mL, diluting to 50mL with methanol, shaking up, filtering, and taking the subsequent filtrate to obtain the test solution.

The determination method comprises the following steps: the control solution and the sample solution were each precisely aspirated by 5. mu.L each, and the resulting solutions were injected into a liquid chromatograph, and measured to obtain the results of detection shown in Table 4.

TABLE 4 table of test results

Group of	Content of aesculetin
		Example 2	706.1
Example 3	1385.8
		Example 4	1536.4

As can be seen from the data in table 4, the transdermal permeability of the ointment of philippine violet herb: example 4> example 3> example 2, demonstrating that the improved ointment base significantly enhances the drug permeability.

Example 18

The viola philippica ointments of example 2 and example 4, and the O/W ointment base of example 4 were subjected to in vitro antibacterial activity study experiments:

respectively inoculating the staphylococcus aureus and escherichia coli bacterial suspensions which are incubated for 16-18h into a culture medium. The experimental samples are the viola yedoensis makino ointment of example 2 and example 4 and the O/W type ointment base of example 4, 0.15g of the ointment is respectively and uniformly applied on a circular filter paper with the diameter of 1.0cm, and then the filter paper is pasted on an agar culture medium. Then incubated in a 37 ℃ incubator for 24 h. The antibacterial effect of the drug was evaluated by measuring the diameter of the zone of inhibition (zone of inhibition diameter = zone of inhibition after inhibition-original diameter of plaster before inhibition), and the specific results are shown in table 5.

TABLE 5 results of antibacterial experiments

In table 5, a represents: p <0.05 compared to O/W ointment base; b represents that P is less than 0.05 compared with O/W type ointment base. The results show that: the ointment of the Chinese violet has obvious bacteriostatic action on staphylococcus aureus and escherichia coli.

Example 19

Viola yedoensis ointment stability investigation experiment:

the viola philippica ointment of example 4 is used for experiments, and the method specifically comprises the following steps:

1) and (3) centrifugal experiment: centrifuge at 4000RPM for 30 minutes. The results showed no delamination.

2) Cold and heat resistance test: subpackaging the sample with 12g aluminum tube, and respectively standing at 55 deg.C for 6h and-15 deg.C for 24 h. The results show that oil-water separation occurs after the temperature is returned to room temperature.

3) Accelerated stabilization experiment: 3 batches of Viola yedoensis Makino ointment are prepared as in example 4, and are packaged by 12g of aluminum tubes, and the test sample is placed in a stability inspection box with 30 ℃ and 65% of relative humidity, and is sampled at 0 month, 1 month, 3 months and 6 months respectively to inspect the stability, and the specific results are shown in Table 6.

Table 6 table of stability test results

The result shows that the relevant indexes have no obvious change in the investigation period, which indicates that the viola yedoensis makino ointment has good stability. Studies have shown that both beeswax and lanolin can increase or improve the ointment base permeability. The aesculetin is one of active substances with antibacterial and anti-inflammatory effects in Chinese violet, and can be used as a marker for characterizing the permeability of a medicament.

It should be noted that most of the traditional Viola yedoensis Makino ointment in the prior art adopts sesame oil as a matrix, and has the problems of low drug permeability, easy drying and caking when being applied to an affected part, and unsatisfactory percutaneous permeability, which affects the curative effect of the drug. The invention takes the concentrated ointment of the Chinese violet as the raw material, and adds the ointment substrate to mix to prepare the ointment of the Chinese violet; wherein, the raw materials of the ointment matrix at least comprise any one of sesame oil, beeswax and lanolin, and the medicine permeability can be improved by the ointment matrix, thereby having wide market prospect.

While the preferred embodiments of the present invention have been described in detail, the present invention is not limited to the above embodiments, and various changes can be made without departing from the spirit of the present invention within the knowledge of those skilled in the art. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications of the invention may be made without departing from the scope of the invention.

Claims

1. An ointment based on Chinese violet, which is characterized in that the ointment based on the Chinese violet is prepared by taking Chinese violet concentrated paste as a raw material and adding an ointment matrix for mixing; wherein, the herba violae concentrated paste is prepared by decocting herba violae with water, evaporating and concentrating to paste; the ointment matrix is prepared from at least one of oleum Sesami, Cera flava, and lanolin.

2. The Viola based ointment of claim 1, wherein said evaporation concentration is such that the cream yield is 20-23 wt%.

3. The Viola based ointment of claim 2, further comprising the step of adding 0.05-0.15wt% ethylparaben after evaporation concentration to form a paste.

4. The ointment based on viola yedoensis makino as claimed in claim 1, wherein the mass ratio of the concentrated ointment of viola yedoensis makino to the ointment base is 80-90: 10-20.

5. The ointment based on Chinese violet according to claim 4, wherein the raw materials of the ointment base comprise sesame oil and beeswax, and the mass ratio of the concentrated ointment of Chinese violet to the beeswax is 80-90:8-12: 4-6.

6. The Viola yedoensis Makino-based ointment of claim 4, wherein the ointment base comprises the following raw materials in parts by weight: 30-40 parts of glyceryl monostearate, 130 parts of stearic acid 110-containing material, 50-70 parts of liquid paraffin, 90-110 parts of white vaseline, 40-60 parts of lanolin, 3-5 parts of triethanolamine, 0.8-1.2 parts of ethylparaben and 650 parts of water 600-containing material.

7. The Viola yedoensis Makino-based ointment of claim 6, wherein the ointment base is prepared by: weighing ethylparaben according to a certain proportion, dissolving in water, adding glyceryl monostearate, stearic acid, liquid paraffin, white vaseline, lanolin and triethanolamine, heating to 75-85 deg.C, mixing, and condensing to obtain ointment matrix.

8. A method for preparing a Viola based ointment as claimed in any of claims 1-7, comprising the steps of:

weighing the concentrated ointment of the Chinese violet according to the proportion, and uniformly mixing the concentrated ointment of the Chinese violet with an ointment matrix to obtain the ointment based on the Chinese violet.

9. A Viola yedoensis Makino-based ointment prepared by the method for preparing Viola yedoensis Makino-based ointment according to claim 8.

10. Use of a viola-based ointment as defined in any one of claims 1 to 7 for the preparation of a medicament for antibacterial and/or pus-expelling.