CN110934828A - Asarone oral emulsion and preparation method thereof - Google Patents
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Abstract
The invention discloses an asarone oral emulsion and a preparation method thereof, belonging to the technical field of medicines. The asarone oral emulsion is prepared from the following raw materials in percentage by weight: asarone 0.5-1 wt%, emulsifier 0.32-0.38 wt%, corrective 6-9 wt%, suspending agent 0.7-1.2 wt%, potassium sorbate 0.08-0.12 wt%, essence 0.08-0.12 wt% and purified water 88.18-92.32 wt%. The invention also discloses a preparation method of the asarone oral emulsion. In the asarone oral emulsion, asarone is dispersed in water in ultrafine emulsion particles, is released immediately after oral administration, is absorbed and released quickly after oral administration, obviously improves the bioavailability, the release degree and other properties of the medicine, is suitable for the old, children and patients with dysphagia, and has the advantages of simple administration method, quick effect, strong effect and stable quality.
Description
Technical Field
The invention relates to an asarone oral emulsion and a preparation method thereof, belonging to the technical field of medicines.
Background
Asarone, also known as α -asarone or α -asarone, chemically known as 2,4, 5-trimethoxy-1-propenyl benzene, is a main effective component of traditional Chinese medicine grassleaf sweelflag rhizome, has various pharmacological actions of calming, anti-convulsion, spasmolysis, asthma relieving, phlegm eliminating, cough relieving, blood fat reducing, cholagogue, cancer resistance and the like, and has inhibition effects on the growth of pneumococcus, staphylococcus aureus and escherichia coli to different degrees.
From the published literature on the clinical treatment of upper respiratory tract infection, bronchitis, bronchial asthma, acute and chronic cholecystitis, cholelithiasis, epileptic seizure and other diseases by asarone, the dosage forms of asarone only comprise three dosage forms of oral tablets (30mg), injection (2 ml: 8mg) and capsules (30 mg). Because the asarone is hardly dissolved in water, the asarone can be prepared into capsules and tablets of solid oral preparations, which are not beneficial to the release of the asarone after oral administration, and the bioavailability is lower. In view of the excellent safety of asarone, it is necessary to improve the shortcomings of asarone preparations, thereby expanding the clinical application thereof. The oral emulsion can be directly absorbed, has quick drug effect, is suitable for the old, children and dysphagia patients, has simple administration method and strong drug effect, and can bring better medical effect to the patients. However, there is no asarin oral emulsion in the market at present, so it is necessary to research an asarin oral emulsion and a preparation method thereof to solve the disadvantages of the prior art.
Disclosure of Invention
The invention aims to provide an asarone oral emulsion. In the asarone oral emulsion, asarone is dispersed in water in ultrafine emulsion particles, is released immediately after oral administration, is absorbed and released quickly after oral administration, obviously improves the bioavailability, the release degree and other properties of the medicine, is suitable for the old, children and patients with dysphagia, and has the advantages of simple administration method, quick effect, strong effect and stable quality. The flavoring agent and essence are added into the emulsion, so that the medication compliance of patients is further improved. Therefore, the asarone oral emulsion has good application prospect and is a good substitute for asarone oral tablets, injections and capsules.
The technical scheme for solving the technical problems is as follows: an asarone oral emulsion is prepared from the following raw materials in percentage by weight: asarone 0.5-1 wt%, emulsifier 0.32-0.38 wt%, corrective 6-9 wt%, suspending agent 0.7-1.2 wt%, potassium sorbate 0.08-0.12 wt%, essence 0.08-0.12 wt% and purified water 88.18-92.32 wt%.
The asarone oral emulsion has the beneficial effects that:
in the asarone oral emulsion, asarone is dispersed in water in ultrafine emulsion particles, is released immediately after oral administration, is absorbed and released quickly after oral administration, obviously improves the bioavailability, the release degree and other properties of the medicine, is suitable for the old, children and patients with dysphagia, and has the advantages of simple administration method, quick effect, strong effect and stable quality. The flavoring agent and essence are added into the emulsion, so that the medication compliance of patients is further improved. Therefore, the asarone oral emulsion has good application prospect and is a good substitute for asarone oral tablets, injections and capsules.
On the basis of the technical scheme, the invention can be further improved as follows.
Further, the material is prepared from the following raw materials in percentage by weight: asarone 0.5%, emulsifying agent 0.32%, flavoring agent 6%, suspending agent 0.7%, potassium sorbate 0.08%, essence 0.08% and purified water 92.32%.
The adoption of the further beneficial effects is as follows: the obtained asarone oral emulsion has optimal drug effect.
Further, the material is prepared from the following raw materials in percentage by weight: asarone 0.8%, emulsifying agent 0.36%, corrective 8%, suspending agent 1%, potassium sorbate 0.1%, essence 0.1% and purified water 89.64%.
The adoption of the further beneficial effects is as follows: the obtained asarone oral emulsion has optimal drug effect.
Further, the material is prepared from the following raw materials in percentage by weight: asarone 1%, emulsifying agent 0.38%, corrective 9%, suspending agent 1.2%, potassium sorbate 0.12%, essence 0.12% and purified water 88.18%.
The adoption of the further beneficial effects is as follows: the obtained asarone oral emulsion has optimal drug effect.
Further, the emulsifier is tween 80.
The adoption of the further beneficial effects is as follows: tween 80 is adopted as the emulsifier, so that the emulsifying effect is better.
Further, the flavoring agent is xylitol.
The adoption of the further beneficial effects is as follows: the asarin oral emulsion of the present invention is acidic, and therefore, a flavor that is stable in acidic conditions needs to be added. Xylitol belongs to a sugar that is stable in acidic conditions.
Further, the suspending agent is tragacanth.
The adoption of the further beneficial effects is as follows: the suspending agent is tragacanth, and the effect is better.
The second object of the present invention is to provide a method for preparing the above oral emulsion of asarone. The asarone oral emulsion disclosed by the invention is simple in preparation method, mild in operation condition, low in production cost, high in production efficiency, wide in market prospect and suitable for industrial popularization and application.
The technical scheme for solving the technical problems is as follows: a method for preparing asarone oral emulsion comprises the following steps:
step 1: weighing the following raw materials in percentage by weight: asarone 0.5-1 wt%, emulsifier 0.32-0.38 wt%, corrective 6-9 wt%, suspending agent 0.7-1.2 wt%, potassium sorbate 0.08-0.12 wt%, essence 0.08-0.12 wt% and purified water 88.18-92.32 wt%;
step 2: heating and dissolving the asarone weighed in the step 1 in a hot water bath, adding the emulsifier weighed in the step 1, and uniformly stirring to obtain an oil phase;
and step 3: adding the purified water weighed in the step 1 into a high-speed homogenizing mixer, adding the suspending agent weighed in the step 1, heating for swelling, uniformly stirring, adding the flavoring agent and potassium sorbate weighed in the step 1, and stirring for dissolving to obtain a water phase;
and 4, step 4: starting a high-speed homogenizing stirrer, adding the oil phase obtained in the step (2) into the water phase obtained in the step (3), stirring while adding, and then homogenizing to obtain a homogeneous emulsion;
and 5: when the temperature of the homogeneous emulsion in the step 4 is reduced to below 30 ℃, adding the essence weighed in the step 1, and uniformly stirring to obtain emulsion;
step 6: and (5) filling the emulsion obtained in the step (5), sealing and sterilizing to obtain the asarone oral emulsion.
The preparation method of the asarone oral emulsion has the beneficial effects that:
the asarone oral emulsion disclosed by the invention is simple in preparation method, mild in operation condition, low in production cost, high in production efficiency, wide in market prospect and suitable for industrial popularization and application.
On the basis of the technical scheme, the invention can be further improved as follows.
Further, in the step 2, the temperature of the hot water bath is 48-52 ℃; the temperature during stirring is 48-52 ℃.
The adoption of the further beneficial effects is as follows: by adopting the parameters, the asarin can be well dissolved, and the generated impurities are less.
Further, in the step 3, the temperature for heating and swelling is 52-54 ℃; the temperature when stirring and dissolving is 52-54 ℃.
The adoption of the further beneficial effects is as follows: with the above parameters, the emulsifier, the taste corrigent and the potassium sorbate can be well dissolved.
Further, in step 4, the homogenizing speed is 2500r/min, and the time is 5 min.
The adoption of the further beneficial effects is as follows: with the above parameters, the homogenization effect is optimal.
Further, in step 6, the sterilization is performed at 115 ℃ for 30 min.
The adoption of the further beneficial effects is as follows: by adopting the parameters, the sterilization effect is better.
Detailed Description
The principles and features of this invention are described below in conjunction with specific embodiments, which are set forth merely to illustrate the invention and are not intended to limit the scope of the invention.
Example 1:
the asarin oral emulsion is prepared from the following raw materials in parts by weight: asarone 40g, Tween 8018g, xylitol 400g, tragacanth 50g, potassium sorbate 5g, essence 5g and purified water 4482 g.
The preparation method of the asarone oral emulsion comprises the following steps:
step 1: weighing the following raw materials in parts by weight: asarone 40g, Tween 8018g, xylitol 400g, tragacanth 50g, potassium sorbate 5g, essence 5g and purified water 4482 g;
step 2: heating and dissolving the asarone weighed in the step 1 in a hot water bath at 48 ℃, adding the Tween 80 weighed in the step 1, and uniformly stirring at 48 ℃ to obtain an oil phase;
and step 3: adding the purified water weighed in the step 1 into a high-speed homogenizing mixer, adding the tragacanth weighed in the step 1, heating and swelling at 52 ℃, uniformly stirring, adding the xylitol and the potassium sorbate weighed in the step 1, and stirring and dissolving at 52 ℃ to obtain a water phase;
and 4, step 4: starting a high-speed homogenizing stirrer, adding the oil phase obtained in the step (2) into the water phase obtained in the step (3), stirring while adding, and then homogenizing at the homogenizing speed of 2500r/min for 5min to obtain a homogeneous emulsion;
and 5: when the temperature of the homogeneous emulsion in the step 4 is reduced to below 30 ℃, adding the essence weighed in the step 1, and uniformly stirring to obtain emulsion;
step 6: and (4) filling the emulsion obtained in the step (5), sealing, and sterilizing at 115 ℃ for 30min to obtain the asarone oral emulsion.
Example 2:
the asarin oral emulsion is prepared from the following raw materials in parts by weight: asarone 25g, Tween 8016g, xylitol 300g, tragacanth 35g, potassium sorbate 4g, essence 4g and purified water 4616 g.
The preparation method of the asarone oral emulsion comprises the following steps:
step 1: weighing the following raw materials in parts by weight: asarone 25g, Tween 8016g, xylitol 300g, tragacanth 35g, potassium sorbate 4g, essence 4g and purified water 4616 g;
step 2: heating and dissolving the asarone weighed in the step 1 in a hot water bath at 50 ℃, adding the Tween 80 weighed in the step 1, and uniformly stirring at 50 ℃ to obtain an oil phase;
and step 3: adding the purified water weighed in the step 1 into a high-speed homogenizing mixer, adding the tragacanth weighed in the step 1, heating and swelling at 53 ℃, uniformly stirring, adding the xylitol and the potassium sorbate weighed in the step 1, and stirring and dissolving at 53 ℃ to obtain a water phase;
and 4, step 4: starting a high-speed homogenizing stirrer, adding the oil phase obtained in the step (2) into the water phase obtained in the step (3), stirring while adding, and then homogenizing at the homogenizing speed of 2500r/min for 5min to obtain a homogeneous emulsion;
and 5: when the temperature of the homogeneous emulsion in the step 4 is reduced to below 30 ℃, adding the essence weighed in the step 1, and uniformly stirring to obtain emulsion;
step 6: and (4) filling the emulsion obtained in the step (5), sealing, and sterilizing at 115 ℃ for 30min to obtain the asarone oral emulsion.
Example 3:
the asarin oral emulsion is prepared from the following raw materials in parts by weight: 50g of asarone, 8019g of tween, 450g of xylitol, 60g of tragacanth, 6g of potassium sorbate, 6g of essence and 4409g of purified water.
The preparation method of the asarone oral emulsion comprises the following steps:
step 1: weighing the following raw materials in parts by weight: asarone 40g, Tween 8018g, xylitol 400g, tragacanth 50g, potassium sorbate 5g, essence 5g and purified water 4482 g;
step 2: heating and dissolving the asarone weighed in the step 1 in a hot water bath at 52 ℃, adding the Tween 80 weighed in the step 1, and uniformly stirring at 52 ℃ to obtain an oil phase;
and step 3: adding the purified water weighed in the step 1 into a high-speed homogenizing mixer, adding the tragacanth weighed in the step 1, heating and swelling at 54 ℃, uniformly stirring, adding the xylitol and the potassium sorbate weighed in the step 1, and stirring and dissolving at 54 ℃ to obtain a water phase;
and 4, step 4: starting a high-speed homogenizing stirrer, adding the oil phase obtained in the step (2) into the water phase obtained in the step (3), stirring while adding, and then homogenizing at the homogenizing speed of 2500r/min for 5min to obtain a homogeneous emulsion;
and 5: when the temperature of the homogeneous emulsion in the step 4 is reduced to below 30 ℃, adding the essence weighed in the step 1, and uniformly stirring to obtain emulsion;
step 6: and (4) filling the emulsion obtained in the step (5), sealing, and sterilizing at 115 ℃ for 30min to obtain the asarone oral emulsion.
The result of the detection
1. Mass measurement
The asarin oral emulsions prepared in examples 1 to 3 were subjected to the measurement of the particle size, single impurity, total impurity, and content of the emulsion particles, and the results are shown in table 1.
TABLE 1 Mass measurement results
2. Period of validity
The shelf life of the asarone oral emulsions of examples 1-3 were tested. The examination standards of the effective period are as follows: if the asarin content in the asarin oral emulsion sample to be identified is 93-107%, the single impurity content is less than 0.5%, the total impurity content is less than 1.5%, the average particle size is less than 30 μm, and the retention time of the HPLC peak is the same as that of the asarin of the reference substance, the asarin oral emulsion sample is considered to be effective. Through detection, the effective period of the asarone oral emulsion of the examples 1-3 can be kept for more than two years, and the quality is stable.
3. Stability of acceleration
A01-batch asarin oral emulsion prepared in example 1 was taken, stability was sampled at 30 + -2 deg.C and relative humidity of 65 + -5%, and samples were taken once at 1 month, 2 months, 3 months and 6 months during the test period, and the results are shown in Table 2.
TABLE 2 accelerated stability test results
4. Taste of the product
The asarin oral emulsion of example 2 was taken and subjected to mouth taste evaluation by mouth taste method. The evaluation of 100 selected healthy subjects was based on the following: age, sex, growing environment, drinking, smoking, disease, mood, preference for food and drink, taste preference, etc. as the limiting conditions; for taste testing of the samples, the degree of sweetness was graded with reference to the "clinically usual pain grading method": a line segment is divided into 5 equal parts, which are sequentially numbered, and 6 numbers are described in text to indicate the sweetness level of the solution by a human taster with reference to the circle of a number. The sweetness was graded as follows: 0-no sweetness; 1-sweet taste can be perceived; 2-obvious sweet taste; 3-significant sweetness and difficulty in swallowing; 4-strong sweet taste, vomiting immediately; 5-extreme sweet, causing vomiting. The subjects were evaluated to hold the oral liquid in the mouth for 10s each time. The results are shown in Table 3.
TABLE 3 sweetness perception grade sample number distribution
| Sweetness rating | Number of people | Percentage of |
| Is not provided withSweet taste | 0 | 0 |
| Can sense sweet taste | 15 | 15％ |
| Has obvious sweet taste | 80 | 80％ |
| The sweet taste is too heavy | 5 | 5％ |
| Extreme sweet causing vomiting | 0 | 0 |
The results show that the asarone oral emulsion provided by the invention is excellent in quality and taste, and can be expected to obtain good reverberation in the market.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Claims (10)
1. An asarone oral emulsion is characterized by being prepared from the following raw materials in percentage by weight: asarone 0.5-1 wt%, emulsifier 0.32-0.38 wt%, corrective 6-9 wt%, suspending agent 0.7-1.2 wt%, potassium sorbate 0.08-0.12 wt%, essence 0.08-0.12 wt% and purified water 88.18-92.32 wt%.
2. The asarin oral emulsion of claim 1, wherein the asarin oral emulsion is prepared from the following raw materials in percentage by weight: asarone 0.5%, emulsifying agent 0.32%, flavoring agent 6%, suspending agent 0.7%, potassium sorbate 0.08%, essence 0.08% and purified water 92.32%.
3. The asarin oral emulsion of claim 1, wherein the asarin oral emulsion is prepared from the following raw materials in percentage by weight: asarone 0.8%, emulsifying agent 0.36%, corrective 8%, suspending agent 1%, potassium sorbate 0.1%, essence 0.1% and purified water 89.64%.
4. The asarin oral emulsion of claim 1, wherein the asarin oral emulsion is prepared from the following raw materials in percentage by weight: asarone 1%, emulsifying agent 0.38%, corrective 9%, suspending agent 1.2%, potassium sorbate 0.12%, essence 0.12% and purified water 88.18%.
5. The oral emulsion of asarone of any one of claims 1-4, wherein said emulsifying agent is tween 80, said flavoring agent is xylitol, and said suspending agent is tragacanth.
6. The preparation method of the asarone oral emulsion is characterized by comprising the following steps:
step 1: weighing the following raw materials in percentage by weight: asarone 0.5-1 wt%, emulsifier 0.32-0.38 wt%, corrective 6-9 wt%, suspending agent 0.7-1.2 wt%, potassium sorbate 0.08-0.12 wt%, essence 0.08-0.12 wt% and purified water 88.18-92.32 wt%;
step 2: heating and dissolving the asarone weighed in the step 1 in a hot water bath, adding the emulsifier weighed in the step 1, and uniformly stirring to obtain an oil phase;
and step 3: adding the purified water weighed in the step 1 into a high-speed homogenizing mixer, adding the suspending agent weighed in the step 1, heating for swelling, uniformly stirring, adding the flavoring agent and potassium sorbate weighed in the step 1, and stirring for dissolving to obtain a water phase;
and 4, step 4: starting a high-speed homogenizing stirrer, adding the oil phase obtained in the step (2) into the water phase obtained in the step (3), stirring while adding, and then homogenizing to obtain a homogeneous emulsion;
and 5: when the temperature of the homogeneous emulsion in the step 4 is reduced to below 30 ℃, adding the essence weighed in the step 1, and uniformly stirring to obtain emulsion;
step 6: and (5) filling the emulsion obtained in the step (5), sealing and sterilizing to obtain the asarone oral emulsion.
7. The method of claim 6, wherein in step 2, the temperature of the hot bath is between 48 ℃ and 52 ℃; the temperature during stirring is 48-52 ℃.
8. The method of claim 6, wherein the temperature of said heated swelling in step 3 is 52-54 ℃; the temperature when stirring and dissolving is 52-54 ℃.
9. The method of claim 6, wherein the homogenization in step 4 is performed at 2500r/min for 5 min.
10. The method of any one of claims 6-9, wherein the sterilization in step 6 is performed at 115 ℃ for 30 min.
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| CN111700882A (en) * | 2020-07-06 | 2020-09-25 | 中国药科大学 | Asarin sublingual administration system |
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