CN110101709B - Compound camphor emulsifiable paste and preparation method thereof - Google Patents
Compound camphor emulsifiable paste and preparation method thereof Download PDFInfo
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Abstract
The invention provides a compound camphor cream which comprises, by weight, 18-25 parts of camphor, 10-18 parts of menthol, 7-12 parts of methyl salicylate, 3-7 parts of diphenhydramine, 0.5-1.2 parts of chlorhexidine gluconate, 1-2 parts of glycyrrhetinic acid, 45-55 parts of stearic acid, 20-30 parts of liquid paraffin, 15-25 parts of glycerin monostearate/distearate, 7-12 parts of triethanolamine, 45-55 parts of propylene glycol, 0.065-0.075 part of methyl p-hydroxybenzoate and 250-290 parts of water. The compound camphor emulsifiable paste has reasonable dosage of each medicine in the prescription, does not contain hormone, and has obvious functions of relieving itching and promoting skin damage to subside for dermatosis such as dermatitis, eczema, cutaneous pruritus, neurodermatitis, insect bite dermatitis, papular urticaria and the like.
Description
Technical Field
The invention relates to a compound camphor cream and a preparation method thereof.
Background
The camphor is a skin irritant, can stimulate skin cold receptors to have a cool feeling after being applied to the skin, can make the skin red by being applied to local parts with force, can improve local blood circulation, has weak local drunkenness feeling, and can relieve pain, itching and inflammation. Proper dosage of the composition is taken orally to warm the stomach and make the stomach comfortable, and large dosage of the composition has stimulation effect and can cause nausea and vomiting. Has the clinical effects of easing pain and relieving itching. The systemic action of camphor is mainly to excite the central nervous system, especially to the higher central nervous system. A large amount of the medicine acts on the motor area and the brain stem of the cerebral cortex, and epileptiform convulsion is easy to cause.
Camphora can be made into various preparations, such as Camphora water or Camphora spirit, and can be topically applied for treating neuralgia, myalgia or arthritis, and contact dermatitis caused by topical couple; the appropriate amount of the menthol has very few toxic and side effects, and the menthol can be taken orally and used externally, so the clinical application is very wide; diphenhydramine is a derivative of ethanolamine and is the earliest H1 receptor antagonist; glycyrrhetinic acid has antiinflammatory, antiulcer, antiallergic, antiviral, blood lipid reducing, antitussive, antiasthmatic, and expectorant effects; chlorhexidine gluconate is a disinfectant and antiseptic, and has antibacterial effect on gram-positive and gram-negative bacteria; the methyl salicylate has local irritation, and has effects of promoting local blood circulation, relieving swelling, diminishing inflammation, relieving pain and itching, etc.
The compound camphor emulsifiable paste is a skin external application, is suitable for insect bite dermatitis, allergic dermatitis, truth-seeking urticaria, eczema, pruritus, neurodermatitis and the like, and is also used for shoulder pain, myalgia and skin pain after scald.
The prior compound camphor cream process has the following problems that the process amount, the feeding sequence and the temperature control of triethanolamine are not reasonable enough, so that the cream has thinner appearance and insufficient stability.
Disclosure of Invention
The invention provides a formula and a preparation method of a novel compound camphor cream by improving the formula and the preparation method of the compound camphor cream, and particularly, the appearance of a finished product is thin and thick and is moderate and the stability is improved by improving the process proportion of raw materials, adjusting the feeding sequence and strictly controlling the temperature.
In order to realize the purpose, the technical scheme is as follows: the compound camphor cream comprises, by weight, 18-25 parts of camphor, 10-18 parts of menthol, 7-12 parts of methyl salicylate, 3-7 parts of diphenhydramine, 0.5-1.2 parts of chlorhexidine gluconate, 1-2 parts of glycyrrhetinic acid, 45-55 parts of stearic acid, 20-30 parts of liquid paraffin, 15-25 parts of glycerin monostearate/distearate, 7-12 parts of triethanolamine, 45-55 parts of propylene glycol, 0.065-0.075 part of methyl p-hydroxybenzoate, and 250-290 parts of water.
The amount of the improved emulsifier triethanolamine is increased, and the auxiliary emulsifier stearic acid is selected for better emulsification, because stearic acid is the auxiliary emulsifier for increasing the viscosity of the oil phase, the stability of the emulsion can be increased, the viscosity of the emulsifier can be improved, the strength of an emulsion film can be enhanced, and the emulsion drops can be prevented from merging.
Preferably, the compound camphor cream comprises the following components, by weight, 22.1 parts of camphor, 14.4 parts of menthol, 9.6 parts of methyl salicylate, 5.5 parts of diphenhydramine, 0.960 part of chlorhexidine gluconate, 1.44 parts of glycyrrhetinic acid, 48 parts of stearic acid, 24 parts of liquid paraffin, 19.2 parts of glycerin mono/distearate, 9.6 parts of triethanolamine, 48 parts of propylene glycol, 0.072 part of methyl p-hydroxybenzoate and 273.3 parts of water.
The invention provides a preparation method of the compound camphor cream, which comprises the following steps:
(1) adding glycyrrhetinic acid into propylene glycol, and stirring to obtain a suspension;
(2) preparation of an aqueous phase: mixing triethanolamine, propylene glycol, methyl p-hydroxybenzoate and water, heating to 82-85 deg.C, stirring, and maintaining at 82-85 deg.C to obtain water phase;
(3) preparing an oil phase: mixing stearic acid, liquid paraffin and glyceryl monostearate, heating to melt, starting stirring when the temperature reaches 50 ℃, sequentially adding methyl salicylate, camphor and menthol when the temperature is 85-90 ℃ and completely melting, stirring until the methyl salicylate, the camphor and the menthol are completely dissolved and uniformly mixed, and maintaining the temperature at 85-90 ℃ to obtain an oil phase;
(4) mixing the water phase obtained in the step (2) and the oil phase obtained in the step (3), and stirring and homogenizing at 78-82 ℃, the stirring speed of 40rpm and the vacuum degree of-80 kpa;
(5) then cooling to 60 ℃, adding the suspension obtained in the step (1), diphenhydramine and chlorhexidine gluconate, and stirring and homogenizing under the vacuum degree of-0.6 MPa and the rotating speed of 2200 rpm;
(6) then cooling to 35 ℃ or below, reducing the stirring speed from 30rpm to 15rpm along with the temperature reduction, and breaking the vacuum to obtain the compound camphor cream.
Preferably, the weight ratio of the propylene glycol in the step (1) to the propylene glycol in the step (2) is 19.2: 28.8.
preferably, the stirring time in the step (2) is 10 minutes.
Preferably, the stirring time in the step (4) is 15 minutes.
Preferably, the stirring time in the step (5) is 10 minutes.
The invention provides application of the compound camphor cream in preparing a pharmaceutical composition for treating skin diseases.
Preferably, the skin disease comprises eczema, cutaneous pruritus, neurodermatitis, insect bite dermatitis, papular urticaria.
Has the advantages that:
the compound camphor cream has the advantages that the compound camphor cream has reasonable dosage and no hormone in the prescription, has obvious effects of relieving itching and promoting skin damage to subside for dermatosis such as dermatitis, eczema, cutaneous pruritus, neurodermatitis, insect bite dermatitis, papular urticaria and the like, is well tolerated by patients, has no side effect on human bodies, has no dependence or rebound elasticity, and is safe to use.
Detailed Description
To better illustrate the objects, aspects and advantages of the present invention, the present invention will be further described with reference to specific examples.
Example 1
1. The production formula and the preparation process before improvement are as follows:
1.1 production formula before improvement: 22.1 parts of camphor, 14.4 parts of menthol, 9.6 parts of methyl salicylate, 5.5 parts of diphenhydramine, 0.960 part of chlorhexidine gluconate, 1.44 parts of glycyrrhetinic acid, 48 parts of stearic acid, 24 parts of liquid paraffin, 19.2 parts of glyceryl monostearate, 4.1 parts of triethanolamine, 48 parts of propylene glycol, 0.072 parts of methyl p-hydroxybenzoate and 267.8 parts of water.
1.2, a preparation process:
(1) mixing 1.44 parts by weight of glycyrrhetinic acid and 19.2 parts by weight of propylene glycol (B), and stirring to obtain a suspension for later use;
(2) preparation of an aqueous phase: introducing 4.1 parts by weight of triethanolamine, 28.8 parts by weight of propylene glycol, 0.072 parts by weight of methyl p-hydroxybenzoate and 267.8 parts by weight of purified water into a water-phase pot, stirring, introducing steam into an interlayer, heating to 70-80 ℃, stirring for about 10 minutes, and maintaining the temperature at 70-80 ℃ for later use;
(3) preparing an oil phase: adding 48 parts by weight of stearic acid, 24 parts by weight of liquid paraffin and 19.2 parts by weight of glyceryl monostearate into an oil pan, heating to melt, sequentially adding 9.6 parts by weight of methyl salicylate, 22.1 parts by weight of camphor and 14.4 parts by weight of menthol when the temperature reaches 75 ℃, stirring until the methyl salicylate, the camphor and the menthol are completely dissolved and uniformly mixed, and maintaining the temperature at 70-80 ℃;
(4) and (3) controlling the emulsification and charging sequence and the temperature:
uniformly stirring the suspension obtained in the step (1), the water phase obtained in the step (2), 0.960 parts by weight of chlorhexidine gluconate solution and 5.5 parts by weight of diphenhydramine at 70 ℃ and at the stirring speed of 40rpm, sucking the oil phase obtained in the step (3), uniformly stirring, and maintaining at 70 ℃; adjusting the vacuum degree, starting a homogenizer when the vacuum degree is more than-0.6 MPa, setting the rotating speed to 2200rpm, and homogenizing for 10 minutes;
(5) closing the steam bypass valve, opening the cooling water inlet valve, reducing the stirring speed from 30rpm to 15rpm along with the temperature reduction, cooling to below 35 ℃, and breaking the vacuum paste discharge.
2. The improved formula and preparation process are as follows:
2.1 improved formula: 22.1 parts of camphor, 14.4 parts of menthol, 9.6 parts of methyl salicylate, 5.5 parts of diphenhydramine, 0.960 part of chlorhexidine gluconate, 1.44 parts of glycyrrhetinic acid, 48 parts of stearic acid, 24 parts of liquid paraffin, 19.2 parts of glyceryl monostearate, 9.6 parts of triethanolamine, 48 parts of propylene glycol, 0.072 parts of methyl p-hydroxybenzoate and 273.3 parts of water.
2.2 the preparation process comprises the following steps:
(1) mixing 1.44 parts by weight of glycyrrhetinic acid and 19.2 parts by weight of propylene glycol (B), and stirring to obtain a suspension for later use;
(2) preparation of an aqueous phase: introducing 9.6 parts by weight of triethanolamine, 28.8 parts by weight of propylene glycol, 0.072 parts by weight of methyl p-hydroxybenzoate and 273.3 parts by weight of purified water into a water-phase pot, stirring, introducing steam into an interlayer, heating to 82-85 ℃, stirring for about 10 minutes, and maintaining the temperature at 80-85 ℃ for later use;
(3) preparing an oil phase: adding 48 parts by weight of stearic acid, 24 parts by weight of liquid paraffin and 19.2 parts by weight of glyceryl monostearate into an oil pan, heating to melt, starting stirring when the temperature reaches 50 ℃, sequentially adding 9.6 parts by weight of methyl salicylate, 22.1 parts by weight of camphor and 14.4 parts by weight of menthol when the temperature is 85-90 ℃ and completely melting, stirring until the methyl salicylate, the camphor and the menthol are completely dissolved and uniformly mixed, and keeping the temperature above 85 ℃ for later use;
(4) and (3) controlling the emulsification and charging sequence and the temperature:
mixing the water phase obtained in the step (2) and the oil phase obtained in the step (3), and stirring and homogenizing for 15 minutes at 78-82 ℃, the stirring speed of 40rpm and the vacuum degree of-80 kpa; then cooling to 60 ℃, and adding the suspension obtained in the step (1), diphenhydramine and chlorhexidine gluconate; adjusting the vacuum degree, starting a homogenizer when the vacuum degree is more than-0.6 MPa, setting the rotating speed to 2200rpm, and homogenizing for 10 minutes;
(5) closing the steam bypass valve, opening the cooling water inlet valve, reducing the stirring speed from 30rpm to 15rpm along with the temperature reduction, cooling to 35 ℃ or lower, breaking the vacuum, and discharging.
3. The amount of triethanolamine used in the preparation process directly affected the consistency of the cream appearance, as shown in Table 1.
TABLE 1 comparison of the amount of triethanolamine used
| Before/after process improvement | Triethanolamine batch | Appearance presentation |
| Before improvement | 4.1 parts by weight | Is thinner |
| After improvement | 9.6 parts by weight | Moderate in thickness |
4. By increasing the amount of triethanolamine, changing the feeding sequence, controlling the preparation temperature, performing long-term test under the condition close to the actual storage condition, monitoring the property change of the sample, and comparing to obtain the following table
The character detection results of every three months for two different batches before and after the improvement of the sampling inspection process are as follows:
the results of the long-term test comparison of the samples before modification are shown in Table 2.
TABLE 2 detection results of traits before improvement
The improved samples were compared in long-term experiments, and the results are shown in Table 3.
TABLE 3 detection results of post-improvement traits
Compared with the results of the long-term tests, the improved process solves the problem that the cream is easy to separate oil from water along with the lapse of time, and achieves the effect of improving the overall stability of the cream.
5. Long-term test of content determination is carried out on the finished product before and after improvement, the detection is carried out once every three months, and the results are shown in tables 4 and 5, so that the content of the effective components in the effective date is ensured to meet the specification, and a better treatment effect can be achieved.
TABLE 4 product stability test before improvement
| Principal Components | 0 month | 3 month | 6 month |
| Menthol crystal | 99.88％ | 90.12％ | 85.23％ |
| Salicylic acid methyl ester | 99.55％ | 93.80％ | 87.42％ |
| Camphor | 99.68％ | 91.35％ | 84.58％ |
| Diphenhydramine | 98.67％ | 88.40％ | 80.91％ |
| Glycyrrhetinic acid | 98.92％ | 93.52％ | 89.65％ |
| Chlorhexidine gluconate | 99.18％ | 89.66％ | 81.78％ |
TABLE 5 product stability test after improvement
| Principal Components | 0 month | 3 month | 6 month |
| Menthol crystal | 99.93％ | 97.02％ | 95.28％ |
| Salicylic acid methyl ester | 99.75％ | 98.50％ | 96.52％ |
| Camphor | 99.88％ | 97.55％ | 95.18％ |
| Diphenhydramine | 99.77％ | 97.21％ | 95.36％ |
| Glycyrrhetinic acid | 99.82％ | 97.89％ | 96.10％ |
| Chlorhexidine gluconate | 99.78％ | 98.16％ | 96.46％ |
From the results in tables 4 and 5, it is clear that the product stability after modification is significantly better than before modification.
Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention and not for limiting the protection scope of the present invention, and although the present invention is described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions can be made on the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.
Claims (2)
1. The compound camphor cream is characterized by comprising the following components, by weight, 22.1 parts of camphor, 14.4 parts of menthol, 9.6 parts of methyl salicylate, 5.5 parts of diphenhydramine, 0.960 part of chlorhexidine gluconate, 1.44 parts of glycyrrhetinic acid, 48 parts of stearic acid, 24 parts of liquid paraffin, 19.2 parts of glyceryl monostearate, 9.6 parts of triethanolamine, 48 parts of propylene glycol, 0.072 part of methyl p-hydroxybenzoate and 273.3 parts of water;
the preparation method comprises the following steps:
(1) adding glycyrrhetinic acid into propylene glycol, and stirring to obtain a suspension;
(2) preparation of an aqueous phase: mixing triethanolamine, propylene glycol, methyl p-hydroxybenzoate and water, heating to 82-85 deg.C, stirring, and maintaining at 82-85 deg.C to obtain water phase;
(3) preparing an oil phase: mixing stearic acid, liquid paraffin and glyceryl monostearate, heating to melt, starting stirring when the temperature reaches 50 ℃, sequentially adding methyl salicylate, camphor and menthol when the temperature is 85-90 ℃ and completely melting, stirring until the methyl salicylate, the camphor and the menthol are completely dissolved and uniformly mixed, and maintaining the temperature at 85-90 ℃ to obtain an oil phase;
(4) mixing the water phase obtained in the step (2) and the oil phase obtained in the step (3), and stirring and homogenizing at 78-82 ℃, the stirring speed of 40rpm and the vacuum degree of-80 kpa;
(5) then cooling to 60 ℃, adding the suspension obtained in the step (1), diphenhydramine and chlorhexidine gluconate, and stirring and homogenizing under the vacuum degree of-0.6 MPa and the rotating speed of 2200 rpm;
(6) cooling to 35 deg.C or below, reducing stirring speed from 30rpm to 15rpm with temperature decrease, and removing vacuum to obtain the compound Camphora cream.
2. The method of preparing the compound camphor cream of claim 1 comprising the steps of:
(1) adding glycyrrhetinic acid into propylene glycol, and stirring to obtain a suspension;
(2) preparation of an aqueous phase: mixing triethanolamine, propylene glycol, methyl p-hydroxybenzoate and water, heating to 82-85 deg.C, stirring for 10 min, and maintaining at 82-85 deg.C to obtain water phase; wherein the weight ratio of the propylene glycol in the step (1) to the propylene glycol in the step (2) is 19.2: 28.8 of;
(3) preparing an oil phase: mixing stearic acid, liquid paraffin and glyceryl monostearate, heating to melt, starting stirring when the temperature reaches 50 ℃, sequentially adding methyl salicylate, camphor and menthol when the temperature is 85-90 ℃ and completely melting, stirring until the methyl salicylate, the camphor and the menthol are completely dissolved and uniformly mixed, and maintaining the temperature at 85-90 ℃ to obtain an oil phase;
(4) mixing the water phase obtained in the step (2) and the oil phase obtained in the step (3), and stirring for 15 minutes at 78-82 ℃, at the stirring speed of 40rpm and at the vacuum degree of-80 kpa for homogenization;
(5) then cooling to 60 ℃, adding the suspension obtained in the step (1), diphenhydramine and chlorhexidine gluconate, and stirring for 10 minutes and homogenizing under the vacuum degree of-0.6 MPa and the rotating speed of 2200 rpm;
(6) then cooling to 35 ℃ or below, reducing the stirring speed from 30rpm to 15rpm along with the temperature reduction, and breaking the vacuum to obtain the compound camphor cream.
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| CN107998114A (en) * | 2017-12-26 | 2018-05-08 | 重庆希尔安药业有限公司 | Camphor peppermint willow ester emulsifiable paste and preparation method thereof |
| CN108992451A (en) * | 2018-07-09 | 2018-12-14 | 漳州无极药业有限公司 | A kind of emulsifiable paste and preparation method thereof with anti-inflammatory anti-itch antibiotic effect |
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