Disclosure of Invention
The invention aims to solve the problems that the existing electrodeless ointment product has burning pain to skin when in use, the preparation method is complex and the production cost is high; the cream with the anti-inflammatory, itching-relieving and antibacterial effects has the characteristics of small irritation to skin, non-greasy cream and easiness in cleaning.
The applicant finds a new technical problem in the process of researching the technical problem, and the non-polar ointment serving as the OTC A medicine has the validity period of 3 years, is a stock medicine for many families, and usually does not use up the ointment. In the process of storing the non-polar ointment, the content of the effective components is reduced due to the decomposition or reaction consumption of the effective components, so that the curative effect is reduced or even lost, the trouble of a user is brought, and the contradiction between doctors and patients is even caused. The applicant finds that the content of methyl salicylate and beclomethasone dipropionate in the effective components can be reduced by 10% after 3 years when the electrodeless paste is stored under natural conditions, and other components can be changed. Therefore, the improvement of the stability of the effective components in the product to ensure better curative effect for a long time is another key technical problem to be solved by the invention. The cream provided by the invention also has the characteristics of strong stability of effective components and long storage time.
The invention also provides a preparation method of the cream with the effects of diminishing inflammation, relieving itching and resisting bacteria, so as to solve the problems of complex preparation method and high production cost of the existing product. The preparation method provided by the invention is simple to operate and low in preparation cost.
In order to achieve the purpose, the technical scheme of the invention is as follows:
the cream with the anti-inflammatory, itching relieving and antibacterial effects comprises the following components in percentage by weight:
1.0-5.0% of menthol, 5.0-10.0% of camphor, 1.0-5.0% of methyl salicylate, 0.5-1.0% of borneol, 0.1-0.5% of thymol, 0.01-0.05% of beclomethasone dipropionate, 10.0-78% of emulsifier Gelot 646.0, 3.0-6.0% of octadecanol, 4.0-7.0% of monoglyceride and the balance of purified water; the pH value of the cream with the anti-inflammatory, itching relieving and antibacterial effects is 7.0 +/-0.5.
Further, the cream with the anti-inflammatory, itching-relieving and antibacterial effects comprises the following components in percentage by weight:
4.0-5.0% of menthol, 8.0-10.0% of camphor, 4.0-5.0% of methyl salicylate, 0.8-1.0% of borneol, 0.4-0.5% of thymol, 0.03-0.05% of beclomethasone dipropionate, 647.0-9.0% of emulsifier Gelot, 4.0-5.0% of octadecanol, 5.0-6.0% of monoglyceride and the balance of purified water.
Further, the cream with the anti-inflammatory, itching-relieving and antibacterial effects comprises the following components in percentage by weight:
4.5% of menthol, 9.0% of camphor, 4.5% of methyl salicylate, 0.9% of borneol, 0.45% of thymol, 0.05% of beclomethasone dipropionate, an emulsifier Gelot 648.0%, 4.5% of octadecanol, 5.5% of monoglyceride and the balance of purified water.
Further, the cream with the anti-inflammatory, itching-relieving and antibacterial effects also comprises 0.1-0.5% of ethanol based on the total weight.
The invention further discloses a preparation method of the cream with the anti-inflammatory, itching-relieving and antibacterial effects, which comprises the following steps:
1) weighing the raw materials according to the weight percentage;
2) mixing an emulsifier Gelot 64, octadecanol and monoglyceride, adding purified water, heating to a first temperature, and uniformly stirring to obtain a mixture A;
3) cooling the mixture A to a second temperature, adding menthol, camphor, borneol and thymol, and continuously stirring to obtain a paste B;
4) cooling the paste B to a third temperature, adding methyl salicylate and beclomethasone dipropionate, stirring and cooling to room temperature to obtain the ointment B.
Further, the first temperature in the step 2) is 70-90 ℃.
Further, the second temperature in the step 3) is 55-60 ℃.
Further, the third temperature in the step 4) is 48-52 ℃.
Further, in the step 4), the cream B is cooled to a third temperature, methyl salicylate, beclomethasone dipropionate and ethanol accounting for 0.1-0.5% of the total weight are added, and the mixture is stirred and cooled to room temperature, so that the cream with the anti-inflammatory, itching-relieving and antibacterial effects is obtained.
The invention also provides the ointment prepared by the preparation method of the cream with the anti-inflammatory, itching-relieving and antibacterial effects.
Has the advantages that: the applicant well solves the problem of stability of effective components of the product through a product formula with a unique effect which is elaborately designed after scientific experiments, the content change of the methyl salicylate and the beclomethasone dipropionate is controlled within 5 percent after the product is stored for 3 years under natural conditions, and the product still keeps better effects in the aspects of diminishing inflammation, relieving itching and resisting bacteria, so that the treatment effect of the product is stable within 3 years, and the rights and interests of patients are better guaranteed. The cream of the formula has good treatment effects on skin inflammation, pruritus and fungal infection, can be used for treating insect bite dermatitis, papular urticaria, eczema, contact dermatitis, neurodermatitis, skin pain and itching and the like, and can also be used for treating anal pruritus.
In addition, in the invention, the emulsifier Gelot 64, octadecanol and monoglyceride are adopted to form a phase 1, and a uniform phase 2 can be formed after purified water is added, so that the technical troubles that in the production of the traditional non-polar paste, the water phase and the oil phase are incompatible, the preparation needs to be separated, and finally the water phase and the oil phase are mixed are solved. The production process is simplified due to the generation of the phase 2, and the rest raw materials are added in batches and stirred uniformly, so that the time and labor for finally mixing the two phases in the traditional process are avoided, and a large amount of time is needed for forming the incompatible two phases into a uniform and stable phase state under the action of the surfactant because the volumes of the oil phase and the water phase are large in the traditional process.
Furthermore, the mixture A is cooled to the second temperature, and then the menthol, the borneol, the thymol and the camphor are added, so that the volatilization of oil components can be effectively avoided. And cooling the paste B to a third temperature, and adding the rest raw materials, wherein the hydrolysis reaction is easy to occur between the methyl salicylate and the beclomethasone dipropionate at the temperature higher than the third temperature, and the stirring of the paste is not facilitated due to the excessively low temperature.
In a word, the cream of the formula has the characteristics of small irritation to skin, non-greasy cream and easiness in cleaning, the emulsifier Gelot 64, octadecanol, monoglyceride and water are utilized to form a homogeneous body in the preparation method, the process is simplified, the cream also has the advantages of more stable active ingredients and longer effective period, and the method is simple to operate and lower in preparation cost.
In order to better illustrate the effects of the present invention, the main components and effects thereof are further illustrated as follows:
menthol: the topical preparation has antipruritic, antiinflammatory, and analgesic effects, and can provide local cool feeling. It is used clinically in treating pain, inflammation and swelling. It can also be orally administered for treating headache, rhinitis, pharyngitis, laryngitis, etc.
Synthesizing camphor: has effects in dredging orifices; promoting qi stagnation; removing dirt; killing parasites and relieving itching; relieving swelling and pain. The camphor has mild stimulation and antiseptic effects when being applied to skin, and has the effects of dispelling wind and slightly eliminating phlegm on central nervous system, circulatory system and oral camphor (which is indicated to be edible).
Methyl salicylate: topical rubefacient is used for external application. Has local stimulating effect, and can promote local blood circulation, and topical or topical application can produce skin vasodilatation, red skin, and reflex influence on skin, muscle, nerve and joint of corresponding parts, and has repercussive, antiinflammatory and analgesic effects, and also has antipruritic effect. Can be used for treating sprain, contused wound, lumbago, myalgia, neuralgia, and antipruritic.
Borneol: the traditional Chinese medicine mostly takes the effects of restoring consciousness, inducing resuscitation, clearing heat, relieving pain, preventing corrosion and promoting tissue regeneration, and the modern pharmacological research shows that the borneol has various medicinal effects, including the effects of easily permeating blood brain barrier, promoting medicine absorption, resisting ischemia and injury of a circulatory system, bidirectionally regulating and protecting a central nervous system, resisting bacteria, resisting inflammation, relieving pain, resisting fertility, promoting wound healing and the like.
Thymol: can promote movement of trachea cilia, is beneficial to secretion of trachea mucus, has effect of eliminating phlegm, and also has antibacterial effect, so can be used for treating tracheitis, pertussis, etc.
Beclomethasone dipropionate: is a potent topical glucocorticoid drug, has anti-inflammatory, antiallergic and antipruritic effects, and can inhibit bronchial exudate, eliminate bronchial mucosa swelling, and relieve bronchial spasm.
The emulsifier Gelot 64 is a mixture of glyceryl stearate and PEG-75 stearate, and is a commercially available product.
Octadecanol is a basic raw material of cream and emulsion, has the function of thickening the emulsion, and is an emulsion stabilizer. Monoglyceride, i.e., fatty acid monoglyceride, is used as a surfactant. The addition of ethanol may aid in the dissolution of beclomethasone dipropionate.
Detailed Description
The technical solution of the present invention is further illustrated by the following examples. The examples do not specify particular techniques or conditions, and are performed according to the techniques or conditions described in the literature in the art or according to the product specifications. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products commercially available.
Example 1
The preparation method of the cream with the anti-inflammatory, itching-relieving and antibacterial effects comprises the following steps:
1) weighing the raw materials according to the dosage in the table 1;
2) mixing an emulsifier Gelot 64, octadecanol and monoglyceride, heating to 80 ℃, and adding the mixture into purified water heated to 80 ℃ in advance under the condition of stirring to obtain a mixture A;
3) cooling the mixture A to 58 deg.C, adding Mentholum, Camphora, Borneolum Syntheticum and thymol, and stirring to obtain paste B;
4) cooling the paste B to 50 deg.C, adding the rest materials, stirring, and cooling to room temperature.
The prepared paste is milky white, the paste is fine and smooth in texture, and the pH value is 7.0 +/-0.5.
TABLE 1 Scale for raw materials (parts by weight)
Example 2
The preparation method of the cream with the anti-inflammatory, itching-relieving and antibacterial effects comprises the following steps:
1) weighing the raw materials according to the dosage in the table 1;
2) mixing an emulsifier Gelot 64, octadecanol and monoglyceride, heating to 85 ℃, and adding the mixture into purified water which is heated to 85 ℃ in advance under the condition of stirring to obtain a mixture A;
3) cooling the mixture A to 55 deg.C, adding Mentholum, Camphora, Borneolum Syntheticum and thymol, and stirring to obtain paste B;
4) cooling the paste B to 50 deg.C, adding the rest materials, stirring, and cooling to room temperature.
The prepared paste is milky white, the paste is fine and smooth in texture, and the pH value is 7.0 +/-0.5.
Example 3
The preparation method of the cream with the anti-inflammatory, itching-relieving and antibacterial effects comprises the following steps:
1) weighing the raw materials according to the dosage in the table 1;
2) mixing an emulsifier Gelot 64, octadecanol and monoglyceride, heating to 75 ℃, and adding the mixture into purified water heated to 75 ℃ in advance under the condition of stirring to obtain a mixture A;
3) cooling the mixture A to 56 deg.C, adding Mentholum, Camphora, Borneolum Syntheticum and thymol, and stirring to obtain paste B;
4) cooling the paste B to 50 deg.C, adding the rest materials, stirring, and cooling to room temperature.
The prepared paste is milky white, the paste is fine and smooth in texture, and the pH value is 7.0 +/-0.5.
Example 4
The preparation method of the cream with the anti-inflammatory, itching-relieving and antibacterial effects comprises the following steps:
1) weighing the raw materials according to the dosage in the table 1;
2) mixing an emulsifier Gelot 64, octadecanol and monoglyceride, heating to 70 ℃, and adding the mixture into purified water which is heated to 70 ℃ in advance under the condition of stirring to obtain a mixture A;
3) cooling the mixture A to 55 deg.C, adding Mentholum, Camphora, Borneolum Syntheticum and thymol, and stirring to obtain paste B;
4) cooling the paste B to 48 deg.C, adding the rest materials, stirring, and cooling to room temperature.
The prepared paste is milky white, the paste is fine and smooth in texture, and the pH value is 7.0 +/-0.5.
Example 5
The preparation method of the cream with the anti-inflammatory, itching-relieving and antibacterial effects comprises the following steps:
1) weighing the raw materials according to the dosage in the table 1;
2) mixing an emulsifier Gelot 64, octadecanol and monoglyceride, heating to 90 ℃, and adding the mixture into purified water which is heated to 90 ℃ in advance under the condition of stirring to obtain a mixture A;
3) cooling the mixture A to 60 ℃, adding menthol, camphor, borneol and thymol, and continuously stirring to obtain a paste B;
4) cooling the paste B to 52 deg.C, adding the rest materials, stirring, and cooling to room temperature.
The prepared paste is milky white, the paste is fine and smooth in texture, and the pH value is 7.0 +/-0.5.
Example 6
The preparation method of the cream with the anti-inflammatory, itching-relieving and antibacterial effects comprises the following steps:
1) weighing the raw materials according to the dosage in the table 1;
2) mixing an emulsifier Gelot 64, octadecanol and monoglyceride, heating to 80 ℃, and adding the mixture into purified water heated to 80 ℃ in advance under the condition of stirring to obtain a mixture A;
3) cooling the mixture A to 58 deg.C, adding Mentholum, Camphora, Borneolum Syntheticum and thymol, and stirring to obtain paste B;
4) cooling the paste B to 50 deg.C, adding the rest materials, stirring, and cooling to room temperature.
The prepared paste is milky white, the paste is fine and smooth in texture, and the pH value is 7.0 +/-0.5.
Example 7
The preparation method of the cream with the anti-inflammatory, itching-relieving and antibacterial effects comprises the following steps:
1) weighing the raw materials according to the dosage in the table 1;
2) mixing an emulsifier Gelot 64, octadecanol and monoglyceride, heating to 85 ℃, and adding the mixture into purified water which is heated to 85 ℃ in advance under the condition of stirring to obtain a mixture A;
3) cooling the mixture A to 55 deg.C, adding Mentholum, Camphora, Borneolum Syntheticum and thymol, and stirring to obtain paste B;
4) cooling the paste B to 50 deg.C, adding the rest materials, stirring, and cooling to room temperature.
The prepared paste is milky white, the paste is fine and smooth in texture, and the pH value is 7.0 +/-0.5.
Comparative example 1
The cream with the anti-inflammatory, itching relieving and antibacterial effects is prepared according to a conventional method and comprises the following steps:
1) weighing the raw materials; every 10 g of the inorganic ointment contains 0.35 g of menthol, 0.56 g of synthetic camphor, 0.3 g of methyl salicylate, 0.05 g of borneol, 0.025 g of thymol and 0.001 g of beclometasone propionate. Auxiliary materials: taking 0.01 g of dimethyl sulfoxide, stearic acid, monoglyceride, white vaseline, octadecanol, glycerol, sodium hydroxide and potassium hydroxide, and taking a proper amount of purified water to dissolve the sodium hydroxide and the potassium hydroxide.
2) Mixing menthol, camphor, borneol, thymol, methyl salicylate, beclomethasone dipropionate and dimethyl sulfoxide, and heating to 40 ℃ for dissolving to obtain a mixture A;
3) mixing emulsifier octadecanol, monoglyceride, white vaseline and stearic acid, and heating to 85 deg.C to obtain mixture B;
4) mixing purified water, glycerol, sodium hydroxide and potassium hydroxide, and heating to 80 ℃ to obtain a water-phase mixture C;
5) adding the mixture A into the mixture B under the condition of stirring to obtain an oil phase mixture D;
6) the oil phase mixture D is added into the water phase mixture C under the condition of stirring for emulsification, and the mixing takes a lot of time to complete the emulsification process. Stirring and cooling to room temperature to obtain the product.
The prepared paste is milky white, the paste texture is relatively hard, and the pH value is 8.3.
Effect verification
Randomly selecting a sample amount of 30 persons, smearing the prepared paste on an arm for sensory evaluation, and obtaining results shown in the following table.
TABLE 2 sensory evaluation table (human)
As can be seen from Table 2, the ointment prepared by the formula and the method has the characteristics of small skin irritation, no greasiness and easiness in cleaning.
The content of methyl salicylate and beclometasone dipropionate in the paste is tested, the methyl salicylate is detected by adopting a gas chromatography internal standard calibration method, the beclometasone dipropionate is detected by adopting a high performance liquid chromatography internal standard method, the content change condition of the effective components is analyzed, wherein the content reduction ratio is (original content-content after being stored for 3 years)/original content is 100%, and the result is shown in table 3.
TABLE 3 change table of effective component content (%)
It can be seen from table 3 that the content of methyl salicylate and beclometasone dipropionate in the ointment prepared by the formula and the method disclosed by the invention is reduced to be within 5% after being stored for 3 years, while the content of the ointment obtained by the formula in the comparative example is about 10%.
Clinical experiments
78 skin pruritus and inflammation patients admitted to dermatology department of Chinese medicine college in China are selected as study objects, wherein 43 male patients and 35 female patients are selected, the age is 26-59 years, the average age is 39 years, and the course of disease is 2 months-10 years. The 78 patients were divided into control group (39) and treatment group (39) by random number table method, and the difference between the two groups of patients in the general data such as sex, age, course of disease and illness state was not significant (P > 0.05), and the patients had no statistical significance and were comparable. The control group was applied topically to the affected part with commercial electrodeless ointment (manufactured by Shanghai Yanan pharmaceutical industry (Hubei) Co., Ltd.) 2 times daily for 10 days. The treatment group applied the ointment prepared in example 1 of the present invention to the affected part 2 times a day for 10 days.
Evaluation criteria for effects: and (3) healing: the skin inflammation and pruritus of the patient completely disappear, and related examination results show that pathogenic staphylococci and streptococcus on the surface of the skin are negative. The effect is shown: the skin inflammation and pruritus of the patient are obviously improved, and the related inspection results show that pathogenic staphylococci and streptococcus on the skin surface are negative. And (4) invalidation: the skin inflammation and pruritus of the patient are not improved or even aggravated, and the related examination results show that pathogenic staphylococci and streptococci on the surface of the skin are positive. Total effective rate (number of healing people + number of effective people)/total number of people 100%.
The therapeutic effect after 10 days of use is shown in the following table.
TABLE 4 therapeutic Effect table
| Group of | Healing/human body | Show effect/human | Invalid/human | The total effective rate% |
| Control group | 17 | 12 | 10 | 74.36% |
| Treatment group | 28 | 8 | 3 | 92.31% |
As can be seen from Table 4, the ointment prepared by the invention has better anti-inflammatory, itching relieving and antibacterial effects, and the total effective rate of the product is about 18 percent higher than that of the non-polar ointment sold on the market.
The preferred embodiments of the present invention have been described in detail, however, the present invention is not limited to the specific details of the above embodiments, and various simple modifications may be made to the technical solution of the present invention within the technical idea of the present invention, and these simple modifications are within the protective scope of the present invention.
It should be noted that the various features described in the above embodiments may be combined in any suitable manner without departing from the scope of the invention. The invention is not described in detail in order to avoid unnecessary repetition.
In addition, any combination of the various embodiments of the present invention is also possible, and the same should be considered as the disclosure of the present invention as long as it does not depart from the spirit of the present invention.