Xinguailing ointment as well as preparation method and application thereof

Abstract

The invention discloses a Xinfukanling ointment and a preparation method thereof. The Xinfukanling ointment is prepared from the following raw material components in parts by weight: 2 to 4 parts of metronidazole, 0.5 to 1 part of radix stemonae, 0.02 to 0.03 part of herba agrimoniae, 0.5 to 0.8 part of radix angelicae, 0.2 to 0.3 part of fructus cnidii, 1 to 3 parts of chaulmoogratree seed, 5 to 6 parts of stearic acid, 2 to 4 parts of glyceryl mono / distearate, 1 to 2 parts of hexadecanol and 1 to 2 parts of octadecanol. 1-3 parts of light liquid paraffin, 0.1-0.2 part of ethylparaben, 1-2 parts of triethanolamine, 8-10 parts of glycerin, 0.03-0.05 part of three-flower essence, and the balance of purified water, totaling 100 parts. According to the invention, all the raw material components are carefully selected and proportioned, so that the Xinfukanling ointment with excellent stability and curative effect is successfully prepared. Compared with the prior art, through the synergistic effect of all the components, the permeation efficiency and bioavailability of the medicine are improved, the treatment compliance and safety are improved, and a better treatment effect and a better application prospect are achieved.

Description

Technical Field

[0001] The invention belongs to the field of medicine, and specifically relates to a formula and a preparation method of an external Chinese and Western medicine combined preparation, in particular to a preparation method and application of Xinfumanling ointment. Background Art

[0002] Acne vulgaris is the most common chronic inflammatory skin disease that occurs on the face, chest, and shoulders, which are rich in hair follicles and sebaceous glands. It is caused by the increase in testosterone secretion in the human body during puberty, which leads to active sebaceous glands, blocked hair follicles, and affects the discharge of sebum, which in turn forms acne, nodules, papules, pustules, etc. In addition, acne vulgaris is more common in adolescents, and the treatment period is long and the means are limited, which affects the beauty of the face, causes serious psychological pressure on patients, and affects their study and daily life. Studies have shown that the combination of Xinfu Manling Ointment and Isotretinoin Erythromycin Gel can effectively improve the erythema and pigmentation problems of patients with acne vulgaris and reduce the body's inflammatory response.

[0003] In addition, the new Fumanling ointment has definite mite killing, antipruritic, analgesic, cooling and other effects, and is particularly effective for shallow rosacea. Rosacea, also known as "rosacea", is also a chronic disfiguring skin disease. It is prone to occur in the middle part of the face where the sebaceous glands are rich, and is mainly manifested by skin flushing, capillary dilation, seborrhea, papules and pustules. As the disease progresses, even nodules, hypertrophy and hyperplasia may appear. Epidemiological studies have shown that some rosacea is related to the number of human Demodex infections. Demodex parasitizes in the sebaceous glands of the human body. When the number of mites reaches a certain condition, it can induce an inflammatory reaction to form rosacea. Mite-killing preparations can cure this disease. A clinical treatment study on 442 cases of rosacea by the Dermatology Research Laboratory of the Affiliated Hospital of Qingdao Medical College, Qingdao Dermatology Prevention and Treatment Institute, the Affiliated Hospital of Qingdao Medical College, and Jinan Dermatology Prevention and Treatment Institute showed that the efficacy of Fumanling can reach 98.42%.

[0004] Xinfumanling ointment has a definite curative effect, strong mite killing ability, little side effect, and is suitable for external use. However, the preparation method of Xinfumanling ointment was reported relatively early, so it is necessary to continuously explore new technologies and methods to improve the defects. Summary of the invention

[0005] The purpose of the present invention is to provide a new fumanling ointment and a preparation method thereof, and through the optimal combination of metronidazole and components of effective parts of traditional Chinese medicine and the contents of various components, a Chinese and Western medicine combined preparation for external treatment of rosacea and acne vulgaris with high efficacy and few adverse reactions is obtained.

[0006] In order to achieve the above-mentioned purpose of the present invention, the following technical scheme is adopted:

[0007] The first aspect of the present invention provides a new fumanling ointment for treating facial inflammatory skin diseases. The new fumanling ointment consists of metronidazole, a traditional Chinese medicine composition, auxiliary materials and purified water.

[0008] Preferably, the Chinese medicine composition is Stemona tuberosa, Agrimoniae herb, Angelica dahurica, Cnidium monnieri, and Fructus pyriferae.

[0009] The raw materials used in the present invention are as follows:

[0010] Stemona: It has the effects of moistening the lungs, lowering qi, relieving cough, and killing insects. It is used for new and long-term coughs, coughs caused by tuberculosis, and whooping cough; it is used externally for head lice, body lice, pinworm disease, and genital itching. Honey Stemona moistens the lungs and relieves coughs. It is used for coughs caused by yin deficiency and fatigue.

[0011] Agrimony: It has the effects of astringency, hemostasis, dysentery, and insecticide. It is widely used in various bleeding syndromes, such as hematemesis, hematuria, bloody stool, metrorrhagia, hemoptysis, epistaxis, dysentery, fatigue, carbuncle, bruises, and traumatic bleeding.

[0012] Angelica dahurica: It has the effects of dispelling wind and relieving exterior symptoms, dispelling cold and relieving pain, removing dampness and opening the orifices, reducing swelling and discharging pus.

[0013] Cnidium monnieri: warm in nature, bitter in taste. It has the effects of drying dampness, dispelling wind, killing insects, warming the kidney and strengthening yang. It is used for impotence, cold uterus, cold and damp leucorrhea, dampness and back pain; external treatment of vulvar eczema, vaginal itching in women, and trichomonas vaginitis.

[0014] Fructus Caryophylli: pungent, hot, toxic. Has the effects of dispelling wind, expelling poison, killing insects, etc. Used for leprosy; externally used to treat scabies and ringworm.

[0015] Preferably, the auxiliary materials are stearic acid, mono- and distearic glyceryl acid, cetyl alcohol, stearyl alcohol, light liquid paraffin, ethyl hydroxybenzoate, triethanolamine, glycerin, and trifloral essence.

[0016] Further preferably, the new fumanling ointment is composed of the following raw materials in parts by weight: 2-4 parts of metronidazole, 0.5-1 parts of stemona, 0.02-0.03 parts of agrimony, 0.5-0.8 parts of angelica dahurica, 0.2-0.3 parts of cnidium monnieri, 1-3 parts of cyperus rotundus, 5-6 parts of stearic acid, 2-4 parts of mono- and distearic acid glyceryl, 1-2 parts of hexadecanol, 1-2 parts of octadecyl alcohol, 1-3 parts of light liquid paraffin, 0.1-0.2 parts of ethyl hydroxybenzoate, 1-2 parts of triethanolamine, 8-10 parts of glycerin, 0.03-0.05 parts of trifloral essence, and purified water is added to 100 parts.

[0017] The second aspect of the present invention provides a method for preparing the above-mentioned Xinfumanling ointment, which comprises two parts: raw material extraction and emulsification.

[0018] Preferably, the raw material extraction is divided into

[0019] (1) Preparation of extracts of Stemona tuberosa and Agrimoniae;

[0020] (2) Preparation of extracts of Cnidium monnieri and Angelica dahurica;

[0021] (3) Oil pressing from the radix daphne.

[0022] Preferably, the preparation method of the extract of Stemona and Herba Agrimoniae is to put Stemona and Herba Agrimoniae into an extraction tank, add ethanol, and heat and soak. Reflux for 35 minutes at 80±10°C, stop heating, and then put the liquid medicine into a stainless steel barrel; then add ethanol, reflux for 35 minutes, stop heating, and put the liquid medicine into a stainless steel barrel. Put the combined liquid medicine into a concentration tank, condense and heat to concentrate. Filter the concentrated liquid medicine into a clean stainless steel barrel, weigh and set aside.

[0023] Further preferably, the soaking temperature is 30°C, the soaking time is 1 hour, and the heating concentration temperature is 95°C.

[0024] Preferably, the preparation method of the Cnidium monnieri and Angelica dahurica extract is to put Cnidium monnieri and Angelica dahurica into an extraction tank, add purified water, and soak. 95±15°C, reflux for 35 minutes, stop heating, and then put the liquid medicine into a stainless steel barrel; then add purified water, reflux for 35 minutes, stop heating, and put the liquid medicine into a stainless steel barrel. Put the combined liquid medicine into a concentration tank, condense and heat to concentrate. Filter the concentrated liquid medicine into a clean stainless steel barrel, weigh and set aside.

[0025] Preferably, the concentrated medicinal solution is filtered through a 120-mesh sieve.

[0026] Preferably, the soaking temperature is 30°C, the soaking time is 1 hour, and the heating concentration temperature is 95±15°C.

[0027] Preferably, the method for preparing the oil from the radish is to wash the radish with drinking water for three times, put it into a blast drying oven for drying, add the dried radish into an oil press for oil pressing, and filter and weigh the pressed radish oil.

[0028] More preferably, the drying condition is drying at 80° C. for 60 minutes.

[0029] Preferably, the filter screen has a mesh size of 120.

[0030] Preferably, the emulsification step is:

[0031] (1) Preparation of main ingredients;

[0032] (2) Preparation of oil phase;

[0033] (3) Preparation of aqueous phase;

[0034] (4) Emulsification.

[0035] Further preferably, the main ingredient is prepared by uniformly mixing metronidazole and purified water.

[0036] Preferably, the oil phase is prepared by adding the oil phase materials taro oil, stearic acid, glyceryl mono- and distearate, hexadecanol, stearyl alcohol, and light liquid paraffin into an oil phase tank, stirring and heating to 90° C. for use.

[0037] Preferably, the aqueous phase is prepared by adding aqueous phase materials Stemona agrimony extract, Cnidium monnieri and Angelica dahurica extract, triethanolamine, glycerin, purified water and ethylparaben into an aqueous phase tank and heating the tank to 90° C. for standby use.

[0038] Preferably, the emulsification step is to start fast stirring and slow stirring, pump the aqueous phase liquid into the emulsification tank, and then pump the oil phase liquid into the emulsification tank for homogenization. After the homogenization is completed, slowly stir and cool down at 88°C. Add metronidazole and Sanhua essence into the emulsification tank, homogenize, cool down to about 30°C, and stop stirring. Use a colloid mill to stir evenly.

[0039] More preferably, the slow stirring is performed to cool the mixture to 50°C.

[0040] The preparation method of the new fumanling ointment provided by the present invention has the following advantages:

[0041] (1) The operation steps are simple and industrial production is easy to control.

[0042] (2) The present invention obtains a combination of Chinese and Western medicine preparation for external treatment of rosacea and acne vulgaris with high efficacy and few adverse reactions by optimizing the combination of metronidazole and effective parts of traditional Chinese medicine and the content of various components.

[0043] (3) The present invention provides a new Fumanling ointment product with good safety and definite use effect, providing patients with a new choice. DETAILED DESCRIPTION

[0044] The following embodiments of the technical solution of the present invention are described in detail in conjunction with the embodiments. The following embodiments are only used to more clearly illustrate the technical solution of the present invention, and are therefore only used as examples, and cannot be used to limit the protection scope of the present invention.

[0045] It should be noted that the experimental methods used in the implementation examples are all conventional methods unless otherwise specified; the materials, reagents, etc. used, unless otherwise specified, can be obtained from commercial channels.

[0046] In the present invention, unless otherwise specified, all "parts" and percentages (%) refer to percentages by weight.

[0047] In the present invention, unless otherwise specified, the sum of all percentages in all compositions is 100%.

[0048] In the present invention, unless otherwise specified, the numerical range "ab" represents an abbreviation of any real number combination between ab, where a and b are real numbers. For example, the numerical range "0-5" means that all real numbers between "0-5" have been listed in this document, and "0-5" is just an abbreviation of these numerical combinations.

[0049] In the present invention, unless otherwise specified, all embodiments and preferred embodiments mentioned herein can be combined with each other to form a new technical solution.

[0050] In the present invention, unless otherwise specified, all technical features and preferred features mentioned herein can be combined with each other to form a new technical solution.

[0051] In the present invention, unless otherwise specified, all the steps mentioned herein may be performed sequentially or randomly, but are preferably performed sequentially; for example, the method includes steps (a) and (b), which means that the method may include steps (a) and (b) performed sequentially, or may include steps (b) and (a) performed sequentially; for example, the method may further include step (c), which means that step (c) may be added to the method in any order, for example, the method may include steps (a), (b) and (c), or may include steps (a), (c) and (b), or may include steps (c), (a) and (b), etc.

[0052] In the present invention, unless otherwise specified, the specific numerical values ​​and specific substances in the embodiments of the present invention may be combined with other features of the description part of the present invention; for example, if the specification mentions that the reaction temperature is 10-100°C, and the embodiment mentions that the reaction temperature is 20°C, then it can be considered that the present invention has specifically disclosed the range of 10-20°C, or the range of 20-100°C, and this range can be combined with other features of the description part to form a new technical solution.

[0053] Example 1

[0054] A new mitogen ointment is prepared by weighing the following raw materials: 30 g of metronidazole, 5 g of stemona, 0.25 g of herbaceous agrimony, 5 g of angelica dahurica, 2.5 g of cnidium monnieri, 20 g of cyperus rotundus, 55 g of stearic acid, 30 g of glyceryl mono- and distearate, 10 g of hexadecanol, 10 g of stearyl alcohol, 20 g of light liquid paraffin, 1 g of ethyl hydroxybenzoate, 10 g of triethanolamine, 80 g of glycerol, 0.5 mL of three-flower essence, and adding purified water to 1000 g.

[0055] (1) Extraction

[0056] ① Preparation of extracts of Stemona and Herba Agrimoniae: Put 5g of Stemona and 0.25g of Herba Agrimoniae into the extraction tank, add ethanol, turn on the power switch, set the temperature to 30℃, and soak for 1 hour. Open the condensation water valve, turn on the power switch, set the temperature to 80±10℃, reflux for 35 minutes, stop heating, and put the liquid into a stainless steel barrel; add ethanol, turn on the power switch, reflux for 35 minutes, stop heating, and put the liquid into a stainless steel barrel. Put the combined liquid into the concentration tank, open the condensation water valve, turn on the power switch, heat and concentrate, set the temperature to 95℃, heat and concentrate until the relative density meets the internal control requirements, and stop heating. Filter the concentrated liquid through a 120-mesh sieve into a clean stainless steel barrel, weigh and set aside. ② Preparation of extracts of Cnidium monnieri and Angelica dahurica: Put 2.5g of Cnidium monnieri and 5g of Angelica dahurica into the extraction tank, add purified water, turn on the power switch, set the temperature to 30℃, and soak for 1 hour. Open the condensate valve, turn on the power switch, set the temperature to 95±15℃, reflux for 35 minutes, stop heating, and put the liquid medicine into a stainless steel barrel; then add purified water, turn on the power switch, reflux for 35 minutes, stop heating, and put the liquid medicine into a stainless steel barrel. Place the combined liquid medicine in a concentration tank, open the condensate valve, turn on the power switch, heat and concentrate, set the temperature to 95±15℃, heat and concentrate until the relative density meets the internal control requirements, and stop heating. Filter the concentrated liquid medicine through a 120-mesh sieve into a clean stainless steel barrel, weigh and set aside. ③ Dafengzi oil pressing: Wash 20g of Dafengzi with drinking water 3 times, put it in a blast drying oven for drying, drying temperature: 80℃, and dry for 60 minutes. Add the dried Dafengzi into the oil press for oil pressing, and the squeezed Dafengzi oil is filtered through a 120-mesh sieve and weighed.

[0057] (2) Emulsification

[0058] ① Preparation of main ingredients: Mix 30g of metronidazole and purified water in advance.

[0059] ② Preparation of oil phase: Add oil phase materials such as taro oil, 55g stearic acid, 30g mono- and distearic glycerides, 10g hexadecanol, 10g octadecyl alcohol, and 20g light liquid paraffin into the oil phase tank, stir and heat to 90°C for use.

[0060] ③ Preparation of water phase: Add water phase materials Stemona agrimony extract, Cnidium monnieri and Angelica dahurica extract, 10g triethanolamine, 80g glycerin, purified water and 1g ethylparaben into the water phase tank and heat to 90℃ for use.

[0061] ④ Emulsification: Start fast stirring and slow stirring, pump the water phase liquid into the emulsification tank, then pump the oil phase liquid into the emulsification tank, homogenize, and after homogenization, slowly stir and cool down at 88℃. When the temperature drops to about 50℃, add metronidazole and 0.5mL Sanhua essence into the emulsification tank, homogenize, cool to about 30℃, and stop stirring. Use a colloid mill to stir well to get the new Fumanling ointment.

[0062] Example 2

[0063] A new mitogen ointment is prepared by weighing the following raw materials: 40 g of metronidazole, 5 g of stemona, 0.3 g of herbaceous agrimony, 6 g of angelica dahurica, 2.5 g of cnidium monnieri, 20 g of cyperus rotundus, 55 g of stearic acid, 25 g of glyceryl mono- and distearate, 10 g of hexadecanol, 10 g of stearyl alcohol, 20 g of light liquid paraffin, 1 g of ethyl hydroxybenzoate, 10 g of triethanolamine, 80 g of glycerol, 0.5 mL of three-flower essence, and adding purified water to 1000 g.

[0064] (1) Extraction

[0065] ① Preparation of extracts of Stemona and Herba Agrimoniae: Put 5g of Stemona and 0.3g of Herba Agrimoniae into the extraction tank, add ethanol, turn on the power switch, set the temperature to 30℃, and soak for 1 hour. Open the condensation water valve, turn on the power switch, set the temperature to 80±10℃, reflux for 35 minutes, stop heating, and put the liquid medicine into a stainless steel barrel; add ethanol, turn on the power switch, reflux for 35 minutes, stop heating, and put the liquid medicine into a stainless steel barrel. Put the combined liquid medicine into the concentration tank, open the condensation water valve, turn on the power switch, heat and concentrate, set the temperature to 95℃, heat and concentrate until the relative density meets the internal control requirements, and stop heating. Filter the concentrated liquid medicine through a 120-mesh sieve into a clean stainless steel barrel, weigh and set aside. ② Preparation of extracts of Cnidium monnieri and Angelica dahurica: Put 2.5g of Cnidium monnieri and 6g of Angelica dahurica into the extraction tank, add purified water, turn on the power switch, set the temperature to 30℃, and soak for 1 hour. Open the condensate valve, turn on the power switch, set the temperature to 95±15℃, reflux for 35 minutes, stop heating, and put the liquid medicine into a stainless steel barrel; then add purified water, turn on the power switch, reflux for 35 minutes, stop heating, and put the liquid medicine into a stainless steel barrel. Place the combined liquid medicine in a concentration tank, open the condensate valve, turn on the power switch, heat and concentrate, set the temperature to 95±15℃, heat and concentrate until the relative density meets the internal control requirements, and stop heating. Filter the concentrated liquid medicine through a 120-mesh sieve into a clean stainless steel barrel, weigh and set aside. ③ Dafengzi oil pressing: Wash 20g of Dafengzi with drinking water 3 times, put it in a blast drying oven for drying, drying temperature: 80℃, and dry for 60 minutes. Add the dried Dafengzi into the oil press for oil pressing, and the squeezed Dafengzi oil is filtered through a 120-mesh sieve and weighed.

[0066] (2) Emulsification

[0067] ① Preparation of main ingredients: Mix 40g of metronidazole and purified water evenly in advance.

[0068] ② Preparation of oil phase: Add oil phase materials such as taro oil, 55g stearic acid, 25g mono- and distearic glycerides, 10g hexadecanol, 10g octadecyl alcohol, and 20g light liquid paraffin into the oil phase tank, stir and heat to 90°C for use.

[0069] ③ Preparation of water phase: Add water phase materials Stemona agrimony extract, Cnidium monnieri and Angelica dahurica extract, 10g triethanolamine, 80g glycerin, purified water and 1g ethylparaben into the water phase tank and heat to 90℃ for use.

[0070] ④ Emulsification: Start fast stirring and slow stirring, pump the water phase liquid into the emulsification tank, then pump the oil phase liquid into the emulsification tank, homogenize, and after homogenization, slowly stir and cool down at 88℃. When the temperature drops to about 50℃, add metronidazole and 0.5mL Sanhua essence into the emulsification tank, homogenize, cool to about 30℃, and stop stirring. Use a colloid mill to stir well to get the new Fumanling ointment.

[0071] Example 3

[0072] A new mitogen ointment is prepared by weighing the following raw materials: 30 g of metronidazole, 8 g of stemona, 0.25 g of herbaceous agrimony, 5 g of angelica dahurica, 2.5 g of cnidium monnieri, 20 g of cyperus rotundus, 50 g of stearic acid, 30 g of glyceryl mono- and distearate, 10 g of hexadecanol, 10 g of stearyl alcohol, 15 g of light liquid paraffin, 1 g of ethyl hydroxybenzoate, 10 g of triethanolamine, 85 g of glycerol, 0.5 mL of three-flower essence, and adding purified water to 1000 g.

[0073] (1) Extraction

[0074] ① Preparation of extracts of Stemona and Herba Agrimoniae: Put 8g of Stemona and 0.25g of Herba Agrimoniae into the extraction tank, add ethanol, turn on the power switch, set the temperature to 30℃, and soak for 1 hour. Open the condensation water valve, turn on the power switch, set the temperature to 80±10℃, reflux for 35 minutes, stop heating, and put the liquid medicine into a stainless steel barrel; add ethanol, turn on the power switch, reflux for 35 minutes, stop heating, and put the liquid medicine into a stainless steel barrel. Put the combined liquid medicine into the concentration tank, open the condensation water valve, turn on the power switch, heat and concentrate, set the temperature to 95℃, heat and concentrate until the relative density meets the internal control requirements, and stop heating. Filter the concentrated liquid medicine through a 120-mesh sieve into a clean stainless steel barrel, weigh and set aside. ② Preparation of 2.5g of Cnidium monnieri and 5g of Angelica dahurica extract: Put Cnidium monnieri and Angelica dahurica into the extraction tank, add purified water, turn on the power switch, set the temperature to 30℃, and soak for 1 hour. Open the condensate valve, turn on the power switch, set the temperature to 95±15℃, reflux for 35 minutes, stop heating, and put the liquid medicine into a stainless steel barrel; then add purified water, turn on the power switch, reflux for 35 minutes, stop heating, and put the liquid medicine into a stainless steel barrel. Place the combined liquid medicine in a concentration tank, open the condensate valve, turn on the power switch, heat and concentrate, set the temperature to 95±15℃, heat and concentrate until the relative density meets the internal control requirements, and stop heating. Filter the concentrated liquid medicine through a 120-mesh sieve into a clean stainless steel barrel, weigh and set aside. ③ Dafengzi oil pressing: Wash 20g of Dafengzi with drinking water 3 times, put it in a blast drying oven for drying, drying temperature: 80℃, and dry for 60 minutes. Add the dried Dafengzi into the oil press for oil pressing, and the squeezed Dafengzi oil is filtered through a 120-mesh sieve and weighed.

[0075] (2) Emulsification

[0076] ① Preparation of main ingredients: Mix 30g of metronidazole and purified water in advance.

[0077] ② Preparation of oil phase: Add oil phase materials such as taro oil, 50g stearic acid, 30g mono- and distearic glycerides, 10g hexadecanol, 10g octadecyl alcohol, and 15g light liquid paraffin into the oil phase tank, stir and heat to 90°C for use.

[0078] ③ Preparation of water phase: Add water phase materials Stemona agrimony extract, Cnidium monnieri and Angelica dahurica extract, 10g triethanolamine, 85g glycerol, purified water and 1g ethylparaben into the water phase tank and heat to 90℃ for use.

[0079] ④ Emulsification: Start fast stirring and slow stirring, pump the water phase liquid into the emulsification tank, then pump the oil phase liquid into the emulsification tank, homogenize, and after homogenization, slowly stir and cool down at 88℃. When the temperature drops to about 50℃, add metronidazole and 0.5mL Sanhua essence into the emulsification tank, homogenize, cool to about 30℃, and stop stirring. Use a colloid mill to stir well to get the new Fumanling ointment.

[0080] The invention obtains a Chinese and Western medicine combined preparation for external treatment of rosacea and acne vulgaris with high efficacy and few adverse reactions by optimizing the combination of metronidazole and components of effective parts of traditional Chinese medicine and the contents of various components.

[0081] Safety Experiment

[0082] According to the technical guidelines for the study of chemical drug irritation, allergy and hemolysis, the samples obtained in Examples 1 to 3 were subjected to facial skin irritation and allergy tests, and the results showed that they were non-irritating and non-allergic.

[0083] Clinical Application

[0084] (1) Clinical application of rosacea

[0085] The subjects were healthy adolescent patients with rosacea, aged 16 to 30 years old, 60 males and 60 females, with a disease course of 2 weeks to one year.

[0086] The above cases were randomly divided into two groups. The treatment group had 65 cases, including 6 mild cases, 39 moderate cases, and 20 severe cases. The control group had 55 cases, including 5 mild cases, 36 moderate cases, and 14 severe cases. The treatment group used Xinfu Manling ointment for local external application, and washed the affected area with warm water before treatment, once in the morning and once in the evening. The control group used Fusidic acid cream, and the method was the same as above.

[0087] The treatment results are shown in Table 1

[0088] Table 1

[0089]

[0090] Note: There is a significant difference between the two groups at P < 0.05 as shown in the chi-square test.

[0091] (2) Clinical application of acne vulgaris

[0092] The subjects were healthy adolescent patients with acne vulgaris, aged 16 to 30 years old, including 67 males and 67 females, with disease course ranging from 2 weeks to one and a half years.

[0093] The above cases were randomly divided into two groups. The treatment group had 72 cases, including 4 mild cases, 49 moderate cases, and 19 severe cases. The control group had 62 cases, including 2 mild cases, 43 moderate cases, and 17 severe cases. The treatment group used Xinfu Manling ointment combined with isotretinoin erythromycin gel for local external application. The affected area was washed with warm water before treatment, once in the morning and once in the evening. The control group used isotretinoin erythromycin gel cream, and the method was the same as above.

[0094] The treatment results are shown in Table 2

[0095] Table 2

[0096]

[0097] Note: There is a significant difference between the two groups at P < 0.05 as shown in the chi-square test.

[0098] The above studies show that the new Fumanling ointment obtained by the technical solution of the present application has a good therapeutic effect on rosacea and acne vulgaris.

[0099] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein by equivalents. These modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be included in the scope of the claims and specification of the present invention.

Claims

1. A method for preparing a new fumanling ointment, characterized in that: The preparation method comprises two parts: raw material extraction and emulsification.

2. The method for preparing the new fumanling ointment according to claim 1, characterized in that: The raw materials of the new fuminling ointment are metronidazole, a Chinese medicine composition, auxiliary materials, and purified water. The Chinese medicine composition is Stemona tuberosa, Agrimoniae, Angelica dahurica, Cnidium monnieri, and Fructus dasyphyllae. The auxiliary materials are stearic acid, mono- and distearic acid glyceric acid, hexadecanol, octadecyl alcohol, light liquid paraffin, ethyl hydroxybenzoate, triethanolamine, glycerin, and triflora essence.

3. The method for preparing the new fumanling ointment according to claim 2, characterized in that: The new fumanling ointment is composed of the following raw materials in parts by weight: 2-4 parts of metronidazole, 0.5-1 parts of stemona, 0.02-0.03 parts of agrimony, 0.5-0.8 parts of angelica dahurica, 0.2-0.3 parts of cnidium monnieri, 1-3 parts of cyperus rotundus, 5-6 parts of stearic acid, 2-4 parts of mono- and distearic acid glyceryl, 1-2 parts of hexadecanol, 1-2 parts of octadecyl alcohol, 1-3 parts of light liquid paraffin, 0.1-0.2 parts of ethyl hydroxybenzoate, 1-2 parts of triethanolamine, 8-10 parts of glycerol, 0.03-0.05 parts of trifloral essence, and purified water is added to 100 parts.

4. The method for preparing the new fumanling ointment according to claim 1, characterized in that: The raw material extraction is divided into (1) Preparation of extracts of Stemona tuberosa and Agrimoniae; (2) Preparation of extracts of Cnidium monnieri and Angelica dahurica; (3) Oil pressing from the radix daphne.

5. The method for preparing the new fumanling ointment according to claim 4, characterized in that: The preparation method of the extract of Stemona and Herba Agrimoniae is as follows: put Stemona and Herba Agrimoniae into an extraction tank, add ethanol, and heat and soak. The soaking temperature is 30°C, the soaking time is 1 hour, reflux for 35 minutes at 80±10°C, stop heating, and then put the liquid medicine into a stainless steel barrel; then add ethanol, reflux for 35 minutes, stop heating, and put the liquid medicine into a stainless steel barrel. Put the combined liquid medicine into a concentration tank and condense. Heat and concentrate at 95°C. Filter the concentrated liquid medicine into a clean stainless steel barrel, weigh and set aside.

6. The method for preparing the new fumanling ointment according to claim 4, characterized in that: The preparation method of the Cnidium monnieri and Angelica dahurica extract is as follows: Cnidium monnieri and Angelica dahurica are put into an extraction tank, purified water is added, and the mixture is soaked. The mixture is refluxed at 95±15°C for 35 minutes, and the heating is stopped. The mixture is then placed in a stainless steel barrel. Purified water is added, the mixture is refluxed for 35 minutes, and the heating is stopped. The mixture is placed in a stainless steel barrel. The combined mixture is placed in a concentration tank, and the mixture is condensed, heated, and concentrated. The concentrated mixture is filtered into a clean stainless steel barrel, and weighed for later use.

7. The method for preparing the new fumanling ointment according to claim 5 or 6, characterized in that: The concentrated medicinal solution is filtered through a 120-mesh screen.

8. The method for preparing the new fumanling ointment according to claim 6, characterized in that: The soaking temperature is 30°C, the soaking time is 1 hour, and the heating concentration temperature is 95±15°C.

9. The method for preparing the new fumanling according to claim 4, characterized in that: The method for preparing the oil from the radish is as follows: washing the radish with drinking water for three times, placing it in a blast drying oven for drying, drying it at 80° C. for 60 minutes, adding the dried radish into an oil press for oil pressing, filtering the pressed radish oil, and weighing it.

10. The method for preparing the new fumanling ointment according to claim 1, characterized in that: The emulsification step is: (1) Preparation of main ingredients. Mix metronidazole and purified water evenly. (2) Preparation of oil phase. Add the oil phase materials of taro oil, stearic acid, glyceryl mono- and distearate, hexadecanol, stearyl alcohol, and light liquid paraffin into the oil phase tank, stir and heat to 90°C for use. (3) Preparation of aqueous phase: Add the aqueous phase materials, Stemona agrimoniae extract, Cnidium monnieri and Angelica dahurica extract, triethanolamine, glycerol, purified water and ethylparaben into the aqueous phase tank and heat to 90°C for later use. (4) Emulsification. Turn on fast stirring and slow stirring, pump the water phase liquid into the emulsification tank, then pump the oil phase liquid into the emulsification tank, homogenize, and after homogenization, slowly stir at 88℃ and cool to 50℃. Add metronidazole and Sanhua essence to the emulsification tank, homogenize, cool to about 30℃, and stop stirring. Use a colloid mill to stir evenly.

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