Self-drying traditional Chinese medicine gel ointment, preparation method and application thereof

Abstract

The present invention belongs to the technical field of traditional Chinese medicine, and discloses a self-drying Chinese medicine gel and a preparation method thereof. A standard portion of self-drying Chinese medicine gel ointment is prepared according to the following proportions and steps: S1, preparing a mixture of Chinese medicine powders; S2, preparing auxiliary agents: preparing ABCD solutions respectively; S3, preparing a self-drying Chinese medicine gel ointment. The self-drying Chinese medicine gel ointment is applied as an external application medicine on the outer surface of the skin of the affected part of the patient to treat lymphedema. The present invention makes the prepared self-drying Chinese medicine gel ointment suitable as an external application medicine by simultaneously improving the drug components, auxiliary agent components, proportions and preparation methods, and is applied on the outer surface of the skin of the affected part, and can form a thicker self-adhesive coating to treat lymphedema in a targeted manner; and the present invention adopts common Chinese medicinal materials, has a simple preparation method, a small number of coating times, no component residue, convenient use, stable and significant efficacy, a short treatment cycle, and low comprehensive cost.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine, and in particular to a self-drying traditional Chinese medicine gel ointment, a preparation method and application thereof. Background Art

[0002] Lymphedema refers to the proliferation of subcutaneous fibrous connective tissue and hardening of fat caused by repeated infection of soft tissue fluid on the body surface due to obstruction of lymph flow in certain parts of the body. If it is a limb, it will become thicker. In the later stage, the skin becomes thicker, rougher, and tougher like elephant skin, also known as "elephanthiosis". Clinically, lymphedema manifests as hyperplasia of skin and subcutaneous tissue, deeper wrinkles, thickening, hardening and roughening of the skin, and there may be thorns and wart-like protrusions, which look like elephant skin. In the early stage, the affected limb is swollen, which can be relieved after lifting. In the late stage, the affected limb is obviously swollen, the surface is keratinized and rough, and it is rubbery. A few may have skin cracks, ulcers or wart-like growths.

[0003] Primary lymphedema is mainly caused by lesions in the reticular layer of the dermis and subcutaneous tissue. There is a lot of lymph fluid in the interstitial space, and the collagen fibers in the dermal papilla show transparent degeneration. There are different degrees of lymphocyte infiltration around the blood vessels. In the early stage of secondary lymphedema, there is inflammatory cell infiltration, and in the late stage, there is tissue fibrosis. At present, breast cancer-related lymphedema is particularly common in clinical practice. According to literature reports, the incidence of lymphedema after breast cancer surgery reaches 25% to 50%. Lymphedema after breast cancer surgery is mainly caused by the destruction of postoperative lymph nodes and lymphatic vessels, which causes the obstruction of lymphatic return pathways and the accumulation of a large amount of protein-rich lymph fluid in the interstitial space. As a disease with lymphatic circulation disorders in patients due to multiple complex causes, the cure rate of lymphedema is currently low, and there is no mature treatment plan. The current treatment methods used in clinical practice include surgical treatment, drug treatment and physical therapy.

[0004] Among them, drug treatment mainly uses oral diuretics (including Western medicine and Chinese medicine diuretics). Although these drugs can achieve a short-term swelling effect, if patients take them for a long time, they may cause adverse reactions such as hypotension and electrolyte disorders. For example, diosmin tablets often cause gastrointestinal reactions of varying degrees; intravenous infusion of β-aescin sodium or interferon can easily cause phlebitis, rash, etc. Traditional Chinese medicine has a certain effect on the treatment of lymphedema, mainly using some diuretic and swelling-reducing, blood circulation and collateral-activating drugs for treatment, and the main method of administration is oral administration. However, oral administration not only increases the burden on the patient's gastrointestinal tract, but also easily causes systemic adverse reactions, and long-term use is prone to toxicity.

[0005] In order to solve this problem, the document of Chinese invention patent application No. 202010670409.X discloses a topical composition for treating lymphedema, a gel and a preparation method thereof. The topical composition provided by the invention includes rhubarb extract, Poria extract, Artemisia argyi extract, saffron extract, Panax notoginseng total saponins, as well as bisabolol, glycyrrhetinic acid, and menthol. The components in the composition act synergistically, and have excellent effects of diuresis and swelling, promoting blood circulation and relieving pain, anti-inflammatory and antibacterial, preventing skin tissue infection, and promoting the healing of skin trauma. The gel provided by the invention includes the topical composition, a multifunctional transdermal absorption promoter and a matrix excipient. The multifunctional transdermal absorption promoter can effectively promote the transdermal absorption and effective utilization of the active ingredients in the topical composition, and can play a role in assisting the treatment of lymphedema, complementing the topical composition, and improving the therapeutic effect of lymphedema. The gel is simple to use, low in price, can be carried with you, and can be used at any time.

[0006] However, the gel provided by the above invention patent is an aqueous gel made from extracts of various Chinese herbal medicines. On the one hand, it uses many types of Chinese medicines and the preparation methods of the extracts are complicated. Among them, rhubarb, saffron, Panax notoginseng, etc. are all precious Chinese medicinal materials with high comprehensive costs; on the other hand, the prepared gel is an aqueous gel, and the coating formed on the patient's skin surface is thin, the water evaporates quickly, and the drug effect lasts for a short time. Patients are required to apply it evenly on the affected limb once a day in the morning, noon and evening, and use it many times, and also need to cooperate with physical therapy to achieve better therapeutic effects; on the one hand, it cannot be prepared at low cost and in large quantities, and on the other hand, the application times are frequent, the drug effect is not long-lasting and not continuous, and it cannot meet the patient's experience and demand for efficacy. Summary of the invention

[0007] The purpose of the present invention is to provide a self-drying Chinese medicine gel ointment and a preparation method thereof in view of the above-mentioned deficiencies of the prior art, wherein a scientifically compatible mixture of Chinese medicine powders (crude drugs) is directly used as the drug component in the self-drying Chinese medicine gel ointment, and a self-drying Chinese medicine gel ointment coating with a thickness of 5-10 mm formed thereby provides continuous and lasting active drug ingredients to the patient's skin; the self-drying Chinese medicine gel ointment achieves firm adhesion, rapid film formation, and protection of the internal humidity of the coating through an auxiliary agent, and automatically hardens and falls off after 12 hours, so that the patient can obtain continuous The invention has an efficacy of 12 hours, and can be applied continuously, so that the affected limb can be continuously supplemented with moisture and drug ingredients through the skin, shortening the treatment cycle and improving the treatment effect. The invention makes simultaneous improvements on drug ingredients, auxiliary ingredients, proportions and preparation methods, so that the prepared self-drying Chinese medicine gel ointment is suitable for being used as an external application medicine and is applied on the outer surface of the skin of the affected part to treat lymphedema in a targeted manner. Moreover, the invention adopts common Chinese medicinal materials, has a simple preparation method, a small number of application times, no residual ingredients, is easy to use, has stable and significant efficacy, a short treatment cycle and a low overall cost.

[0008] In order to achieve the above object, the technical solution adopted by the present invention is:

[0009] A method for preparing a self-drying traditional Chinese medicine gel ointment, characterized in that it comprises the following steps:

[0010] S1. Preparation of Chinese medicine powder mixture:

[0011] The Chinese medicine powder is a mixture of 5±1g of Stephania tetrandra, 10±2g of Astragalus, 15±3g of Poria, 10±2g of Cinnamomum cassia, 10±2g of Alisma orientalis, 10±2g of Fructus liquidambar formosana, 10±2g of Radix Rehmanniae, 10±2g of Fructus Corni, 10±2g of Hedyotis diffusa and 20±2g of Sodium Sulfate, which is ground into powder, sieved and prepared into a Chinese medicine powder mixture with a total weight of 110±15g, and stored for later use;

[0012] S2. Preparation of auxiliary agents:

[0013] The auxiliary agent includes: 180±30g of deionized water, 200g of polyvinyl alcohol acetal, 50g of dibutyl phthalate, 130±30ml of acetone, 3±1g of alginate, 5±2g of hydroxypropyl chitosan, 20ml of azone, 20ml of glycerol, and 5ml of honey; specifically includes:

[0014] S21, preparing solution A: taking 1 / 3 of deionized water and hydroxypropyl chitosan, heating and mixing evenly to fully dissolve the hydroxypropyl chitosan, preparing solution A, and storing for later use;

[0015] S22, preparing solution B: taking 1 / 3 of deionized water and oxidized alginate, heating and mixing evenly to fully dissolve the oxidized alginate to prepare solution A, and storing for later use;

[0016] S22, preparing solution C: taking 1 / 3 of deionized water, glycerin, and honey, heating and mixing them evenly to prepare solution C, and saving for later use;

[0017] S23, preparing solution D: adding 200 g of polyvinyl acetal, 50 g of dibutyl phthalate, and 130±30 ml of acetone into a reaction kettle, heating, and continuously stirring to uniformly mix, and when the temperature rises to 90-95° C., a solution D is obtained;

[0018] S3, self-drying Chinese medicine gel ointment:

[0019] Keeping constant temperature and continuous stirring, slowly add the Chinese medicine powder mixture and azone to the D solution heated to 90-95° C. in the reactor, stop heating after stirring at a low speed for 10-30 minutes, continue stirring at a low speed and slowly add the C solution, the B solution, and the A solution in sequence, finally stir at a high speed for 10-30 minutes, cool to room temperature, and obtain a self-drying Chinese medicine gel ointment;

[0020] S4, filling

[0021] The self-drying Chinese medicine gel ointment is filled into a plastic soft tube by a filling machine, and then into a tube, which is sealed and sterilized to obtain the self-drying Chinese medicine gel ointment in a soft tube sealed package.

[0022] A self-drying traditional Chinese medicine gel ointment, characterized in that it is prepared by the above method.

[0023] The invention discloses an application of a self-drying Chinese medicine gel ointment, which is applied as an external medicine on the outer surface of the skin of a patient's affected part to treat lymphedema.

[0024] Compared with the prior art, the self-drying Chinese medicine gel ointment, preparation method and application thereof provided by the present invention have at least the following beneficial effects:

[0025] 1. The present invention improves the drug ingredients, auxiliary ingredients, proportions and preparation methods simultaneously, so that the prepared self-drying Chinese medicine gel ointment is suitable for external application, which is applied on the outer surface of the affected skin to form a thicker moisturizing self-adhesive coating (thickness of 5-10mm) for targeted treatment of lymphedema; and the present invention uses common Chinese medicinal materials, has a simple preparation method, a small number of coating times, no residual ingredients, easy use, stable and significant efficacy, short treatment cycle, and low overall cost.

[0026] 2. The self-drying Chinese medicine gel ointment and the preparation method thereof provided by the present invention adopt a scientifically compatible mixture of Chinese medicine powders (crude drugs, raw materials) directly as the drug ingredient in the self-drying Chinese medicine gel ointment, and the self-drying Chinese medicine gel ointment coating provides continuous and lasting drug active ingredients to the patient's skin; the self-drying Chinese medicine gel ointment is assisted by an auxiliary agent to form a thicker moisturizing self-adhesive coating, and further realizes the coating being firmly attached, quickly forming a film, protecting the internal humidity of the coating, and continuously supplying water and medicine for about 12 hours. After about 12 hours, the coating automatically hardens and falls off; the patient can obtain a therapeutic effect lasting 12 hours each time it is applied, and the application can be continuous, so that the affected limb can obtain uninterrupted transdermal replenishment of moisture and drug ingredients, shortening the treatment cycle and improving the treatment effect.

[0027] 3. The present invention adds auxiliary components such as bonding, sustained release, moisturizing, and coagulation to the raw material formula of traditional Chinese medicine mainly in powder form, and cooperates with 50-80 mesh powder raw material medicine powder. After mixing, a uniform self-adhesive, moisturizing toothpaste-like gel ointment can be formed, which is filled into a plastic hose, sealed, and sterilized to form a finished product that can be used by patients at any time; when in use, the patient directly squeezes out the gel ointment, and after coating, it is firmly bonded to the outer surface of the affected skin to form an ointment coating with a thickness of about 5-10mm. A large amount of moisture and drug components contained in the coating can provide no less than 12 hours of transdermal treatment for the affected area, which is far superior to the same type of external gel products in the prior art. The coating thickness of the existing similar products is micron-level, and the continuous treatment time of a single coating is less than 30 minutes. It cannot provide moisture and drug components to the affected area for a long time and continuously, so its treatment course cannot be stable and continuous.

[0028] 4. The Chinese medicine powder mixture (raw material medicine) adopted in the present invention has a scientific and reasonable compatibility, and the dosage of the components can be increased or decreased according to different symptoms (mild, moderate, severe, etc.); during the process of heating, stirring, mixing, etc. to prepare the gel ointment, most of the effective ingredients of each raw Chinese medicine powder can be dissolved and enter the gel, and a small part of the effective ingredients that are not easy to dissolve slowly dissolve and gradually enter the gel during the 12-hour treatment process when the ointment forms a thicker coating attached to the patient's skin, providing about 12 hours of drug supply to the affected area.

[0029] 5. The auxiliary agent components used in the present invention include various types, which cooperate with each other, wrap the Chinese medicine powder mixture, and dissolve the active ingredients in each Chinese medicine powder, form a gel ointment, after the patient applies the ointment to the affected part skin surface, its stronger cohesiveness can obtain a thicker coating, a larger coverage area, and the coating can also be firmly bonded to the skin, and does not fall off for a long time (12 hours); in the coating during long-term transdermal treatment, each auxiliary agent component assists the Chinese medicine powder to transport moisture and the active ingredient of the medicine to the affected part, and the active ingredient in the Chinese medicine powder that is not dissolved in the preparation process can be continuously dissolved, further improve the utilization rate of the active ingredient in the Chinese medicine powder, improve the efficacy, reduce the dosage, and save treatment costs. After the ointment coating of the present invention lasts for about 12 hours, due to the gradual exhaustion of internal moisture and drug ingredients, the coating is gradually dried, easy to fall off, can fall off by itself, and the drug gel component or drug residue will not be left on the skin surface, which is convenient for patients to use.

[0030] 6. The self-drying Chinese medicine gel ointment provided by the present invention is suitable for sealed packaging with ointment. Since the coating formed by it is thick, the effective coverage area is large, and the amount of water and active ingredients coated is large, it can support continuous treatment for about 12 hours, and can treat lymphedema of different degrees, refractory severe lymphedema, especially those with enlarged pores, high skin tension, scleroderma, limb pain, and numbness symptoms, and has good therapeutic effects in softening the skin, unblocking meridians, removing blood stasis, and helping to establish lateral circulation; and it is easy to manufacture, store, carry and use.

[0031] The above is an overview of the technical solution of the invention. The present invention will be further described below in conjunction with specific implementation methods. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the following is a detailed description in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0033] Example 1

[0034] This embodiment was trial-produced and tested based on the treatment needs of clinical cases in Guangdong Provincial Hospital of Traditional Chinese Medicine, and has been actually applied to 8 cases. Compared with other topical gel products purchased on the market, it has produced significant positive therapeutic effects and significantly shortened the course of treatment.

[0035] The method for preparing the self-drying Chinese medicine gel ointment provided in this embodiment is to prepare a standard portion of the self-drying Chinese medicine gel ointment according to the following proportions and steps:

[0036] S1. Preparation of Chinese medicine powder mixture:

[0037] The Chinese medicine powder is a mixture of 5 grams of Stephania tetrandra, 10 grams of Astragalus, 15 grams of Poria, 10 grams of Cinnamomum cassia, 10 grams of Rhizoma Alismatis, 10 grams of Fructus Liquidambar, 10 grams of Radix Rehmanniae, 10 grams of Fructus Corni, 10 grams of Hedyotis diffusa and 20 grams of Sodium Sulfate, which is ground into powder, passed through a 50-mesh sieve and prepared into a Chinese medicine powder mixture with a total weight of 110 grams, and stored for later use;

[0038] S2. Preparation of auxiliary agents:

[0039] The auxiliary agent includes: 180 grams of deionized water, 200 grams of polyvinyl formal, 50 grams of dibutyl phthalate, 130 ml of acetone, 3 grams of alginate, 5 grams of hydroxypropyl chitosan, 20 ml of azone, 20 ml of glycerol, and 5 ml of honey; specifically includes:

[0040] S21, preparing solution A: taking 1 / 3 of deionized water and hydroxypropyl chitosan, heating and mixing evenly to fully dissolve the hydroxypropyl chitosan, preparing solution A, and storing for later use;

[0041] S22, preparing solution B: taking 1 / 3 of deionized water and oxidized alginate, heating and mixing evenly to fully dissolve the oxidized alginate to prepare solution A, and storing for later use;

[0042] S22, preparing solution C: taking 1 / 3 of deionized water, glycerin, and honey, heating and mixing them evenly to prepare solution C, and saving for later use;

[0043] S23, preparing solution D: adding 200 g of polyvinyl formal, 50 g of dibutyl phthalate, and 130 ml of acetone into a reaction kettle, heating, and continuously stirring to uniformly mix, and when the temperature rises to 90-95° C., a solution D is obtained;

[0044] The heating in steps S21, S22 and S23 is heating to 80-90°C; the stirring speed during mixing is 30-50r / min;

[0045] S3. Preparation of self-drying Chinese medicine gel ointment:

[0046] Keeping constant temperature and continuous stirring, slowly add the Chinese medicine powder mixture and azone to the D solution heated to 90-95° C. in the reactor, stop heating after stirring at a low speed for 10-30 minutes, continue stirring at a low speed and slowly add the C solution, the B solution, and the A solution in sequence, finally stir at a high speed for 10-30 minutes, cool to room temperature, and obtain a standard portion of self-drying Chinese medicine gel ointment; due to the evaporation of part of the deionized water and the auxiliary agent during the preparation process, the final ointment volume of each standard portion (single portion) is about 310-350 ml;

[0047] The low-speed stirring in step S3 is 50-80 r / min, and the high-speed stirring is 300-500 r / min.

[0048] S4, filling

[0049] The prepared standard amount of self-drying Chinese medicine gel ointment is filled into a soft tube by a filling machine, and then sealed and sterilized to obtain the self-drying Chinese medicine gel ointment in a soft tube sealed package.

[0050] In step S4, the filling hose is a full plastic composite hose, and its effective filling volume is 150-350ml, and the dosage is determined according to the severity of the patient's symptoms and the course of treatment. (The full plastic composite hose for filling complies with the national light industry standard "Full plastic composite hose for toothpaste (QB / T4192-2011)")

[0051] In this embodiment, a standard portion of self-drying Chinese medicine gel ointment is filled into two 150 ml soft tubes (the ointment capacity of each standard portion is about 310-350 ml, leaving a filling margin), to obtain two sealed self-drying Chinese medicine gel ointment finished products.

[0052] In other embodiments, in order to save costs, mass produce and fill, the proportions of the materials required for a standard portion of self-drying Chinese medicine gel ointment in steps S1-S3 can be multiplied by an integer multiple (for example, 10 times), and steps S1-S4 can be repeated to prepare multiple portions of self-drying Chinese medicine gel ointment in batches, which are then filled in batches.

[0053] The self-drying traditional Chinese medicine gel ointment provided in this embodiment is prepared by the aforementioned method.

[0054] An application of a self-drying Chinese medicine gel ointment, which is applied as an external medicine on the outer surface of the skin of a patient's affected part to treat lymphedema, comprises the following steps:

[0055] A1: The patient applies the self-drying Chinese medicine gel ointment on the outer surface of the affected skin to form a Chinese medicine gel cake-like coating with a thickness of 50-70 mm;

[0056] A2: The outer surface of the Chinese medicine gel coating forms a film and a protective shell within 2-3 minutes, so that the surface inside the coating no longer flows and is tightly attached to the outer surface of the affected skin. The coating adheres to the affected skin for 12 hours without falling off, and the internal moisture does not evaporate;

[0057] A3: The water and drug components in the Chinese medicine gel coating continue to flow to the side close to the skin surface. The drug components continue to soften the skin, enter the subcutaneous tissue through the skin pores, reach the lymphedema lesions, dredge the meridians, remove blood stasis, help establish lateral circulation, and produce therapeutic effects.

[0058] A4: As the duration of treatment increases, the water content and drug components in the Chinese medicine gel coating gradually decrease, and the Chinese medicine gel coating gradually hardens. After about 12 hours, the Chinese medicine gel coating agglomerates, dries, and falls off by itself, leaving no Chinese medicine gel components on the skin surface.

[0059] A5: After the first coating of the self-drying Chinese medicine gel ointment falls off, reapply the self-drying Chinese medicine gel ointment on the outer surface of the affected skin for the second time to form a Chinese medicine gel cake coating with a thickness of 5-10mm again. Repeat steps A1-A4 to continuously deliver the moisture and drug ingredients in the Chinese medicine gel coating to treat refractory severe lymphedema, especially those with enlarged pores, high skin tension, scleroderma, limb swelling and pain, and numbness.

[0060] Practical application case 1:

[0061] The patient, Yan Moumou, female, 67 years old, had swelling in her left limbs for more than 2 months. The local skin was intact, and her skin color and temperature were normal. She complained that she started to swell after lifting heavy objects. She underwent physical air pressure therapy, functional exercise, and wearing pressure cuffs in the outpatient clinic, but there was no obvious improvement, so she sought traditional Chinese medicine treatment. The patient underwent modified radical mastectomy for left breast cancer on September 23, 2021, with 4 / 17 lymph nodes. After the operation, according to the patient's pathological immunohistochemistry report, she underwent chemotherapy, radiotherapy, and endocrine therapy. The patient had no history of major diseases such as diabetes and hypertension, and had no history of drug or food allergies.

[0062] In the hospital where the patient was treated, the doctor used the self-drying Chinese medicine gel ointment prepared in this embodiment, specifically two 150ml hoses, and applied 30-35ml to the outer surface of the affected skin each time, so that the ointment formed a Chinese medicine gel cake-like coating with a thickness of 50-60mm on the surface of the affected skin, and the ointment coating dried and fell off once every 12 hours; after the previous ointment coating fell off, it was re-applied at an interval of 1-2 hours to form a Chinese medicine gel cake-like coating with a thickness of 50-60mm on the outer surface of the affected skin for the second time, and it was applied again at an interval of 1-2 hours after it fell off, and so on. After continuous treatment for 5 days, the self-drying Chinese medicine gel ointment filled with two 150ml hoses was used up, and the treatment effect was relatively significant, as shown in the following Table 1:

[0063] Table 1

[0064]

[0065] Note: Edema degree: mild 2cm; moderate 4-6cm; severe >6cm. Arm circumference measurement: from the base of the thumb, wrist crease, wrist crease 6cm-12cm-18cm-24cm-30cm-36cm-40cm, compared with the healthy side, calculated based on the maximum difference.

[0066] The situations of the other 7 cases are similar to that of patient Yan. After 5 days of continuous treatment with 300 ml of external self-drying Chinese medicine gel ointment, their final efficacy characteristics are basically the same, so they are not listed one by one. Some of the patients said that the treatment time required by other oral or external medications is 2-3 times longer than that of the self-drying Chinese medicine gel ointment provided by the embodiment of the present invention, and the efficacy is prone to recurrence and instability. However, the self-drying Chinese medicine gel ointment provided by the present invention has a short course of treatment, continuous and stable efficacy, less number of dressing changes, and it automatically falls off when the time comes, which is convenient to use.

[0067] Example 2

[0068] This embodiment is trial-produced, experimented and improved based on the treatment needs of clinical cases in Guangdong Provincial Hospital of Traditional Chinese Medicine on the basis of Embodiment 1, and has been actually applied to 10 cases. Compared with other topical gel products purchased on the market, it has produced significant positive therapeutic effects and significantly shortened the course of treatment.

[0069] A method for preparing a self-drying Chinese medicine gel ointment, wherein a standard amount of the self-drying Chinese medicine gel ointment is prepared according to the following proportions and steps:

[0070] S1. Preparation of Chinese medicine powder mixture:

[0071] The Chinese medicine powder is a mixture of 4 grams of Stephania tetrandra, 11 grams of Astragalus, 16 grams of Poria, 9 grams of Cinnamomum cassia, 8 grams of Rhizoma Alismatis, 12 grams of Fructus Liquidambar, 9 grams of Radix Rehmanniae, 11 grams of Fructus Corni, 12 grams of Hedyotis diffusa and 18 grams of Sodium Sulfate, which is ground into powder, passed through a 60-sieve and prepared into a Chinese medicine powder mixture with a total weight of 110 grams, and stored for later use;

[0072] S2. Preparation of auxiliary agents:

[0073] The auxiliary agent includes: 210 grams of deionized water, 200 grams of polyvinyl formal, 50 grams of dibutyl phthalate, 160 ml of acetone, 4 grams of alginate, 7 grams of hydroxypropyl chitosan, 20 ml of azone, 20 ml of glycerol, and 5 ml of honey; specifically includes:

[0074] S21, preparing solution A: taking 1 / 3 of deionized water and hydroxypropyl chitosan, heating and mixing evenly to fully dissolve the hydroxypropyl chitosan, preparing solution A, and storing for later use;

[0075] S22, preparing solution B: taking 1 / 3 of deionized water and oxidized alginate, heating and mixing evenly to fully dissolve the oxidized alginate to prepare solution A, and storing for later use;

[0076] S22, preparing solution C: taking 1 / 3 of deionized water, glycerin, and honey, heating and mixing them evenly to prepare solution C, and saving for later use;

[0077] S23, preparing solution D: adding 200 g of polyvinyl formal, 50 g of dibutyl phthalate, and 160 ml of acetone into a reaction kettle, heating, and continuously stirring to uniformly mix, and when the temperature rises to 90-95° C., a solution D is obtained;

[0078] S3. Preparation of self-drying Chinese medicine gel ointment:

[0079] Keeping constant temperature and stirring continuously, slowly add the Chinese medicine powder mixture and azone to the D solution heated to 90-95° C. in the reactor, stop heating after stirring at a low speed for 15-20 minutes, continue stirring at a low speed and slowly add the C solution, the B solution, and the A solution in sequence, finally stir at a high speed for 15-20 minutes, cool to room temperature, and obtain a standard portion of self-drying Chinese medicine gel ointment;

[0080] S4, filling

[0081] The prepared standard portion of the self-drying Chinese medicine gel ointment is filled into two 200ml hoses by a filling machine, sealed and sterilized to obtain the self-drying Chinese medicine gel ointment sealed and packaged in hoses. In this embodiment, the ratio of the Chinese medicine powder is appropriately adjusted, the amount of deionized water is increased, and the heating time is shortened, so that the final volume of the ointment obtained is about 360-410ml, which is suitable for filling in two 200ml ointments for sealed storage.

[0082] The invention discloses an application of a self-drying Chinese medicine gel ointment, which is applied as an external medicine on the outer surface of the affected skin of a patient to treat lymphedema of different degrees, and is particularly effective for skin fibrosis or elephantiasis.

[0083] A1: The patient applies the self-drying Chinese medicine gel ointment on the outer surface of the affected skin to form a Chinese medicine gel cake-like coating with a thickness of 80-100 mm;

[0084] A2: The outer surface of the Chinese medicine gel coating forms a film and a protective shell within 2-3 minutes, so that the surface inside the coating no longer flows and is tightly attached to the outer surface of the affected skin. The coating adheres to the affected skin for 12 hours without falling off, and the internal moisture does not evaporate;

[0085] A3: The water and drug components in the Chinese medicine gel coating continue to flow to the side close to the skin surface. The drug components continue to soften the skin, enter the subcutaneous tissue through the skin pores, reach the lymphedema lesions, dredge the meridians, remove blood stasis, help establish lateral circulation, and produce therapeutic effects.

[0086] A4: As the duration of treatment increases, the water content and drug components in the Chinese medicine gel coating gradually decrease, and the Chinese medicine gel coating gradually hardens. After about 12 hours, the Chinese medicine gel coating agglomerates, dries, and falls off by itself, leaving no Chinese medicine gel components or drug residues on the skin surface.

[0087] A5: After the first coating of the self-drying Chinese medicine gel ointment falls off, reapply the self-drying Chinese medicine gel ointment on the outer surface of the affected skin for the second time to form a Chinese medicine gel cake coating with a thickness of 5-10mm again. Repeat steps A1-A4 to continuously deliver the moisture and drug ingredients in the Chinese medicine gel coating to treat refractory severe lymphedema, especially those with enlarged pores, high skin tension, scleroderma, limb swelling and pain, and numbness.

[0088] Practical application case 2

[0089] The patient, Su Moumou, female, 56 years old, had swelling in her left limbs for more than 8 months. The local skin was intact, and her skin color and temperature were normal. She complained that her left limbs began to swell around May 2022. She received physical air pressure therapy, functional exercise, and wearing pressure cuffs in the outpatient clinic, but there was no obvious improvement. She went to the hospital for treatment due to worsening edema. The patient underwent breast-conserving surgery for left breast cancer on April 11, 2019, with 1 / 4 of the lymph nodes removed. After the operation, according to the patient's pathological immunohistochemistry report, she underwent chemotherapy, radiotherapy, and endocrine therapy. The patient had no history of major diseases such as diabetes and hypertension, and had no history of drug or food allergies.

[0090] The self-drying Chinese medicine gel ointment prepared in this example was used, 200 ml soft tubes were used to hold 2 pieces, and the coating method was the same as in Example 1. The treatment was continued for 7 days, and the treatment effect was quite significant. The specific characteristics are shown in Table 2 below:

[0091] Table 2

[0092]

[0093] Note: Edema degree: mild 2cm; moderate 4-6cm; severe >6cm. Arm circumference measurement: from the base of the thumb, wrist crease, wrist crease 6cm-12cm-18cm-24cm-30cm-36cm-40cm, compared with the healthy side, calculated based on the maximum difference.

[0094] The situations of the other 9 cases are similar to that of patient Su. After 7 days of continuous treatment with 400 ml of external self-drying Chinese medicine gel ointment, their final efficacy characteristics are basically the same, so they are not listed one by one. Some of the patients said that the treatment time required by other oral or external medications is 2-3 times longer than that of the self-drying Chinese medicine gel ointment provided by the embodiment of the present invention, and the efficacy is prone to recurrence and instability. However, the self-drying Chinese medicine gel ointment provided by the present invention has a short course of treatment, continuous and stable efficacy, less number of dressing changes, and it automatically falls off when the time comes, which is convenient to use.

[0095] Example 3

[0096] This embodiment is trial-produced, tested and improved based on Embodiments 1 and 2, based on the treatment needs of clinical cases in Guangdong Provincial Hospital of Traditional Chinese Medicine, and has been actually applied to 12 patients with relatively severe conditions. Compared with other topical gel products purchased on the market, it has produced significant positive therapeutic effects and significantly shortened the course of treatment.

[0097] A method for preparing a self-drying Chinese medicine gel ointment, wherein a standard amount of the self-drying Chinese medicine gel ointment is prepared according to the following proportions and steps:

[0098] S1. Preparation of Chinese medicine powder mixture:

[0099] The Chinese medicine powder is a mixture of 6 grams of Stephania tetrandra, 12 grams of Astragalus, 18 grams of Poria, 12 grams of Cinnamomum cassia, 12 grams of Alisma, 11 grams of Fructus Liquidambar, 12 grams of Radix Rehmanniae, 12 grams of Fructus Corni, 11 grams of Hedyotis diffusa and 19 grams of Sodium Sulfate, which is ground into powder, passed through an 80-mesh sieve and prepared into a Chinese medicine powder mixture with a total weight of 125 grams, and stored for later use;

[0100] S2. Preparation of auxiliary agents:

[0101] The auxiliary agent includes: 150 grams of deionized water, 200 grams of polyvinyl formal, 50 grams of dibutyl phthalate, 100 ml of acetone, 2 grams of alginate, 3 grams of hydroxypropyl chitosan, 20 ml of azone, 20 ml of glycerol, and 5 ml of honey; specifically includes:

[0102] S21, preparing solution A: taking 1 / 3 of deionized water and hydroxypropyl chitosan, heating and mixing evenly to fully dissolve the hydroxypropyl chitosan, preparing solution A, and storing for later use;

[0103] S22, preparing solution B: taking 1 / 3 of deionized water and oxidized alginate, heating and mixing evenly to fully dissolve the oxidized alginate to prepare solution A, and storing for later use;

[0104] S22, preparing solution C: taking 1 / 3 of deionized water, glycerin, and honey, heating and mixing them evenly to prepare solution C, and saving for later use;

[0105] S23, preparing solution D: adding 200 g of polyvinyl formal, 50 g of dibutyl phthalate, and 100 ml of acetone into a reaction kettle, heating, and continuously stirring to uniformly mix, and when the temperature rises to 90-95° C., a solution D is obtained;

[0106] S3. Preparation of self-drying Chinese medicine gel ointment:

[0107] Keep constant temperature and continue stirring, slowly add the Chinese medicine powder mixture and azone to the D solution heated to 90-95°C in the reactor, stop heating after stirring at a low speed for 10-15 minutes, continue stirring at a low speed and slowly add the C solution, the B solution, and the A solution in sequence, finally stir at a high speed for 10-15 minutes, cool to room temperature, and obtain a standard portion of self-drying Chinese medicine gel ointment, each portion of which has a capacity of about 260-270 ml;

[0108] Prepare in three batches, or add each raw material component in an integral multiple of 3 and prepare once to obtain three standard portions of self-drying traditional Chinese medicine gel ointment;

[0109] S4, filling

[0110] The prepared standard amount of self-drying Chinese medicine gel ointment is filled into a single 250ml plastic hose by a filling machine, sealed and sterilized, and 3 hoses of self-drying Chinese medicine gel ointment are obtained and delivered to the patient for use. For critically ill patients, 2-3 250ml self-drying Chinese medicine gel ointments are generally required.

[0111] The application of the self-drying Chinese medicine gel ointment comprises the following steps:

[0112] A1: The patient applies 40-50 ml of the self-drying Chinese medicine gel ointment on the outer surface of the affected skin to form a Chinese medicine gel cake-like coating with a thickness of 75-100 mm;

[0113] A2: The outer surface of the Chinese medicine gel coating forms a film and a protective shell within 2-3 minutes, so that the surface inside the coating no longer flows and is tightly attached to the outer surface of the affected skin. The coating adheres to the affected skin for 12 hours without falling off, and the internal moisture does not evaporate;

[0114] A3: The water and drug components in the Chinese medicine gel coating continue to flow to the side close to the skin surface. The drug components continue to soften the skin, enter the subcutaneous tissue through the skin pores, reach the lymphedema lesions, dredge the meridians, remove blood stasis, help establish lateral circulation, and produce therapeutic effects.

[0115] A4: As the duration of treatment increases, the moisture and drug ingredients in the Chinese medicine gel coating gradually decrease and the Chinese medicine gel coating gradually hardens. After about 12 hours, the Chinese medicine gel coating agglomerates, dries, and falls off by itself, without leaving Chinese medicine gel, drug residues and other ingredients on the skin surface.

[0116] A5: After the first coating of self-drying Chinese medicine gel ointment falls off, reapply the self-drying Chinese medicine gel ointment on the outer surface of the affected skin for a second time after an interval of 1-2 hours to form a Chinese medicine gel cake coating with a thickness of 5-10mm again. Repeat steps A1-A4 to continuously deliver moisture and drug ingredients in the Chinese medicine gel coating for targeted treatment of refractory severe lymphedema, especially those with enlarged pores, high skin tension, scleroderma, limb swelling and pain, and numbness.

[0117] Practical application case 3

[0118] The patient, Zhang Moumou, female, 53, had swelling in the right limb for more than 2 months, the local skin was intact, the skin color and temperature were normal, edema began to occur in the 5th cycle of chemotherapy, and limb function was limited. She sought medical treatment to improve her limb function. The patient underwent modified radical mastectomy for right breast cancer on June 30, 2022, with 0 / 4 lymph nodes. After the operation, according to the patient's pathological immunohistochemistry report, she underwent chemotherapy, radiotherapy, and endocrine therapy. The patient had no history of major diseases such as diabetes and hypertension, and had no history of drug or food allergies.

[0119] Two 250 ml self-drying Chinese medicine gel ointments prepared in this example were used for continuous treatment for 5 days, and the treatment effect was quite significant. The main characteristics before and after the treatment are shown in Table 3 below:

[0120]

[0121] Note: Edema degree: mild 2cm; moderate 4-6cm; severe >6cm. Arm circumference measurement: from the base of the thumb, wrist crease, wrist crease 6cm-12cm-18cm-24cm-30cm-36cm-40cm, compared with the healthy side, calculated based on the maximum difference.

[0122] The conditions of the other 11 cases were similar to those of patient Su, and were all relatively severe. After 5 days of continuous treatment with 500 ml of external self-drying Chinese medicine gel ointment, their final efficacy characteristics were basically the same, so they are not listed one by one. Some of the patients said that the treatment time required by other oral or external medications was 2-3 times longer than that of the self-drying Chinese medicine gel ointment provided by the embodiment of the present invention, and the efficacy was prone to recurrence and instability. However, the self-drying Chinese medicine gel ointment provided by the present invention had a short course of treatment, continuous and stable efficacy, less number of dressing changes, and it would automatically fall off when the time came, making it easy to use.

[0123] Example 4

[0124] This embodiment is trial-produced, experimented and improved based on Embodiments 1-3 and the treatment needs of clinical cases in Guangdong Provincial Hospital of Traditional Chinese Medicine, and has been actually applied to more than 20 patients with mild symptoms. Compared with other topical gel products purchased on the market, it has produced significant positive therapeutic effects and significantly shortened the course of treatment.

[0125] The self-drying Chinese medicine gel ointment and its application provided in this embodiment are substantially the same as those in Embodiments 1-3, except that:

[0126] The Chinese medicine powder is a mixture of 5 grams of Stephania tetrandra, 8 grams of Astragalus, 12 grams of Poria, 8 grams of Cinnamomum cassia, 11 grams of Alisma, 8 grams of Fructus Liquidambar, 8 grams of Radix Rehmanniae, 8 grams of Fructus Corni, 8 grams of Hedyotis diffusa and 22 grams of Sodium Sulfate, which is ground into powder, sieved and prepared into a Chinese medicine powder mixture with a total weight of 98 grams, and stored for later use;

[0127] S2. Preparation of auxiliary agents:

[0128] The auxiliary agent includes: 200 grams of deionized water, 200 grams of polyvinyl formal, 50 grams of dibutyl phthalate, 150 ml of acetone, 3 grams of alginate, 6 grams of hydroxypropyl chitosan, 20 ml of azone, 20 ml of glycerol, and 5 ml of honey;

[0129] The other steps are the same as those in Example 1-3;

[0130] During its application, according to the actual situation of the patient, 150ml-300ml can be used for coating treatment, with 20-30ml applied each time to form a Chinese medicine gel cake coating with a thickness of more than 50mm, which will automatically fall off after about 12 hours, and a second coating can be done after an interval of 1-2 hours. Continuous treatment for 3-5 days can achieve relatively significant therapeutic effects.

[0131] Example 5

[0132] This embodiment is trial-produced, tested and improved based on Embodiments 1-4, based on the treatment needs of clinical cases in Guangdong Provincial Hospital of Traditional Chinese Medicine, and has been actually applied to more than 30 patients with more serious conditions. Compared with other topical gel products purchased on the market, it has produced significant positive therapeutic effects and significantly shortened the course of treatment.

[0133] The self-drying Chinese medicine gel ointment and its application provided in this embodiment are substantially the same as those in Embodiments 1-4, except that:

[0134] The Chinese medicine powder is a mixture of 5.5 grams of Stephania tetrandra, 9 grams of Astragalus, 17 grams of Poria, 11 grams of Cinnamomum cassia, 9 grams of Alisma orientalis, 9 grams of Fructus liquidambar formosana, 11 grams of Radix Rehmanniae, 9 grams of Fructus Corni, 9 grams of Hedyotis diffusa and 22 grams of Sodium Sulfate, which is ground into powder, sieved and prepared into a Chinese medicine powder mixture with a total weight of 115.5 grams, and stored for later use;

[0135] S2. Preparation of auxiliary agents:

[0136] The auxiliary agent includes: 200 grams of deionized water, 200 grams of polyvinyl formal, 50 grams of dibutyl phthalate, 150 ml of acetone, 3.5 grams of alginate, 6 grams of hydroxypropyl chitosan, 20 ml of azone, 20 ml of glycerol, and 5 ml of honey;

[0137] The other steps are the same as those in Example 1-4.

[0138] During its application, according to the actual situation of the patient, 300ml-500ml can be used for coating treatment, with 40-60ml applied each time to form a Chinese medicine gel cake coating with a thickness of more than 65mm, which will automatically fall off after about 12 hours, and a second coating can be done after an interval of 1-2 hours. Continuous treatment for 5-7 days can achieve relatively significant therapeutic effects.

[0139] The above embodiments of the present invention focus on the deficiencies of the prior art and the severity of the disease. By simultaneously improving the drug ingredients, auxiliary ingredients, ratios and preparation methods, the prepared self-drying Chinese medicine gel ointment is suitable for use as an external application medicine, which is applied on the outer surface of the affected skin to form a thicker self-adhesive coating (thickness 5-10mm) for targeted treatment of lymphedema of different severity. Moreover, the present invention uses common Chinese medicinal materials, has a simple preparation method, a small number of coatings, no residual ingredients, is easy to use, has a stable and significant therapeutic effect, a short treatment cycle, and a low overall cost.

[0140] According to the disclosure and teaching of the above description, the technical personnel in the field to which the present invention belongs can also change and modify the above embodiment, including the ratio of each specific component, the specific parameters such as the process conditions can be selected within the range recorded therein, and the technical effects recorded in the present invention can be achieved, so the present invention will not list them one by one. Therefore, the present invention is not limited to the specific embodiments disclosed and described above, and some modifications and changes to the invention should also fall within the protection scope of the claims of the present invention.

Claims

1. A method for preparing a self-drying Chinese medicine gel ointment, characterized in that: Prepare a standard amount of self-drying Chinese medicine gel ointment according to the following proportions and steps: S1. Preparation of Chinese medicine powder mixture: The Chinese medicine powder is a mixture of 5±1g of Stephania tetrandra, 10±2g of Astragalus, 15±3g of Poria, 10±2g of Cinnamomum cassia, 10±2g of Alisma orientalis, 10±2g of Fructus liquidambar formosana, 10±2g of Radix Rehmanniae, 10±2g of Fructus Corni, 10±2g of Hedyotis diffusa and 20±2g of Sodium Sulfate, which is ground into powder, sieved and prepared into a Chinese medicine powder mixture with a total weight of 110±15g, and stored for later use; S2. Preparation of auxiliary agents: The auxiliary agent includes: 180±30 g of deionized water, 200 g of polyvinyl formal, 50 g of dibutyl phthalate, 130±30 ml of acetone, 3±1 g of oxidized alginate, 5±2 g of hydroxypropyl chitosan, 20 ml of azone, 20 ml of glycerol, and 5 ml of honey; specifically includes: S21, preparing solution A: taking 1 / 3 of deionized water and hydroxypropyl chitosan, heating and mixing evenly to fully dissolve the hydroxypropyl chitosan, preparing solution A, and storing for later use; S22, preparing solution B: taking 1 / 3 of deionized water and oxidized alginate, heating and mixing evenly to fully dissolve the oxidized alginate to prepare solution B, and storing for later use; S22, preparing solution C: taking 1 / 3 of deionized water, glycerin, and honey, heating and mixing them evenly to prepare solution C, and saving for later use; S23, preparing solution D: adding 200 g of polyvinyl acetal, 50 g of dibutyl phthalate, and 130±30 ml of acetone into a reaction kettle, heating, and continuously stirring to uniformly mix, and when the temperature rises to 90-95° C., a solution D is obtained; S3. Preparation of self-drying Chinese medicine gel ointment: Keeping constant temperature and stirring continuously, slowly add the Chinese medicine powder mixture and azone to the D solution heated to 90-95° C. in the reactor, stop heating after stirring at a low speed for 10-30 minutes, continue stirring at a low speed and slowly add the C solution, the B solution, and the A solution in sequence, finally stir at a high speed for 10-30 minutes, cool to room temperature, and obtain a standard portion of self-drying Chinese medicine gel ointment; The low-speed stirring in step S3 is 50-80 r / min, and the high-speed stirring is 300-500 r / min.

2. The method for preparing the self-drying Chinese medicine gel ointment according to claim 1, characterized in that: It also includes the following steps: S4, filling The prepared standard amount of self-drying Chinese medicine gel ointment is filled into a soft tube by a filling machine, and then sealed and sterilized to obtain the self-drying Chinese medicine gel ointment in a soft tube sealed package.

3. The method for preparing the self-drying Chinese medicine gel ointment according to claim 2, characterized in that: It also includes the following steps: According to the proportion of each material required for the standard portion of self-drying Chinese medicine gel ointment in steps S1-S3, multiply it by an integer multiple, repeat steps S1-S4, prepare multiple portions of self-drying Chinese medicine gel ointment in batches, and then fill them in batches.

4. The method for preparing the self-drying Chinese medicine gel ointment according to claim 3, characterized in that: The powder in step S1 is ground into powder and sieved through a 50-80 mesh sieve.

5. The method for preparing the self-drying Chinese medicine gel ointment according to claim 1 or 2, characterized in that: The heating in steps S21, S22 and S23 is to heat to 80-90°C; the stirring speed during mixing is 30-50r / min.

6. The method for preparing the self-drying Chinese medicine gel ointment according to claim 2, characterized in that: In step S4, the filling hose is a fully plastic composite hose, and its effective filling volume is 150-350 ml.

7. A self-drying Chinese medicine gel ointment, characterized in that: The invention is prepared by the method according to any one of claims 1 to 6.

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