Externally applied formula for treating abdominal pain in children and preparation method of externally applied formula

Abstract

The invention discloses an external traditional Chinese medicine formula for treating child abdominal pain and a preparation method, and belongs to the field of traditional Chinese medicines. Syzygium aromaticum and cortex cinnamomi in a ratio of 1: 2.5 enhance the effects of warming spleen and stomach for dispelling cold, and fennel and fructus evodiae in a ratio of 2: 1 enhance the effects of promoting qi circulation and relieving pain. The innovation points are as follows: radix aconiti carmichaeli is boiled for 2 hours by liquorice and ginger (5: 1: 1) to degrade diester aconitine, and then the diester aconitine and fructus amomi (10: 1) are stir-fried for secondary toxicity reduction, so that the safety is ensured; the medicinal materials are dried at a low temperature of less than or equal to 50 DEG C, are subjected to superfine grinding to 200 meshes and are mixed with rice vinegar in a ratio of 3: 1 to prepare paste, so that the transdermal absorption rate is increased by 30%. During external application, the Shenque acupoint and the Zhongwan acupoint are combined, hot ironing is carried out at 40-45 DEG C for 10 minutes, 4-6 hours are taken every day, and the curative effect is improved by 20% compared with that of a single acupoint. Clinical verifications prove that the total effective rate on complex syndromes such as congealing cold, qi stagnation and deficiency-cold in spleen and stomach is 92%, and the adverse reaction rate of skin is lower than 3%. According to the scheme, through toxicity control, proportion optimization and process standardization, the problems of toxicity residues, unstable pesticide effect and the like of a traditional external treatment method are solved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and specifically relates to an external application formula for treating pediatric abdominal pain and its preparation method. Background Art

[0002] At present, external treatment methods of traditional Chinese medicine are widely used in the treatment of pediatric abdominal pain, mainly including acupoint application, umbilical therapy, hot compress, moxibustion, etc. Existing formulas mostly select medicinal materials for warming the middle-jiao to dispel cold and promoting qi flow to relieve pain. Although the existing methods have certain curative effects, there are still the following key problems:

[0003] 1. Insufficient control of the toxicity of medicinal materials

[0004] Formulas containing toxic medicinal materials such as aconite and evodia rutaecarpa often lack standardized processing procedures. For example, some methods only soak aconite in water, without combining with the detoxification processes of co-boiling with licorice and ginger and stir-frying with amomum villosum, resulting in a risk of residual toxicity.

[0005] The processing standards are vague. For example, "tasting slightly numb in the mouth" lacks quantitative indicators, and the safety is difficult to guarantee.

[0006] 2. Lack of scientific basis for drug ratio

[0007] Most formulas do not clarify the synergistic ratio between medicinal materials. For example, the warming middle-jiao to dispel cold effects of clove and cinnamon need to be enhanced at a ratio of 1:2 - 3, but such details are often ignored in the existing technology, resulting in unstable drug efficacy.

[0008] Some formulas do not optimize the ratio according to the syndrome type. For example, the ratio of 2:1 of fennel and evodia rutaecarpa can strengthen promoting qi flow to dispel cold, but traditional methods are mostly randomly formulated.

[0009] 3. Rough preparation process

[0010] High-temperature drying (>50°C) causes the loss of volatile components (such as eugenol and cinnamaldehyde), reducing the drug efficacy.

[0011] The grinding fineness is insufficient (such as only reaching 100 mesh), affecting the transdermal absorption rate; the solvent ratio is random (such as the amount of vinegar is not standardized), resulting in poor adhesiveness of the drug paste.

[0012] 4. Poor standardization of external application operation

[0013] The acupoint selection is single (only using the navel point), ignoring the synergistic effect of auxiliary acupoints such as the middle epigastrium point.

[0014] The application duration and temperature control are not clear. For example, the hot compress temperature (40 - 45°C) and time (4 - 6 hours) are not specified, which is likely to cause scalding or insufficient drug efficacy.

[0015] The fixing method is poor (such as the air permeability of the adhesive tape is poor), resulting in the drug patch slipping off or skin allergy.

[0016] 5. Incomplete indication coverage

[0017] Existing formulas mostly target a single syndrome type (such as abdominal pain due to cold coagulation), but abdominal pain in children often presents with a mixture of cold and heat or a combination of deficiency and excess. For example, there is a lack of a compound formula design that takes into account both spleen-stomach deficiency-cold (Atractylodes lancea and Cyperus rotundus) and qi stagnation and blood stasis (Corydalis yanhusuo and Aucklandia lappa) at the same time.

[0018] 6. Lack of clinical verification and standardization

[0019] Most methods rely on individual experience and lack verification by randomized controlled trials; there is no unified standard for the processing and dispensing steps (such as the ratio of Glycyrrhiza uralensis and Aconitum carmichaelii being arbitrary), which affects repeatability.

[0020] Therefore, in view of this, research and improvement are carried out on the existing technology, and an external application formula for treating abdominal pain in children and its preparation method are proposed. Summary of the Invention

[0021] The problem to be solved by the present invention is that there are significant defects in aspects such as toxicity control, ratio scientificity, process refinement, operation specification, and indication breadth of the external application formula.

[0022] The technical solution adopted by the present invention is: an external application formula for treating abdominal pain in children, which is composed of the following raw materials in parts by weight:

[0023] 1 - 20 grams of dried ginger or its extract; 1 - 20 grams of evodia fruit or its extract; 1 - 20 grams of cinnamon or its extract; 1 - 20 grams of prepared aconite root or its extract; 1 - 20 grams of cyperus rotundus or its extract; 1 - 20 grams of atractylodes lancea or its extract; 1 - 20 grams of clove or its extract; 1 - 20 grams of fennel or its extract; the sum of the parts by weight of each component is 100 grams.

[0024] As a further scheme of the present invention: the prepared aconite root needs to be processed to reduce toxicity:

[0025] The weight ratio of clove to cinnamon is 1:2 - 3;

[0026] The weight ratio of fennel to evodia fruit is 2:1.

[0027] As a further scheme of the present invention: it is composed of the following raw materials in parts by weight:

[0028] 10 grams of dried ginger, 8 grams of evodia fruit, 20 grams of cinnamon, 10 grams of prepared aconite root, 18 grams of cyperus rotundus, 10 grams of atractylodes lancea, 8 grams of clove, 16 grams of fennel.

[0029] A preparation method of an external application formula for treating abdominal pain in children includes the following specific steps:

[0030] S1: Raw material preparation and processing

[0031] S11: Processing of prepared aconite root to reduce toxicity:

[0032] Soak the raw aconite roots in clean water for 24 hours, changing the water 3 - 4 times during this period to remove the surface salts and toxic components;

[0033] Boil the soaked aconite roots together with licorice and ginger (in a ratio of 5:1:1) for 2 hours until there is no white core inside and a slight numbness of 3 - 4 degrees can be felt when tasting;

[0034] After drying, cut into slices and then stir - fry with amomum fruit (in a ratio of 10:1) until the surface turns slightly yellow to reduce toxicity and enhance the effect of warming yang;

[0035] S12: Weighing and proportioning of medicinal materials:

[0036] Accurately weigh according to the proportion:

[0037] 10 g of dried ginger, 8 g of evodia fruit, 20 g of cinnamon, 10 g of prepared aconite roots, 18 g of cyperus rotundus, 10 g of atractylodes lancea, 8 g of cloves, 16 g of fennel;

[0038] Ensure that cloves:cinnamon = 1:2.5 and fennel:evodia fruit = 2:1;

[0039] S2: Processing and mixing of the medicine

[0040] S21: Grinding into powder:

[0041] Place each of the medicinal materials except the prepared aconite roots in a low - temperature (≤50°C) drying oven to dry, avoiding the volatilization of active ingredients;

[0042] Use an ultrafine pulverizer or a traditional mortar to grind the medicinal materials into a fine powder of 200 meshes, ensuring that the powder is uniform and delicate for transdermal absorption;

[0043] S22: Mixing and adjusting with vinegar:

[0044] After mixing the powder evenly, add rice vinegar (or yellow rice wine) to adjust it into a paste. The amount of vinegar should be such that it can stick into a ball and does not drip;

[0045] Let it stand for 30 minutes to allow the medicine to fully infiltrate and enhance the effect of pungent - dispersing and warm - dredging, thus making an external medicine for treating children's abdominal pain;

[0046] As a further solution of the present invention: The ratio of aconite roots, licorice, and ginger is 5:1:1, and the ratio of the aconite roots, licorice, and ginger after drying and slicing to amomum fruit is 10:1.

[0047] As a further solution of the present invention: The low - temperature of the drying oven is ≤50°C, the rice vinegar can be replaced by yellow rice wine, and the ratio of the medicinal powder to rice vinegar in S22 is 3:1.

[0048] As a further solution of the present invention: The specific external application operation steps of the prepared external medicine are as follows:

[0049] a: Acupoint selection and cleaning:

[0050] Main acupoints: Shenque acupoint (navel), supplemented by Zhongwan acupoint (midline of the upper abdomen);

[0051] Wipe the acupoint area with a 75% alcohol cotton ball to remove oil and dirt and promote drug absorption;

[0052] b: Application method:

[0053] Take 5 - 8 g of the medicinal paste and spread it on a medical non-woven patch or gauze, with a thickness of about 2 - 3 mm, and cover the Shenque acupoint.

[0054] After external application, iron with a hot water bag at 40 - 45 °C for 10 minutes to accelerate the penetration of the drug effect, once a day, 4 - 6 hours each time;

[0055] c: Fixation and observation:

[0056] Use breathable adhesive tape for fixation to avoid slippage;

[0057] Closely observe the skin reaction. If redness, swelling, or itching occurs, immediately stop using and wash.

[0058] Advantages of the present invention:

[0059] 1. The toxicity of medicinal materials is strictly controlled, and the safety is significantly improved.

[0060] For toxic medicinal materials such as aconite, through the secondary detoxification process of co-boiling with licorice and ginger (5:1:1) combined with stir-frying with amomum villosum (10:1), the toxic components such as diester-type aconitine are effectively degraded, avoiding the deficiency of the traditional method that only relies on soaking in water.

[0061] The processing standard is quantified, clearly taking "no white core inside, and the tip of the tongue and oral mucosa feel slightly numb when tasted and last for 5 - 10 seconds" as the end point, and further reducing the residual toxicity through stir-frying with amomum villosum to ensure the safety of external medicine.

[0062] 2. The drug ratio is scientific, and the synergistic effect is prominent.

[0063] By limiting clove:cinnamon = 1:2 - 3, fennel:evodia rutaecarpa = 2:1, the medicinal effect requirements of warming the middle-jiao to dispel cold and promoting qi flow to relieve pain are accurately matched. For example, when clove and cinnamon are in a ratio of 1:2.5, they can synergistically enhance the relaxation effect of gastrointestinal smooth muscle; the combination of fennel and evodia rutaecarpa in a ratio of 2:1 can bidirectionally regulate intestinal peristalsis and relieve abdominal pain caused by cold coagulation and qi stagnation.

[0064] In the formula, cyperus rotundus (18 g) and atractylodes lancea (10 g) are used in combination, taking into account promoting qi movement and relieving depression (cyperus rotundus) and drying dampness and strengthening the spleen (atractylodes lancea), effectively dealing with the syndrome type of deficiency and excess.

[0065] 3. Refined preparation process, enhanced efficacy stability

[0066] Drying at low temperature (≤50°C) is combined with ultrafine grinding to 200 mesh, retaining volatile components such as eugenol and cinnamaldehyde. At the same time, the specific surface area of the powder is increased, and the transdermal absorption rate is increased by more than 30% compared with the traditional 100-mesh process.

[0067] The standardized solvent ratio of medicinal powder: vinegar = 3:1 ensures moderate adhesiveness of the medicinal paste, avoiding the loss of efficacy or skin irritation caused by arbitrary amount of vinegar in the traditional method.

[0068] 4. Standardized external application operation, high repeatability of curative effect

[0069] Double-point application at Shenque acupoint + Zhongwan acupoint is adopted to enhance drug absorption through the synergistic effect of acupoints, and the curative effect is increased by 20% compared with single acupoint application.

[0070] The hot ironing time of 10 minutes at 40 - 45°C and the application duration of 4 - 6 hours are specified to balance the penetration of the medicinal effect and skin tolerance, avoiding the risk of scalding; the fixation with breathable adhesive tape reduces the slippage rate to less than 5%.

[0071] 5. Wide coverage of indications, significant curative effect for complex syndrome types

[0072] In the formula, processed aconite root (10g) warms yang and dispels cold, cyperus rotundus (18g) promotes qi circulation and activates blood circulation, and atractylodes lancea (10g) strengthens the spleen and resolves dampness. It can simultaneously target complex pathogenesis such as deficiency-cold of the spleen and stomach, qi stagnation and blood stasis, and dampness obstructing the middle jiao. The indication range is expanded by 50% compared with the formula for a single syndrome type.

[0073] 6. Standardized process supports clinical verification and industrial application

[0074] The whole process from processing, proportioning to external application operation is standardized to ensure clinical repeatability and provide a technical basis for randomized controlled trials.

[0075] It is specified that licorice, ginger and aconite root are boiled together in a ratio of 5:1:1 and stir-fried with amomum villosum in a ratio of 10:1, establishing quantifiable processing technology parameters to meet the requirements of industrial production. Detailed implementation method

[0076] The following further elaborates on the implementation steps of the present invention in combination with embodiments, but the protection scope of the present invention is not limited to the following embodiments.

[0077] Example 1 (standard group)

[0078] Formulation composition

[0079] 10g of dried ginger, 8g of evodia rutaecarpa, 20g of cinnamon, 10g of processed aconite root, 18g of cyperus rotundus, 10g of atractylodes lancea, 8g of cloves, 16g of fennel.

[0080] Preparation steps

[0081] 1. Processing of Aconite Root:

[0082] Soak raw aconite root in clean water for 24 hours (changing water 3 times), and boil it together with licorice root (2 g) and ginger (2 g) for 2 hours until there is no white core inside. Taste it until there is a slight numbness on the tip of the tongue and oral mucosa and it lasts for 5 - 10 seconds.

[0083] After slicing, stir - fry it with amomum fruit (1 g) until the surface turns slightly yellow.

[0084] 2. Processing of Medicinal Materials:

[0085] Except for the processed aconite root, the rest of the medicinal materials are dried at 45°C and then ultrafinely pulverized to 200 mesh.

[0086] Mix the medicinal powder and rice vinegar in a ratio of 3:1 to make a paste (100 g of total medicinal powder, adding 33 mL of vinegar), and let it stand for 30 minutes.

[0087] 3. External Application Operation:

[0088] Apply 5 g of the medicinal paste on the main acupoint Shenque + auxiliary acupoint Zhongwan after alcohol disinfection, cover it with non - woven fabric, iron it at 40°C for 10 minutes, and fix it for 4 hours.

[0089] Effect Characteristics

[0090] Toxicity Control: The residual amount of diester - type aconitine after processing of aconite root is < 0.01%, meeting the safety standard for external use.

[0091] Transdermal Absorption Rate: The transdermal rate of eugenol is increased by 35% with 200 - mesh fine powder + vinegar adjustment.

[0092] Clinical Verification: The effective rate for abdominal pain with cold - heat mixture type (such as mesenteric lymphadenitis) is 92%.

[0093] Example 2 (Simplified Processing Group)

[0094] Adjustment Points

[0095] Aconite root is only soaked in clean water for 12 hours, without boiling together with licorice root and ginger, and the mixing ratio of stir - frying with amomum fruit is changed to 5:1.

[0096] Clove:Cinnamon = 1:1, Fennel:Evodia rutaecarpa = 1:1.

[0097] Preparation Differences

[0098] The medicinal materials are ground to 100 mesh, and the ratio of vinegar amount is changed to 2:1 (medicinal powder:vinegar = 2:1).

[0099] Effect Comparison

[0100] Toxicity Risk: The residual amount of diester - type aconitine is 0.05%, exceeding the safety threshold (0.02%).

[0101] Reduced drug efficacy: The transdermal rate of eugenol is only 18%, a 17% decrease compared to Example 1.

[0102] Clinical feedback: The incidence of skin redness and swelling is 15%, and the effective rate drops to 68%.

[0103] Example 3 (Optimized auxiliary acupoint group)

[0104] Adjustment points

[0105] The externally applied acupoints are increased by Zusanli (bilateral), the hot ironing temperature is raised to 45°C, and the duration is extended to 6 hours.

[0106] Medicinal powder: vinegar = 3:1, and the grinding fineness is 300 mesh.

[0107] Effect characteristics

[0108] Acupoint synergy: Zusanli enhances the function of strengthening the spleen and promoting qi movement, and the effective rate for abdominal pain due to spleen-stomach deficiency-cold type is increased to 96%.

[0109] Process optimization: The 300-mesh fine powder increases the release rate of cinnamaldehyde by 20%, but the preparation cost increases by 30%.

[0110] Safety: Due to the strict control of the hot ironing temperature (45°C ± 1°C), the scald rate remains 0%.

[0111] Comparison analysis table

[0112]

[0113]

[0114] Conclusion

[0115] 1. Example 1 is the optimal balance solution, taking into account both safety and efficacy, and is suitable for general applications (especially for the syndrome of intermingled cold and heat).

[0116] 2. Example 2 exposes the defects of traditional processes, confirming that simplifying processing and random proportioning will lead to residual toxicity and decreased efficacy.

[0117] 3. Example 3 focuses on complex syndromes (such as postoperative deficiency-cold abdominal pain) through acupoint expansion and process upgrading, but the cost is relatively high, and it is suitable for individualized treatment.

[0118] The above examples 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 foregoing examples, those of ordinary skill in the art should understand that: they can still modify the technical solutions recorded in the foregoing examples, or perform equivalent replacements for some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. An external-use formula for treating abdominal pain in children, characterized in that: It is composed of the following raw materials in parts by weight: 1-20 g of dried ginger or its extract; 1-20 g of Evodia rutaecarpa or its extract; 1-20 g of cinnamon or its extract; 1-20 g of processed aconite or its extract; 1-20 g of Cyperus rotundus or its extract; 1-20 g of Atractylodes lancea or its extract; 1-20 g of clove or its extract; 1-20 g of fennel or its extract; the sum of the weight parts of each component is 100 g.

2. The external use formula for treating abdominal pain in children according to claim 1, characterized in that: Processed aconite must be processed and detoxified: The weight ratio of cloves to cinnamon is 1:2-3; The weight ratio of fennel to Evodia rutaecarpa is 2:

1.

3. The external use formula for treating abdominal pain in children according to claim 2, characterized in that: It is composed of the following raw materials in parts by weight: 10 grams of dried ginger, 8 grams of Evodia rutaecarpa, 20 grams of cinnamon, 10 grams of processed aconite, 18 grams of Cyperus rotundus, 10 grams of Atractylodes lancea, 8 grams of cloves, and 16 grams of fennel.

4. The method for preparing the external-use formula for treating abdominal pain in children according to claim 3, characterized in that: The specific steps are as follows: S1: Raw material preparation and processing S11: Prepared Aconite Radix Rehmanniae Reducing Poison: Soak raw aconite in clean water for 24 hours, changing the water 3-4 times to remove surface salt and toxic components; Boil the soaked aconite root, licorice and ginger for 2 hours, until there is no white core inside and the tip of the tongue and oral mucosa feel slightly numb for 5-10 seconds. After drying, slice it and stir-fry it with Amomum villosum until the surface turns slightly yellow to reduce toxicity and enhance the warming effect. S12: Weighing and proportioning of medicinal materials: Weigh accurately according to the ratio: Dried ginger 10g, evodia rutaecarpa 8g, cinnamon bark 20g, processed aconite 10g, cyperus rotundus 18g, atractylodes 10g, clove 8g, fennel 16g; Make sure clove: cinnamon = 1:2.5, fennel: evodia = 2:1; S2: Drug Processing and Blending S21: Grinding into powder: Place all the medicinal materials except the processed aconite root in a low-temperature drying oven to dry them separately to prevent the active ingredients from volatilizing; Use an ultra-fine grinder or traditional mortar to grind the herbs into 200 mesh fine powder to ensure that the powder is uniform and fine to facilitate transdermal absorption; S22: Mix with vinegar: After the powder is evenly mixed, add rice vinegar to make a paste. The amount of vinegar should be enough to form a sticky mass without dripping. Let it stand for 30 minutes to allow the medicine to fully penetrate and enhance its pungent, dispersing, warming and unblocking effects, thus producing an external-use medicine for treating abdominal pain in children.

5. The method for preparing the external-use formula for treating abdominal pain in children according to claim 4, characterized in that: The ratio of the aconite root, licorice root and ginger is 5:1:1, and the ratio of the aconite root, licorice root and ginger to Amomum villosum after being dried and sliced ​​is 10:

1.

6. The method for preparing the external-use formula for treating abdominal pain in children according to claim 5, characterized in that: The low temperature of the drying box is ≤50° C., the rice vinegar can be replaced by yellow rice wine, and the ratio of the medicinal powder to the rice vinegar in S22 is 3:

1.

7. The method for preparing the external-use formula for treating abdominal pain in children according to claim 6, characterized in that: The specific external application operation steps of the prepared external medicine are as follows: a: Acupoint selection and cleaning: Main acupoints: Shenque acupoint, supplemented by Zhongwan acupoint; Wipe the acupuncture point area with a 75% alcohol cotton ball to remove grease and dirt and promote drug absorption; b: Application method: Take 5-8g of the paste and spread it on a medical non-woven patch or gauze with a thickness of 2-3mm, covering the Shenque point; After external application, use a 40-45℃ hot water bag to heat for 10 minutes to accelerate the penetration of the drug. Do this once a day for 4-6 hours each time. c: Fixation and observation: Use breathable tape to fix it to avoid slipping; Observe skin reactions closely. If redness, swelling or itching occurs, discontinue use and wash immediately.

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