Traditional Chinese medicine navel paste for relaxing bowels as well as preparation method and application thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine, and discloses a traditional Chinese medicine navel patch for relaxing bowels and a preparation method and application thereof.The navel patch is prepared from, by weight, 5-15 parts of mangnolia officinalis, 20-60 parts of raw rhubarb, 20-60 parts of immature bitter oranges, 10-30 parts of mirabilite, 10-30 parts of borneol, 5-15 parts of betel nuts, 5-15 parts of croton seeds, 10-20 parts of common sage herbs and 10-20 parts of horseweed herb through extraction and purification. The volume of the pill is matched with the size of the navel of a patient, the pill is attached to the navel wall skin, the medicine efficacy penetrates through the navel and then is directly absorbed to enter systemic circulation, and through cooperation of the multiple traditional Chinese medicine components, the good treatment effect on constipation of different syndromes can be achieved. Meanwhile, the maximum medicine efficacy can be achieved through the pills with the minimum size, and the safe and reliable curative effect is achieved. Effective components of pure traditional Chinese medicines are extracted, and medicine components with sensitization possibility are removed. The traditional Chinese medicine composition has the advantages of safety, mildness, difficulty in allergy and the like on the basis of retaining the original medicine effect.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and more specifically discloses a traditional Chinese medicine bowel-clearing navel patch and a preparation method and application thereof. Background Art

[0002] Constipation is a common digestive system disease characterized by decreased bowel movements, dry stool, and difficult or incomplete defecation. According to the latest statistics, the prevalence of constipation among adults in my country is 7.0% to 20.3%, and the incidence rate increases year by year with age. As a type of constipation, functional constipation of the real heat type accounts for a large proportion of constipation patients. Studies have shown that among people with functional constipation, the incidence of functional constipation of the real heat type can reach about 20% of constipation patients.

[0003] There are many treatments for functional constipation. Western medicine generally uses laxatives for oral administration and enema for external use to relieve constipation symptoms. Traditional Chinese medicine for constipation includes a variety of treatment methods such as oral or external use of Chinese medicine, acupuncture, acupoint application, etc., with significant efficacy. Bao Guangqin et al. used Huanglian Jiedu Decoction plus or minus to treat real heat type constipation, with significant efficacy. However, many patients with functional constipation have a long course of disease, and the medication is effective in the short term, but constipation still exists after stopping the medication. Oral medications for clearing heat and dredging the bowels usually have a large gastrointestinal irritation reaction, and generally solve the problem of constipation in a short period of time. Long-term use of such drugs often causes gastrointestinal discomfort, such as nausea, vomiting, etc. For patients with weak gastrointestinal function, they should be used with caution. At the same time, studies have shown that long-term use of such drugs has certain risks of liver and kidney damage, neurotoxicity, allergic reactions and addiction. Wei Zhonghong and others pointed out that laxative Chinese medicines containing anthraquinone active ingredients (such as rhubarb, mirabilite, and immature bitter orange) have the risk of pro-inflammatory carcinogenesis, which can damage the integrity of the intestinal mucosal barrier, leading to chronic low-level inflammation of the colon, thereby promoting the development of colon cancer. In clinical practice, there is also a method of retaining enema with Dachengqi decoction to relieve constipation, but the effect is relatively limited and the operation is complicated, which is not conducive to long-term use at home by patients.

[0004] Compared with oral administration, the external application of umbilical patch for clearing away heat and dredging bowels has the advantages of simple operation, mild drug effect, no liver and kidney metabolic toxicity and suitability for long-term use. In the current prior art, there are also methods for treating constipation due to heat through umbilical patch. For example, Guo Meng found that the application of Dachengqi Decoction to Shenque acupoint can effectively treat constipation due to heat in the intestine, which is manifested by significantly shortening the time of the first defecation after treatment, and prominently improving the abdominal pain and bloating caused by constipation due to heat in the intestine. However, the commonly used method for making umbilical patch pills is to directly crush and mix the therapeutic drugs to form pills, which has the disadvantages of low effective ingredients, unstable efficacy, and allergic redness and itching of the umbilicus after application, which has certain limitations on the long-term application of patients with constipation due to heat. Summary of the invention

[0005] The main technical problem solved by the present invention is to provide a traditional Chinese medicine Tongfu navel patch and its preparation method and application, which can solve the current long-term, safe and effective treatment of excess heat type functional constipation and reduce the problem of skin allergies after skin patching.

[0006] In order to solve the above technical problems, according to one aspect of the present invention, more specifically, a Chinese medicine bowel-clearing navel patch is provided, which is prepared by extracting and purifying the following Chinese medicine components in parts by weight: 5-15 parts of Magnolia officinalis, 20-60 parts of raw rhubarb, 20-60 parts of Citrus aurantium, 10-30 parts of Sodium Sulfate, 10-30 parts of Borneolum Syntheticum, 5-15 parts of Areca Nut, 5-15 parts of Croton, 10-20 parts of Saposhnikovia divaricata, and 10-20 parts of Erigeron aviculare.

[0007] Furthermore, the navel patch is prepared by extracting and purifying the following Chinese medicinal components in parts by weight: 10 parts of Magnolia officinalis, 40 parts of raw rhubarb, 40 parts of Citrus aurantium, 20 parts of Sodium Sulfate, 20 parts of Borneol, 15 parts of Areca catechu, 10 parts of Croton seeds, 10 parts of Saposhnikovia divaricata, and 20 parts of Erigeron aviculare.

[0008] According to another aspect of the present invention, there is provided a method for preparing a Chinese medicine bowel-clearing navel patch, comprising the following steps:

[0009] S1. Weighing the Fructus Aurantii Immaturus according to the above weight proportions, collecting volatile oil by distillation to obtain volatile oil A, medicinal residue A and extract A;

[0010] S2, concentrating the extract A to obtain a concentrated solution A;

[0011] S3, weighing raw rhubarb, betel nut and croton according to the above weight parts, mixing and drying the residue A, firstly extracting with ethanol reflux to obtain an ethanol extract, then recovering the ethanol and concentrating to obtain a concentrated solution B;

[0012] S4, weighing Magnolia officinalis, Sodium Sulfate, Borneol, Herba Saposhnikoviae and Erigeron fasciata according to the above weight proportions, and grinding into fine powder to obtain powder C;

[0013] S5, combining volatile oil A, concentrate A, concentrate B and powder C, and mixing them evenly to obtain a Chinese medicine extract for treating constipation;

[0014] S6. The Chinese medicine extract obtained in step S5 is blended with vaseline, and then the medicine is made into pills of suitable size to fill the umbilical depression, and fixed with an external dressing to obtain a Chinese medicine bowel-clearing umbilical patch.

[0015] Furthermore, in step S1, when preparing volatile oil A, it is collected by steam distillation. Steam distillation does not require the use of organic solvents, thus avoiding the contamination of the product by solvent residues.

[0016] Furthermore, in step S2, when the extract A is concentrated, the relative density of the concentrated solution A is 1.1-1.3. Since the concentrated solution has a larger mass, the unit volume of the liquid can provide more effective ingredients, reducing waste.

[0017] Furthermore, the relative density of the concentrated solution A is 1.2. The high-density concentrated solution can reduce the liquid volume in the subsequent processing steps, which is convenient for subsequent processing and use.

[0018] Furthermore, when the extract A is concentrated, the concentration temperature is 65° C. The relatively low temperature of 65° C. helps to protect the heat-sensitive components therein and avoid decomposition or loss at excessively high temperatures.

[0019] Furthermore, in step S3, 60% to 90% ethanol with a concentration of 3 to 12 times the mass of the residue A is used for reflux extraction 2 to 3 times, each time for 1 to 3 hours, filtered, the ethanol extracts are combined, and the ethanol is recovered and concentrated to obtain a concentrated solution B. Reflux extraction is carried out by continuous heating to make the solvent fully contact with the sample, the extraction rate is faster, and the production efficiency can be effectively improved.

[0020] Furthermore, the ethanol is recovered and concentrated to a concentrated solution B having a relative density of 1.1 to 1.3 at 65°C.

[0021] Furthermore, the first extraction was performed with 70% ethanol at a concentration of 6 times the mass of the residue A for 2 hours, and the second extraction was performed with 70% ethanol at a concentration of 5 times the mass of the residue A for 2 hours, filtered, the ethanol extracts were combined, the ethanol was recovered and concentrated to a concentrated solution B with a relative density of 1.2 at 65°C.

[0022] This Chinese medicine Tongfu navel patch can be used in products for the treatment of functional constipation of excess heat type in a long-term, safe, effective and convenient manner.

[0023] The beneficial effects of the Chinese medicine bowel-clearing navel patch and the preparation method thereof of the present invention are:

[0024] (1) The present invention uses a different preparation method from the traditional one, extracting, filtering and concentrating raw rhubarb, betel nut and croton through ethanol reflux, purifying the effective ingredients of traditional Chinese medicine and removing the drug ingredients with the potential of causing allergies. On the basis of retaining the original efficacy, it has the advantages of being safe, mild and not prone to allergies.

[0025] (2) The pill of the present invention is adapted to the size of the patient's navel. It fits the navel wall skin, and the drug power penetrates the navel and is directly absorbed into the systemic circulation. Through the combination of multiple Chinese medicine components, it can have a good therapeutic effect on constipation of different syndromes. At the same time, it can exert the maximum drug power through the smallest pill volume, achieving a safe and reliable therapeutic effect.

[0026] (3) The navel patch prepared by the present invention has the functions of sustained release and long-term effect, and the effective ingredients can act on the affected area for a long time. The navel patch has fewer side effects and adverse reactions than oral drugs, is relatively safe and convenient, and increases the patient's medication compliance. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present invention is further described in detail below with reference to the accompanying drawings and specific implementation methods.

[0028] Figure 1 A comparison chart of pills prepared by different methods. DETAILED DESCRIPTION

[0029] The present invention will be described in detail below with reference to the accompanying drawings and in combination with embodiments. It should be noted that the embodiments and features in the embodiments of the present application can be combined with each other without conflict.

[0030] Example 1

[0031] The invention discloses a Chinese medicine bowel-clearing navel patch, which comprises the following Chinese medicine components in parts by weight, extracted and purified: 5 parts of magnolia bark, 20 parts of raw rhubarb, 20 parts of immature bitter orange, 10 parts of sodium sulfate, 10 parts of borneol, 5 parts of areca nut, 5 parts of croton seeds, 10 parts of snow primrose, and 10 parts of fleabane.

[0032] The preparation method of the traditional Chinese medicine bowel-clearing navel patch is as follows:

[0033] S1. Weighing the Fructus Aurantii Immaturus according to the above weight proportions, collecting volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A;

[0034] S2, extract A, concentrated to a concentrate A with a relative density of 1.1 at 65°C;

[0035] S3, weighing raw rhubarb, betel nut and croton according to the above weight parts, mixing the dried medicinal residue A, refluxing and extracting with 60% ethanol at a concentration of 5 times the mass of medicinal residue A for 1 hour, and refluxing and extracting with 60% ethanol at a concentration of 7 times the mass of medicinal residue A for 1 hour, filtering, combining the ethanol extracts, recovering ethanol and concentrating to a concentrated solution B with a relative density of 1.1 at 65°C;

[0036] S4, weighing Magnolia officinalis, Sodium Sulfate, Borneol, Herba Saposhnikoviae and Erigeron fasciata according to the above weight proportions, and grinding into fine powder to obtain powder C;

[0037] S5, combining volatile oil A, concentrate A, concentrate B and powder C, and mixing them evenly to obtain a Chinese medicine extract for treating constipation;

[0038] S6. The Chinese medicine extract obtained in step S5 is blended with vaseline, and then the medicine is made into pills of suitable size to fill the umbilical depression, and fixed with an external dressing to obtain a Chinese medicine bowel-clearing umbilical patch.

[0039] Example 2

[0040] The invention discloses a Chinese medicine bowel-clearing navel patch, which comprises the following Chinese medicine components in parts by weight, extracted and purified: 10 parts of magnolia bark, 40 parts of raw rhubarb, 40 parts of immature bitter orange, 20 parts of sodium sulfate, 20 parts of borneol, 15 parts of areca nut, 10 parts of croton seeds, 10 parts of snow primrose, and 20 parts of fleabane.

[0041] The preparation method of the traditional Chinese medicine bowel-clearing navel patch is as follows:

[0042] S1. Weighing the Fructus Aurantii Immaturus according to the above weight proportions, collecting volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A;

[0043] S2, extract A, concentrated to a concentrate A with a relative density of 1.2 at 65°C;

[0044] S3, according to the above weight parts, weigh raw rhubarb, betel nut and croton, mix the dried medicinal residue A, use 6 times the weight of medicinal residue A and 70% ethanol to reflux extract for 2h, and use 5 times the weight of medicinal residue A and 70% ethanol to reflux extract for 2h, filter, combine the ethanol extracts, recover the ethanol and concentrate to a concentrated solution B with a relative density of 1.2 at 65°C;

[0045] S4, weighing Magnolia officinalis, Sodium Sulfate, Borneol, Herba Saposhnikoviae and Erigeron fasciata according to the above weight proportions, and grinding into fine powder to obtain powder C;

[0046] S5, combining volatile oil A, concentrate A, concentrate B and powder C, and mixing them evenly to obtain a Chinese medicine extract for treating constipation;

[0047] S6, the Chinese medicine extract obtained in step S5 is mixed with vaseline, and then the medicine is made into pills of suitable size to fill the umbilical depression, such as Figure 1 As shown in (b) in the figure, and fixed with external dressing, the Chinese medicine Tongfu navel patch can be obtained.

[0048] Example 3

[0049] The invention discloses a Chinese medicine bowel-clearing navel patch, which comprises the following Chinese medicine components in parts by weight, extracted and purified: 13 parts of magnolia bark, 50 parts of raw rhubarb, 55 parts of immature bitter orange, 27 parts of sodium sulfate, 30 parts of borneol, 12 parts of areca nut, 15 parts of croton seeds, 15 parts of snow primrose, and 15 parts of fleabane.

[0050] The preparation method of the traditional Chinese medicine bowel-clearing navel patch is as follows:

[0051] S1. Weighing the Fructus Aurantii Immaturus according to the above weight proportions, collecting volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A;

[0052] S2, extract A, concentrated to a concentrate A with a relative density of 1.3 at 65°C;

[0053] S3, weighing raw rhubarb, betel nut and croton according to the above weight parts, mixing the dried medicinal residue A, refluxing and extracting for 3 hours with 90% ethanol at a concentration of 10 times the mass of medicinal residue A for the first time, and refluxing and extracting for 3 hours with 90% ethanol at a concentration of 12 times the mass of medicinal residue A for the second time, filtering, combining the ethanol extracts, recovering ethanol and concentrating to a concentrated solution B with a relative density of 1.3 at 65°C;

[0054] S4, weighing Magnolia officinalis, Sodium Sulfate, Borneol, Herba Saposhnikoviae and Erigeron fasciata according to the above weight proportions, and grinding into fine powder to obtain powder C;

[0055] S5, combining volatile oil A, concentrate A, concentrate B and powder C, and mixing them evenly to obtain a Chinese medicine extract for treating constipation;

[0056] S6. The Chinese medicine extract obtained in step S5 is blended with vaseline, and then the medicine is made into pills of suitable size to fill the umbilical depression, and fixed with an external dressing to obtain a Chinese medicine bowel-clearing umbilical patch.

[0057] Example 4

[0058] The invention discloses a Chinese medicine bowel-clearing navel patch, which comprises the following Chinese medicine components in parts by weight, extracted and purified: 15 parts of magnolia bark, 60 parts of raw rhubarb, 60 parts of immature bitter orange, 30 parts of sodium sulfate, 30 parts of borneol, 15 parts of areca nut, 15 parts of croton seeds, 20 parts of snow primrose, and 20 parts of fleabane.

[0059] The preparation method of the traditional Chinese medicine bowel-clearing navel patch is as follows:

[0060] S1. Weighing the Fructus Aurantii Immaturus according to the above weight proportions, collecting volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A;

[0061] S2, extract A, concentrated to a concentrate A with a relative density of 1.3 at 65°C;

[0062] S3, weighing raw rhubarb, betel nut and croton according to the above weight parts, mixing the dried medicinal residue A, refluxing and extracting for 3 hours with 90% ethanol at a concentration of 10 times the mass of medicinal residue A for the first time, and refluxing and extracting for 3 hours with 90% ethanol at a concentration of 12 times the mass of medicinal residue A for the second time, filtering, combining the ethanol extracts, recovering ethanol and concentrating to a concentrated solution B with a relative density of 1.3 at 65°C;

[0063] S4, weighing Magnolia officinalis, Sodium Sulfate, Borneol, Herba Saposhnikoviae and Erigeron fasciata according to the above weight proportions, and grinding into fine powder to obtain powder C;

[0064] S5, combining volatile oil A, concentrate A, concentrate B and powder C, and mixing them evenly to obtain a Chinese medicine extract for treating constipation;

[0065] S6. The Chinese medicine extract obtained in step S5 is blended with vaseline, and then the medicine is made into pills of suitable size to fill the umbilical depression, and fixed with an external dressing to obtain a Chinese medicine bowel-clearing umbilical patch.

[0066] Comparative Example 1

[0067] The difference between Comparative Example 1 and Example 1 is that the raw materials are: 5 parts of Magnolia officinalis, 20 parts of raw rhubarb, 20 parts of Citrus aurantium, 10 parts of Sodium Sulfate, 10 parts of Erigeron Speciosa; 10 parts of Borneolum, 5 parts of Areca Nut, and 5 parts of Croton, which are as follows:

[0068] The invention discloses a Chinese medicine bowel-clearing navel patch, which comprises the following Chinese medicine components in parts by weight, extracted and purified: 10 parts of magnolia bark, 40 parts of raw rhubarb, 40 parts of immature bitter orange, 20 parts of sodium sulfate, 10 parts of snow primrose, and 20 parts of fleabane.

[0069] The preparation method of the traditional Chinese medicine bowel-clearing navel patch is as follows:

[0070] S1. Weighing the Fructus Aurantii Immaturus according to the above weight proportions, collecting volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A;

[0071] S2, extract A, concentrated to a concentrate A with a relative density of 1.2 at 65°C;

[0072] S3, weigh raw rhubarb according to the above weight parts, mix with the dried medicinal residue A, extract with 6 times the weight of medicinal residue A and 70% ethanol at a concentration of reflux for 2h for the first time, and extract with 5 times the weight of medicinal residue A and 70% ethanol at a concentration of reflux for 2h for the second time, filter, combine the ethanol extracts, recover the ethanol and concentrate to a concentrated solution B with a relative density of 1.2 at 65°C;

[0073] S4, weighing Magnolia officinalis, Sophora flavescens, Herba Anemarrhenae and Erigeron erythrorhizon according to the above weight parts, and grinding into fine powder to obtain powder C;

[0074] S5, combining volatile oil A, concentrate A, concentrate B and powder C, and mixing them evenly to obtain a Chinese medicine extract for treating constipation;

[0075] S6. The Chinese medicine extract obtained in step S5 is blended with vaseline, and then the medicine is made into pills of suitable size to fill the umbilical depression, and fixed with an external dressing to obtain a Chinese medicine bowel-clearing umbilical patch.

[0076] Comparative Example 2

[0077] The difference between Comparative Example 2 and Example 1 lies in the raw materials: 5 parts of Magnolia officinalis, 20 parts of raw rhubarb, 20 parts of Citrus aurantium, 10 parts of Sodium bicarbonate, 10 parts of Borneol, 10 parts of Areca catechu, 5 parts of Croton, and 10 parts of Erigeron hortensis; there is also 10 parts of Snow Primrose, which is specifically as follows: a Chinese medicine bowel-clearing navel patch, which is prepared by extracting and purifying the following Chinese medicine components in parts by weight: 10 parts of Magnolia officinalis, 40 parts of raw rhubarb, 40 parts of Citrus aurantium, 20 parts of Sodium bicarbonate, 20 parts of Borneol, 15 parts of Areca catechu, 10 parts of Croton, and 20 parts of Erigeron hortensis.

[0078] The preparation method of the traditional Chinese medicine bowel-clearing navel patch is as follows:

[0079] S1. Weighing the Fructus Aurantii Immaturus according to the above weight proportions, collecting volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A;

[0080] S2, extract A, concentrated to a concentrate A with a relative density of 1.2 at 65°C;

[0081] S3, according to the above weight parts, weigh raw rhubarb, betel nut and croton, mix the dried medicinal residue A, use 6 times the weight of medicinal residue A and 70% ethanol to reflux extract for 2h, and use 5 times the weight of medicinal residue A and 70% ethanol to reflux extract for 2h, filter, combine the ethanol extracts, recover the ethanol and concentrate to a concentrated solution B with a relative density of 1.2 at 65°C;

[0082] S4, weighing Magnolia officinalis, Sodium Sulfate and Erigeron affine according to the above weight parts, and grinding them into fine powder to obtain powder C;

[0083] S5, combining volatile oil A, concentrate A, concentrate B and powder C, and mixing them evenly to obtain a Chinese medicine extract for treating constipation;

[0084] S6. The Chinese medicine extract obtained in step S5 is blended with vaseline, and then the medicine is made into pills of suitable size to fill the umbilical depression, and fixed with an external dressing to obtain a Chinese medicine bowel-clearing umbilical patch.

[0085] Comparative Example 3

[0086] The difference between Comparative Example 3 and Example 1 is that the raw materials are: 5 parts of Magnolia officinalis, 20 parts of raw rhubarb, 20 parts of Citrus aurantium, 10 parts of Sodium Sulfate, 10 parts of Borneolum, 10 parts of Areca Nut, 5 parts of Croton; and 10 parts of Erigeron Fleabane, as follows:

[0087] The invention discloses a Chinese medicine bowel-clearing navel patch, which comprises the following Chinese medicine components in parts by weight, extracted and purified: 10 parts of magnolia bark, 40 parts of raw rhubarb, 40 parts of immature bitter orange, 20 parts of sodium sulfate, 20 parts of borneol, 15 parts of areca nut, 10 parts of croton seeds, and 10 parts of saussurea ovata.

[0088] The preparation method of the traditional Chinese medicine bowel-clearing navel patch is as follows:

[0089] S1. Weighing the Fructus Aurantii Immaturus according to the above weight proportions, collecting volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A;

[0090] S2, extract A, concentrated to a concentrate A with a relative density of 1.2 at 65°C;

[0091] S3, according to the above weight parts, weigh raw rhubarb, betel nut and croton, mix the dried medicinal residue A, use 6 times the weight of medicinal residue A and 70% ethanol to reflux extract for 2h, and use 5 times the weight of medicinal residue A and 70% ethanol to reflux extract for 2h, filter, combine the ethanol extracts, recover the ethanol and concentrate to a concentrated solution B with a relative density of 1.2 at 65°C;

[0092] S4, weighing Magnolia officinalis, Sodium Sulfate, Borneol and Herba Saposhnikoviae Herba according to the above weight proportions, and grinding them into fine powder to obtain drug powder C;

[0093] S5, combining volatile oil A, concentrate A, concentrate B and powder C, and mixing them evenly to obtain a Chinese medicine extract for treating constipation;

[0094] S6. The Chinese medicine extract obtained in step S5 is blended with vaseline, and then the medicine is made into pills of suitable size to fill the umbilical depression, and fixed with an external dressing to obtain a Chinese medicine bowel-clearing umbilical patch.

[0095] Comparative Example 4

[0096] The difference between Comparative Example 4 and Example 1 is that the raw materials are: 5 parts of Magnolia officinalis, 20 parts of raw rhubarb, 20 parts of Citrus aurantium, 10 parts of Sodium Sulfate, 10 parts of Borneolum Syntheticum, 10 parts of Areca Nut, 5 parts of Croton; and 10 parts of Erigeron Fleabane, as follows:

[0097] The invention discloses a Chinese medicine bowel-clearing navel patch, which comprises the following Chinese medicine components in parts by weight, extracted and purified: 10 parts of magnolia bark, 40 parts of raw rhubarb, 40 parts of immature bitter orange, 20 parts of sodium sulfate, 20 parts of borneol, 15 parts of areca nut, 10 parts of croton seeds, and 10 parts of saussurea ovata.

[0098] The preparation method of the Chinese medicine bowel-clearing navel patch is as follows: weigh the above raw materials by weight, grind them into fine powder, then mix them with vaseline, and make the medicine into pills of a size suitable for filling the navel depression, such as Figure 1 As shown in (a), the external dressing is applied and fixed to obtain a comparative Tongfu navel patch.

[0099] Comparative Example 5

[0100] The difference between Comparative Example 5 and Example 1 is that the raw materials are: 2 parts of Magnolia officinalis, 10 parts of raw rhubarb, 10 parts of Citrus aurantium, 3 parts of Sodium Sulfate, 5 parts of Borneol, 2 parts of Areca catechu, 2 parts of Croton, 5 parts of Snow Primrose, and 5 parts of Erigeron argentea, as follows:

[0101] The invention discloses a Chinese medicine bowel-clearing navel patch, which comprises the following Chinese medicine components in parts by weight, extracted and purified: 3 parts of magnolia bark, 10 parts of raw rhubarb, 10 parts of immature bitter orange, 7 parts of sodium sulfate, 5 parts of borneol, 3 parts of areca nut, 3 parts of croton seeds, 5 parts of snow primrose, and 5 parts of fleabane.

[0102] The preparation method of the traditional Chinese medicine bowel-clearing navel patch is as follows:

[0103] S1. Weighing the Fructus Aurantii Immaturus according to the above weight proportions, collecting volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A;

[0104] S2, extract A, concentrated to a concentrate A with a relative density of 1.2 at 65°C;

[0105] S3, according to the above weight parts, weigh raw rhubarb, betel nut and croton, mix the dried medicinal residue A, use 6 times the weight of medicinal residue A and 70% ethanol to reflux extract for 2h, and use 5 times the weight of medicinal residue A and 70% ethanol to reflux extract for 2h, filter, combine the ethanol extracts, recover the ethanol and concentrate to a concentrated solution B with a relative density of 1.2 at 65°C;

[0106] S4, weighing Magnolia officinalis, Sodium Sulfate, Borneol, Herba Saposhnikoviae and Erigeron fasciata according to the above weight proportions, and grinding into fine powder to obtain powder C;

[0107] S5, combining volatile oil A, concentrate A, concentrate B and powder C, and mixing them evenly to obtain a Chinese medicine extract for treating constipation;

[0108] S6. The Chinese medicine extract obtained in step S5 is blended with vaseline, and then the medicine is made into pills of suitable size to fill the umbilical depression, and fixed with an external dressing to obtain a Chinese medicine bowel-clearing umbilical patch.

[0109] Comparative Example 6

[0110] The difference between Comparative Example 6 and Example 1 is that the raw materials are: 15 parts of Magnolia officinalis, 45 parts of raw rhubarb, 20 parts of Citrus aurantium, 30 parts of Sodium Sulfate, 25 parts of Borneol, 15 parts of Areca nut, 15 parts of Croton, 20 parts of Herba Saposhnikoviae, and 15 parts of Erigeron erythrorhizon, as follows:

[0111] The invention discloses a Chinese medicine bowel-clearing navel patch, which comprises the following Chinese medicine components in parts by weight, extracted and purified: 20 parts of magnolia bark, 65 parts of raw rhubarb, 65 parts of immature bitter orange, 40 parts of sodium sulfate, 35 parts of borneol, 20 parts of areca nut, 20 parts of croton seeds, 30 parts of snow primrose, and 25 parts of fleabane.

[0112] The preparation method of the traditional Chinese medicine bowel-clearing navel patch is as follows:

[0113] S1. Weighing the Fructus Aurantii Immaturus according to the above weight proportions, collecting volatile oil by steam distillation to obtain volatile oil A, medicinal residue A and extract A;

[0114] S2, extract A, concentrated to a concentrate A with a relative density of 1.2 at 65°C;

[0115] S3, according to the above weight parts, weigh raw rhubarb, betel nut and croton, mix the dried medicinal residue A, use 6 times the weight of medicinal residue A and 70% ethanol to reflux extract for 2h, and use 5 times the weight of medicinal residue A and 70% ethanol to reflux extract for 2h, filter, combine the ethanol extracts, recover the ethanol and concentrate to a concentrated solution B with a relative density of 1.2 at 65°C;

[0116] S4, weighing Magnolia officinalis, Sodium Sulfate, Borneol, Herba Saposhnikoviae and Erigeron fasciata according to the above weight proportions, and grinding into fine powder to obtain powder C;

[0117] S5, combining volatile oil A, concentrate A, concentrate B and powder C, and mixing them evenly to obtain a Chinese medicine extract for treating constipation;

[0118] S6. The Chinese medicine extract obtained in step S5 is blended with vaseline, and then the medicine is made into pills of suitable size to fill the umbilical depression, and fixed with an external dressing to obtain a Chinese medicine bowel-clearing umbilical patch.

[0119] The method of using the Chinese medicine bowel-clearing navel patch prepared in Examples 1 to 4 and Comparative Examples 1 to 6 is as follows:

[0120] (1) The patient exposes his navel and makes sure that the local skin is not damaged or red and swollen. Clean the navel and surrounding skin with a clean damp cloth.

[0121] (2) Apply the medicine to the navel and press the center of the patch appropriately to fully fill the navel with the ointment. After the patch is applied for 3-4 hours, remove it by yourself and clean the navel with a clean wet cloth or cotton swab.

[0122] (3) Take once a day, one course of treatment is 7 days.

[0123] Clinical trials

[0124] 1. Materials and methods

[0125] 1.1 Case source

[0126] One hundred outpatients who met the inclusion criteria were selected.

[0127] 1.2 Diagnostic criteria

[0128] 1.2.1 Diagnostic criteria for functional constipation

[0129] The diagnostic criteria for functional constipation of the International Functional Gastrointestinal Disorders (FGIDS)-Rome IV are used. It is necessary to exclude intestinal and systemic organic factors, drugs and other causes of constipation and meet the following criteria.

[0130] (1) Two or more of the following symptoms must be present: ① Defecation is labored at least 25% of the time; ② The stool is lumpy or hard at least 25% of the time; ③ There is a sense of incomplete defecation at least 25% of the time; ④ There is a sense of anorectal obstruction or blockage at least 25% of the time; ⑤ At least 25% of the time, defecation requires manual assistance (such as using fingers to assist defecation, pelvic floor support); ⑥ Spontaneous bowel movements are less than 3 times a week.

[0131] (2) Loose stools rarely occur when laxatives are not used;

[0132] (3) Not meeting the diagnostic criteria for IBS-C;

[0133] Symptoms occurred at least 6 months before diagnosis, and symptoms in the past 3 months met the above diagnostic criteria.

[0134] 1.2.2 TCM symptom diagnostic criteria

[0135] Refer to the diagnostic criteria for heat accumulation constipation proposed in the "Consensus on the Diagnosis and Treatment of Functional Constipation with Integrated Traditional Chinese and Western Medicine" issued in 2017.

[0136] (1) Main symptoms: ① Dry and hard stool; ② Foul-smelling stool and / or dry mouth and bad breath and / or short and dark urine.

[0137] (2) Secondary symptoms: ① Abdominal distension or abdominal pain; ② Flushed face and irritability; ③ Or body fever.

[0138] (3) Tongue and pulse: Red tongue, yellow fur, slippery and rapid pulse.

[0139] Determination of syndrome type: main symptoms are required, and diagnosis can be made by adding 1-2 secondary symptoms, with reference to tongue and pulse.

[0140] 1.3 Inclusion criteria

[0141] (1) Patients aged 18 to 60 years old with informed consent;

[0142] (2) Those who meet the diagnostic criteria for functional constipation and TCM syndrome type criteria (heat accumulation constipation);

[0143] (3) Patients who had not received other drug treatment within two weeks before the experiment;

[0144] (4) Agree not to use other treatments for constipation during treatment.

[0145] 1.4 Exclusion criteria

[0146] (1) Primary gastrointestinal diseases or systemic diseases, endocrine or metabolic diseases involving the gastrointestinal tract;

[0147] (2) Pregnant or lactating women; those who have taken morphine, anticholinergics, calcium channel blockers, neuroleptics, sedatives, antidepressants, etc. for a long time or recently (within 3 months);

[0148] (3) Patients who meet the criteria for constipation-predominant irritable bowel syndrome;

[0149] (4) Patients with severe heart, brain, liver, kidney diseases, congenital diseases, history of mental illness or family history of mental illness;

[0150] (5) Those who are known to be allergic to the ingredients in the study drugs, or those who have eczema around the navel, navel sores, etc. and are not suitable for navel compress therapy;

[0151] (6) Failure to use the medication as prescribed, inability to judge the efficacy or incomplete data that affect the efficacy judgment:

[0152] (7) Patients with a history of abdominal and perineal surgery.

[0153] 2. Research Methods

[0154] 2.1 Treatment methods and grouping

[0155] Patients with functional constipation of excess heat type were randomly divided into 10 groups, with 10 patients in each group. Application method: The researchers trained the patients to apply 1 patch per day, apply it to the navel at 10 am, and remove it at 2 pm, once a day, and one week as a course of treatment. The Chinese medicine Tongfu navel patch prepared in Examples 1 to 4 and Comparative Examples 1 to 6 was used for 2 courses of treatment respectively according to the above-mentioned use method.

[0156] 2.2 Observation indicators

[0157] 2.2.1 Western medicine clinical efficacy evaluation indicators: bowel movement frequency (times / week).

[0158] 2.2.2 TCM clinical symptoms and signs efficacy observation scoring scale: The scoring scale was developed based on the TCM symptom efficacy evaluation standards in the "Consensus on the Diagnosis and Treatment of Functional Constipation with Integrated Traditional Chinese and Western Medicine" issued in 2017.

[0159] 2.2.3 Allergy rate record

[0160] If the patient's skin becomes red or itchy after application, please record it at any time.

[0161] The test results are shown in Table 1.

[0162] Table 1 Comparison of defecation frequency and TCM symptom scores of patients with navel patch in the embodiment and comparative example Grouping Example 1 Example 2 Example 3 Example 4 Comparative Example 1 Comparative Example 2 Comparative Example 3 Comparative Example 4 Comparative Example 5 Comparative Example 6 Frequency of bowel movements 3.2 5.4 4 3.8 1.6 2 2 4.6 1.8 4.2 TCM Points 18.88±3.52 22.38±5.22 19.21±4.82 18.32±5.14 15.42±5.12 14.94±5.62 15.13±4.52 20.96±4.51 13.18±4.12 20.11±5.13

[0163] After two courses of treatment, each patient in each group was asked about the site of use. If the site of use became red and itchy, it was considered an allergy. The results were statistically analyzed to obtain the allergy rate of each group of patients, which was (allergic number / total number) × 100%. The allergy situation is shown in Table 2.

[0164] Table 2 Allergy status of patients in each group Grouping Example 1 Example 2 Example 3 Example 4 Comparative Example 1 Comparative Example 2 Comparative Example 3 Comparative Example 4 Comparative Example 5 Comparative Example 6 Allergy rate 0% 0% 0% 0% 0% 0% 0% 40% 0% 20%

[0165] It can be seen from Examples 1 to 4 in Table 1 and Comparative Examples 1 to 3 in Table 1 that the pills made by using Magnolia officinalis, Rhubarb, Citrus aurantium, Sodium sulfate, Borneol, Areca nut, Croton, Herba Saussureae, and Erigeron hortensis in the present invention and the navel patch made by using the pills have good therapeutic effects on patients with functional constipation of excess heat type, and the therapeutic effect of Example 2 is the most significant. And it can be seen from Examples 1 to 4 in Table 2 and Comparative Examples 4 to 6 in Table 2 that the pills made by using Magnolia officinalis, Rhubarb, Citrus aurantium, Sodium sulfate, Borneol, Areca nut, Croton, Herba Saussureae, Erigeron hortensis and corresponding contents in the present invention not only have good constipation treatment effects, but also are more gentle and non-irritating during use, have a lower allergy rate, are safer after use, and reduce the allergic situation of redness and itching at the use site during use. And it can be known from Examples 1 to 4 and Comparative Example 6 that the excess of Magnolia officinalis, Rhubarb, Fructus Aurantii Immaturus, Sodium Sulfate, Borneol, Areca Nut, Croton, Herba Saussureae, and Herba Erigerae used in the present invention will lead to increased toxicity in the prepared pills, thereby causing sensitization to occur easily during use. At the same time, it can be known from Examples 1 to 4 and Comparative Example 5 that the insufficient amount of Magnolia officinalis, Rhubarb, Fructus Aurantii Immaturus, Sodium Sulfate, Borneol, Areca Nut, Croton, Herba Saussureae, and Herba Erigerae used in the present invention will lead to the curative effect not reaching the expected effect. In addition, it can be known from Examples 1 to 4 and Comparative Example 4 that the preparation steps of the umbilical patch of the present invention can purify the effective ingredients of traditional Chinese medicine, remove the drug ingredients with sensitization possibility, so as to avoid sensitization during use. The Chinese medicine umbilical patch for bowel movement can be used for the treatment of functional constipation of real heat type for a long time, safely, effectively and conveniently.

[0166] And by Figure 1 It can be seen that the purification method of the present invention can make the volume of the pill smaller, make the navel patch more suitable for use, and the pill has less squeezing feeling on the navel, making it more comfortable to use. That is, the preparation mechanism of the drug is the navel patch preparation method mentioned above, and the drug components can be purified by the above method, so that a smaller pill can be obtained.

[0167] Of course, the above description is not a limitation of the present invention, and the present invention is not limited to the above examples. Changes, modifications, additions or substitutions made by ordinary technicians in this technical field within the essential scope of the present invention also fall within the protection scope of the present invention.

Claims

1. A Chinese medicine bowel-clearing navel patch, characterized in that: The navel patch is prepared by extracting and purifying the following traditional Chinese medicine components in parts by weight: 5-15 parts of magnolia bark, 20-60 parts of raw rhubarb, 20-60 parts of immature bitter orange, 10-30 parts of sodium sulfate, 10-30 parts of borneol, 5-15 parts of areca nut, 5-15 parts of croton seeds, 10-20 parts of snow primrose and 10-20 parts of fleabane.

2. The Chinese medicine bowel-clearing navel patch according to claim 1, characterized in that: The navel patch is prepared by extracting and purifying the following traditional Chinese medicine components in parts by weight: 10 parts of magnolia bark, 40 parts of raw rhubarb, 40 parts of immature bitter orange, 20 parts of sodium sulfate, 20 parts of borneol, 15 parts of areca nut, 10 parts of croton seeds, 10 parts of snow primrose and 20 parts of fleabane.

3. A method for preparing the Chinese medicine bowel-clearing navel patch according to any one of claims 1 to 2, characterized in that: The following steps are involved: S1. Weighing the Fructus Aurantii Immaturus according to the above weight proportions, collecting volatile oil by distillation to obtain volatile oil A, medicinal residue A and extract A; S2, concentrating the extract A to obtain a concentrated solution A; S3, weighing raw rhubarb, betel nut and croton according to the above weight parts, mixing and drying the residue A, firstly extracting with ethanol reflux to obtain an ethanol extract, then recovering the ethanol and concentrating to obtain a concentrated solution B; S4, weighing Magnolia officinalis, Sodium Sulfate, Borneol, Herba Saposhnikoviae and Erigeron fasciata according to the above weight proportions, and grinding into fine powder to obtain powder C; S5, combining volatile oil A, concentrate A, concentrate B and powder C, and mixing them evenly to obtain a Chinese medicine extract for treating constipation; S6. The Chinese medicine extract obtained in step S5 is blended with vaseline, and then the medicine is made into pills of suitable size to fill the umbilical depression, and fixed with an external dressing to obtain a Chinese medicine bowel-clearing umbilical patch.

4. The method for preparing the Chinese medicine bowel-clearing navel patch according to claim 3, characterized in that: In step S1, when preparing volatile oil A, it is collected by steam distillation.

5. The method for preparing the Chinese medicine bowel-clearing navel patch according to claim 3, characterized in that: The relative density of concentrated liquid A is 1.1~1.

3.

6. The method for preparing the Chinese medicine bowel-clearing navel patch according to claim 5, characterized in that: The relative density of concentrate A is 1.

2.

7. The method for preparing the Chinese medicine bowel-clearing navel patch according to claim 1, characterized in that: When the extract A is concentrated, the concentration temperature is 65°C.

8. The method for preparing the Chinese medicine bowel-clearing navel patch according to claim 1, characterized in that: In step S3, 60% to 90% ethanol with a concentration of 3 to 12 times the mass of the residue A is used for reflux extraction 2 to 3 times, each time for 1 to 3 hours, filtered, the ethanol extracts are combined, the ethanol is recovered and concentrated to a concentrated solution B with a relative density of 1.1 to 1.3 at 65°C.

9. The method for preparing the Chinese medicine bowel-clearing navel patch according to claim 8, characterized in that: The first time, 6 times the mass of the residue A was used for reflux extraction with 70% ethanol in a concentration of 2h, and the second time, 5 times the mass of the residue A was used for reflux extraction with 70% ethanol in a concentration of 2h, filtered, combined the ethanol extracts, recovered ethanol and concentrated to a concentrated solution B with a relative density of 1.2 at 65°C.

10. The Chinese medicine Tongfu Xiangqi patch prepared by the preparation method of the Chinese medicine Tongfu Xiangqi patch according to any one of claims 4 to 9, characterized in that: This navel patch is used in products for treating functional constipation of the real heat type.

Images