External pharmaceutical composition for abdominal distension after lumbar general anesthesia and patch of external pharmaceutical composition

Abstract

The invention belongs to the technical field of medicines, and relates to an external pharmaceutical composition for lumbar vertebra general anesthesia postoperative abdominal distension and a patch thereof, and the external pharmaceutical composition is prepared from frankincense, cinnamon, radix aconiti preparata, radix bupleuri, semen raphani, rhizoma atractylodis, fennel, borneol and fentanyl. Through combined action of traditional Chinese medicines and western medicines, the external medicine composition can remarkably relieve gastrointestinal symptoms of patients with functional abdominal distension and improve gastrointestinal functions of the patients, and is remarkable in clinical effect. The external medicine composition is high in safety and exact in clinical curative effect.

Description

Technical Field

[0001] The invention belongs to the technical field of medicines and relates to an external-use medicinal composition and a patch thereof for abdominal distension after lumbar general anesthesia. Background Art

[0002] Abdominal distension is also called "abdominal distension", "abdominal distension" and "slight abdominal distension". Traditional Chinese medicine believes that abdominal distension is mostly caused by invasion of cold, dampness, fire and heat, obstruction of meridian qi, and also caused by deficiency of body fluid and blood, and accumulation of qi and blood. The causes of abdominal distension are relatively complex. Zhongjing mainly discusses that sweating, vomiting, and diarrhea are improper, leading to fullness due to deficiency of the middle part, evil heat or dry stool accumulation or cold stagnation, qi stagnation, phlegm and fluid stagnation, and abdominal distension. Treat the symptoms in an emergency and treat the root cause in a slow manner. In clinical practice, the first thing to do is to solve the symptom of abdominal distension.

[0003] Functional abdominal distension refers to recurrent abdominal distension, pressure or gas blockage, and (or) observable increase in abdominal circumference. The main symptoms of this disease are abdominal distension, often accompanied by bowel sounds, increased flatus, frequent belching and other symptoms. Although this disease may coexist with other functional bowel diseases, abnormal bowel habits (constipation or diarrhea) rarely occur, and there is occasional mild abdominal pain, and these symptoms are milder than abdominal distension in frequency and degree. The pathogenesis of functional abdominal distension is still unclear. At present, it is generally believed to be related to factors such as increased intestinal gas production, gastrointestinal motility disorders, changes in visceral sensitivity and small intestinal bacterial overgrowth. The "Guidelines for the Diagnosis and Treatment of Functional Abdominal Distension in Common Digestive System Diseases in Traditional Chinese Medicine (Grassroots Doctor Edition)" divides functional abdominal distension into liver depression and qi stagnation syndrome, spleen and stomach dampness and heat syndrome, diet stagnation syndrome, cold and heat syndrome, spleen deficiency and dampness obstruction syndrome, middle-jiao deficiency and cold syndrome and intestinal dryness and fluid deficiency syndrome.

[0004] Fentanyl is a synthetic strong opioid drug, and its transdermal patch is mainly indicated for chronic moderate and severe cancer pain. The literature (Xiao Li, Han Lingmin, Han Chunshan. Observation on the efficacy of fentanyl transdermal patch in the treatment of patients with cancer abdominal distension [J]. Journal of North Sichuan Medical College, 2015, 30(6):4) reported that in the treatment of patients with cancer abdominal distension, compared with various oral drugs, fentanyl patch has a unique advantage in the treatment of patients who are difficult to take oral drugs due to its transdermal absorption route, and the treatment effect is obvious. Fentanyl transdermal patch provides an effective treatment method for relieving clinical symptoms of many patients with cancer abdominal distension.

[0005] Functional abdominal distension is one of the common clinical symptoms. The effect of Western medicine treatment is not ideal. Treatment with traditional Chinese medicine can effectively improve symptoms and improve efficacy. Summary of the invention

[0006] In order to overcome the shortcomings and deficiencies in the prior art, the present invention aims to provide an external-use pharmaceutical composition with stable clinical efficacy and high efficiency in relieving abdominal distension, and in particular, to provide an external-use pharmaceutical composition and a patch thereof for abdominal distension after lumbar general anesthesia.

[0007] The present invention also provides a method for preparing the external medicine composition.

[0008] The present invention also provides medical use of the external medicine composition.

[0009] Specifically, the technical problem to be solved by the present invention is achieved through the following technical solutions.

[0010] The first aspect of the present invention provides an external medicinal composition for treating abdominal distension after lumbar general anesthesia, wherein the external medicinal composition is prepared from frankincense, cinnamon bark, processed Chuanwu, bupleurum, radish seed, atractylodes, fennel, borneol and fentanyl.

[0011] Specifically, the topical pharmaceutical composition is made of the following raw materials in parts by weight: 13-18 parts of frankincense, 18-22 parts of cinnamon, 13-18 parts of processed Chuanwu, 13-18 parts of bupleurum, 13-18 parts of radish seeds, 4-8 parts of atractylodes, 13-18 parts of fennel, 3-7 parts of borneol and 0.003-0.005 parts of fentanyl.

[0012] In one embodiment of the present invention, the topical pharmaceutical composition is made of the following raw materials in parts by weight:

[0013] 15 parts of frankincense, 20 parts of cinnamon bark, 15 parts of processed Chuanwu, 15 parts of bupleurum, 15 parts of radish seeds, 6 parts of atractylodes, 15 parts of fennel, 5 parts of borneol and 0.004 parts of fentanyl.

[0014] The second aspect of the present invention provides a method for preparing the external pharmaceutical composition, comprising the following steps: grinding all raw materials into fine powder, passing through a 200-mesh sieve, adding auxiliary materials, and preparing an external preparation.

[0015] Furthermore, the dosage form of the external preparation is a lotion, a patch, a paste, an ointment, a gel, a film coating or a papule.

[0016] Furthermore, the dosage form of the external preparation is a patch.

[0017] The third aspect of the present invention provides use of the external pharmaceutical composition in preparing a drug for treating abdominal distension.

[0018] Furthermore, the present invention provides use of the external pharmaceutical composition in preparing a drug for treating functional abdominal distension.

[0019] The principles of TCM treatment for abdominal distension are warming, circulation, unblocking, the combination of warming and unblocking, the combination of warming and circulation, and the combination of circulation and unblocking. Warming means "warming the cold", which can eliminate the coagulation, tightness, and spasm caused by the cold evil. Circulation means "moving the stagnant", using qi-regulating drugs to unblock the qi and eliminate qi stagnation and abdominal distension. Unblocking means "relieving the blockage", and there are different methods such as expelling water, purging, and breaking fatigue. Because cold can stagnate qi and cold can coagulate blood, qi stagnation can also stagnate water and blood, and old food, water, and fatigue can also lead to poor qi movement. Therefore, clinical application often uses warming and circulation, circulation and unblocking, which is the method of Zhang Zhongjing according to the symptoms. Abdominal distension and fullness are nothing more than cold and heat, deficiency and excess, and deficiency and excess.

[0020] The external-use medicinal composition for relieving abdominal distension is composed of frankincense, cinnamon bark, processed aconite, bupleurum root, radish seed, atractylodes, fennel, borneol and fentanyl.

[0021] Frankincense: It tastes spicy and bitter, is warm in nature, and enters the heart, liver, and spleen meridians. It has the effects of promoting blood circulation, relieving pain, reducing swelling and promoting tissue regeneration.

[0022] Cinnamon: It tastes spicy and sweet, is warm in nature, and enters the bladder meridian. It warms and dredges the meridians, helps yang and transforms qi, balances and descends qi, and is used for cold pain in the abdomen, amenorrhea due to cold blood, running pig, joint pain, phlegm and fluid, and edema.

[0023] Processed Chuanwu: spicy in taste, hot in nature, enters the heart, liver, kidney, and spleen meridians, dispels cold and dampness, disperses wind evil, warms the meridians, relieves pain, treats wind-cold and dampness arthritis, rheumatoid arthritis, cramps in the limbs, hemiplegia, headache, cold pain in the heart and abdomen, and swelling and toxins in the genitals.

[0024] Bupleurum: It tastes pungent and bitter, is slightly cold in nature, and enters the liver, gallbladder, and lung meridians. It has the effects of dispersing and reducing fever, soothing the liver and relieving depression, and raising Yang Qi.

[0025] Radish seeds: spicy and sweet in taste, neutral in nature, enter the spleen, lung and stomach meridians, have the effects of digesting food, relieving stagnation, descending qi and resolving phlegm, and are used to treat food accumulation and qi stagnation, abdominal distension, diarrhea, heaviness after dysentery, cough with sputum, and qi reversal and wheezing.

[0026] Atractylodes: It tastes pungent and bitter, and is warm in nature. It enters the spleen, stomach, and liver meridians. It has the effects of strengthening the spleen, drying dampness, relieving depression, and eliminating filth. It is used to treat dampness that blocks the spleen, fatigue and lying down, abdominal distension, loss of appetite, vomiting, diarrhea, dysentery, malaria, phlegm and fluid, edema, seasonal colds, wind-cold and dampness, foot paralysis, and night blindness.

[0027] Fennel: spicy in taste, warm in nature, enters the liver meridian, kidney meridian, spleen meridian, stomach meridian, stimulates appetite, regulates qi and dispels cold, helps the yang channel, and treats coldness in the middle burner, loss of appetite, nausea and vomiting, cold pain in the abdomen; hernia pain, swollen and painful testicles; spleen and stomach qi stagnation, abdominal distension and pain.

[0028] Borneol: It tastes pungent and bitter, and is cool in nature. It enters the heart meridian, spleen meridian and lung meridian. It has the effects of opening the orifices and refreshing the mind, clearing away heat and relieving pain. It can assist in the treatment of arthritis, coma, red and swollen eyes, throat congestion and mouth ulcers and other symptoms.

[0029] The Chinese medicine composition has reasonable compatibility, and the drugs are used together to warm the meridians and dredge the collaterals, regulate qi and relieve pain. The Chinese and Western compound medicine composition of the present invention has a synergistic effect, and has a significant advantage in relieving abdominal distension compared with chemical medicine single prescription preparations and pure Chinese medicine preparations.

[0030] Compared with the prior art, the present invention has the following beneficial effects:

[0031] (1) External treatment with traditional Chinese medicine is to directly deliver the medicine to the affected area through external administration, thereby achieving the purpose of eliminating pathogens and curing diseases. The external medicine composition of the present invention can significantly relieve the gastrointestinal symptoms of patients with functional abdominal distension and improve their gastrointestinal function, with significant clinical effects.

[0032] (2) The external-use pharmaceutical composition for relieving abdominal distension of the present invention has a synergistic effect of Chinese and Western medicines, and has a stable clinical efficacy and a high effectiveness rate in relieving abdominal distension. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 Comparison of abdominal circumference between the two groups before and after treatment

[0034] Compared with the control group, * P<0.05, ** P<0.01; compared with the experimental group 3, # P<0.05.

[0035] Figure 2 Comparison of gastrointestinal transit function between the two groups before and after treatment

[0036] Compared with the control group, * P<0.05, ** P<0.01; compared with the experimental group 3, # P<0.05.

[0037] Figure 3 To compare the clinical efficacy between the two groups. Specific embodiments

[0038] The content of the present invention is further described in detail below through specific implementation methods, but this should not be understood as the scope of the above subject matter of the present invention is limited to the following examples. The following examples are used to illustrate the technical solution of the present invention rather than to limit the scope of protection of the present invention. If a person of ordinary skill in the art modifies or replaces the technical solution of the present invention with an equivalent without departing from the essence and scope of the technical solution of the present invention, it still belongs to the scope of protection of the present invention.

[0039] Example 1: External-use pharmaceutical composition patch of the present invention

[0040] Frankincense 15g, cinnamon 20g, processed Chuanwu 15g, bupleurum 15g, radish seeds 15g, atractylodes 6g, fennel 15g, borneol 5g and fentanyl 0.004g.

[0041] Grind each raw material into fine powder, pass through a 200-mesh sieve to obtain fine powder; dissolve the acrylic pressure-sensitive adhesive and azone in ethyl acetate, add the fine powder, stir evenly with glycerin, apply on the non-woven fabric backing layer, dry at 70°C, apply the adhesive layer of polyethylene glycol, cover with a polyester film protective layer, cut into 6cm×7cm patches, package, and sterilize to obtain the product.

[0042] Example 2: External-use pharmaceutical composition patch of the present invention

[0043] Frankincense 13g, cinnamon 18g, processed Chuanwu 18g, bupleurum 18g, radish seeds 15g, atractylodes 4g, fennel 18g, borneol 7g and fentanyl 0.003g.

[0044] The preparation method is similar to that of Example 1.

[0045] Example 3: External-use pharmaceutical composition patch of the present invention

[0046] Frankincense 13g, cinnamon 22g, processed Chuanwu 13g, Bupleurum 13g, Radish Seed 13g, Atractylodes 8g, fennel 13g, borneol 3g and fentanyl 0.005g.

[0047] The preparation method is similar to that of Example 1.

[0048] Example 4: External-use pharmaceutical composition of the present invention, cataplasm

[0049] Frankincense 15g, cinnamon 20g, processed Chuanwu 13g, bupleurum 18g, radish seeds 18g, atractylodes 8g, fennel 13g, borneol 7g and fentanyl 0.005g.

[0050] Each raw material drug is ground into fine powder, passed through a 200-mesh sieve to obtain fine powder; 3% carbomer is mixed with the above powder, stirred to fully swell, and a mixed solution A is formed; 20% polyvinyl alcohol and 2% azone are dispersed in 10% glycerol and stirred to form a mixed solution B; the mixed solution A and the mixed solution B are mixed evenly, kept warm at 60° C. for 10 hours, and after the carbomer and polyvinyl alcohol (PVA) are fully swollen, they are coated on a non-woven fabric and sheared to obtain the product.

[0051] Example 5: External-use pharmaceutical composition of the present invention, cataplasm

[0052] Frankincense 15g, cinnamon 18g, processed Chuanwu 13g, bupleurum 15g, radish seeds 15g, atractylodes 6g, fennel 18g, borneol 3g and fentanyl 0.003g.

[0053] The preparation method is similar to that of Example 4.

[0054] Comparative Example 1

[0055] Myrrh 15g, cinnamon twig 20g, processed Chuanwu 15g, Bupleurum 15g, Radish Seed 15g, Magnolia officinalis 6g, fennel 15g, borneol 5g and fentanyl 0.004g.

[0056] The preparation method is similar to that of Example 1.

[0057] Comparative Example 2

[0058] 15g of frankincense, 20g of cinnamon, 15g of processed Chuanwu, 15g of bupleurum, 15g of radish seeds, 6g of atractylodes, 15g of fennel and 5g of borneol.

[0059] The preparation method is similar to that of Example 1.

[0060] Clinical Example Observation on the therapeutic effect of the external medicinal composition of the present invention on functional abdominal distension

[0061] 1. Materials and Methods

[0062] 1. Clinical data

[0063] A total of 120 patients with functional abdominal distension who visited the outpatient clinic of our hospital were selected. They were randomly divided into control group, experimental group 1, experimental group 2 and experimental group 3, with 30 patients in each group. Among them, there were 13 males and 17 females in the control group, with an average age of (46.32±5.32) years old; there were 12 males and 18 females in experimental group 1, with an average age of (48.16±5.04) years old; there were 13 males and 17 females in experimental group 2, with an average age of (47.81±5.29) years old; there were 11 males and 19 females in experimental group 3, with an average age of (46.98±4.67) years old.

[0064] There was no statistical difference in the general information of patients in each group (P>0.05), and they were comparable.

[0065] 2. Diagnostic criteria

[0066] The diagnostic criteria for functional abdominal distension in the "Guidelines for the Diagnosis and Treatment of Functional Abdominal Distension in Traditional Chinese Medicine for Common Digestive System Diseases (Primary Doctor Edition)" are as follows: recurrent abdominal distension and / or abdominal expansion for at least 1 day per week; abdominal distension and / or abdominal expansion is more prominent than other symptoms; symptoms have occurred for at least 6 months before diagnosis and have met the diagnostic criteria in the past 3 months; abdominal distension may be accompanied by mild abdominal pain and mild abnormal bowel movements.

[0067] 3. Inclusion criteria

[0068] Meet the above diagnostic criteria; age ≥ 18 years old; patients and their families sign the informed consent.

[0069] 4. Exclusion criteria

[0070] Patients with lesions of the heart, liver, brain, kidney and other organs; hypertension, tumors, glucose metabolism disorders; those with contraindications to scraping such as skin damage, weak constitution and coagulation dysfunction; those who cannot tolerate scraping due to their own or medical factors; those with mental illness; pregnant or lactating women; functional abdominal distension caused by surgery or trauma; refused to participate in this study.

[0071] 5. Treatment Methods

[0072] The control group applied fentanyl transdermal patch (8.4 mg / patch), one patch per day, changed every 72 hours.

[0073] In test group 1, the patch of comparative example 1 was applied around the navel of the patient, in test group 2, the patch of comparative example 2 was applied around the navel of the patient, and in test group 3, the patch of example 1 was applied around the navel of the patient. Each group applied one patch for 24 hours, one patch per day.

[0074] After 2 weeks of treatment, abdominal circumference, gastrointestinal transit function and clinical efficacy of the two groups were observed.

[0075] 6. Observation indicators

[0076] 6.1 Gastrointestinal Symptom Rating Scale (GSRS) scores before and after treatment

[0077] The scale includes 16 items such as upper abdominal pain, chest discomfort, acid reflux, hunger pain, nausea, bowel sounds, abdominal distension, throat discomfort, bad breath, urination, constipation, diarrhea, and loose stools. It is scored as 0, 1, 2, and 3 points respectively according to no symptoms, being aware of the presence of symptoms after prompting, symptoms existing but not affecting daily life, and symptoms affecting daily life.

[0078] 6.2 Abdominal circumference before and after treatment

[0079] After having a bowel movement on an empty stomach in the morning, the patient lies flat with legs straightened to expose the abdomen. Using the navel as the reference point, use a soft tape measure to wrap it horizontally around the abdomen once to measure the abdominal circumference at the level of the navel.

[0080] 6.3 Gastrointestinal transit test before and after treatment

[0081] The gastrointestinal transmission function was determined in turn. The patient took a capsule containing barium when eating in the morning, and an upright abdominal plain film was taken 48 hours after taking the medicine for observation.

[0082] 6.4 Comparison of clinical efficacy between the two groups

[0083] The efficacy index was calculated by nimodipine method: efficacy index = (GSRS score before treatment - GSRS score after treatment) / GSRS score before treatment × 100%.

[0084] Clinical cure: upper abdominal pain, abdominal distension and other symptoms and signs disappear, with an efficacy index ≥ 95%; markedly effective: upper abdominal pain, abdominal distension and other symptoms and signs significantly improved, with an efficacy index of 70%≤<95%; effective: upper abdominal pain, abdominal distension and other symptoms and signs improved, with an efficacy index of 30%≤<70%; ineffective: no improvement in upper abdominal pain, abdominal distension and other symptoms and signs, with an efficacy index of <30%.

[0085] Total effective rate = (number of clinically cured + markedly effective + effective) cases / total number of cases × 100%.

[0086] 7. Statistical methods

[0087] SPSS 19.0 software was used for data processing. The data of each group were subjected to normal distribution test and variance homogeneity test, and the inter-group comparison was performed with one-way analysis of variance, with P < 0.05 as the difference being statistically significant.

[0088] 2. Results

[0089] 1. Comparison of abdominal circumference and gastrointestinal transit function before and after treatment

[0090] Before treatment, there were no significant differences in abdominal circumference and gastrointestinal transit function among the groups.

[0091] After treatment, the abdominal circumference of groups 1, 2 and 3 was smaller than that before treatment, and the difference was statistically significant. The abdominal circumference of group 3 was smaller than that of the control group, group 1 and group 2. Figure 1 shown.

[0092] The gastrointestinal transit function of the test group 1, test group 2 and test group 3 was enhanced compared with that before treatment, and the difference was statistically significant. The gastrointestinal transit function of the test group 3 was better than that of the control group, test group 1 and test group 2. Figure 2 shown.

[0093] 2. Comparison of clinical efficacy between the two groups

[0094] Table 1 Comparison of clinical efficacy between the two groups

[0095] Group Number of cases / case Total effective rate / % Control group 30 73.3 Test Group 1 30 80.0 Test Group 2 30 76.6 Experiment 3 groups 30 96.7

[0096] Depend on Figure 3 As shown in Table 1, the total effective rate of the control group was 73.3%, the total effective rate of the test group 2 was 80.0%, the total effective rate of the test group 3 was 76.6%, and the total effective rate of the test group 3 was 96.7%. The clinical efficacy of the test group 3 in improving functional abdominal distension was significantly better than that of the control group, the test group 1, and the test group 2.

[0097] The external-use pharmaceutical composition of the present invention can significantly alleviate the gastrointestinal symptoms of patients with functional abdominal distension, improve their gastrointestinal function, and has a significant clinical effect.

[0098] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A topical pharmaceutical composition for treating abdominal distension after lumbar general anesthesia, characterized in that: The external medicine composition is prepared from the following raw materials: 13-18 parts of frankincense, 18-22 parts of cinnamon bark, 13-18 parts of processed aconite, 13-18 parts of bupleurum, 13-18 parts of radish seeds, 4-8 parts of atractylodes, 13-18 parts of fennel, 3-7 parts of borneol and 0.003-0.005 parts of fentanyl.

2. The external pharmaceutical composition according to claim 1, characterized in that The external medicine composition is prepared from the following raw materials in parts by weight: 15 parts of frankincense, 20 parts of cinnamon bark, 15 parts of processed Chuanwu, 15 parts of bupleurum, 15 parts of radish seeds, 6 parts of atractylodes, 15 parts of fennel, 5 parts of borneol and 0.004 parts of fentanyl.

3. The external pharmaceutical composition according to any one of claims 1 or 2, characterized in that The preparation method of the external medicine composition is as follows: all raw materials are ground into fine powder, passed through a 200-mesh sieve, and auxiliary materials are added to prepare an external preparation.

4. The external pharmaceutical composition according to any one of claims 1 or 2, characterized in that The dosage form of the external pharmaceutical composition is lotion, patch, paste, ointment, gel, film coating or papule.

5. The external pharmaceutical composition according to claim 4, characterized in that The dosage form of the external pharmaceutical composition is a patch.

6. The external pharmaceutical composition according to claim 5, characterized in that The preparation method of the patch is as follows: grind each raw material drug into fine powder, pass it through a 200-mesh sieve to obtain fine powder; dissolve the acrylic pressure-sensitive adhesive and azone in ethyl acetate, add the fine powder, stir evenly with glycerin, apply it on a non-woven fabric backing layer, dry it at 70°C, apply polyethylene glycol as an adhesive layer, cover it with a polyester film protective layer, cut it into 6cm×7cm patches, package it, and sterilize it to obtain the patch.

7. Use of the external medicinal composition according to any one of claims 1 or 2 in the preparation of an external medicament for treating abdominal distension.

8. Use of the external medicinal composition according to any one of claims 1 or 2 in the preparation of an external medicament for treating functional abdominal distension.

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