CN118178559A - Traditional Chinese medicine composition for treating anal sinusitis and preparation method and application thereof - Google Patents

Traditional Chinese medicine composition for treating anal sinusitis and preparation method and application thereof Download PDF

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Publication number
CN118178559A
CN118178559A CN202410486172.8A CN202410486172A CN118178559A CN 118178559 A CN118178559 A CN 118178559A CN 202410486172 A CN202410486172 A CN 202410486172A CN 118178559 A CN118178559 A CN 118178559A
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traditional chinese
chinese medicine
medicine composition
raw materials
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李代颖
范艺缤
唐学贵
吴至久
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Nanchong Traditional Chinese Medicine Hospital
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Nanchong Traditional Chinese Medicine Hospital
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Abstract

The invention provides a traditional Chinese medicine composition for treating anal sinusitis as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 30-60 parts of bletilla striata, 15-30 parts of hedgehog skin, 10-20 parts of pollen typhae, 15-30 parts of climbing groundsel herb, 10-20 parts of gallnut, 10-20 parts of catechu, 15-20 parts of pseudo-ginseng, 5-10 parts of aloe, 25-30 parts of borneol, 15-30 parts of kuh-seng, 5-15 parts of glauber salt, 15-30 parts of rhizoma corydalis and 15-30 parts of nutgrass galingale rhizome. The traditional Chinese medicine composition disclosed by the invention is accurate in compatibility, can effectively improve symptoms such as anal sinusitis swelling, falling, pain, incomplete defecation and the like, greatly improves the treatment effect of anal sinusitis, is externally applied to the medicine composition, reaches a disease place, and is convenient to clinically use. The invention provides a safe and effective traditional Chinese medicine composition for treating anal sinusitis, and has good application prospect.

Description

Traditional Chinese medicine composition for treating anal sinusitis and preparation method and application thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating anal sinusitis as well as a preparation method and application thereof.
Background
Anal sinusitis is also known as anal cryptitis, and refers to acute and chronic inflammation occurring in the anal sinus and glands. In the acute stage, there are discomfort such as burning, swelling, falling, pain, moist and itching of anus, incomplete defecation, etc., and anoscope detection shows that the anal sinus is full of blood and edema, part of patients can see pus or bloody secretion, the anal sinus is pressed, hard or sunken, and serious patients can see perianal abscess, anal fistula, etc. If the disease is repeatedly caused, the symptoms are prolonged and develop into chronic periods, and part of patients are suffering from anxiety, depression and other symptoms, so that the life quality of the patients is seriously affected. Western medicine mainly uses anti-inflammatory and analgesic drugs to relieve anal sinusitis symptoms, but has poor curative effect and inaccurate long-term curative effect, if the illness state is heavier, operation treatment such as anal sinus incision drainage or incision hanging wire is needed, but operation treatment cost is high, and various postoperative complications such as anus bulge and anus discomfort caused by postoperative scars can be possibly caused. Thus, clinical treatment is still dominated by conservative treatment.
Anal sinusitis belongs to the category of 'dirty toxin' in traditional Chinese medicine, and is caused by abnormal spleen and stomach transportation and transformation, damp toxin accumulation, unsmooth qi and blood circulation and accumulation in anus due to improper diet or pungent and spicy overeating and thick sweet taste. The patent application with publication number CN107551046A discloses a formula for treating anal sinusitis, which takes four-leaf ginseng, pseudo-ginseng, rehmannia root, donkey-hide gelatin and fleece-flower root as raw material medicines, and is decocted with water for administration, and the formula is used for clearing heat and relieving pain and mainly treats anal sinusitis; the patent application with publication number CN107890492A discloses a formula for treating anal sinusitis, which takes rhizoma corydalis, tree peony bark, viola philippica, semiaquilegia root, garden burnet root, kudzuvine root, baical skullcap root, gentian and coptis root as raw material medicines, and is also prepared into an oral preparation for administration to treat anal sinusitis. However, at present, the anus Dou Yanshang for traditional Chinese medicine treatment has no diagnosis and treatment standard and guide, and is usually used by doctors through experience, so that the curative effect is not exact. Meanwhile, most of the medicines are orally taken, and due to the special and hidden anatomical position and structure of the anal sinus, the conventional oral method is difficult to directly reach the affected part to exert the efficacy.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides a traditional Chinese medicine composition for treating anal sinusitis, and a preparation method and application thereof.
The invention provides a traditional Chinese medicine composition for treating anal sinusitis, which is prepared from the following raw materials in parts by weight:
30-60 parts of bletilla striata, 15-30 parts of hedgehog skin, 10-20 parts of pollen typhae, 15-30 parts of climbing groundsel herb, 10-20 parts of gallnut, 10-20 parts of catechu, 15-20 parts of pseudo-ginseng, 5-10 parts of aloe, 25-30 parts of borneol, 15-30 parts of kuh-seng, 5-15 parts of glauber salt, 15-30 parts of rhizoma corydalis and 15-30 parts of nutgrass galingale rhizome.
Further, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
60 parts of bletilla striata, 30 parts of hedgehog skin, 20 parts of cattail pollen, 30 parts of climbing groundsel herb, 20 parts of Chinese gall, 20 parts of catechu, 20 parts of pseudo-ginseng, 10 parts of aloe, 30 parts of borneol, 30 parts of radix sophorae flavescentis, 15 parts of glauber salt, 30 parts of rhizoma corydalis and 30 parts of nutgrass galingale rhizome.
Further, the pollen typhae is pollen typhae.
Further, the traditional Chinese medicine composition is a preparation prepared by taking medicinal powder of the raw materials in weight ratio or water and/or organic solvent extracts of the raw materials as active ingredients and adding pharmaceutically acceptable auxiliary materials or auxiliary ingredients.
Further, the preparation is an external preparation.
Further, the external preparation is solution, ointment, gel or suppository.
The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
(1) Weighing the raw materials according to the weight ratio;
(2) The medicine powder of the raw materials, or the water and/or organic solvent extract of the raw materials, and pharmaceutically acceptable auxiliary materials or auxiliary components.
Further, the preparation method comprises the following steps:
(1) Pulverizing the raw materials into powder respectively, weighing the raw material powder according to the weight ratio, and uniformly mixing;
(2) Taking the mixed fatty glyceride as a matrix, heating and melting, uniformly mixing with the raw material powder in the step (1), and cooling to obtain the suppository.
The invention also provides application of the traditional Chinese medicine composition in preparing medicines for treating anal sinusitis.
Further, the medicine has the functions of clearing heat and detoxicating, eliminating dampness and relieving itching, reducing swelling and relieving pain, removing blood stasis and stopping bleeding, promoting qi circulation and soothing liver.
The anal sinusitis has the remarkable characteristics of pain, itching and sore, so the invention provides a method for multi-target treatment of clearing away heart-fire and toxic materials, detumescence and acesodyne, eliminating dampness and itching, removing stasis and stopping bleeding, promoting qi circulation and soothing liver under the guidance of the theory of traditional Chinese medicine integral concept based on the theory of heart, heat, blood stasis and toxin, and provides a traditional Chinese medicine composition capable of rapidly relieving symptoms such as anal sinusitis swelling, falling, pain, dislike defecation and the like. The clinical application achieves satisfactory clinical curative effect.
The traditional Chinese medicine composition takes kuh-seng as a monarch, cattail pollen, hedgehog skin, rhizoma bletillae and gallnut as ministers, nutgrass galingale rhizome, climbing groundsel herb, catechu, pseudo-ginseng, aloe and rhizoma corydalis as assistants, and Natrii sulfas and borneol as guides. The "Shen is specially used for treating fire in heart meridian" indicated in Ben Cao Jing Bai Zhi Ji, which has the actions of clearing heat and drying dampness, dispelling wind and destroying parasites, and eliminating sore and relieving itching, so it is monarch to use Shen. Ben Cao Zhengyi (materia Medica): pollen Typhae, especially human qi system …, can remove blood stasis and treat qi and blood stagnation, and promote the normal exertion of the function of "heart governing blood". Bai Ji has the actions of astringing to stop bleeding, relieving swelling and promoting tissue regeneration, and is indicated for internal and external bleeding, carbuncle and swelling, etc. Shennong Ben Cao Jing (Shennong's herbal): it is indicated for sores and ulcers, because it can be used for treating the non-ulcer, the non-adult can be resolved, and the non-adult can be used for healing sores and promoting tissue regeneration. "Hedgehog skin is used for treating damp-heat and blood heat in large intestine, five hemorrhoids with yin failing to descend blood, red and white blood, and five blood juices are not only used in Ben Cao Jing Shu". Drug Property theory (L): the clinical application of the traditional Chinese medicine for treating the hemorrhoids with the symptoms of wind and blood purging in the main intestine and hemorrhoids with the symptoms of first-class or not-ill hemorrhoids shows that the hedgehog skin has remarkable effects of cooling blood, detoxifying and relieving pain. The lung is exterior-interior with the large intestine, the anal sinus is the end of the large intestine, and the Chinese gall has the functions of astringing the lung to reduce fire, astringing to stop bleeding, astringing dampness to promote tissue regeneration and healing sore. Catechu has effects of eliminating dampness, promoting granulation, healing sore, and stopping bleeding. The Yunnan Bencao (herbal medicine) states that: the Qianliguang is used for washing scabies and tinea, removing skin and wind heat, has good effects of clearing heat and detoxicating, killing parasites and relieving itching, and is mainly used for treating carbuncle and sore, diarrhea and dysentery, skin eczema and the like. Notoginseng radix has effects of removing blood stasis, stopping bleeding, relieving swelling, relieving pain, stopping bleeding, and promoting blood circulation without damaging new. Aloe can purge fire, detoxify, remove blood stasis and kill parasites. The drug theory indicates that Natrii sulfas, for treating heart heat dysphoria and stagnation of five viscera, has the effects of purging heat and relaxing bowels, softening hardness and resolving hard mass, clearing heat and detoxicating, and promoting aging to cause new. Borneol has the effects of clearing heat and relieving pain, and is externally used for relieving swelling, pain and itching. Yan Hu Suoxin powder, bitter and diarrhea and warmth-promoting, which are good medicines for treating both blood and qi, and qi in blood, qi and blood, and relieving pain. Rhizoma Cyperi can promote circulation of qi, relieve depression, regulate menstruation and relieve pain. The qi circulation is then repeated for self-removal. For qi stagnation, it is specially indicated for qi stagnation because of its strong pungent and strong fragrance. .. although it has mild flowing action, the materials are fast enough to keep the property of the materials without dryness and dispersion, so they can be frequently used without abuses%. The whole formula has the effects of clearing away heart-fire, removing toxic materials, relieving swelling and pain, eliminating dampness, relieving itching, removing blood stasis, stopping bleeding, promoting qi circulation and soothing liver.
The traditional Chinese medicine composition disclosed by the invention is accurate in compatibility, can effectively improve symptoms such as anal sinusitis swelling, falling, pain, incomplete defecation and the like, greatly improves the treatment effect of anal sinusitis, and is convenient to clinically use through direct administration (preparation into suppository or gel and other anal administration) to a patient. The invention provides a safe and effective traditional Chinese medicine composition for treating anal sinusitis, and has good application prospect.
It should be apparent that, in light of the foregoing, various modifications, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.
The above-described aspects of the present invention will be described in further detail below with reference to specific embodiments in the form of examples. It should not be understood that the scope of the above subject matter of the present invention is limited to the following examples only. All techniques implemented based on the above description of the invention are within the scope of the invention.
Detailed Description
The materials and equipment used in the embodiments of the present invention are all known products and are obtained by purchasing commercially available products.
EXAMPLE 1 preparation of the Chinese medicinal composition of the invention
The formula (according to the weight parts of the raw materials): 60 parts of bletilla striata, 30 parts of hedgehog skin, 20 parts of raw pollen typhae, 30 parts of climbing groundsel herb, 20 parts of Chinese gall, 20 parts of catechu, 20 parts of pseudo-ginseng, 10 parts of aloe, 30 parts of borneol, 30 parts of radix sophorae flavescentis, 15 parts of sodium sulphate, 30 parts of rhizoma corydalis and 30 parts of nutgrass galingale rhizome.
Preparation method (suppository for example):
The thirteen medicines are respectively crushed into fine powder (100 meshes), sieved and uniformly mixed according to the formula in parts by weight; heating and melting mixed fatty glyceride (as matrix) in water bath at 60-80deg.C, adding above medicinal powder while stirring, grinding with colloid mill, filling into mould at 40-50deg.C, and cooling to obtain suppository containing 3.0g of medicinal powder per granule.
EXAMPLE 2 preparation of the Chinese medicinal composition of the invention
The formula (according to the weight parts of the raw materials): 50 parts of bletilla striata, 25 parts of hedgehog skin, 15 parts of raw pollen typhae, 25 parts of climbing groundsel herb, 18 parts of Chinese gall, 18 parts of catechu, 18 parts of pseudo-ginseng, 8 parts of aloe, 28 parts of borneol, 25 parts of radix sophorae flavescentis, 12 parts of sodium sulphate, 25 parts of rhizoma corydalis and 25 parts of nutgrass galingale rhizome.
The preparation method comprises the following steps: as in example 1.
EXAMPLE 3 preparation of the Chinese medicinal composition of the invention
The formula (according to the weight parts of the raw materials): 30 parts of bletilla striata, 15 parts of hedgehog skin, 10 parts of raw pollen typhae, 15 parts of climbing groundsel herb, 10 parts of Chinese gall, 10 parts of catechu, 15 parts of pseudo-ginseng, 5 parts of aloe, 25 parts of borneol, 15 parts of radix sophorae flavescentis, 5 parts of sodium sulphate, 15 parts of rhizoma corydalis and 15 parts of nutgrass galingale rhizome.
The preparation method comprises the following steps: as in example 1.
EXAMPLE 4 preparation of the Chinese medicinal composition of the invention
The formula (according to the weight parts of the raw materials): 10 parts of bletilla striata, 10 parts of hedgehog skin, 10 parts of raw pollen typhae, 10 parts of climbing groundsel herb, 10 parts of Chinese gall, 10 parts of catechu, 10 parts of pseudo-ginseng, 10 parts of aloe, 10 parts of borneol, 10 parts of radix sophorae flavescentis, 10 parts of glauber salt, 10 parts of rhizoma corydalis and 10 parts of nutgrass galingale rhizome.
The preparation method comprises the following steps: as in example 1.
The beneficial effects of the present invention are demonstrated by specific test examples below.
Test example 1, clinical study
1. Clinical data
150 18-65-Year-old anal sinusitis patients who are collected and treated by 2022, 1 month to 2023, 12 months of traditional Chinese medicine hospitals in south China are selected and randomly divided into an observation group (1), an observation group (2), an observation group (3), an observation group (4) and a control group, wherein 30 patients are in each group. The differences in sex, age and course of disease among the 5 groups are not statistically significant (P > 0.05) and are comparable.
Inclusion criteria:
(1) Anal sinusitis diagnostic criteria: ① There are sense of anal distention, burning sensation in the anus, and there are different degrees of wetness or itching at the anus with tingling pain or dull pain; ② Anal palpation prompts the contraction of the anal orifice during finger diagnosis, and obvious tenderness and induration exist in the diseased anal sinus; ③ Anoscopy suggests that congestion, edema, obvious increase of anal secretions and the like exist in the anal sinus and the anal valve; ④ The probe examination prompts the anal crypt. ①～④ The need is satisfied at the same time.
(2) The study subjects informed and signed the relevant consent.
The above (1) and (2) need to be satisfied simultaneously.
Exclusion criteria:
(1) Patients with other serious anorectal diseases such as anal fissure, anal fistula, perianal abscess, mixed hemorrhoids and the like;
(2) Serious heart, liver, kidney and other viscera dysfunction, AIDS or malignant tumor;
(3) Those who are intolerant to treatment or who are not able to continue to complete treatment;
(4) Other related drug treatments were used within 1 week prior to group entry.
Any one of the above (1) to (4) satisfies, i.e., excludes.
General data for each group of patients is shown in Table 1.
Table 1. General data comparison (n=30, example)
The differences in gender, age, and course of disease between 5 groups were not statistically significant (p < 0.05) by chi-square test and analysis of variance.
2. Therapeutic method
The control group adopts indomethacin Xin Funan oxazolone suppository (national standard of medicine 42022558, of Hubei Dongxin pharmaceutical Co., ltd.) for the treatment of anal diseases. The observation group (1) was given the Chinese medicine suppository according to example 1, the observation group (2) was given the Chinese medicine suppository according to example 2, the observation group (3) was given the Chinese medicine suppository according to example 3, and the observation group (4) was given the Chinese medicine suppository according to example 4. All groups were dosed 2 times (1 granule each time) on 1 day, the anus was tamponade in the morning and evening (post-defecation), and the continuous treatment was carried out for 3 weeks as a treatment course, and the overall treatment effect was observed after one treatment course was ended and the dosing was stopped for 1 week.
3. Observation of clinical efficacy
Standard of efficacy:
And (3) healing: after treatment, each symptom and sign of the patient completely disappear, and normal is indicated by anorectal examination and the like;
the effect is shown: after treatment, each symptom and sign of the patient are obviously improved;
Invalidation: after treatment, the symptoms and signs of the patients are not improved or aggravated.
Total effective rate= (cure+onset)/total case number x 100%.
4. Statistical method
Data processing was performed using SPSS25.0 software, metering data was expressed in (x.+ -.s), counts were expressed in examples (n) and percent (%), and differences were statistically significant in p < 0.05 using the χ2 test.
5. Results
Compared with the control group, the differences of the observation group (1), the observation group (2), the observation group (3) and the observation group (4) have statistical significance (p is less than 0.05), and the total effective rate is higher than that of the control group. See table 2.
TABLE 2 comparison of total effective rate and clinical efficacy (n,%)
The effective and ineffective are two kinds of variables, and the chi-square test is adopted, so that compared with a control group, the observation group (1), the observation group (2), the observation group (3) and the observation group (4) have statistical significance (p < 0.05), and the total effective rate is higher than that of the control group.
Compared with the control group, the observation group (1), the observation group (2) and the observation group (3) have statistical significance (p < 0.05), and the cure rate is higher than that of the control group; the observation group (4) had no statistical significance (p > 0.05) compared to the control group. See table 3.
TABLE 3 clinical efficacy comparison of cure Rate (n,%)
The non-parameter Wilcoxon rank sum test of unidirectional ordered data is adopted, and compared with a control group, the observation group (1), the observation group (2) and the observation group (3) have statistical significance (p < 0.05), and the cure rate is higher than that of the control group; the observation group (4) had no statistical significance (p > 0.05) compared to the control group.
Comparison between observation groups: group (1), group (2), group (3), group (4) for comparison of recovery rates: the cure rate difference among the observation group (1), the observation group (2) and the observation group (3) has no statistical significance (p is more than 0.05); the recovery rates of the observation group (1), the observation group (2), the observation group (3) and the observation group (4) are compared, the differences have statistical significance (p < 0.008), and the recovery rates are higher than those of the observation group (4). See table 4.
TABLE 4 clinical efficacy comparison of cure Rate (n,%)
The check level α=0.05/6=0.008 was corrected using the one-way ordered data non-parametric Wilcoxon rank sum test. The observed group (1), the observed group (2), the observed group (3) and the observed group (4) are compared with each other in terms of cure rate, the difference has statistical significance (p < 0.008), and the cure rate is higher than that of the observed group (4).
6. Conclusion(s)
The results of this study showed that: ① Compared with the control group, the total effective rate of the observation group is higher than that of the control group, and the difference has statistical significance; the cure rates of the observation group (1), the observation group (2) and the observation group (3) are higher than those of the control group, and the difference has statistical significance; the differences in the observation group (4) compared to the control group were not statistically significant. ② Comparison of recovery rates between the observation groups: the recovery rate and the total effective rate difference among the observation groups (1, 2) and (3) have no statistical significance; the recovery rate and the total effective rate of the observation group (1), the observation group (2), the observation group (3) and the observation group (4) are compared, the difference has statistical significance, and the recovery rate and the total effective rate are higher than those of the observation group (4).
Therefore, the traditional Chinese medicine composition has definite curative effect on anal sinusitis.
In conclusion, the traditional Chinese medicine composition disclosed by the invention is accurate in compatibility, can effectively improve symptoms such as anal sinusitis swelling, falling, pain, incomplete defecation and the like, greatly improves the treatment effect of anal sinusitis, and is convenient to clinically use through direct administration (preparation into suppository or gel and other anal administration) to a diseased site. The invention provides a safe and effective traditional Chinese medicine composition for treating anal sinusitis, and has good application prospect.

Claims (10)

1. A traditional Chinese medicine composition for treating anal sinusitis is characterized in that: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:
30-60 parts of bletilla striata, 15-30 parts of hedgehog skin, 10-20 parts of pollen typhae, 15-30 parts of climbing groundsel herb, 10-20 parts of gallnut, 10-20 parts of catechu, 15-20 parts of pseudo-ginseng, 5-10 parts of aloe, 25-30 parts of borneol, 15-30 parts of kuh-seng, 5-15 parts of glauber salt, 15-30 parts of rhizoma corydalis and 15-30 parts of nutgrass galingale rhizome.
2. The traditional Chinese medicine composition according to claim 1, wherein: the traditional Chinese medicine is prepared from the following raw materials in parts by weight:
60 parts of bletilla striata, 30 parts of hedgehog skin, 20 parts of cattail pollen, 30 parts of climbing groundsel herb, 20 parts of Chinese gall, 20 parts of catechu, 20 parts of pseudo-ginseng, 10 parts of aloe, 30 parts of borneol, 30 parts of radix sophorae flavescentis, 15 parts of glauber salt, 30 parts of rhizoma corydalis and 30 parts of nutgrass galingale rhizome.
3. The traditional Chinese medicine composition according to claim 2, wherein: the pollen Typhae is pollen Typhae.
4. The traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that: the preparation is prepared by taking medicinal powder of the raw materials in weight ratio or water and/or organic solvent extracts of the raw materials as active ingredients and adding pharmaceutically acceptable auxiliary materials or auxiliary ingredients.
5. The traditional Chinese medicine composition according to claim 4, wherein: the preparation is an external preparation.
6. The traditional Chinese medicine composition according to claim 5, wherein: the external preparation is in the form of solution, ointment, gel, or suppository.
7. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 6, which is characterized in that: it comprises the following steps:
(1) Weighing the raw materials according to the weight ratio;
(2) The medicine powder of the raw materials, or the water and/or organic solvent extract of the raw materials, and pharmaceutically acceptable auxiliary materials or auxiliary components.
8. The method of manufacturing according to claim 7, wherein: it comprises the following steps:
(1) Pulverizing the raw materials into powder respectively, weighing the raw material powder according to the weight ratio, and uniformly mixing;
(2) Taking the mixed fatty glyceride as a matrix, heating and melting, uniformly mixing with the raw material powder in the step (1), and cooling to obtain the suppository.
9. Use of the traditional Chinese medicine composition according to any one of claims 1-6 in the preparation of a medicament for treating anal sinusitis.
10. Use according to claim 9, characterized in that: the medicine has the effects of clearing heat and detoxicating, eliminating dampness and relieving itching, detumescence and relieving pain, removing blood stasis and stopping bleeding, promoting qi circulation and soothing liver.
CN202410486172.8A 2024-04-22 2024-04-22 Traditional Chinese medicine composition for treating anal sinusitis and preparation method and application thereof Pending CN118178559A (en)

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