Traditional Chinese medicine composition for treating bedsore and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating bedsore and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from, by weight, 10-15 parts of gallnut, 10-15 parts of dried alum and 2-5 parts of common andrographis herb, and the traditional Chinese medicine composition is blended with iodophor with the same volume when used and smeared on an affected part. Clinical tests prove that the traditional Chinese medicine composition for treating bedsore provided by the invention takes effect quickly, is high in total effective rate, has the effect equivalent to that of Pu Ji bedsore ointment, and is short in treatment course, not easy to relapse and free of toxic and side effects on human bodies. Meanwhile, the traditional Chinese medicine composition disclosed by the invention needs a small amount of medicinal materials, and the used medicinal materials are common medicinal materials in pharmacopeia and are easy to purchase. In a word, the traditional Chinese medicine composition provided by the invention has a remarkable treatment effect on bedsore and has a remarkable clinical popularization value.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating bedsores and a preparation method thereof. Background Art

[0002] Bedsores, also known as "pressure sores", are characterized by skin damage and long-term unhealed sores. They are mostly caused by long-term bed rest, poor circulation of qi and blood, and lack of skin nourishment. They are often caused by friction and skin damage and infection. Clinical syndrome differentiation is divided into qi stagnation and blood stasis, toxic accumulation and ulceration, and qi and blood deficiency. Clinically, according to the formation process and severity of bedsores, bedsores are divided into stage I: local skin is intact, with non-fading erythema, which can recover on its own if properly protected; stage II: skin integrity is damaged, local blisters, epidermal shedding can form ulcers; stage III: superficial skin necrosis at the pressure site, black scab-like or subcutaneous fat can be seen, and the skin barrier disappears; stage IV: subcutaneous tissue may be necrotic, and severe cases may develop into osteomyelitis and myelitis, often accompanied by bacterial infection, large amounts of exudate and stench. Once bedsores occur, they are difficult to cure. If secondary infection occurs, the condition may worsen. In severe cases, osteomyelitis, sepsis and hypoproteinemia may even endanger life. About 60,000 people die from complications of bedsores every year, and bedsores have become the number one "killer" of typical bedridden patients. Bedsores not only bring pain to patients, but also directly threaten their lives. For patients who are bedridden for a long time, they also increase their mental and life burdens. At present, there is no very ideal drug for the treatment of bedsores in clinical practice. Western medicine surgical treatment is only for patients with severe conditions, but it is risky and has a large opening, which causes great pain to patients, high costs, and slow healing. The use of antibiotics to treat bedsores is only effective for wound infection, but it affects the healing time of the wound. Most of the existing drugs for treating bedsores in the folk are homemade and self-used, and the required raw materials are relatively large, the individualized treatment is serious, and there is no unified Chinese medicine treatment. Based on this, there is an urgent need to provide a safe and more effective Chinese medicine composition for treating bedsores. Summary of the invention

[0003] The purpose of the present invention is to provide a Chinese medicine composition for treating bedsores and a preparation method thereof, so as to solve the problems existing in the above-mentioned prior art. The Chinese medicine composition of the present invention has a significant therapeutic effect on bedsores and has no toxic side effects on the human body, and has significant clinical promotion value.

[0004] To achieve the above object, the present invention provides the following solutions:

[0005] The invention provides a traditional Chinese medicine composition for treating bedsores. The composition is composed of the following raw materials in parts by weight: 10-15 parts of gallnut, 10-15 parts of alum and 2-5 parts of andrographis paniculata.

[0006] Furthermore, it is composed of the following raw materials in parts by weight: 10 parts of Galla chinensis, 10 parts of Alum and 2 parts of Andrographis paniculata.

[0007] The present invention also provides a method for preparing the Chinese medicine composition, which is characterized by comprising the following steps:

[0008] Take the gallnut and grind it into fine powder of 2-10 μm to obtain the gallnut ultrafine powder;

[0009] Calcine alum, cool it, and grind it into powder to obtain alum powder;

[0010] Grind and dry Andrographis paniculata to obtain Andrographis paniculata crude powder; add ethanol solution to the Andrographis paniculata crude powder, heat to reflux, and filter under reduced pressure to obtain a filtrate; concentrate the filtrate, rotary evaporate, and dry to obtain an Andrographis paniculata extract;

[0011] The Chinese medicine composition is obtained by mixing the superfine powder of Galla chinensis, the alum powder and the Andrographis paniculata extract.

[0012] Furthermore, the calcination temperature is 100-110° C. and the calcination time is 2 hours.

[0013] Furthermore, the Andrographis paniculata is crushed to 20 meshes.

[0014] Furthermore, the volume ratio of the Andrographis paniculata crude powder to the ethanol solution is 1:10, and the volume concentration of ethanol in the ethanol solution is 75%.

[0015] Furthermore, the heating reflux time is 2 hours and the number of times is 2 times.

[0016] The invention also provides application of the traditional Chinese medicine composition in preparing medicine for treating bedsores.

[0017] The present invention also provides a medicine for treating bedsores, comprising the Chinese medicine composition and pharmaceutically acceptable auxiliary materials.

[0018] Furthermore, the dosage form of the drug includes a liquid dosage form for external use.

[0019] The present invention discloses the following technical effects:

[0020] The Chinese medicinal composition for treating bedsores provided by the invention has rapid effect, high total effective rate, and is equivalent to the effect of Puji bedsore cream, and has a short treatment course and is not prone to recurrence.

[0021] The traditional Chinese medicine composition for treating bedsores provided by the present invention requires less medicinal flavors, and the medicinal materials used are all commonly used medicinal materials in pharmacopoeias and are easy to purchase.

[0022] The traditional Chinese medicine composition for treating bedsores provided by the invention has no toxic side effects on human body and has significant clinical promotion value. DETAILED DESCRIPTION

[0023] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as limiting the present invention, but should be understood as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0024] It should be understood that the terms described in the present invention are only for describing a particular embodiment and are not intended to limit the present invention. In addition, for the numerical range in the present invention, it should be understood that each intermediate value between the upper and lower limits of the scope is also specifically disclosed. The intermediate value in any stated value or stated range, and each smaller range between any other stated value or intermediate value in the described range is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the scope.

[0025] Unless otherwise indicated, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail.

[0026] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments of the present invention description without departing from the scope or spirit of the present invention. Other embodiments derived from the present invention description will be apparent to those skilled in the art. The present invention description and examples are exemplary only.

[0027] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0028] Traditional Chinese medicine believes that bedsores are mostly caused by weak qi and blood, qi stagnation and blood stasis, long-term illness and white bed rest, qi and blood stasis in the compressed part, blood stasis, blocked blood vessels, meridian obstruction, qi and blood loss, internal invasion of toxic evil, muscle tendons and bones malnutrition, then ulcers, lingering and difficult to heal. The medicinal taste used in the present invention is as follows: Galla chinensis astringes the lungs and reduces fire, astringes the intestines to stop diarrhea, astringes sweat and stops bleeding, and collects moisture to astringe sores. It is used to treat chronic cough due to lung deficiency, cough with phlegm due to lung heat, chronic diarrhea and dysentery, night sweats, thirst, blood in stool and hemorrhoids, bleeding due to trauma, carbuncle, sore and toxic, and wet and rotten skin. It has little toxic and side effects; alum: sour, astringent, cold, and toxic. It enters the lung, spleen, stomach, and large intestine meridians. It has the effects of eliminating phlegm, drying dampness, stopping diarrhea, stopping bleeding, detoxifying and killing insects. It is mainly used to treat epilepsy, throat paralysis, salivation, hepatitis, jaundice, yellow swelling, gastric and duodenal ulcers, uterine prolapse, leucorrhea, diarrhea, epistaxis, oral sores, hemorrhoids, scabies, water, fire, and insect injuries; Andrographis paniculata can clear away heat and detoxify, reduce inflammation, reduce swelling, and relieve pain. Among them, Galla chinensis is the main drug, Alum is the ministerial drug, and Andrographis paniculata is the adjuvant drug.

[0029] Example 1

[0030] A traditional Chinese medicine composition for treating bedsores comprises the following raw materials in parts by weight: 10 parts of gallnut, 10 parts of alum and 2 parts of andrographis paniculata.

[0031] Preparation method: The gallnut is crushed into 2 μm fine powder by an ultrafine pulverizer to obtain the gallnut ultrafine powder;

[0032] The dried alum was calcined at 110°C for 2h, cooled naturally, and ground to powder and passed through a 120-mesh sieve to obtain dried alum powder;

[0033] The Andrographis paniculata was crushed into 20 meshes, dried and sieved at 65°C to obtain Andrographis paniculata crude powder; 10 times the volume of 75% ethanol solution was added, heated and refluxed for extraction twice, each time for 2 hours, filtered under reduced pressure, the filtrate was combined, the extract was concentrated and then rotary evaporated, and the Andrographis paniculata extract was obtained after drying;

[0034] The Chinese medicine composition is obtained by mixing the superfine powder of Galla chinensis, the alum powder and the Andrographis paniculata extract. When used, it is mixed with an equal volume of iodine tincture and applied to the affected area.

[0035] Example 2

[0036] A traditional Chinese medicine composition for treating bedsores comprises the following raw materials in parts by weight: 12 parts of Chinese gallnut, 12 parts of alum and 4 parts of Andrographis paniculata.

[0037] Preparation method: The gallnut is crushed into 5 μm fine powder by an ultrafine pulverizer to obtain the gallnut ultrafine powder;

[0038] The dried alum was calcined at 105°C for 2h, cooled naturally, and ground to powder and passed through a 110-mesh sieve to obtain dried alum powder;

[0039] The Andrographis paniculata was crushed into 20 meshes, dried and sieved at 45°C to obtain Andrographis paniculata crude powder; 10 times the volume of 75% ethanol solution was added, heated and refluxed for extraction twice, each time for 2 hours, filtered under reduced pressure, the filtrate was combined, the extract was concentrated and then rotary evaporated, and the Andrographis paniculata extract was obtained after drying;

[0040] The Chinese medicine composition is obtained by mixing the superfine powder of Galla chinensis, the alum powder and the Andrographis paniculata extract. When used, it is mixed with an equal volume of iodine tincture and applied to the affected area.

[0041] Example 3

[0042] A traditional Chinese medicine composition for treating bedsores comprises the following raw materials in parts by weight: 15 parts of gallnut, 15 parts of alum and 5 parts of andrographis paniculata.

[0043] Preparation method: The gallnut is crushed into 10 μm fine powder by an ultrafine pulverizer to obtain the gallnut ultrafine powder;

[0044] The dried alum was calcined at 100°C for 2h, cooled naturally, and ground to powder and passed through a 100-mesh sieve to obtain dried alum powder;

[0045] The Andrographis paniculata was crushed into 20 meshes, dried and sieved at 80°C to obtain Andrographis paniculata crude powder; 10 times the volume of 75% ethanol solution was added, heated and refluxed for extraction twice, each time for 2 hours, filtered under reduced pressure, the filtrate was combined, the extract was concentrated and then rotary evaporated, and the Andrographis paniculata extract was obtained after drying;

[0046] The Chinese medicine composition is obtained by mixing the superfine powder of Galla chinensis, the alum powder and the Andrographis paniculata extract. When used, it is mixed with an equal volume of iodine tincture and applied to the affected area.

[0047] Comparative Example 1

[0048] A traditional Chinese medicine composition for treating bedsores comprises the following raw materials in parts by weight: 10 parts of Chinese gallnut and 10 parts of alum.

[0049] Preparation method: The gallnut is crushed into 2 μm fine powder by an ultrafine pulverizer to obtain the gallnut ultrafine powder;

[0050] The dried alum was calcined at 110°C for 2h, cooled naturally, and ground to powder and passed through a 120-mesh sieve to obtain dried alum powder;

[0051] Mix the superfine powder of gallnut and alum powder, add an equal volume of iodine tincture and apply to the affected area.

[0052] Comparative Example 2

[0053] A traditional Chinese medicine composition for treating bedsores comprises the following raw materials in parts by weight: 10 parts of red peony root, 10 parts of alum and 2 parts of andrographis paniculata.

[0054] Preparation method: Red peony root is crushed into 2μm fine powder by ultrafine grinder to obtain red peony root ultrafine powder;

[0055] The dried alum was calcined at 110°C for 2h, cooled naturally, and ground to powder and passed through a 120-mesh sieve to obtain dried alum powder;

[0056] The Andrographis paniculata was crushed into 20 meshes, dried and sieved at 65°C to obtain Andrographis paniculata crude powder; 10 times the volume of 75% ethanol solution was added, heated and refluxed for extraction twice, each time for 2 hours, filtered under reduced pressure, the filtrate was combined, the extract was concentrated and then rotary evaporated, and the Andrographis paniculata extract was obtained after drying;

[0057] Mix red peony root ultrafine powder, alum powder and Andrographis paniculata extract, add an equal volume of iodine tincture and apply to the affected area.

[0058] Effect verification example

[0059] 1. Grouping

[0060] Inclusion criteria: Meet the diagnostic criteria for bedsores in the Traditional Chinese Medicine Industry Standard of the People's Republic of China, "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes";

[0061] Exclusion criteria: patients with malignant tumors; patients who are intolerant to the study drugs; patients with impaired consciousness or mental illness.

[0062] A total of 100 patients were observed, including 36 patients in stage II, 34 patients in stage III, and 30 patients in stage IV. They were randomly divided into 1 experimental group (treated with the Chinese medicine composition prepared in Example 1, including 9 patients in stage II, 8 patients in stage III, and 8 patients in stage IV) and 3 control groups (treated with the Chinese medicine composition prepared in comparative examples 1-2 and the conventional drug Puji bedsore cream, respectively, comparative example 1 group including 9 patients in stage II, 8 patients in stage III, and 8 patients in stage IV; comparative example 2 group including 9 patients in stage II, 9 patients in stage III, and 7 patients in stage IV; Puji bedsore cream group including 9 patients in stage II, 9 patients in stage III, and 7 patients in stage IV), twice a day in the morning and evening, two weeks as a course of treatment, and efficacy evaluation was performed after two weeks.

[0063] 2. Treatment methods

[0064] Patients with stage II bedsores: Perform routine disinfection on the skin around the bedsores, rinse the wound with saline, and apply the corresponding medication;

[0065] Patients with stage III and IV bedsores: Use normal saline and 3% hydrogen peroxide to rinse the wound surface, and then apply the corresponding medicine. If there are blisters, they should be punctured under sterile conditions, the epidermis should be peeled off, and the blister fluid should be drained. If the wound is ulcerated, the pus should be wiped off before applying the medicine.

[0066] 3. Efficacy evaluation criteria

[0067] Refer to the efficacy evaluation criteria for bedsores in the TCM Industry Standard of the People's Republic of China, "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes": Cured: brown erythema subsides, or ulcers heal; Improved: erythema does not completely subside, or slough on the ulcer surface falls off, new flesh grows, and the ulcer surface gradually shrinks; Uncured: The ulcer surface enlarges and the ulceration continues. Both cured and improved are effective.

[0068] During the treatment, clinical symptoms (skin temperature difference, pain level, numbness level, erythema area, and swelling level) were monitored and recorded. SPSS 20.0 software was used to process the data. The quantitative data were expressed as (χ ± s) and t test; the enumeration data were expressed as (%) and χ 2 P<0.05 indicated that the difference was statistically significant.

[0069] Evaluation criteria for each clinical symptom:

[0070] Skin temperature difference: Measure the temperature of the wound surface and surrounding skin tissue, and calculate the skin temperature difference.

[0071] Pain severity: 0: no pain; 1-3: mild pain (no impact on sleep); 4-6: moderate pain (impact on sleep); 7-10: severe pain (severe impact on sleep).

[0072] Numbness level: 0-2: responds well to verbal commands, no sensory impairment, and no limitation in the ability to feel or express pain or discomfort; 3-4: responds to verbal commands, but cannot always express discomfort or needs to turn over, or has some sensory impairment in 1-2 limbs, thus limiting the ability to feel pain or discomfort; 5-7: only responds to pain, cannot express discomfort except groaning or irritability, or 1 / 2 of the body has limited ability to feel pain or discomfort due to sensory impairment; 8-10: has no response to painful stimuli due to decreased perception or taking sedatives, or has little ability to feel pain on most surfaces that contact the bed.

[0073] Erythema area: The longest and shortest diameters of the erythema wound were measured, and the area was calculated by length × width.

[0074] Swelling degree: 0-2: minimal swelling; 3-4: non-pitting edema <4 cm; 5-6: non-pitting edema ≥4 cm; 7-8: pitting edema <4 cm; 9-10: pitting edema ≥4 cm.

[0075] 4. Results

[0076] 4.1 Comparison of clinical symptoms

[0077] As can be seen from Table 1, by comparing the patients in each group, compared with the comparative example, the clinical symptoms of the Example 1 group were significantly alleviated, and the effect was equivalent to that of the Puji bedsore cream. There was no significant difference in skin temperature difference and pain degree between the comparative example 1 and the comparative example 2 groups, while there were significant differences in numbness degree, erythema area and swelling degree.

[0078] Table 1 Comparison of clinical symptoms

[0079]

[0080] 4.2 Comparison of clinical efficacy

[0081] Comparing the patients in each group, the total effective rate of Example 1 group was 96%, which was significantly higher than that of Comparative Examples 1 and 2, and was comparable to the effect of Puji bedsore cream (see Table 2).

[0082] Table 2 Comparison of clinical efficacy

[0083]

[0084] 5. Safety analysis of clinical application

[0085] During the clinical application, the safety of the drug was always observed. No patient had skin rash or other allergic reactions or adverse reactions. Long-term use showed that the Chinese medicine composition provided by the present invention was safe and reliable for clinical application.

[0086] The embodiments described above are only descriptions of the preferred modes of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by ordinary technicians in this field should all fall within the protection scope determined by the claims of the present invention.

Claims

1. A Chinese medicine composition for treating bedsores, It is characterized in that The invention is composed of the following raw materials in parts by weight: 10-15 parts of gallnut, 10-15 parts of alum and 2-5 parts of andrographis paniculata.

2. The Chinese medicine composition according to claim 1, It is characterized in that The invention is composed of the following raw materials in parts by weight: 10 parts of Chinese gallnut, 10 parts of alum and 2 parts of Andrographis paniculata.

3. A method for preparing the Chinese medicine composition according to claim 1, It is characterized in that The following steps are involved: Take the gallnut and grind it into fine powder of 2-10 μm to obtain the gallnut ultrafine powder; Calcine alum, cool it, and grind it into powder to obtain alum powder; Grind and dry Andrographis paniculata to obtain Andrographis paniculata crude powder; add ethanol solution to the Andrographis paniculata crude powder, heat to reflux, and filter under reduced pressure to obtain a filtrate; concentrate the filtrate, rotary evaporate, and dry to obtain an Andrographis paniculata extract; The Chinese medicine composition is obtained by mixing the superfine powder of Galla chinensis, the alum powder and the Andrographis paniculata extract.

4. The preparation method according to claim 3, It is characterized in that The calcination temperature is 100-110° C. and the calcination time is 2 hours.

5. The preparation method according to claim 3, It is characterized in that The Andrographis paniculata is crushed into 20 meshes.

6. The preparation method according to claim 3, It is characterized in that The volume ratio of the crude Andrographis paniculata powder to the ethanol solution is 1:10, and the volume concentration of ethanol in the ethanol solution is 75%.

7. The preparation method according to claim 3, It is characterized in that The heating reflux time is 2 hours and the number of times is 2 times.

8. Use of the Chinese medicine composition according to claim 1 in preparing a medicament for treating bedsores.

9. A medicine for treating bedsores, It is characterized in that The invention comprises the Chinese medicine composition according to claim 1, and pharmaceutically acceptable excipients.

10. The drug according to claim 9, It is characterized in that The dosage form of the drug includes a liquid dosage form for external use.

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