Traditional Chinese medicine composition for adjuvant therapy of alcohol thorns caused by damp-heat and insect toxicity and preparation process of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for adjuvant therapy of hops caused by damp-heat and insect toxicity and a preparation process thereof, and the traditional Chinese medicine composition for adjuvant therapy of hops caused by damp-heat and insect toxicity is mainly prepared from the following traditional Chinese medicine raw materials by weight: 400-600g of radix sophorae flavescentis, 400-600g of cortex phellodendri chinensis, 400-600g of radix stemonae, 300-500g of fructus cnidii, 200-400g of smoked plum, 30-50g of borneol and 15-35g of sulfur. The invention further discloses the preparation method of the traditional Chinese medicine composition for adjuvant therapy of the alcohol thorns caused by damp-heat and insect toxins. The liniment is proper in medicine selection, refined for external use, capable of quickly reaching the affected part with medicine efficacy, quick in effect and convenient to use; both symptoms and root causes can be treated; side effects are few. And the traditional Chinese medicine composition has a remarkable curative effect on acne rosacea (acne rosacea and acne) caused by damp-heat and insect toxicity.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition and its preparation process, and in particular to a traditional Chinese medicine composition for adjuvant treatment of acne caused by damp-heat and insect toxins and its preparation process. Background Art

[0002] There are a variety of existing Chinese and Western medicines for treating acne (also known as acne vulgaris) caused by damp-heat and insect toxins. Among them, there are mainly four categories of Western medicines for treating acne, namely isotretinoin and tretinoin for treating mild to moderate acne, doxycycline and minocycline for treating moderate and severe acne, spironolactone and contraceptives for treating acne with manifestations of high androgen, and glucocorticoids for treating severe nodular acne and conglobate acne. The traditional Chinese medicines for treating acne mainly include Baixiao Dan, Jiawei Xiaoyao Pills, Liuwei Dihuang Pills, and Angelica Tablets, etc. Although these Chinese and Western medicines have significant curative effects, generally speaking, there are still the following deficiencies: some can only relieve the symptoms but not cure the root cause; some have relatively large side effects. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to overcome the deficiencies of the prior art and provide a traditional Chinese medicine composition for adjuvant treatment of acne caused by damp-heat and insect toxins and its preparation process. The traditional Chinese medicine composition of the present invention is used for adjuvant treatment of acne caused by damp-heat and insect toxins, can relieve the symptoms and cure the root cause, has good curative effects, and has few side effects.

[0004] The technical solution adopted by the present invention to solve its technical problems is as follows:

[0005] The traditional Chinese medicine composition (hereinafter referred to as Baibo Liniment) for adjuvant treatment of acne caused by damp-heat and insect toxins of the present invention is mainly made from the following traditional Chinese medicine raw materials in the following weight ratios:

[0006] Sophora flavescens 400 - 600 g, Phellodendron amurense Rupr. 400 - 600 g, Stemona sessilifolia (Miq.) Miq. 400 - 600 g, Fructus Cnidii 300 - 500 g, Fructus Mume 200 - 400 g, Borneol 30 - 50 g, Sulfur 15 - 35 g.

[0007] A more preferred scheme is: Sophora flavescens 450 - 550 g, Phellodendron amurense Rupr. 450 - 550 g, Stemona sessilifolia (Miq.) Miq. 450 - 550 g, Fructus Cnidii 350 - 450 g, Fructus Mume 250 - 350 g, Borneol 35 - 45 g, Sulfur 20 - 30 g.

[0008] A further preferred scheme is: Sophora flavescens 475 - 525 g, Phellodendron amurense Rupr. 475 - 525 g, Stemona sessilifolia (Miq.) Miq. 475 - 525 g, Fructus Cnidii 375 - 425 g, Fructus Mume 275 - 325 g, Borneol 38 - 42 g, Sulfur 22 - 28 g.

[0009] A more preferred formulation is: Sophora flavescens 500 g, Phellodendron amurense Rupr. 500 g, Stemona japonica (Bl.) Miq. 500 g, Cnidium monnieri (L.) Cuss. 400 g, Prunus mume Sieb. et Zucc. 300 g, Borneol 40 g, Sulfur 25 g.

[0010] The preparation method of the traditional Chinese medicine composition (abbreviated as Baibo Liniment) for adjuvant treatment of acne caused by damp-heat and insect toxins of the present invention includes the following steps:

[0011] (1) The Sophora flavescens medicinal materials are cleaned, cut, and dried to obtain clean medicinal materials for standby;

[0012] (2) The Phellodendron amurense Rupr. and Stemona japonica (Bl.) Miq. are cleaned, cut, dried, and pulverized to obtain coarse medicinal powder for standby;

[0013] (3) The Sulfur is cleaned, dried, and pulverized to obtain coarse medicinal powder for standby;

[0014] (4) The Cnidium monnieri (L.) Cuss. and Prunus mume Sieb. et Zucc. are cleaned and dried to obtain clean medicinal materials for standby;

[0015] (5) The six medicinal materials of Sophora flavescens, Phellodendron amurense Rupr., Stemona japonica (Bl.) Miq., Cnidium monnieri (L.) Cuss., Prunus mume Sieb. et Zucc., and Sulfur except Borneol are added with water equivalent to 6 times the total mass of the six medicinal materials and soaked for 0.5 hour, then decocted by heating for 1 hour, and the extract is collected for standby;

[0016] (6) The medicinal materials after the first decoction in step (5) are decocted continuously for 2 times, each time adding water equivalent to 6 times the total mass of the six medicinal materials and decocting for 1 hour, and the extract is collected for standby;

[0017] (7) The three extracts collected in step (5) and step (6) are combined, filtered, and the filtrate is concentrated to a relative density of 1.22 - 1.28 (65 °C), ethanol is added to make the alcohol content reach 75% (volume ratio), stirred evenly, allowed to stand overnight, the supernatant is taken, the precipitate is filtered, the filtrate is combined with the supernatant, the ethanol is recovered until there is no ethanol smell, Borneol is added (Borneol can be dissolved in an appropriate amount of ethanol and then added), and then 2 g of sodium benzoate is added (sodium benzoate can be dissolved in an appropriate amount of hot water and then added), water is added to 1000 ml, stirred evenly, allowed to stand, filtered, and filled to obtain the product.

[0018] Usage of the traditional Chinese medicine composition - Baibo Liniment of the present invention:

[0019] (1) For acne patients, especially young men and women, with acne mainly occurring on the face, forehead, chest, and upper back, the rash is dark red papules, seborrhea, enlarged hair follicle openings, and in severe cases, there are blackhead acne, pustules, nodules, abscesses, pigmentation, and scars, with a chronic course. Apply the medicine to the affected area 4 times a day, and 7 days is a treatment course.

[0020] (2) Rosacea patients who are prone to develop the disease during menopause in women and puberty in men, manifested mainly by erythema of the skin lesions, mostly involving the nasal tip, alae nasi, both cheeks, forehead and other parts. In a few cases, the nose is normal and the disease only occurs on both cheeks and the forehead. Apply the medicine to the affected area 4 times a day, and 15 days is a course of treatment.

[0021] (3) For patients with surface swelling and redness caused by mosquito bites, apply the medicine to the affected area 4 times a day, and 3 - 5 days is a course of treatment.

[0022] In the traditional Chinese medicine composition of the present invention - Baibo Liniment, Sophora flavescens is extremely bitter and cold, with the effects of clearing heat and drying dampness, cooling blood and detoxifying, killing insects and relieving itching, so it is used as the monarch drug; Phellodendron amurense is bitter and cold, with the effects of clearing heat and drying dampness, purging fire and detoxifying, and can clear the accumulated heat in the lung and stomach, strengthening the effect of Sophora flavescens in treating acne and rosacea, thus serving as the minister drug; Cnidium monnieri is pungent, bitter and warm, with the effects of drying dampness and killing insects, relieving itching, and is a commonly used drug for treating eczema, scabies, skin itching and other diseases; Sulfur is hot in nature, and is good at killing insects and relieving itching externally; Fructus Mume is sour, astringent and flat in nature, with the effect of astringing and killing insects, and "Compendium of Materia Medica Seeking Truth" states that it is warm in nature. "Compendium of Materia Medica" records that "Fructus Mume has the effects of killing insects and relieving the toxicity of sulfur"; Since "the lung governs qi, is responsible for dispersing and diffusing, externally combines with the skin and hair, and has its orifice in the nose", Stemona japonica is used to promote the flow of lung qi to disperse the pathogenic heat stagnated in the skin, face and nose, and Stemona japonica also has the effect of killing insects and relieving itching. The above four drugs all help the monarch drug in drying dampness, killing insects and relieving itching, and with the relatively warm nature of these four drugs, it prevents the prescription from being overly bitter and cold, having an effect of mutual restraint, so they are the assistant drugs in the prescription. Borneol in the prescription serves as the envoy drug. Borneol has the effect of dissipating heat and relieving pain externally, so "Compendium of Materia Medica" states that it has the effect of "dispelling stagnant fire". This product is often combined with other heat-clearing and detoxifying drugs and is used externally to treat sores and scabies All the above drugs are combined to achieve the effects of clearing heat and drying dampness, cooling blood and detoxifying, killing insects and relieving itching. It is used for acne (acne vulgaris), rosacea and other diseases caused by dampness and heat in the lung and stomach, and blood heat stagnating in the skin.

[0023] Positive effects: The present invention selects appropriate drugs and refines the liniment for external use, so that the medicinal power can quickly reach the affected area, with quick results, convenient use; it can not only relieve the symptoms but also treat the root cause; and it has few side effects. It has a significant curative effect on acne (rosacea, acne vulgaris) caused by dampness, heat and insect toxins. Detailed implementation mode

[0024] The following further elaborates on the present invention with specific embodiments.

[0025] Embodiment

[0026] The traditional Chinese medicine composition of this embodiment - Baibo Liniment is made from the following traditional Chinese medicine raw materials: 500g of Sophora flavescens, 500g of Phellodendron amurense var. sutchuenense, 500g of Stemona japonica, 400g of Cnidium monnieri, 300g of Fructus Mume, 40g of Borneol, and 25g of Sulfur.

[0027] Preparation method:

[0028] (1) The Sophora flavescens herbs are cleaned, cut, and dried to obtain the cleaned herbs for standby.

[0029] (2) The Phellodendron amurense var. sutchuenense and Stemona japonica are cleaned, cut, dried, and pulverized to obtain the crude powder of the herbs for standby.

[0030] (3) The sulfur is cleaned, dried, and pulverized to obtain the crude powder of the herb for standby.

[0031] (4) The Fructus Cnidii and Fructus Mume are cleaned and dried to obtain the cleaned herbs for standby.

[0032] (5) Six herbs including Sophora flavescens, Phellodendron amurense var. sutchuenense, Stemona japonica, Fructus Cnidii, Fructus Mume, and sulfur except borneol are added with water equivalent to 6 times the total mass of the six herbs and soaked for 0.5 hour, then decocted by heating for 1 hour, and the extract is collected.

[0033] (6) The herbs after the first decoction are continuously decocted 2 times, each time adding water equivalent to 6 times the total mass of the six herbs and decocted for 1 hour, and the extract is collected.

[0034] (7) The three extracts collected are combined, filtered, and the filtrate is concentrated to a relative density of 1.22 - 1.28 (65 °C), ethanol is added to make the ethanol content reach 75% (volume ratio), stirred evenly, left standing overnight, the supernatant is taken, the precipitate is filtered, the filtrate is combined with the supernatant, the ethanol is recovered until there is no ethanol smell, borneol (dissolved in an appropriate amount of ethanol) is added, then 2 g of sodium benzoate (dissolved in an appropriate amount of hot water) is added, water is added to 1000 ml, stirred evenly, left standing, filtered, and filled to obtain the product.

[0035] The clinical efficacy of the traditional Chinese medicine composition - Baibo Liniment in this example was verified, and the results are summarized as follows:

[0036] Clinical data

[0037] There were 187 cases in the treatment group and the control group. 67 cases were observed in the First Affiliated Hospital of Guangxi University of Chinese Medicine, and 60 cases were observed in each of the Second Affiliated Hospital and the People's Hospital of Guangxi Zhuang Autonomous Region.

[0038] I) General information:

[0039] The included observation objects were all male and female patients aged 18 - 65 years old, meeting the diagnostic criteria for acne and rosacea. There were 126 cases in the treatment group, using Baibo Liniment. There were 61 cases in the control group. For acne patients, Weifu Ointment produced by Hunan Tianlong Pharmaceutical Co., Ltd. was used, and for rosacea patients, Fuman Kexing Ointment produced by Xinxiang People's Pharmaceutical Factory of Henan Xinyi Pharmaceutical Group was used.

[0040] II) Diagnostic criteria

[0041] 1. Acne

[0042] 1) Commonly seen in young men and women, it usually starts during puberty and is prone to occur on the face, forehead, chest, and upper back.

[0043] 2) The skin rashes are dark red papules, seborrhea, and enlarged hair follicle openings. In severe cases, there are blackhead acne, pustules, nodules, abscesses, pigmentation, and scars, with a chronic course.

[0044] 3) TCM syndrome differentiation can be divided into:

[0045] ① Syndrome of wind-heat in the lung meridian: Manifested as flushing of the face, hot acne, pain, or pustules, thin yellow tongue coating, red tongue, rapid and thready pulse, etc.

[0046] ② Syndrome of damp-heat in the stomach and intestine: The skin rashes are red and painful, accompanied by constipation, dark urine, poor appetite, abdominal distension, yellow and greasy tongue coating, slippery and rapid pulse, etc.

[0047] ③ Syndrome of spleen dysfunction in transportation: The skin rashes are not brightly red, recurrent, or form cysts, or are accompanied by poor appetite, loose stools, fatigue, thin white tongue coating, soggy and slippery pulse, etc.

[0048] 2. Rosacea

[0049] 1) Prone to occur in female menopause and male puberty.

[0050] 2) The skin lesions are mainly erythema, mostly involving the nasal tip, alae nasi, cheeks, forehead and other parts. In a few cases, the nose is normal and only occurs on the cheeks and forehead.

[0051] 3) According to the symptoms, it can be divided into three types:

[0052] ① Erythematotelangiectatic type: The skin shows diffuse flushing, which is initially transient, appearing and disappearing, and is more obvious when exposed to cold wind, eating spicy and other irritating foods, or when emotionally tense and excited. Over time, it persists. The surface is greasy and smooth, and telangiectasia can be seen. Some cases can develop into the papular type after several years.

[0053] ② Papular type: On the basis of the erythematous patch, scattered acne-like papules or small pustules appear. Some are large and hard papules. There are obvious telangiectasia on the nose, forming intertwined red threads. There is slight itching. The skin color gradually changes from bright red to purple-brown. It can last for many years, and very few cases can develop into the rhinophyma type.

[0054] ③ Rhinophyma type: Clinically rare, mostly in late-stage patients. It is manifested as the enlargement of the papules on the tip of the nose, which can fuse, protrude above the skin surface, the nodules enlarge, the skin thickens, the surface is uneven, and the skin color is purple-red.

[0055] III) Dosage and administration

[0056] Apply an appropriate amount externally, rub it on the affected area, 4 times a day. For acne patients, use it continuously for 7 days. For rosacea patients, use it continuously for 15 days. Before the trial, conduct a detailed physical examination on the subjects routinely, and those who meet the case selection criteria will be included in the observation subjects. After the trial, for acne patients, follow up once on the 3rd and 7th days respectively. For rosacea patients, follow up once every 5 days. Inquire about the medication situation, and record the condition and side effects. The treatment effect is evaluated by the scoring method. The curative effect judgment is directly made by the observer. Do not use other similar drugs during the observation period.

[0057] (IV) Results:

[0058] ◆ Curative effect evaluation criteria

[0059] 1) Acne:

[0060] ① Recent cure: The rash has subsided, and no new rash appears within the course of treatment.

[0061] ② Marked effect: Most of the rashes have subsided, and new rashes occasionally appear within the course of treatment.

[0062] ③ Effective: Some of the rashes have subsided, and new rashes occasionally appear within the course of treatment.

[0063] ④ Ineffective: Those who do not meet the above criteria.

[0064] 2) Rosacea:

[0065] ① Marked effect: Papules and pustules disappear, and erythema and edema are significantly reduced.

[0066] ② Effective: Papules, pustules, erythema and edema are all reduced.

[0067] ③ Ineffective: Those who do not meet the above criteria.

[0068] ◆ Treatment results:

[0069] 1. Comparison of the witness scores before and after treatment: See Table 1

[0070] 2. Comparison of the curative effects between the treatment group and the control group: See Table 2

[0071] (V) Conclusion:

[0072] Baibo Liniment is a pure traditional Chinese medicine preparation for external use. Through clinical observation of 126 cases, and using Weifu Ointment (for acne) and Fuman Kexing (for rosacea), 61 cases as positive controls. The results prove that Baibo Liniment has good therapeutic effects on both acne and rosacea. After treatment, the number of acne reduces, and the swelling, redness and pain are significantly alleviated. For rosacea patients, symptoms such as papules, pustules, erythema and edema in the affected area also improve significantly (P<0.01, see Table 1), suggesting that Baibo Liniment indeed has the effects of clearing heat and drying dampness, cooling blood and detoxifying, killing insects and relieving itching.

[0073] In this group of 126 cases, the total effective rates of acne and rosacea were 92.2% and 95.2%, respectively. The total effective rates of the control group were 86.7% and 90.3%, respectively. There was no significant difference between the two groups (P>0.05, see Table 2). This suggests that the efficacy of Baibai Liniment in treating acne is similar to that of Weifu Cream, and the efficacy of Baibai Liniment in treating rosacea is similar to that of Fudu Kexing.

[0074] Table 1 Comparison of witness scores before and after treatment (X±SD)

[0075]

[0076] Note: P values ​​were all < 0.01 for comparison before and after treatment

[0077] Table 2 Comparison of efficacy between the treatment group and the control group (Ridit analysis)

[0078]

[0079] Note: There was no significant difference in the efficacy among the groups (P>0.05), indicating that the efficacy of the Chinese medicine composition of the present invention was similar to that of the control group.

Claims

1. A Chinese medicine composition for assisting the treatment of alcohol thorns caused by damp-heat and insect poison, characterized in that: It is mainly made of Chinese medicine raw materials in the following weight ratio: Sophora flavescens 400-600g, Phellodendron chinense 400-600g, Stemona japonica 400-600g, Cnidium monnieri 300-500g, Prunus mume 200-400g, Borneol 30-50g, Sulfur 15-35g.

2. The Chinese medicine composition for assisting the treatment of alcohol thorns caused by damp-heat and insect poison according to claim 1, characterized in that: The invention is mainly prepared from Chinese medicinal raw materials in the following weight proportions: 450-550g of Sophora flavescens, 450-550g of Phellodendron chinense, 450-550g of Stemona bulbus, 350-450g of Cnidium monnieri, 250-350g of Prunus mume, 35-45g of Borneolum, and 20-30g of sulfur.

3. The Chinese medicine composition for assisting the treatment of alcohol thorns caused by damp-heat and insect poison according to claim 2, characterized in that: The invention is mainly prepared from Chinese medicinal raw materials in the following weight proportions: 475-525g of Sophora flavescens, 475-525g of Phellodendron chinense, 475-525g of Stemona bulbus, 375-425g of Cnidium monnieri, 275-325g of Prunus mume, 38-42g of Borneolum, and 22-28g of sulfur.

4. The Chinese medicine composition for assisting the treatment of alcohol thorns caused by damp-heat and insect poison according to claim 3, characterized in that: The invention is mainly prepared from Chinese medicinal raw materials in the following weight proportions: 500g of Sophora flavescens, 500g of Phellodendron chinense, 500g of Stemona bulbus, 400g of Cnidium monnieri, 300g of Prunus mume, 40g of Borneolum Syntheticum and 25g of sulfur.

5. A method for preparing a Chinese medicine composition for assisting the treatment of alcohol thorns caused by damp-heat and insect poison as claimed in any one of claims 1 to 4, characterized in that: The following steps are involved: (1) Cleaning, cutting and drying the Sophora flavescens medicinal materials to obtain the clean medicinal materials for later use; (2) Clean, cut, dry and crush the Phellodendron chinense and Stemona tuberosa to obtain a coarse powder for later use; (3) Purify, dry and crush the sulfur to obtain a crude powder for later use; (4) Clean and dry the Cnidium monnieri and Prunus mume to obtain the clean medicinal materials for later use; (5) adding water equivalent to 6 times the total weight of the six medicinal materials, namely, Sophora flavescens, Phellodendron chinense, Stemona tuber, Cnidium monnieri, Prunus mume and sulfur, except Borneolum, soaking for 0.5 hour, heating and decocting for 1 hour, collecting the extract and setting aside; (6) decocting the medicinal materials extracted in step (5) for two more times, adding water equivalent to 6 times the total weight of the six medicinal materials each time, and decocting for 1 hour, collecting the extract and setting aside; (7) The three extracts from step (5) and step (6) are combined and collected, filtered, and the filtrate is concentrated to a relative density of 1.22 to 1.28, ethanol is added to make the alcohol content reach 75%, stirred evenly, allowed to stand overnight, the supernatant is taken, the precipitate is filtered, the filtrate is combined with the supernatant, and the ethanol is recovered until there is no ethanol taste, borneol is added, and then 2 g of sodium benzoate is added, and water is added to 1000 ml, stirred evenly, allowed to stand, filtered, and bottled.

6. The method for preparing the Chinese medicine composition for assisting the treatment of alcohol thorns caused by damp-heat and insect poison according to claim 5, characterized in that: In step (7), borneol is dissolved in ethanol before adding, and sodium benzoate is dissolved in hot water before adding.

Images