A traditional Chinese medicine ointment for treating acne, a preparation method and application thereof

Abstract

The present application relates to a kind of traditional Chinese medicine ointment for treating acne and its preparation method and application, the ointment is prepared from the following components by weight fraction: 12-20 parts of cassia twig, 12-20 parts of white peony root, 9-12 parts of raw rehmannia, 9-12 parts of radix scrophulariae, 9-12 parts of salvia miltiorrhiza, 9-12 parts of chuanxiong, 6-12 parts of prepared pinellia, 3-6 parts of fried licorice root.Compared with prior art, the ointment of the present application can simultaneously exert the synergistic effect of multiple traditional Chinese medicines, and has multiple effects such as regulating ying and wei, clearing heat and cooling blood, resolving phlegm and removing blood stasis, etc., can inhibit the secretion of oil, and improve the immunity of skin, so as to play the role of antibacterial and anti-inflammatory, and can more comprehensively treat acne.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine ointment for treating acne, its preparation method, and its application. Background Technology

[0002] Acne, also known as pimples, is a common skin condition that primarily affects adolescents but can also impact people of all ages. Traditional treatments often rely on chemical drugs, which may have side effects with long-term use. Traditional Chinese medicine (TCM) has a long history of treating acne and possesses unique advantages. In ancient TCM texts, acne is categorized under "lung-wind acne," "facial sores," and "rosacea," with the earliest mention in the *Suwen* (Plain Questions) chapter "On the Circulation of Vital Energy," which states, "When sweating is exposed to dampness, acne and prickly heat arise." The *Yizong Jinjian* (Golden Mirror of Medicine) explicitly mentions the term "lung-wind acne," indicating that its location is in the lungs and related to the accumulation of wind and heat. Furthermore, acne with red, swollen pustules is classified as "heat-toxin sores," while nodules and cysts are related to "phlegm and blood stasis." Clinically, these need to be differentiated based on the characteristics of the skin lesions. The theory of *ying* and *wei* (nutritive and defensive qi) is the core theory of qi and blood circulation in TCM. The *Ling Shu* (Spiritual Pivot), in its chapter "The Meeting of Ying and Wei," states: "Ying (nutritive qi) resides within the vessels, while Wei (defensive qi) resides outside. Ying circulates continuously, reaching its final meeting every fifty cycles." The relationship between imbalance of Ying and Wei and acne includes: Weakness of Wei Qi: When Wei Qi is weak, the pores are not tightly closed, allowing wind, heat, and dampness to easily invade the skin surface, inducing acne; Stagnation of Ying and Blood: Stagnation of Ying Qi leads to poor blood circulation, causing heat toxins and blood stasis to accumulate on the face, forming redness, swelling, and pustules; Imbalance of Ying and Wei leading to metabolic disorders: Modern research suggests that imbalance of Ying and Wei can affect skin microcirculation, sebaceous gland secretion, and keratin metabolism, directly related to the inflammatory response and abnormal follicular keratinization in acne. Traditional Chinese medicine treatment of acne must focus on the core pathogenesis of "imbalance of Ying and Wei," using the harmonization of Ying and Wei as the guiding principle, combined with methods such as clearing heat and detoxifying, promoting blood circulation and removing blood stasis, and strengthening the spleen and resolving dampness, to achieve "treating both internal and external factors." Currently, there is a lack of highly effective, safe, and minimally invasive traditional Chinese medicine combination for treating acne. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine ointment for treating acne, its preparation method and application. The ointment, through the synergistic effect of multiple traditional Chinese medicines, can simultaneously exert multiple effects such as harmonizing the body's vital energy, clearing heat and cooling blood, resolving phlegm and removing blood stasis, inhibiting sebum secretion, and improving skin immunity, thereby playing an antibacterial and anti-inflammatory role and being able to treat acne more comprehensively.

[0004] This invention provides a traditional Chinese medicine ointment for treating acne, which is prepared by weight of the following components: 12-20 parts of cinnamon twig, 12-20 parts of white peony root, 9-12 parts of raw rehmannia root, 9-12 parts of scrophularia root, 9-12 parts of salvia root, 9-12 parts of chuanxiong rhizome, 6-12 parts of prepared pinellia tuber, and 3-6 parts of prepared licorice root.

[0005] Preferably, the ointment is prepared by weight of the following components: 15 parts cinnamon twig, 15 parts white peony root, 12 parts rehmannia root, 12 parts scrophularia root, 9 parts salvia root, 9 parts chuanxiong rhizome, 6 parts prepared pinellia tuber, and 3 parts prepared licorice root.

[0006] The present invention also provides a method for preparing a traditional Chinese medicine ointment for treating acne, comprising the following steps: raw material preparation, medicinal material processing, mixing and decocting, filtering and concentrating, and packaging and storage.

[0007] The present invention also provides the application of a traditional Chinese medicine ointment for treating acne in the preparation of acne treatment agents.

[0008] Preferably, the pharmaceutical preparation further includes a pharmaceutically acceptable carrier and / or excipients.

[0009] Preferably, the pharmaceutically acceptable carrier and / or excipient includes at least one of diluent, binder, surfactant, humectant, adsorbent, lubricant, filler, and disintegrant.

[0010] Preferably, the dosage form of the medicine is a decoction, capsule, granule, tablet, pill, mixture, oral liquid, or an aqueous extract of the above-mentioned raw materials.

[0011] The principle of this invention is as follows:

[0012] The principal herbs are cinnamon twig and white peony root, which harmonize the Ying and Wei, promote Yang and astringe Yin. Cinnamon twig is pungent and warm, promotes Yang, helps Wei Qi to reach the outside, opens the pores to expel evil, and warms the blood vessels to disperse cold stagnation. Its nature is ascending and dispersing, which can guide the medicine to the head and face, targeting the characteristic of acne occurring in the Yang position (face); white peony root is sour and sweet, astringes Yin, benefits Ying and blood to guard the inside, softens the liver and relieves urgency, restrains the pungent and dispersing nature of cinnamon twig, and prevents warm dryness from damaging Yin. The combination of the two originates from the Cinnamon Twig Decoction in the Treatise on Cold Damage, which is a classic pair of herbs for harmonizing Ying and Wei. Cinnamon twig and white peony root have synergistic effects: (1) Harmonizing Ying and Wei: Cinnamon twig promotes Wei Qi, and white peony root nourishes Ying and blood, restoring the balance of Ying and Wei "externally solid and internally guarded", enhancing the skin barrier function and reducing the invasion of external evils (wind, heat and dampness); (2) Regulating Qi and Blood: Cinnamon twig warms and promotes the circulation of Qi and blood, and white peony root nourishes blood to prevent blood heat from running rampant, which fits the core pathogenesis of acne "heat and blood stasis intertwined".

[0013] The accompanying herbs are Rehmannia glutinosa and Scrophularia ningpoensis—clearing heat and cooling blood, nourishing yin and reducing fire. Rehmannia glutinosa, being sweet, cold, and moistening, directly enters the blood, clearing heat and cooling blood, nourishing yin and generating fluids, targeting acne with blood heat and stasis (redness, swelling, pustules, nodules) and excessive heat damaging yin (dry skin, persistent scars). Scrophularia ningpoensis, bitter, salty, and slightly cold, nourishes yin and reduces fire, detoxifies and dissipates nodules, especially effective in clearing floating fire (such as recurrent facial acne). Together with Rehmannia glutinosa, it enhances the blood-cooling and stasis-dispersing effects. The combination of Scrophularia ningpoensis and Rehmannia glutinosa clears heat and toxins from the blood, reducing follicular inflammation (corresponding to modern medicine's "inhibition of Propionibacterium acnes"); it also prevents dryness and yin damage: restraining the warming and drying properties of herbs like Cinnamomum cassia and Pinellia ternata, avoiding long-term use that depletes yin fluids, embodying the holistic view of "harmonizing yin and yang."

[0014] Adjuvant herbs: Danshen, Chuanxiong, and processed Banxia—activating blood circulation and resolving phlegm, eliminating damp-heat. Danshen, bitter and slightly cold, activates blood circulation, removes blood stasis, cools the blood, reduces swelling, improves microcirculation around hair follicles, promotes inflammation absorption, and prevents post-acne pigmentation and scarring. Chuanxiong, pungent and warm, is a "qi-regulating herb in the blood," ascending to the head and face to activate blood circulation and regulate qi. Combined with Danshen, it enhances the ability to disperse blood stasis, targeting nodules and cysts formed by "prolonged acne affecting the collaterals." Processed Banxia: The herbs are pungent, warm, and drying, which can resolve phlegm, relieve nausea and vomiting, and dispel stagnation. They can resolve phlegm and turbidity caused by damp-heat stagnation in the spleen and stomach (such as oily acne and seborrheic dermatitis). They can also clear blockages in the pores. The combination of these three herbs helps to harmonize the Ying and Wei (nutritive and defensive qi) with cinnamon twig and white peony root. In addition, pinellia resolves phlegm, and salvia miltiorrhiza and chuanxiong invigorate blood circulation, which can eliminate the pathological products of "damp-heat → phlegm and blood stasis", which is consistent with the pathogenesis chain of "heat toxin and phlegm and blood stasis" in acne. Chuanxiong ascends to the head and face, guiding the herbs directly to the affected area. Pinellia descends nausea and vomiting, preventing the herbs from spreading too much.

[0015] The guiding herb is prepared licorice root—which harmonizes the other herbs, invigorates qi, and regulates the middle jiao. Prepared licorice root is sweet and neutral, harmonizing the pungent and warm nature of cinnamon twig and the cold nature of raw rehmannia root, making the overall formula balanced in terms of temperature. It also tonifies the spleen and stomach, aids in the transformation of nutrients and qi, and strengthens the foundation of "harmonizing nutrient and qi". In addition, when prepared licorice root is combined with white peony root, it transforms into yin through its sour and sweet properties, enhancing the ability to nourish yin and soften the liver, and alleviating acne induced by liver stagnation transforming into fire (such as stress acne). When combined with pinellia, it alleviates the toxicity of pinellia, protects the spleen and stomach, and prevents dryness and dampness from damaging body fluids. The entire formula revolves around harmonizing the Ying and Wei (nutritive and defensive qi): Cinnamon twig and white peony root form the core, rebuilding the dynamic balance of "Ying-Wei-Qi-Blood-Metabolism" in the skin, fundamentally improving the constitution prone to acne recurrence; it combines clearing and tonifying, attacking without harming the body's vital energy: Rehmannia root and Scrophularia root clear heat and cool the blood without causing stagnation, Salvia miltiorrhiza and Ligusticum chuanxiong invigorate blood without depleting blood, and Pinellia ternata resolve phlegm without depleting Yin, embodying the principle of "eliminating pathogens and supporting the body's vital energy"; it addresses both the upper and lower body, treating both the symptoms and the root cause: For the symptoms: clearing blood heat (Rehmannia root and Scrophularia root), resolving phlegm and blood stasis (Pinellia ternata, Salvia miltiorrhiza, and Ligusticum chuanxiong), quickly relieving redness, swelling, and pustules; For the root cause: harmonizing the Ying and Wei (Cinnamon twig and white peony root), strengthening the spleen and harmonizing the middle jiao (prepared licorice root), regulating immune function and sebum metabolism, reducing recurrence.

[0016] In summary, this invention uses a clear and distinct approach, with the main component being the harmonization of Ying and Wei (nutritive and defensive qi), the secondary component being the clearing of heat and cooling of blood, the auxiliary component being the resolving of phlegm and removing of blood stasis, and the guiding component being licorice root to harmonize the middle jiao (digestive system). This approach aligns with the core pathogenesis of acne, which is "disharmony of Ying and Wei - heat, toxins, phlegm, and blood stasis." Clinically, it can be used for mild to severe inflammatory acne and recurrent cases, and is especially suitable for those with concurrent symptoms of Ying and Wei imbalance, such as dry and oily skin, premenstrual aggravation, and stress-induced acne.

[0017] Compared to the recent patent CN119700864A: Cinnamon twig and white peony root are a classic herbal pair for harmonizing the body's vital energy and blood, enhancing the body's immune function and promoting blood circulation, thereby improving the skin condition of acne patients. Compared to the compound Chinese herbal acne gel mentioned in CN119700864A, the ointment of this invention focuses more on regulating the body's overall functions rather than simply targeting local symptoms. Furthermore, through the synergistic effect of multiple Chinese herbs, the ointment of this invention can simultaneously exert multiple effects such as harmonizing the body's vital energy and blood, clearing heat and cooling blood, and resolving phlegm and removing blood stasis, thus providing a more comprehensive treatment for acne. While the compound in CN119700864A also contains multiple Chinese herbs, its formulation focuses more on clearing heat and detoxifying, and promoting blood circulation and removing blood stasis, with relatively less consideration for harmonizing the body's vital energy and blood, and clearing blood and resolving phlegm. The ointment of this invention is made from pure natural Chinese medicinal materials and contains no chemical additives, therefore having relatively fewer side effects. In contrast, some Western medicine treatments may have significant toxic side effects. For example, oral isotretinoin may cause birth defects and increase blood lipids, while topical hormonal chemicals may cause chronic skin damage.

[0018] Beneficial effects

[0019] Compared with existing technologies, the ointment of the present invention can exert multiple effects such as harmonizing the body's vital energy, clearing heat and cooling blood, resolving phlegm and removing blood stasis through the synergistic effect of multiple Chinese herbs, inhibiting sebum secretion and improving skin immunity, thereby playing an antibacterial and anti-inflammatory role and being able to treat acne more comprehensively. Detailed Implementation

[0020] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the teachings of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined by the appended claims.

[0021] This invention provides a traditional Chinese medicine ointment for treating acne. The ointment is prepared by weight of the following components: 12-20 parts cinnamon twig, 12-20 parts white peony root, 9-12 parts rehmannia root, 9-12 parts scrophularia root, 9-12 parts salvia root, 9-12 parts chuanxiong rhizome, 6-12 parts prepared pinellia tuber, and 3-6 parts prepared licorice root. The preparation method includes the following steps:

[0022] 1. Raw material preparation:

[0023] 1) Raw material selection: Ensuring the purity and absence of impurities in medicinal materials is the foundation for preparing high-quality ointments. By strictly controlling the quality of raw materials, impurities can be avoided during the preparation process, which would affect the purity and efficacy of the ointment.

[0024] 2) Precise weighing: Weigh each medicinal material precisely according to the formula ratio to ensure the stability and consistency of the efficacy.

[0025] 2. Processing of medicinal materials:

[0026] 1) Special processing: For example, Pinellia ternata needs to be processed to eliminate its toxicity and enhance its safety. After processing, the active ingredients of Pinellia ternata can be enhanced, and the efficacy of the ointment can be improved.

[0027] 2) Cleaning and drying: Properly cleaning the medicinal materials removes surface dirt, while drying helps preserve the medicinal materials and facilitates subsequent processing.

[0028] 3. Mixed simmering:

[0029] Mix the prepared medicinal materials evenly, add an appropriate amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 1-2 hours until the liquid is concentrated to an appropriate amount.

[0030] 4. Filtration and Concentration:

[0031] 1) Fine filtration: The decocted medicine needs to be filtered to remove the residue. Fine filtration can remove impurities from the medicine and improve the purity and stability of the ointment.

[0032] 2) Concentration Process: Further concentration to the desired concentration can be achieved by adding appropriate amounts of honey or glycerin as excipients to create an ointment or liquid. Optimizing the concentration process helps improve the concentration and efficacy of the ointment, while also facilitating storage and use.

[0033] 5. Packaging and Storage:

[0034] 1) Aseptic packaging: Ensures that the ointment is not contaminated during the packaging process, which can extend the shelf life of the ointment.

[0035] 2) Store in a cool, dry place: Avoid the ointment from deteriorating due to moisture, high temperature or other factors.

[0036] use:

[0037] Primarily used to treat acne, it has the effects of harmonizing the body's vital energy, clearing heat and cooling the blood, and resolving phlegm and removing blood stasis. When applied topically to the affected area, it can effectively alleviate acne symptoms, promote skin repair, and reduce scar formation.

[0038] The following description is based on specific embodiments:

[0039] Example 1

[0040] Traditional Chinese medicine ointment formula: 15g cinnamon twig, 15g white peony root, 12g rehmannia root, 12g scrophularia root, 9g salvia root, 9g chuanxiong rhizome, 6g prepared pinellia tuber, and 3g prepared licorice root.

[0041] Comparative Example 1

[0042] Traditional Chinese medicine ointment formula: 15g cinnamon twig, 9g white peony root, 12g rehmannia root, 12g scrophularia root, 9g salvia root, 9g chuanxiong rhizome, 6g prepared pinellia tuber, and 3g prepared licorice root.

[0043] Comparative Example 2

[0044] Traditional Chinese medicine ointment formula: Cinnamon twig 9g, white peony root 9g, Rehmannia root 12g, Scrophularia root 12g, Salvia root 9g, Ligusticum root 9g, prepared Pinellia tuber 6g, prepared licorice root 3g.

[0045] Comparative Example 3

[0046] Traditional Chinese medicine ointment formula: 12g Rehmannia glutinosa, 12g Scrophularia ningpoensis, 9g Salvia miltiorrhiza, 9g Ligusticum chuanxiong, 6g Pinellia ternata, and 3g Glycyrrhiza uralensis.

[0047] Application Example 1

[0048] The sample size was 200 participants, aged 15-45 years, excluding those allergic to the herbal ointment described in Example 1 and pregnant women. Among them, 80 patients were aged 15-25, 80 were aged 25-35, and 40 were aged 35-45, with a male-to-female ratio of 1:1. Approximately 70% of the participants had a history of acne for 3-5 years. The sample criteria were: age 15-45 years. A retrospective analysis was conducted with a control group of 100 participants and an experimental group of 100 participants. The control group received minocycline hydrochloride capsules (100 mg × 10 capsules × 1 strip), orally, 100 mg once daily. The experimental group received the herbal ointment described in Example 1 in addition to the treatment given to the control group. Treatment lasted for four weeks. Volunteers were prohibited from using any oil-control products, such as cosmetics, topical medications, or oral health supplements, for 30 days prior to the start of the trial. Before the experiment, the subjects were asked to wash their face and then enter a room at a temperature of 22±1℃ two hours after washing. They were also instructed to apply the product twice a day, once in the morning and once in the evening, and to remain relaxed.

[0049] Clinical assessment of efficacy: Cure is defined as a reduction of over 90% in the rash, with inflammation essentially disappearing and no new rashes appearing; Significant effect is defined as a reduction of 70%-89% in the rash, with significant reduction in inflammation and occasional new rashes appearing; Effective is defined as a reduction of 30%-69% in the rash, with reduction in inflammation and the appearance of new rashes; Ineffective is defined as a reduction of less than 30% in the rash, with inflammation remaining the same or worsening; Total effective rate = 100% - ineffective rate. This determines whether the acne cream is effective in treating the patient's acne, and vice versa.

[0050] Skin lesion scoring: The Global Acne Grading System (GAGS) was used for assessment. The GAGS scoring system divides the face into six regions, and each region is scored based on the type and number of acne lesions (comedones, papules, pustules, nodules, etc.). Scores range from 0 to 4, where 0 indicates no lesions. The sum of the scores from all regions is the patient's total skin lesion score. Specific results are shown in the table below.

[0051] GAGS Assessment Form

[0052]

[0053] Evaluation of efficacy: The overall effective rate in the experimental group was 92%, which was superior to the overall effective rate of 72% in the control group (P<0.05). Clinical observation showed that the effective rates were nearly consistent across different age groups. Regarding skin lesion function assessment, the post-treatment skin lesion score in the experimental group was lower than that in the control group (P<0.05).

[0054] Typical cases using the traditional Chinese medicine ointment of Example 1:

[0055] 1) Zhang**, male, 18 years old, reported a 5-year history of acne. He had previously taken some topical and oral medications, but the effect was not obvious. After using the Chinese herbal ointment twice, the pustules subsided significantly.

[0056] 2) Ms. Sun, 25 years old, reported a 3-year history of acne. She did not pay attention to it at first, but it became more and more serious. Her face even had pigmentation. After applying Chinese medicine ointment for 3 weeks, her acne decreased and her pigmentation also faded.

[0057] 3) Liu**, male, 35 years old, reported a 15-year history of acne. He currently has occasional acne, but his face has a lot of pigmentation. He has used many medications but there has been no significant improvement. After applying a traditional Chinese medicine ointment, his facial acne has almost stopped, but he still has a lot of pigmentation.

[0058] 4) Tang**, female, 20 years old, reported a history of acne for more than a year. She frequently had pustules appearing, and many medications did not show any significant improvement. After applying a traditional Chinese medicine ointment, the acne almost stopped appearing, and her face became much clearer.

[0059] 5) Wang**, female, 25 years old, reported a history of acne for more than 2 years. Small acne bumps would often appear. She had used some topical medications before, but they were not very effective. After applying the Chinese herbal ointment, the small bumps stopped appearing.

[0060] Application Example 2

[0061] The sample size was 150 people. Clinical observations were conducted on the ointments prepared for Comparative Examples 1, 2, and 3, with 50 cases each for each example. The male-to-female ratio and age distribution were similar to those in Application Example 1. Sample conditions were the same as in Application Example 1, including efficacy criteria and ointment application methods. Efficacy evaluation: The overall effective rate for Comparative Example 1 was 84%, for Comparative Example 2 it was 76%, and for Comparative Example 3 it was 72%.

Claims

1. A traditional Chinese medicine ointment for treating acne, characterized in that, The ointment is prepared by weight of the following components: 12-20 parts of cinnamon twig, 12-20 parts of white peony root, 9-12 parts of raw rehmannia root, 9-12 parts of scrophularia root, 9-12 parts of salvia root, 9-12 parts of chuanxiong rhizome, 6-12 parts of prepared pinellia tuber, and 3-6 parts of prepared licorice root.

2. The traditional Chinese medicine ointment for treating acne according to claim 1, characterized in that, The ointment is prepared by weight of the following components: 15 parts cinnamon twig, 15 parts white peony root, 12 parts rehmannia root, 12 parts scrophularia root, 9 parts salvia root, 9 parts chuanxiong rhizome, 6 parts prepared pinellia tuber, and 3 parts prepared licorice root.

3. A method for preparing a traditional Chinese medicine ointment for treating acne as described in any one of claims 1 to 2, characterized in that, The process includes the following steps: raw material preparation, medicinal material processing, mixing and decoction, filtration and concentration, and packaging and storage.

4. The use of a traditional Chinese medicine ointment for treating acne as described in any one of claims 1 to 2 in the preparation of a medicament for treating acne.

5. The application according to claim 4, characterized in that, The pharmaceutical preparation also includes pharmaceutically acceptable carriers and / or excipients.

6. The application according to claim 5, characterized in that, The pharmaceutically acceptable carriers and / or excipients include at least one of diluents, binders, surfactants, humectants, adsorbents, lubricants, fillers, and disintegrants.

7. The application according to claim 4, characterized in that, The dosage form of the medicine is decoction, capsule, granule, tablet, pill, mixture, oral liquid, or water extract of the above raw materials.

Images