A traditional Chinese medicine composition, a traditional Chinese medicine plaster and application for treating precocious puberty in children

Abstract

The present application relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating precocious puberty in children, a traditional Chinese medicine plaster and application. The present application provides a traditional Chinese medicine composition suitable for preparing a traditional Chinese medicine plaster for treating precocious puberty in children, which can effectively treat precocious puberty in children after being prepared into a traditional Chinese medicine plaster. The present application provides an external plaster for children with early breast development, and the plaster has the advantages and characteristics of simplicity, greenness and low cost, and has a wide application prospect.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition, a traditional Chinese medicine plaster, and its application that can be used to treat precocious puberty in children. Background Technology

[0002] Early breast development refers to isolated breast development in girls before the age of 8, without the premature maturation of other secondary sexual characteristics; this is considered pseudoprecocious puberty. Simple early breast development is usually benign, typically manifesting as unilateral breast enlargement, which can be progressive, regress after development, or remain stagnant. Other sexual characteristics develop at the normal age of development. Some children may progress to central precocious puberty. In recent years, the incidence of this condition has been gradually increasing, thus requiring early diagnosis and treatment.

[0003] Premature breast development falls under the category of "mastopathy," and its main pathogenesis includes liver stagnation transforming into fire, yin deficiency with exuberant fire, and phlegm-heat accumulation. Traditional Chinese medicine primarily treats this condition with oral herbal remedies that nourish yin, reduce fire, soften hardened masses, and disperse nodules. However, most children cannot tolerate prolonged oral administration of herbal decoctions; therefore, there is an urgent need to develop an effective topical treatment. Summary of the Invention

[0004] To solve the above-mentioned technical problems, the present invention first provides a traditional Chinese medicine composition, comprising: Vaccaria segetalis, Citrus reticulata leaves, Pharbitis nil, Pharbitis thunbergii, calcined oyster shell and Prunella vulgaris.

[0005] Through extensive screening, this invention has found that the traditional Chinese medicine composition made from the above-mentioned raw materials is suitable for preparing external traditional Chinese medicine plasters and can effectively treat precocious puberty in children.

[0006] Specifically, the traditional Chinese medicine composition of this invention uses Wang Bu Liu Xing (Semen Vaccariae) as its core ingredient. This herb is good at promoting blood circulation and has the functions of activating blood circulation, regulating menstruation, promoting lactation, and reducing swelling. It can directly clear blood stasis in the breast meridians and specifically improve breast pain caused by blood stasis.

[0007] The principal herb is *Vaccaria segetalis*, which has the effects of promoting blood circulation, regulating menstruation, promoting lactation, reducing swelling and dissipating nodules, and relieving pain. It is the core of this formula, as it readily enters the blood, enters the liver meridian, and directly reaches the breast ducts. It clears obstructed qi and blood in the breast, dissipates lumps and stagnation, and relieves breast pain, making it an essential medicine for treating breast lumps, hence its status as the principal herb. The assistant herb is *Citrus reticulata* leaf, whose effects are to soothe the liver, regulate qi, reduce swelling and dissipate nodules. The breast belongs to the liver meridian, and the root cause of breast lumps is often stagnation of liver qi. *Citrus reticulata* leaf specifically enters the liver meridian, regulating qi and relieving stagnation, and clearing the qi mechanism of the breast ducts. *Prunella vulgaris*, bitter and cold, enters the liver and gallbladder, clearing stagnant fire in the liver meridian, resolving phlegm and dissipating nodules. The two herbs combined assist the principal herb in regulating qi and unblocking the meridians. The adjuvant herbs are *Pharbitis nil* and *Pharbitis purpurea* (also known as morning glory seeds), and calcined oyster shell. *Pharbitis nil* is black morning glory seed, and *Pharbitis nil* is white morning glory seed. The two herbs are often used together, and their effects are to drain water, resolve phlegm, dispel blood stasis, and dissipate nodules. Morning glory seeds can expel phlegm and eliminate stagnation, breaking up phlegm and blood stasis in the meridians; when used externally, they can penetrate the skin and collaterals to dissipate local lumps caused by phlegm and blood stasis. Their medicinal properties are smooth and promote the dissipation of phlegm and blood stasis, assisting the principal and assistant herbs in resolving breast lumps. Calcined oyster shell, on the one hand, enhances the overall effect of softening and eliminating lumps, and on the other hand, restrains the harshness of morning glory seeds, together serving as adjuvant herbs.

[0008] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 9-15 parts of Vaccaria segetalis, 9-15 parts of Citrus reticulata leaves, 10-15 parts of Pharbitis nil, 10-15 parts of Pharbitis yedoensis, 15-30 parts of calcined oyster shell, and 15-30 parts of Prunella vulgaris.

[0009] More preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 10-12 parts of Vaccaria segetalis, 10-12 parts of Citrus reticulata leaves, 10-12 parts of Pharbitis nil, 10-12 parts of Pharbitis yedoensis, 20-25 parts of calcined oyster shell, and 20-25 parts of Prunella vulgaris.

[0010] Furthermore, the present invention provides a traditional Chinese medicine preparation, including an extract or extract or particulate matter of the traditional Chinese medicine composition.

[0011] In some embodiments, the particulate matter is in powder form of the traditional Chinese medicine composition.

[0012] Furthermore, the present invention provides a traditional Chinese medicine plaster, wherein the plaster is prepared using the aforementioned traditional Chinese medicine composition as raw material.

[0013] In some embodiments, the raw materials of the traditional Chinese medicine ointment also include: ointment base and liquor.

[0014] Baijiu (a medium for preparing the medicine) can be used as an adjuvant. Baijiu is pungent and warm in nature, and it can promote blood circulation, enhance the efficacy of the medicine, and guide it through the skin and meridians. Baijiu guides the medicine to penetrate the skin and reach the lesion in the breast; it warms and unblocks the meridians, breaks up stagnation of qi and blood, and as an adjuvant, it also helps to promote blood circulation and qi flow.

[0015] Preferably, the plaster base is pine wax.

[0016] Preferably, the liquor is 53% (vol) liquor.

[0017] Preferably, the mass-to-volume ratio of the plaster matrix to the liquor is 1g:(0.5~1.5)mL.

[0018] Preferably, the mass ratio of the plaster matrix to the traditional Chinese medicine composition is 1:(1~3).

[0019] In some embodiments, the preparation method of the traditional Chinese medicine ointment includes: mixing the ground traditional Chinese medicine composition, liquid ointment matrix and white wine.

[0020] In some embodiments, the herbal ointment also includes pharmaceutically acceptable excipients.

[0021] In some implementations, the excipients include matrix-based excipients or functional excipients.

[0022] In some implementations, the matrix-type excipients are used to adjust the paste forming state.

[0023] In some embodiments, the functional excipients are used to adjust performance and efficacy. For example, the functional excipients include, but are not limited to, at least one of thickeners, softeners, fillers, transdermal penetration enhancers, antioxidants, and preservatives.

[0024] Furthermore, the present invention provides a traditional Chinese medicine plaster containing the aforementioned traditional Chinese medicine ointment.

[0025] Preferably, the herbal plaster contains 2-5g of the herbal ointment.

[0026] More preferably, the herbal plaster contains 3-4g of the herbal ointment.

[0027] Preferably, the method for preparing the traditional Chinese medicine plaster is to fill the circular ring in the center of a blank medical non-woven fabric plaster with the traditional Chinese medicine ointment, press it down, and then add an impermeable membrane.

[0028] Furthermore, the present invention provides the application of the aforementioned traditional Chinese medicine composition, the aforementioned traditional Chinese medicine preparation, the aforementioned traditional Chinese medicine ointment, or the aforementioned traditional Chinese medicine plaster in the preparation of a medicine for treating precocious puberty in children.

[0029] In some implementations, the herbal plaster of the present invention can be used in combination with other physical stimulation methods to treat precocious puberty in children.

[0030] Compared with the prior art, the beneficial effects of the present invention are as follows: This invention provides a traditional Chinese medicine composition suitable for preparing a herbal plaster for treating precocious puberty in children. After being prepared into a plaster, this composition can effectively treat precocious puberty in children. This invention also provides a topical plaster for children with early breast development. This plaster has the advantages of being simple, environmentally friendly, and inexpensive, and has broad application prospects. Detailed Implementation

[0031] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of this invention, not all embodiments. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this invention.

[0032] In the embodiments provided in this specification, unless specific techniques or conditions are specified, the techniques or conditions described in the literature in this field, or the product instructions, shall be followed. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels. The following triptorelin was purchased from Chengdu Tiantaishan Pharmaceutical Co., Ltd.: National Drug Approval Number H20058648.

[0033] Example 1 This embodiment provides a traditional Chinese medicine composition, which is composed of the following raw materials: 11g of Vaccaria segetalis, 11g of Citrus reticulata leaves, 11g of Pharbitis nil, 11g of Pharbitis yedoensis, 22g of calcined oyster shell and 22g of Prunella vulgaris.

[0034] Furthermore, in this embodiment, a traditional Chinese medicine plaster was prepared using the above-mentioned traditional Chinese medicine composition as raw material, and the steps are as follows: Grind the above-mentioned Chinese herbal medicine composition to 120 mesh, heat 50g of plaster base (Jiajiachuan brand pine wax base) to liquid state, add 50mL of 53% white wine, add the above-mentioned Chinese herbal medicine composition powder to prepare Chinese herbal medicine plaster; fill 3g of Chinese herbal medicine plaster into the circular ring in the center of a 6cm×6cm medical non-woven fabric blank plaster patch, press it down and add an impermeable membrane to prepare Chinese herbal medicine plaster.

[0035] Example 2 This embodiment provides a traditional Chinese medicine plaster, which differs from Embodiment 1 only in that: Fill the center ring of a 6cm×6cm medical non-woven fabric plaster with 1g of traditional Chinese medicine ointment, press it down, and add an impermeable membrane to make a traditional Chinese medicine plaster.

[0036] Example 3 This embodiment provides a traditional Chinese medicine plaster, which differs from Embodiment 1 only in that: Fill the center ring of a 6cm×6cm blank medical non-woven fabric plaster with 6g of traditional Chinese medicine ointment, press it down, and add an impermeable membrane to make a traditional Chinese medicine plaster.

[0037] Comparative Example This comparative example provides a traditional Chinese medicine composition, which differs from Example 1 only in that: Remove Wang Bu Liu Xing.

[0038] This comparative example provides a traditional Chinese medicine plaster, and the preparation method is the same as in Example 1.

[0039] Test case This experimental example tests the efficacy of the traditional Chinese medicine plasters used in the above-described embodiments and comparative examples in treating precocious puberty (breast development) in children. The steps are as follows: Cases included: Based on the number of cases in the above-described embodiments and comparative examples, the patients were randomly divided into groups, with an additional control group (injected with triptorelin), and 40 patients in each group.

[0040] Treatment regimen: The ages of all cases and the comparative treatment groups were 5–8 (6.63±0.82) years; disease duration was 6–21 (13.61±3.81) months; tumor diameter was 24–37 (30.27±3.83) mm; and body mass index was 15.1–20.4 (17.50±2.68) kg / m². 2 Tanner staging of breast development: 18 cases of stage B2, 18 cases of stage B3, and 4 cases of stage B4; different examples and comparative proportions of traditional Chinese medicine plasters were used, with the plasters applied once every 3 days, twice a week, for 12 consecutive weeks; application method: apply the traditional Chinese medicine plaster to the nodules or painful areas of the child's breast, for 48 hours each time.

[0041] The control group had an age of 5–7 (6.17±0.59) years; a disease duration of 7–22 (14.47±3.74) months; a tumor diameter of 24–39 (30.33±3.90) mm; and a body mass index of 15.3–20.1 (16.90±2.01) kg / m². 2 Breast development was classified into three stages: Tanner stage B2 (18 cases), stage B3 (18 cases), and stage B4 (4 cases). The control group received triptorelin injections during the treatment period, with injections on the day of the first administration, day 14, and day 28, followed by injections every 4 weeks (28 days), consistent with the treatment group. The overall effective rate was the observed outcome indicator. Clinical efficacy was observed before and after treatment. Clinical efficacy observation: After treatment, the efficacy of the children was evaluated according to the relevant literature "Treatment of Simple Premature Glandulation in Girls with Modified Zhi Bai Di Huang Wan Formula". The efficacy was categorized as markedly effective (complete disappearance of the lump), effective (the lump was still palpable, but its size had significantly decreased), and ineffective (the lump was palpable, but its size remained unchanged or even increased). The total effective rate was the percentage of children with markedly effective and effective results out of the total number of children. Statistical analysis was performed using statistical software to compare the differences before and after treatment within and between groups, observing the efficacy and overall symptom regulation of patients before and after medication treatment.

[0042] The test results are shown in Table 1. H is the test statistic of the (Kruskal-Wallis) H test.

[0043] Table 1

[0044] The results show that the total clinical effective rate of the treatment group in all embodiments of the present invention is higher than that of the comparative and control groups, and the improvement of the Tanner stage of breast development is also better than that of the comparative and control groups. This indicates that the traditional Chinese medicine composition and traditional Chinese medicine plaster of the present invention have significant clinical effects in treating early breast development in girls and can effectively improve the breast development of children.

[0045] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, include: Wang Bu Liu Xing, Ju Ye, Hei Chou, Bai Chou, Duan Mu Li, and Xia Ku Cao.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It includes the following components by weight: 9-15 parts of Vaccaria segetalis, 9-15 parts of Citrus reticulata leaves, 10-15 parts of Pharbitis nil, 10-15 parts of Pharbitis yedoensis, 15-30 parts of calcined oyster shell, and 15-30 parts of Prunella vulgaris.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, It includes the following components by weight: 10-12 parts of Vaccaria segetalis, 10-12 parts of Citrus reticulata leaves, 10-12 parts of Pharbitis nil, 10-12 parts of Pharbitis yedoensis, 20-25 parts of calcined oyster shell, and 20-25 parts of Prunella vulgaris.

4. A traditional Chinese medicine preparation, characterized in that, This includes the extract or extract or particulate matter of the traditional Chinese medicine composition according to any one of claims 1 to 3.

5. A traditional Chinese medicine ointment, characterized in that, The herbal ointment is prepared using the herbal composition as described in any one of claims 1 to 3 as raw material.

6. The herbal ointment according to claim 5, characterized in that, The raw materials for the herbal ointment also include: ointment base and white wine.

7. The herbal ointment according to claim 5 or 6, characterized in that, The preparation method of the traditional Chinese medicine ointment includes: mixing the ground traditional Chinese medicine composition, liquid ointment matrix and white wine.

8. The herbal ointment according to claim 5, characterized in that, The herbal ointment also includes pharmaceutically acceptable excipients.

9. A traditional Chinese medicine plaster, characterized in that, It contains the traditional Chinese medicine ointment as described in any one of claims 5 to 8.

10. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3, the traditional Chinese medicine preparation according to claim 4, the traditional Chinese medicine ointment according to any one of claims 5 to 8, or the traditional Chinese medicine plaster according to claim 9 in the preparation of a medicine for treating precocious puberty in children.

Images