阅读说明：本技术 一种用于治疗黄体酮注射导致的臀部硬结的中药组合物及其制备方法与应用 (Traditional Chinese medicine composition for treating hip induration caused by progesterone injection and preparation method and application thereof ) 是由 姚俐 王娜 陈烨 张茂玲 唐纯芳 吴远菲 张曦倩 刘风华 于 2021-08-10 设计创作，主要内容包括：本发明公开了一种用于治疗黄体酮注射导致的臀部硬结的中药组合物及其制备方法与应用,所述中药组合物中含有：防风、乳香、没药、白芷、当归、凤仙透骨草、艾叶、羌活和独活。该中药组合物能够有效治疗肌肉注射黄体酮所导致的臀部硬结,效果明显,起效快,患者接受度高,治疗效果显著。而且,其可以结合中药封包热敷,利用传统中医蒸熨法简化用药难度,患者可居家自行操作,药物组成简单,易于购买,操作便捷,并可反复使用,经济成本低廉,对于长期注射黄体酮后产生的较大、较深的硬结,以及疼痛明显的人群有非常好的治疗效果。(The invention discloses a traditional Chinese medicine composition for treating hip induration caused by progesterone injection and a preparation method and application thereof, wherein the traditional Chinese medicine composition comprises the following components in parts by weight: radix Saposhnikoviae, Olibanum, Myrrha, radix Angelicae Dahuricae, radix Angelicae sinensis, caulis Impatientis, folium Artemisiae Argyi, Notopterygii rhizoma and radix Angelicae Pubescentis. The traditional Chinese medicine composition can effectively treat the hip induration caused by intramuscular injection of progesterone, and has the advantages of obvious effect, quick response, high patient acceptance and obvious treatment effect. Moreover, the traditional Chinese medicine hot compress can be combined with the traditional Chinese medicine packet hot compress, the traditional Chinese medicine steaming and ironing method is utilized to simplify the medicine taking difficulty, a patient can operate at home, the medicine composition is simple, the purchase is easy, the operation is convenient and fast, the medicine can be used repeatedly, the economic cost is low, and the medicine has a very good treatment effect on large and deep induration and obvious pain groups generated after long-term injection of progesterone.)

1. A traditional Chinese medicine composition is characterized by comprising the following components in parts by weight: radix Saposhnikoviae, Olibanum, Myrrha, radix Angelicae Dahuricae, radix Angelicae sinensis, caulis Impatientis, folium Artemisiae Argyi, Notopterygii rhizoma and radix Angelicae Pubescentis.

2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises, by mass: 8-12 parts of divaricate saposhnikovia root, 13-17 parts of frankincense, 13-17 parts of myrrh, 8-12 parts of angelica dahurica, 8-12 parts of angelica, 8-12 parts of garden balsam stem, 8-12 parts of folium artemisiae argyi, 8-12 parts of notopterygium root and 8-12 parts of radix angelicae pubescentis.

3. An external preparation characterized by comprising the Chinese medicinal composition of claim 1 or 2.

4. The external preparation according to claim 3, further comprising an adjuvant;

the adjuvant preferably includes at least one of a preservative, a dispersing agent, a suspending agent, a thickening agent, a solubilizing agent, a wetting agent, a buffering agent, an emulsifying agent, a stabilizing agent, and a transdermal enhancer.

5. The external preparation according to claim 3, wherein the dosage form of the external preparation comprises a patch, a spray, a cream, a drop and a lotion.

6. A method for preparing plaster patch comprises the following steps:

weighing the traditional Chinese medicine composition of claim 2, grinding and crushing, adding a solvent, and preparing an ointment layer;

attaching or smearing the plaster layer on the adhesive layer;

the material of the pasting layer comprises: sol or glue; the material of the adhesive layer is preferably medical sol.

7. The preparation method according to claim 6, wherein a heat generating layer is further provided between the plaster layer and the adhesive layer,

the other side of the plaster layer is also adhered with a heat insulating material;

the heating layer is composed of a packaging material and heating contents;

the packaging material comprises any one of non-woven fabric, spunlace fabric, elastic fabric and polyurethane film;

the heat-generating contents comprise at least one of ferrous iron, activated carbon, vermiculite, sodium chloride and ethanol;

the material of the thermal insulation layer comprises at least one of non-woven fabric and polyethylene.

8. The preparation method according to claim 6, wherein the adhesive layer is provided with air holes;

an anti-seepage material is further attached to one side of the heating layer, which is attached to the plaster layer, and the plaster layer is attached to the anti-seepage material.

9. Use of the Chinese medicinal composition of any one of claims 1-2 for the preparation of a medicament for the treatment of muscle induration;

the muscle induration is preferably a buttock induration caused by progesterone injection.

10. The use according to claim 9, wherein the therapeutic agent is applied by coating or applying to the patient, preferably by hot compress.

Technical Field

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating hip induration after progesterone injection, and a preparation method and application thereof.

Background

Intramuscular injection of progesterone is one of the important luteal phase support modes for in vitro fertilization-embryo transplantation patients, but because progesterone injection has low solubility, high viscosity and difficult diffusion and absorption, after multiple injections at the same part (mainly buttocks), muscle damage, degeneration and atrophy are easily caused, and the change is irreversible. Repeated stimulation for a long time can cause pain, red swelling and induration of an injection part, increase the pain of a patient, influence the treatment compliance of the patient and fail to produce the required curative effect.

In the related art, the commonly used treatment method for the hip induration generated after progesterone injection is as follows: the external application of potato slices, the hot compress of magnesium sulfate, the local irradiation of infrared lamps, massage and the like, but the effects of improving the hip induration by the methods are very limited, the effect is slow, and the patients still have the problems of obvious pain feeling and the like.

Therefore, the development of a medicament capable of quickly relieving or treating the hip induration caused by progesterone injection has extremely important significance for effectively improving the life quality of the in vitro fertilization-embryo transplantation patient and increasing the medication compliance of the in vitro fertilization-embryo transplantation patient.

Disclosure of Invention

The present invention is directed to solving at least one of the problems of the prior art described above. Therefore, the traditional Chinese medicine composition for treating the hip induration caused by progesterone injection and the preparation method and application thereof provided by the invention can quickly relieve or treat the hip induration caused by progesterone injection and reduce the pain, and has very important significance for effectively improving the life quality of in vitro fertilization-embryo transplantation patients and increasing the medication compliance of the patients.

In a first aspect of the present invention, a Chinese medicinal composition is provided, which comprises: radix Saposhnikoviae, Olibanum, Myrrha, radix Angelicae Dahuricae, radix Angelicae sinensis, caulis Impatientis, folium Artemisiae Argyi, Notopterygii rhizoma and radix Angelicae Pubescentis.

The inventor thinks that the hip induration caused by intramuscular injection of progesterone is mostly caused by the fact that tangible objects block qi movement in the theory of traditional Chinese medicine, and qi and blood flow is not smooth and gather to form knots. The inventor considers that the principle of the traditional Chinese medicine treatment is softening hardness to dissipate stagnation, promoting qi circulation to remove blood stasis, and relieving swelling and pain, so that the inventor finds that the combination of the 9 traditional Chinese medicines can achieve the effects of promoting qi circulation to dissipate stagnation, removing blood stasis and relieving pain, thereby generating excellent treatment effect on the hip induration.

Ledebouriella root, pungent and sweet in flavor, warm in nature, enters bladder, liver and spleen meridians. Has the efficacies of relieving exterior syndrome, dispelling wind, eliminating dampness and relieving spasm, and is the key medicine for treating wind and relieving pain. The inventor finds that the divaricate saposhnikovia root has obvious effects of resisting platelet aggregation, showing prothrombin time, reducing blood plasma viscosity and resisting inflammation.

Frankincense: pungent and bitter with slightly warm property, it enters heart, liver and spleen meridians. Has the effects of promoting blood circulation, activating qi-flowing, dredging channels and relieving pain, can reduce swelling and promote granulation when externally used, and is mainly used for treating pain in heart and abdomen, rheumatic arthralgia, traumatic injury, blood stasis and pain, unhealed sore and ulcer and the like.

Myrrh: bitter in taste and neutral in nature, it enters liver, spleen, heart and kidney meridians. Has the effects of removing blood stasis and relieving pain, and can be used for treating traumatic injury, blood stasis, swelling and pain, carbuncle, cellulitis, conjunctival congestion, dysmenorrhea, and promoting granulation.

According to the theory of traditional Chinese medicine, the combination of frankincense and myrrh is the key herb for dredging the viscera and circulating the channels and collaterals, namely, the medicine can treat various pains of the limbs, joints, heart, stomach, hypochondrium and abdomen. The inventor finds that the application of the frankincense and the myrrh in the compound is not the simple addition of the two medicines, and the frankincense and the myrrh are subjected to complicated physical and chemical changes before and after the compatibility, for example, the conductivity of the frankincense and the myrrh is increased after the compatibility (1: 1), and the viscosity and the turbidity of the decoction are changed, which is probably to cause certain insoluble components to better play the role after the compatibility of the medicines. Besides, the frankincense has pharmacological effects of antibiosis, anti-inflammation, anti-tumor, anti-ulcer, antioxidation and the like, the myrrh has the effects of anti-tumor, anticoagulation, analgesia, blood fat reduction and the like, and the combination of the frankincense and the myrrh (1: 1) shows synergistic effect on the inhibition of platelet aggregation and antithrombin activity.

Radix angelicae: pungent in flavor and warm in nature, enter lung, spleen and stomach meridians. Has effects of dispelling pathogenic wind, eliminating dampness, relieving swelling and pain, and can be used for treating headache, supercilium pain, toothache, cold-dampness, abdominal pain, etc.

The main component of radix Angelicae Dahuricae is radix Angelicae Dahuricae coumarin which has pharmacological activities of resisting oxidation, resisting microorganism, resisting virus, resisting coagulation and lowering blood pressure. It is used with radix Saposhnikoviae, and brings out the best in each other, and can exert antipyretic, analgesic and antiinflammatory effects. Especially has obvious inhibition effect on the vasodilatation and exudation of inflammatory tissues.

Chinese angelica: sweet and pungent in flavor, warm in nature, entering liver, heart and spleen meridians. Has effects of replenishing blood, promoting blood circulation, regulating menstruation, relieving pain, loosening bowel, and relieving constipation, and can be used for treating blood deficiency, sallow complexion, giddiness, cardiopalmus, amenorrhea, dysmenorrhea, asthenia cold abdominal pain, rheumatalgia, traumatic injury, etc. And radix Angelicae sinensis has antioxidant, antiaging, antitumor, antiinflammatory, analgesic and antidepressant effects.

Garden balsam stem: bitter and pungent in flavor and warm in nature. Has little toxicity. Can dispel wind-damp, promote blood circulation, remove toxic substance, induce rheumatism and arthralgia, traumatic injury and swelling, amenorrhea, dysmenorrhea, erysipelas, snake and insect bite and other problems. The garden balsam stem has the strongest analgesic effect in the garden balsam stems such as pearl garden balsam stem, iron wire garden balsam stem, sheep horn garden balsam stem, northeast garden balsam stem and the like.

Folium artemisiae argyi: pungent and bitter in flavor, warm in nature, with little toxicity, entering liver, spleen and kidney meridians. It has effects in dispelling cold, relieving pain, warming channels, and stopping bleeding. Can be used for treating lower abdomen psychroalgia, menoxenia, infertility due to cold womb, metrorrhagia, metrostaxis, and metrorrhagia; for external treatment of skin pruritus, vinegar-moxa charcoal can warm meridians to stop bleeding, and can be used for treating deficiency-cold hemorrhage.

The folium Artemisiae Argyi is rich in various bioactive components, and the main effective components of folium Artemisiae Argyi are contained in folium Artemisiae Argyi volatile oil, and have antiinflammatory, antibacterial, analgesic, tranquilizing, and antiasthmatic effects. The folium artemisiae argyi contains more ene terpenoid compounds, can change keratin conformation and properties in cells of stratum corneum and relax bonding force among keratin, forms a micropore channel and increases the permeability of the medicine through intracellular pathways.

Notopterygium root: pungent and bitter with warm nature. It enters bladder and kidney meridians. Has effects in dispelling cold, expelling pathogenic wind, removing dampness, and relieving pain. Can be used for treating wind-cold type common cold, headache, rheumatalgia, and soreness of shoulder and back.

Radix angelicae pubescentis: pungent and bitter with slightly warm nature. It enters kidney and bladder meridians. It has effects in expelling pathogenic wind, removing dampness, relieving arthralgia, and relieving pain. Can be used for treating arthralgia due to wind-cold-dampness, lumbago, gonalgia, and headache due to wind-cold-yin deficiency.

In the invention, the radix angelicae pubescentis and the notopterygium root are used as a medicine pair, the two medicines are combined and mutually reinforced, which belongs to the mutual reinforcement in seven emotions, the notopterygium root is good at moving upper energizer and removing parietal pain, and the radix angelicae pubescentis is good at moving lower energizer and has good effect on lower limb pain. The two herbs are combined together to treat wind-syndrome of foot yin deficiency and wind-syndrome of foot yang deficiency, so as to enhance the actions of dispelling wind-damp, relieving arthralgia and alleviating pain, and to treat the disease location of exterior, interior and exterior. The combination of the above medicines can promote qi circulation, remove blood stasis, relieve swelling and pain, soften hardness and dissipate stagnation, and has excellent curative effect. The combined use of the radix angelicae pubescentis and the notopterygium root has stronger drug effect than the use of single drugs thereof, and can inhibit the abnormal secretion of interleukin, tumor necrosis factor-alpha and prostaglandin E2. From the aspect of the material basis of the medicines, the fact that the original components of the radix angelicae pubescentis and the notopterygium root disappear when the radix angelicae pubescentis and the notopterygium root are used together, but new chemical components are generated proves that the combination of the two medicines is stronger than the rationality of single administration.

Therefore, the combined use of the traditional Chinese medicines has excellent effects of relieving swelling and pain, softening hardness and dissipating stagnation no matter from the aspects of mutual reinforcement and compatibility of the traditional Chinese medicines, or from the aspects of modern medical pharmacology and substance research foundation.

According to the first aspect of the present invention, in some embodiments of the present invention, the traditional Chinese medicine composition comprises, by mass: 8-12 parts of divaricate saposhnikovia root, 13-17 parts of frankincense, 13-17 parts of myrrh, 8-12 parts of angelica dahurica, 8-12 parts of angelica, 8-12 parts of garden balsam stem, 8-12 parts of folium artemisiae argyi, 8-12 parts of notopterygium root and 8-12 parts of radix angelicae pubescentis.

In some preferred embodiments of the present invention, the traditional Chinese medicine composition comprises, by mass: 10 parts of divaricate saposhnikovia root, 15 parts of frankincense, 15 parts of myrrh, 10 parts of angelica dahurica, 10 parts of angelica, 10 parts of garden balsam stem, 10 parts of folium artemisiae argyi, 10 parts of notopterygium root and 10 parts of radix angelicae pubescentis.

In a second aspect of the present invention, there is provided an external preparation comprising the Chinese medicinal composition according to the first aspect of the present invention.

According to a second aspect of the invention, in some embodiments of the invention, the topical formulation further comprises an adjuvant.

In some preferred embodiments of the present invention, the adjuvant comprises at least one of a preservative, a dispersing agent, a suspending agent, a thickening agent, a cosolvent, a wetting agent, a buffer, an emulsifier, a stabilizer, and a transdermal enhancer.

Of course, other adjuvants can be added reasonably by those skilled in the art according to the actual use requirement to enhance or promote the generation of the drug effect.

According to a second aspect of the present invention, in some embodiments of the present invention, the dosage form of the external preparation includes a patch, a spray, a cream, a drop and a lotion.

Of course, the skilled person can select other formulation according to the actual use requirement to enhance or promote the generation of the drug effect.

In a third aspect of the present invention, there is provided a method for producing a plaster, comprising the steps of:

weighing the traditional Chinese medicine composition of the first aspect of the invention, grinding and crushing, adding a solvent, and preparing an ointment layer;

and attaching or smearing the plaster layer on the adhesive layer.

According to a third aspect of the present invention, in some embodiments of the present invention, the material of the adhesive layer is sol or glue.

In some preferred embodiments of the present invention, the material of the adhesive layer is medical sol.

According to a third aspect of the present invention, in some embodiments of the present invention, a heat generating layer is further provided between the plaster layer and the adhesive layer.

According to a third aspect of the present invention, in some embodiments of the present invention, the other side of the plaster layer is further attached or coated with a heat insulating material, and the packing material includes any one of a non-woven fabric, a spunlace fabric, an elastic fabric, and a polyurethane film.

In some preferred embodiments of the invention, the packaging material is a nonwoven fabric.

In some preferred embodiments of the present invention, the heat generating contents include at least one of ferrous iron, activated carbon, vermiculite, sodium chloride, and ethanol.

In some preferred embodiments of the present invention, the material of the thermal insulation layer includes at least one of non-woven fabric and Polyethylene (PE).

In some preferred embodiments of the present invention, the adhesive layer is provided with air holes for allowing air to sufficiently contact with the heat generating layer to react and release heat.

Of course, according to the actual use requirement, the technical personnel in the field can reasonably set the air holes with different numbers and/or different shapes and/or different sizes, thereby meeting the condition requirement of fully contacting the air and the heating layer.

In some preferred embodiments of the present invention, a barrier material is further attached to one side of the heat-generating layer to which the plaster layer is attached, and the plaster layer is attached to the barrier material.

The barrier material includes a pearlescent coating and a conventional non-toxic waterproof material, and is intended to prevent penetration of the plaster into the heat-generating layer.

In some preferred embodiments of the invention, the barrier material is a pearlescent coating.

In some preferred embodiments of the present invention, the method for preparing the plaster patch specifically comprises:

the heat insulating material, the plaster layer, the heating layer and the sticking layer are sequentially stuck together.

The heat insulation material is formed by compounding a non-woven fabric (also called non-woven fabric) and a PE protective film (a PE protective film is attached to one side of the non-woven fabric), the non-woven fabric is purchased from Jialianda non-woven fabric company, the self-adhesive PE protective film is purchased from Shenzhen Shenhua, and of course, other materials with similar heat insulation functions can be adopted by those skilled in the art as a substitute. The heat insulation protective layer can be directly contacted with the skin, so that the trace left after the hot application is avoided, meanwhile, the PE protective film can control the temperature of the hot application in the range that a human body feels comfortable, and the scalding risk caused by overhigh temperature is avoided.

The preparation method of the plaster layer comprises the following steps: according to the formula of the traditional Chinese medicine composition of the first aspect of the invention, all traditional Chinese medicinal materials are weighed and ground into fine powder (the particle size reaches 60 meshes or more). Weighing 30 parts of medical vaseline by mass, heating to melt the medical vaseline, fully mixing the medical vaseline with the ground raw materials, and stirring to obtain a paste.

A heat generation layer: the self-heating layer consists of a wrapping material and self-heating filler, and the self-heating filler is completely wrapped in the wrapping material. The wrapping material may include conventional materials such as non-woven fabric, and the surface of the wrapping material is coated with a barrier material to prevent the contents from leaking out. Wherein, in the embodiment of the invention, the wrapping material is a PET non-woven cloth bag, and the size is as follows: 10X 10cm, purchased from bamboo kitchen supplies in Ruichang City. The anti-seepage material adopts a pearly-lustre anti-seepage film (pearly-lustre coating) and is purchased from macro-flying geotextile factories. The auto-heating filler may be a self-heating material conventional in the art, including but not limited to: the heating bag comprises reduced iron powder, activated carbon, expanded vermiculite, crude salt, water, industrial ethanol and the like, wherein the mixing proportion of the reduced iron powder, the activated carbon, the expanded vermiculite, the crude salt, the water, the industrial ethanol and the like can be obtained by proportioning or adjusting conventional heating bags in the field, and the generated heating temperature and the hot compress duration time can be obtained by adjusting the mixing proportion according to the self requirements of users. In the embodiment of the invention, the self-heating filler is iron powder.

One side of the heating layer is adhered on the adhesive layer, and the other side is coated with the plaster layer. Of course, those skilled in the art can also directly purchase a commercially available self-heating bag as the self-heating layer.

And (3) sticking a layer: the sticking layer is the outermost layer of the Chinese medicinal plaster, and the area of the sticking layer is obviously larger than that of other three-layer structures, so that the sticking layer can have enough area to contact with the skin and stick the whole Chinese medicinal plaster on the skin. The pasting layer is provided with an air hole for the heating layer to fully contact with air to react and release heat. The sticking layer can be completely wrapped and covered on the heating layer (except the side stuck with the pearl coating) to prevent the heating layer from contacting with the skin and damaging the skin.

The material of the adhesive layer can be prepared from various sols and viscose, and the most preferable material is medical sol. In the embodiment of the invention, the adhesive layer is the medical skin-color adhesive tape which is purchased from Jiangsu Hongsheng biology.

The heat insulation protective layer, the self-heating layer and the adhesive layer in the embodiment of the invention can be obtained by purchasing commercially available products.

In a fourth aspect of the present invention, there is provided an application of the Chinese medicinal composition of the first aspect in preparing a medicament for treating muscle induration.

According to a fourth aspect of the invention, in some embodiments of the invention, the muscle induration is a buttock induration resulting from progesterone injection.

According to a fourth aspect of the present invention, in some embodiments of the present invention, the method of using the therapeutic agent is topical application of a film or patch to a patient.

In some preferred embodiments of the present invention, the method of using the therapeutic agent is hot compress.

The inventor thinks that the buttock induration caused by intramuscular injection of progesterone belongs to the category of qi and blood stasis and accumulated heat, and pain is caused by obstruction. After the progesterone is injected into the buttocks, the liquid medicine is accumulated, so that qi and blood channels are blocked, qi movement is not smooth, and visible substances block qi movement, so that blood circulation is affected, and local induration and pain are aggravated. Therefore, the traditional Chinese medicine composition is placed on a pain part after being heated by using a dispensing principle based on softening hardness to dissipate stagnation and promoting qi circulation to remove blood stasis in combination with a steaming and ironing method of the traditional Chinese medicine, and local capillary vessels of the skin are expanded and blood circulation is accelerated through temperature, so that the treatment method of dredging channels and regulating collaterals, and dispelling cold to relieve pain is achieved. In the related art, no report on the traditional Chinese medicine package therapy for treating muscle induration appears.

The invention has the beneficial effects that:

1. the traditional Chinese medicine composition disclosed by the invention can effectively treat hip induration caused by intramuscular injection of progesterone, and is obvious in effect, quick in effect, high in patient acceptance and remarkable in treatment effect.

2. The traditional Chinese medicine composition disclosed by the invention can be combined with traditional Chinese medicine package hot compress, the traditional Chinese medicine steaming and ironing method is utilized to simplify the medicine taking difficulty, a patient can operate at home, the medicine composition is simple, the purchase is easy, the operation is convenient and fast, the repeated use is realized, the economic cost is low, and the traditional Chinese medicine composition has a very good treatment effect on large and deep induration and obvious pain groups generated after long-term progesterone injection.

3. The plaster patch is simple and convenient to use, the existing self-heating bag is utilized, after the packaging bag is opened, air enters the self-heating bag to generate heat, so that the heat is utilized to promote a plaster layer to exert medicine properties and directly reach a focus, and local skin blood vessels are expanded, so that a continuous hot compress effect is achieved, the heat is stable in heating, the duration is controllable, when the hot compress is used, the plaster patch can freely move, the working life is not influenced, good preventive treatment can be performed on people who just start to inject progesterone, and the plaster patch also has an excellent curative effect on people with small induration and a small induration range.

Drawings

Fig. 1 is a schematic structural diagram of a plaster in an embodiment of the present invention, wherein the structure is a heat insulation layer, a plaster layer, a heating layer and an adhesive layer from top to bottom.

Detailed Description

In order to make the objects, technical solutions and technical effects of the present invention more clear, the present invention will be described in further detail with reference to specific embodiments. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.

The experimental materials and reagents used are, unless otherwise specified, all consumables and reagents which are conventionally available from commercial sources.

Example 1

A traditional Chinese medicine composition for treating hip induration caused by progesterone injection comprises the following components in parts by mass: 10 parts of divaricate saposhnikovia root, 15 parts of frankincense, 15 parts of myrrh, 10 parts of angelica dahurica, 10 parts of angelica, 10 parts of garden balsam stem, 10 parts of folium artemisiae argyi, 10 parts of notopterygium root and 10 parts of radix angelicae pubescentis.

Can adopt encapsulation hot compress to treat buttock induration that progesterone injection caused, and the concrete step is:

grinding and pulverizing the Chinese medicinal materials in the Chinese medicinal composition, mixing, and packaging in non-woven fabric packaging bag (the size of the packaging bag is about 10 × 10 cm-15 × 15cm (length × width)). Steaming the packaging bag containing the Chinese medicinal composition, standing, cooling to acceptable temperature of skin surface, and applying on the part with nodes or pain on buttock.

The Chinese medicinal packet can be heated repeatedly for 1-2 times.

Example 2

A traditional Chinese medicine composition for treating hip induration caused by progesterone injection comprises the following components in parts by mass: 8 parts of divaricate saposhnikovia root, 13 parts of frankincense, 13 parts of myrrh, 8 parts of angelica dahurica, 8 parts of angelica, 8 parts of garden balsam stem, 8 parts of folium artemisiae argyi, 8 parts of notopterygium root and 8 parts of radix angelicae pubescentis.

Encapsulation heat application can be used to treat hip induration caused by progesterone injections, as shown in example 1.

Example 3

A traditional Chinese medicine composition for treating hip induration caused by progesterone injection comprises the following components in parts by mass: 12 parts of divaricate saposhnikovia root, 17 parts of frankincense, 17 parts of myrrh, 12 parts of angelica dahurica, 12 parts of angelica, 12 parts of garden balsam stem, 12 parts of folium artemisiae argyi, 12 parts of notopterygium root and 12 parts of radix angelicae pubescentis.

Encapsulation heat application can be used to treat hip induration caused by progesterone injections, as shown in example 1.

Example 4

A Chinese medicinal patch (hot compress patch) comprises 4 layers of structures, wherein the side closest to human skin is the inner side, and the inner side sequentially comprises: a heat insulation layer, a plaster layer, a heating layer and an adhesive layer.

The heat insulation layer is formed by compounding non-woven fabrics (also called non-woven fabrics, purchased from Jialianda non-woven fabrics company) and PE protective films (purchased from Shenzhen Huazhen), and the specific preparation method comprises the following steps: a PE protective film is attached to one side of the non-woven fabric. The insulating layer can be direct and skin contact, can avoid leaving the vestige after the hot compress application is applied, and the PE protection film can make the temperature control of hot compress application feel more comfortable scope at the human body simultaneously, the scald risk that arouses when avoiding the high temperature.

The preparation method of the plaster layer comprises the following steps: weighing the traditional Chinese medicinal materials according to the formula of the traditional Chinese medicine composition in the embodiment 1, and grinding the traditional Chinese medicinal materials into fine powder (the particle size reaches 60 meshes or more). Weighing 30 parts of medical vaseline by mass, heating to melt the medical vaseline, fully mixing the medical vaseline with the ground raw materials, and stirring to obtain a paste.

A heat generation layer: the self-heating layer consists of a wrapping material and self-heating filler, the self-heating filler is completely wrapped in the wrapping material, and the surface of the wrapping material is coated with an impermeable material to prevent the content from seeping out.

The preparation method comprises the following steps: a PET non-woven cloth bag (with the size of 10 multiplied by 10cm, purchased from bamboo-based kitchen supplies store in Ruichang city) is taken, self-heating materials are loaded (the loaded materials in the embodiment are iron powder, certainly, other heating materials in the field can be adopted by technical personnel in the field, including but not limited to reduced iron powder, activated carbon, expanded vermiculite, crude salt and the like, the mixing proportion of the materials can be obtained by proportioning or adjusting the conventional heating bag in the field, the generated heating temperature and the hot compress duration time can be obtained by adjusting the mixing proportion according to the requirements of users), one side for coating a plaster layer is attached with a layer of pearl coating (the plaster layer is coated on the pearl coating) to prevent the plaster from permeating into the heating layer, and the other side is not required to be attached with the pearl coating.

Of course, those skilled in the art can also directly purchase a commercially available self-heating bag as the self-heating layer.

And (3) sticking a layer: the adhesive layer is the outermost layer of the Chinese medicinal plaster, and the area of the adhesive layer is significantly larger than that of other three-layer structures, so that the adhesive layer can have enough area to contact with the skin and adhere the whole Chinese medicinal plaster to the skin. The pasting layer is provided with an air hole for the heating layer to fully contact with air to react and release heat. The sticking layer can be completely wrapped and covered on the heating layer (except the side stuck with the pearl coating) to prevent the heating layer from contacting with the skin and damaging the skin.

The material of the adhesive layer can be prepared from various sols and viscose, and the most preferable material is medical sol. In this embodiment, the adhesive layer is a medical skin-tone adhesive tape (purchased from Jiangsu Hongsheng biology).

The heat insulation layer, the heating layer and the sticking layer in the embodiment can be obtained by purchasing commercially available products.

The structure schematic diagram of the traditional Chinese medicine plaster in the embodiment is shown in fig. 1.

Effect testing

(1) Clinical cases:

the clinical test was carried out using the Chinese medicinal composition of example 1, in the following specific cases:

case 1:

basic conditions are as follows: for a women aged 35 years, 23 days after in vitro fertilization-embryo transfer, progesterone was injected continuously for 26 days, and the left hip part was seen with a macroscopic induration size of about 5 × 5cm, with deep induration sites with significant pain.

Treatment of the condition: after 3 days of enclosure heat application using the Chinese medicinal composition of example 1, the left hip induration was about: 4.5 × 3cm, and the left buttock induration is about 2 days after the hot compress of the traditional Chinese medicine composition is continued: 1 x 2cm, during the administration period, the patient still needs to inject progesterone every day, but the induration range is not enlarged any more, and the pain is obviously disappeared.

Case 2:

basic conditions are as follows: women, 27 years old, 28 days after ivf-embryo transfer, had been injected with progesterone continuously for 24 days, with the left hip visible to the naked eye with a induration size of about: 1.5X 1cm, right hip induration size about: 2X 1.5 cm.

Treatment of the condition: after 1 day of hot compress using the herbal composition of example 1, the left hip induration was about: 0.5X 0.5cm, right induration size about: 1 × 0.5cm, and when the composition is continuously applied for 2 days, the left side hard knot disappears completely, and when the composition is applied for 5 days, the right side hard knot disappears.

(2) And (3) population test:

in order to further show the treatment effect of the traditional Chinese medicine composition in the above examples, 120 cases of patients who are treated by intramuscular injection of progesterone for miscarriage prevention in the reproductive center of the maternal and child care institute in Guangdong province from 3 months in 2021 to 6 months in 2021 were randomly selected.

The inclusion criteria were:

a. the luteal support scheme in the fresh embryo transfer cycle or the freeze-thaw embryo transfer cycle is selected from the group of people who inject progesterone intramuscularly;

b. the content of Human Chorionic Gonadotropin (HCG) in blood is more than 50IU/L on the pregnancy test day;

c. the continuous injection time of the progesterone is 20-60 days.

Exclusion criteria:

a. people with extremely sensitive skin;

b. people who have used other intramuscular injections of drugs before progesterone injection;

c. people with skin diseases such as ulceration and herpes on the surface of the buttocks.

120 patients were randomly divided into treatment groups, observation 1 group, observation 2 group, and observation 3 group, each of which was 30 patients.

The treatment method of each group is as follows:

treatment groups: the preparation and application methods of the above-mentioned Chinese medicinal composition and package in example 1 are the same as those in example 1.

Observe 1 group: the control Chinese medicine packet No. 1 is used, and the preparation and the use method of the packet are the same as those of the embodiment 1; the control traditional Chinese medicine package No. 1 contains 15 parts of divaricate saposhnikovia root, 10 parts of frankincense, 15 parts of dahurian angelica root, 5 parts of Chinese mugwort leaf and 15 parts of pubescent angelica root by mass.

Observation 2 groups: the control Chinese medicine packet No. 2 is used, and the preparation and the use method of the packet are the same as those of the embodiment 1; the control traditional Chinese medicine package No. 2 contains 15 parts by mass of myrrh, 15 parts by mass of angelica, 15 parts by mass of garden balsam stem and 15 parts by mass of notopterygium root.

Observe 3 groups: blank control group.

The treatment groups, observation group 1 and observation group 2 were heated with corresponding Chinese medicinal packet for 30 min after daily progesterone injection, and observation group 3 was not heated with any medicine, but heated with hot towel for 30 min after progesterone injection.

Changes in each test index (diagnosis of hip induration, pain score and early abortion rate) were examined for 60 consecutive days.

The evaluation criteria for each test index are as follows:

a. diagnosis of hip induration:

i degree: the diameter of the hard knot is 1-3 cm; II degree: the diameter of the hard knot is 3-5 cm; and (3) III degree: the diameter of the hard knot is more than 5 cm.

b. Pain scoring:

and evaluating by adopting a visual analogue scoring method (VAS), wherein the total score is 0-10, the higher the score is, the more obvious the pain feeling is, and meanwhile, the pain fading time of the patient is recorded. The result takes the median.

c. Early fluid yield:

the data of each detection is analyzed by SPSS 23.0 software, the measured data is expressed by mean + -standard deviation (x + -s), the comparison between two groups adopts t test, the comparison between multiple groups adopts one-factor variance analysis (F value), and the comparison between two groups adopts LSD method. If the data does not satisfy the homogeneity test for variance, the Kruskal-Wallis test method (H value) is used. The description of the counting data uses the percentage [ n (%)]Denotes, adopts ײTest (X)²). The difference is statistically significant with P < 0.05.

The results are shown in tables 1 and 2.

TABLE 1 comparison of the hardiness degree ratios between the groups

Wherein denotes p < 0.01.

It can be found that, comparing the proportion and proportion of I-degree and III-degree induration, the treated group has significant statistical difference compared with the other 3 groups, and P is less than 0.05. The observation groups 1, 2 and 3 have no significant statistical difference in the incidence of induration in various degrees, and P is more than 0.05. It can thus be shown that significant induration treatment was only achieved with the specific formulation (example 1), and that the treatment was not different from that of the general hot compress and was almost non-therapeutic when the formulation was changed.

Table 2 comparison of VAS scores, pain resolution time, induration area, early fluid production rates for each group

Wherein denotes p < 0.05.

It can be seen that there were significant statistical differences between the treatment group and observation 1, observation 2, and observation 3 groups, with P <0.05, in terms of VAS score, pain resolution time, and induration area. There were no significant statistical differences between the 3 observed groups, P > 0.05. In the aspect of early abortion rate, no obvious statistical difference exists among 4 groups, and P is greater than 0.05, which shows that the traditional Chinese medicine composition in the embodiment has extremely high safety and does not have obvious side effect.

In conclusion, the traditional Chinese medicine composition in the embodiment can effectively relieve pain caused by hip injection, remarkably reduce large-range induration caused by intramuscular injection of progesterone, and has a curative effect obviously superior to that of a control group. Moreover, it can be found that the traditional Chinese medicine package prepared by optionally adjusting the addition and subtraction of the medicinal flavor on the basis of the traditional Chinese medicine composition in the embodiment is not good in the curative effect of treating induration caused by intramuscular injection of progesterone.

The above embodiments are preferred embodiments of the present invention, but the present invention is not limited to the above embodiments, and any other changes, modifications, substitutions, combinations, and simplifications which do not depart from the spirit and principle of the present invention should be construed as equivalents thereof, and all such changes, modifications, substitutions, combinations, and simplifications are intended to be included in the scope of the present invention.