2. English reference ointment [Chinese medicine terminology Committee]. Terminology of Traditional Chinese Medicine (2004)]
Ointment [Xiangya Medical Dictionary]
3 Chinese medicine ointment (ointment [1]) is a Chinese medicine dosage form [2]. It refers to a semi-solid preparation for external use [1][2] made by mixing drugs, fine powder of medicinal materials and extracts of medicinal materials with a suitable matrix.
Western medicine ointment refers to a uniform semi-solid external preparation made by mixing drugs with oily or water-soluble matrix [3]. Because of the different dispersion States of drugs in the matrix, there are solution ointment and suspension ointment. Solution ointment is an ointment made by dissolving (or melting) drugs in matrix or matrix components; Suspension ointment is an ointment made by uniformly dispersing drug fine powder in the matrix.
The main functions of ointment are protecting, moistening skin, preventing cracking, softening and resolving hard mass, sterilizing, relieving itching and removing scars.
4. 1 ointment commonly used substrates ointment substrates can be divided into oily substrates and water-soluble substrates. Commonly used oily substrates include vaseline, paraffin, liquid paraffin, silicone oil, beeswax, stearic acid, lanolin and so on. The water-soluble matrix mainly includes polyethylene glycol [3].
4.2 Indication ointment is suitable for:
1. All chronic dermatoses have scabs, chapped skin, lichenoid transformation, nodules, scales, keloids, spots and other lesions.
2. The skin is dry and itchy.
3. Used for beauty care.
4.3 Contraindications Generally, there are no special contraindications.
Preparation of 4.4 1. Preparation of commonly used drugs: indigo naturalis ointment, essential balm and 3% ~ 5% sulfur ointment.
2. Preparation method: Chinese medicine powder or Chinese medicine extract crushed to more than 200 meshes is mixed with an appropriate matrix to make a uniform and delicate semi-solid paste. Commonly used substrates are oily substrates, emulsion substrates and water-soluble substrates, or honey and beeswax.
4.5 Usage of ointment 1. Apply Bo Tu directly to the skin injury. If the rash is thick, tap and prick the needle with plum blossom needle 2 ~ 3 times a day before smearing. Beauty care, 1 or twice a day.
2. Apply it to gauze and apply it to the affected area. 1 or twice a day.
3. Ultrasonic drug introduction method uses ointment as coupling agent and introduces drugs through ultrasonic wave. See chapter 18 "Ultrasonic Beauty Technology" in physical cosmetology's Operating Specification for Therapeutic Technology.
4.6 Note: 1. Apply it thicker when removing scars.
2. When used for chapped and lichenoid lesions, it is best to blow dry with a hair dryer.
3. Ointment should not be used for skin lesions with more exudation and serious erosion.
4. For ultrasonic importers, please refer to the precautions of "Ultrasonic Beauty Technology".
4.7 Quality requirements of ointment 4.7. 1 The production and storage of ointment shall meet the following requirements in the process of production and storage [3].
First, the choice of ointment matrix should be based on the characteristics of dosage form, drug properties, preparation efficacy, product stability and other factors. Matrices can also be composed of different types of matrices.
Ointment matrix can be divided into oily matrix and water-soluble matrix. Commonly used oily substrates include vaseline, paraffin, liquid paraffin, silicone oil, beeswax, stearic acid, lanolin and so on. The water-soluble matrix mainly includes polyethylene glycol. Emulsifiers commonly used in cream can be divided into oil-in-water type and water-in-oil type. The oil-in-water emulsifier includes sodium soap, triethanolamine soap, fatty alcohol sodium sulfate (sodium dodecyl sulfate) and polysorbate; Water-in-oil emulsifier includes calcium soap, lanolin, monoglyceride, fatty alcohol, etc.
Second, the matrix of the ointment should be uniform and delicate, and there should be no * * * feeling when applied to the skin or mucosa. Insoluble solid drugs in suspension ointment and solid components in ointment should be ground into fine powder by appropriate methods in advance to ensure that the particle size meets the requirements.
3. Moisturizers, preservatives, thickeners, antioxidants and transdermal enhancers can be added to the ointment as needed.
Fourth, the ointment should have an appropriate viscosity, and the consistency of the paste is generally large. However, it should be easily applied to the skin or mucous membrane, not melting, and the viscosity should change little with the seasons.
Five, ointment should be free of rancidity, odor, discoloration, hardening, paste can not have oil-water separation, flatulence phenomenon.
Six, unless otherwise specified, ointment should be kept in a closed place away from light.
4.7.2 Quality inspection Unless otherwise specified, the ointment shall be inspected according to the following methods [3].
Unless otherwise specified, the suspension ointment should be coated with an appropriate amount of test samples, with a thin layer area equivalent to the cover glass area, and coated with 3 pieces. According to the particle size and particle size distribution determination method (the first method in Appendix ⅸ E of Pharmacopoeia II, 20 10), no particles larger than 180μm can be detected.
Quantity? According to the minimum drug loading test method (20 10 version of Pharmacopoeia, Part II, Appendix X F), the inspection shall comply with the regulations.
Sterile ointment used for burns or serious wounds shall be inspected according to the aseptic inspection method (Appendix VII H of Pharmacopoeia Part II, 20 10) and shall conform to the regulations.